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FDA approves first treatment for neuromyelitis optica spectrum disorder
Soliris, a complement inhibitor, is the first FDA-approved treatment for NMOSD, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, according to a news release.
About 73% of patients with NMOSD test positive for anti-AQP4 antibodies, and complement activation resulting from anti-AQP4 antibodies is an underlying cause of the disease, according to the news release from Alexion, the company that markets the drug. The average age of NMOSD onset is 39 years, and the disease can lead to permanent visual impairment and paralysis. The condition, previously known as Devic’s disease, may affect between 4,000 and 8,000 people in the United States. NMOSD may be confused with other neurologic conditions such as multiple sclerosis.
Investigators studied the drug’s effectiveness in a placebo-controlled clinical trial of 143 patients with NMOSD who had anti-AQP4 antibodies. Compared with placebo, Soliris reduced the number of NMOSD relapses by 94% during the 48-week study. Nearly 98% of patients in the PREVENT trial who received Soliris were relapse-free after 48 weeks, compared with 63% of patients who received placebo.
Soliris also reduced hospitalizations and the need for corticosteroids and plasma exchange to treat acute attacks.
Soliris includes a boxed warning about life-threatening and fatal meningococcal infections that have occurred in patients treated with Soliris. Patients should be monitored and evaluated immediately if infection is suspected, according to the FDA announcement. In addition, health care professionals should use caution when administering Soliris to patients with any other infection. No cases of meningococcal infection were observed in the PREVENT trial.
Soliris is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must counsel patients about the risk of meningococcal infection and ensure that patients have been vaccinated with meningococcal vaccines.
Adverse reactions in the NMOSD clinical trial included upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and confusion.
The drug’s use for NMOSD received Orphan Drug designation, which provides incentives for the development of drugs for rare diseases.
Eculizumab first was approved by the FDA in 2007 and also may be used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and myasthenia gravis.
Soliris, a complement inhibitor, is the first FDA-approved treatment for NMOSD, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, according to a news release.
About 73% of patients with NMOSD test positive for anti-AQP4 antibodies, and complement activation resulting from anti-AQP4 antibodies is an underlying cause of the disease, according to the news release from Alexion, the company that markets the drug. The average age of NMOSD onset is 39 years, and the disease can lead to permanent visual impairment and paralysis. The condition, previously known as Devic’s disease, may affect between 4,000 and 8,000 people in the United States. NMOSD may be confused with other neurologic conditions such as multiple sclerosis.
Investigators studied the drug’s effectiveness in a placebo-controlled clinical trial of 143 patients with NMOSD who had anti-AQP4 antibodies. Compared with placebo, Soliris reduced the number of NMOSD relapses by 94% during the 48-week study. Nearly 98% of patients in the PREVENT trial who received Soliris were relapse-free after 48 weeks, compared with 63% of patients who received placebo.
Soliris also reduced hospitalizations and the need for corticosteroids and plasma exchange to treat acute attacks.
Soliris includes a boxed warning about life-threatening and fatal meningococcal infections that have occurred in patients treated with Soliris. Patients should be monitored and evaluated immediately if infection is suspected, according to the FDA announcement. In addition, health care professionals should use caution when administering Soliris to patients with any other infection. No cases of meningococcal infection were observed in the PREVENT trial.
Soliris is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must counsel patients about the risk of meningococcal infection and ensure that patients have been vaccinated with meningococcal vaccines.
Adverse reactions in the NMOSD clinical trial included upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and confusion.
The drug’s use for NMOSD received Orphan Drug designation, which provides incentives for the development of drugs for rare diseases.
Eculizumab first was approved by the FDA in 2007 and also may be used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and myasthenia gravis.
Soliris, a complement inhibitor, is the first FDA-approved treatment for NMOSD, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, according to a news release.
About 73% of patients with NMOSD test positive for anti-AQP4 antibodies, and complement activation resulting from anti-AQP4 antibodies is an underlying cause of the disease, according to the news release from Alexion, the company that markets the drug. The average age of NMOSD onset is 39 years, and the disease can lead to permanent visual impairment and paralysis. The condition, previously known as Devic’s disease, may affect between 4,000 and 8,000 people in the United States. NMOSD may be confused with other neurologic conditions such as multiple sclerosis.
Investigators studied the drug’s effectiveness in a placebo-controlled clinical trial of 143 patients with NMOSD who had anti-AQP4 antibodies. Compared with placebo, Soliris reduced the number of NMOSD relapses by 94% during the 48-week study. Nearly 98% of patients in the PREVENT trial who received Soliris were relapse-free after 48 weeks, compared with 63% of patients who received placebo.
Soliris also reduced hospitalizations and the need for corticosteroids and plasma exchange to treat acute attacks.
Soliris includes a boxed warning about life-threatening and fatal meningococcal infections that have occurred in patients treated with Soliris. Patients should be monitored and evaluated immediately if infection is suspected, according to the FDA announcement. In addition, health care professionals should use caution when administering Soliris to patients with any other infection. No cases of meningococcal infection were observed in the PREVENT trial.
Soliris is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must counsel patients about the risk of meningococcal infection and ensure that patients have been vaccinated with meningococcal vaccines.
Adverse reactions in the NMOSD clinical trial included upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and confusion.
The drug’s use for NMOSD received Orphan Drug designation, which provides incentives for the development of drugs for rare diseases.
Eculizumab first was approved by the FDA in 2007 and also may be used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and myasthenia gravis.
Dr. Eve Espey: Some good news in her 2019 contraceptive update
NASHVILLE, TENN. – There’s some good news on the contraception and reproductive health front, according to a recent update from Eve Espey, MD.
The unintended pregnancy rate in the United States, including among adolescents and young women, is declining, and the U.S. abortion rate is at its lowest level since Roe v. Wade, she said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
A 2016 article based on 2008-2011 data showed that after hovering around 50% for nearly 3 decades, the unintended pregnancy rate dropped “for the first time in a very long period of time,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology, division of family planning at the University of New Mexico, Albuquerque (N Engl J Med. 2016; 374[9]:843-52).
“It doesn’t look that impressive – it basically went down to 45%, but considering the scope and the number of women who are affected by unplanned pregnancy, this is actually a huge public health achievement,” she said. “And I think ... in the next cycles of the [Center for Disease Control and Prevention’s] National Survey of Family Growth ... we’ll hopefully continue to see this and potentially more [decline].”
As for abortion rates, an increase occurred following Roe v. Wade, but rates are now down to pre-Roe levels.
“One of the things that we know about the abortion rate is that the most important determinant ... is access to contraceptives,” Dr. Espey said, noting that both the abortion and unintended pregnancy rate declines are attributable to better and more consistent use of contraceptives, increased abstinence as teens are waiting longer to have sex, and the “meteoric rise in long-acting reversible contraceptive (LARC) use.”
Importantly, while improvements in public health have traditionally only impacted upper-class white women, a reduction is finally occurring in disparities with women of color, but those disparities still remain,” she added. “Just like we’re focusing so much on this relative to maternal mortality, the same kinds of disparities occur in access to reproductive health.”
Dr. Espey also provided updates on other aspects of contraception.
IUDs and other LARC methods
The use of LARCs increased from 2% of contraceptive types used by reproductive-aged women in 2002 to 12% in 2012. The majority of that change was in IUD use, with a small increase in implant use, she said, noting that the latest data from the 2015-2017 cycle of the National Survey of Family Growth shows that the rate is now up to 16%.
“The rise has been nothing that I ever imagined that I would see, certainly in my professional career,” she said.
The huge impact of LARCs on the unintended pregnancy rate is attributable to consistent effectiveness over time, compared with an increasing failure rate over time with short-acting contraceptive methods, she said, explaining that while the failure rate with oral contraceptives is about 8%-9% over the first 3 years, it increases to 53% at 8 years.
It’s a matter of looking at both “typical use” effectiveness and continuation rates: LARCs have continuation rates of about 75%-85%; Depot-Provera, for example, has a 25%-30% continuation rate at 1 year, she noted.
Dr. Espey also attributed the gains to improved access via the Affordable Care Act’s contraceptive mandate, which has been shown in numerous studies to have improved access and consistency of contraceptive use, but which is “currently being chipped away,” and to the federal Title X program that covers family planning care for low income women, including undocumented women.
“These two programs have made a huge impact for us, and I hope that we as ob.gyns. will continue to support them,” she said.
Reproductive justice
Despite their effectiveness, it is important to remember that LARC methods are not right for everyone, Dr. Espey said.
“It’s not all about effectiveness. Women have many reasons for accessing contraception, and our job is not to reduce unintended pregnancy. ... The idea really is that we empower women. ... We should really give choices and trust women to make the best choices for them,” she explained.
Barriers to IUD removal also should be eliminated, she noted, explaining that a woman who wants her IUD removed a month after insertion should have that option.
She said she has “changed her language,” from asking why a woman wants an $800 IUD removed after a month to asking whether she would like to hear about ways to make it better or if she is “just ready to have it removed.”
For those not interested in a discussion about birth control, she suggested providing information about the bedsider.org site.
“This is a great resource for patients,” she said, noting that it is available in both English and Spanish.
U.S. Medical Eligibility Criteria and Selected Practice Recommendations on contraceptive use
The MEC contraceptive guidance, a regularly updated, evidence-based project of the CDC, provides “best practices” information on candidate selection, or the “who” of contraceptive selection (who is a candidate for a particular method), Dr. Espy said, noting that it’s a “handy resource” for in-office use.
The SPR is more of a “how-to” guide that provides specifics on contraceptive use, such as when a woman can rely on the pill for contraception after she starts taking it, or how a woman should be followed after IUD placement, she said.
A free CDC app provides access to both.
Emergency contraception
The best overall emergency contraceptive method is the copper IUD, but often it is less accessible than oral methods, of which ulipristal acetate (ella), is the best choice, Dr. Espy said.
“Ulipristal is kind of a best-kept secret. It’s a selective estrogen-receptor modulator – it actually works better and longer than Plan B (levonorgestrel). What’s great about Plan B is that you can get it over the counter, but ulipristal delays ovulation longer,” she explained.
Contraceptives and obesity
Oral contraceptive efficacy is “so much more about adherence,” than about weight, she said.
With respect to the contraceptive patch, limited evidence suggests that obesity may reduce effectiveness, but “it’s still way better than barrier methods,” and for the contraceptive ring, no evidence suggests that obesity affects efficacy, she said.
For emergency contraception, evidence suggests that ulipristal is more effective than Plan B in women with high body mass index.
OTC contraceptive access
Pharmacy and OTC access are a good idea, Dr. Espy said.
“ACOG now supports both, which is great, and there are now a number of states where women can access contraception through the pharmacy. There are a lot of barriers there as well, and really the answer is OTC access,” she said. “There is a pill right now that is seeking [Food and Drug Administration] approval; it will be a progestin-only pill – the first one to be available over the counter, so I think this is something that we’ll see in the next 5-10 years.”
Additional future directions
One technology in development is a longer-acting injectable, such as a 6- or 9-month Depot-type shot.
Biodegradable implants also are in development. “What a cool idea – it just disappears in your arm, no need to remove it,” Dr. Espey said, adding that nonsurgical permanent sterilization is another possible advance, which would be “a holy grail.”
As for male contraception?
“I’ve been saying for about 25 years that in 5 years we’ll have a male contraceptive, so I’m not going to say it anymore with any kind of time frame, but it’s possible,” she said.
Dr. Espey reported having no financial disclosures.
NASHVILLE, TENN. – There’s some good news on the contraception and reproductive health front, according to a recent update from Eve Espey, MD.
The unintended pregnancy rate in the United States, including among adolescents and young women, is declining, and the U.S. abortion rate is at its lowest level since Roe v. Wade, she said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
A 2016 article based on 2008-2011 data showed that after hovering around 50% for nearly 3 decades, the unintended pregnancy rate dropped “for the first time in a very long period of time,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology, division of family planning at the University of New Mexico, Albuquerque (N Engl J Med. 2016; 374[9]:843-52).
“It doesn’t look that impressive – it basically went down to 45%, but considering the scope and the number of women who are affected by unplanned pregnancy, this is actually a huge public health achievement,” she said. “And I think ... in the next cycles of the [Center for Disease Control and Prevention’s] National Survey of Family Growth ... we’ll hopefully continue to see this and potentially more [decline].”
As for abortion rates, an increase occurred following Roe v. Wade, but rates are now down to pre-Roe levels.
“One of the things that we know about the abortion rate is that the most important determinant ... is access to contraceptives,” Dr. Espey said, noting that both the abortion and unintended pregnancy rate declines are attributable to better and more consistent use of contraceptives, increased abstinence as teens are waiting longer to have sex, and the “meteoric rise in long-acting reversible contraceptive (LARC) use.”
Importantly, while improvements in public health have traditionally only impacted upper-class white women, a reduction is finally occurring in disparities with women of color, but those disparities still remain,” she added. “Just like we’re focusing so much on this relative to maternal mortality, the same kinds of disparities occur in access to reproductive health.”
Dr. Espey also provided updates on other aspects of contraception.
IUDs and other LARC methods
The use of LARCs increased from 2% of contraceptive types used by reproductive-aged women in 2002 to 12% in 2012. The majority of that change was in IUD use, with a small increase in implant use, she said, noting that the latest data from the 2015-2017 cycle of the National Survey of Family Growth shows that the rate is now up to 16%.
“The rise has been nothing that I ever imagined that I would see, certainly in my professional career,” she said.
The huge impact of LARCs on the unintended pregnancy rate is attributable to consistent effectiveness over time, compared with an increasing failure rate over time with short-acting contraceptive methods, she said, explaining that while the failure rate with oral contraceptives is about 8%-9% over the first 3 years, it increases to 53% at 8 years.
It’s a matter of looking at both “typical use” effectiveness and continuation rates: LARCs have continuation rates of about 75%-85%; Depot-Provera, for example, has a 25%-30% continuation rate at 1 year, she noted.
Dr. Espey also attributed the gains to improved access via the Affordable Care Act’s contraceptive mandate, which has been shown in numerous studies to have improved access and consistency of contraceptive use, but which is “currently being chipped away,” and to the federal Title X program that covers family planning care for low income women, including undocumented women.
“These two programs have made a huge impact for us, and I hope that we as ob.gyns. will continue to support them,” she said.
Reproductive justice
Despite their effectiveness, it is important to remember that LARC methods are not right for everyone, Dr. Espey said.
“It’s not all about effectiveness. Women have many reasons for accessing contraception, and our job is not to reduce unintended pregnancy. ... The idea really is that we empower women. ... We should really give choices and trust women to make the best choices for them,” she explained.
Barriers to IUD removal also should be eliminated, she noted, explaining that a woman who wants her IUD removed a month after insertion should have that option.
She said she has “changed her language,” from asking why a woman wants an $800 IUD removed after a month to asking whether she would like to hear about ways to make it better or if she is “just ready to have it removed.”
For those not interested in a discussion about birth control, she suggested providing information about the bedsider.org site.
“This is a great resource for patients,” she said, noting that it is available in both English and Spanish.
U.S. Medical Eligibility Criteria and Selected Practice Recommendations on contraceptive use
The MEC contraceptive guidance, a regularly updated, evidence-based project of the CDC, provides “best practices” information on candidate selection, or the “who” of contraceptive selection (who is a candidate for a particular method), Dr. Espy said, noting that it’s a “handy resource” for in-office use.
The SPR is more of a “how-to” guide that provides specifics on contraceptive use, such as when a woman can rely on the pill for contraception after she starts taking it, or how a woman should be followed after IUD placement, she said.
A free CDC app provides access to both.
Emergency contraception
The best overall emergency contraceptive method is the copper IUD, but often it is less accessible than oral methods, of which ulipristal acetate (ella), is the best choice, Dr. Espy said.
“Ulipristal is kind of a best-kept secret. It’s a selective estrogen-receptor modulator – it actually works better and longer than Plan B (levonorgestrel). What’s great about Plan B is that you can get it over the counter, but ulipristal delays ovulation longer,” she explained.
Contraceptives and obesity
Oral contraceptive efficacy is “so much more about adherence,” than about weight, she said.
With respect to the contraceptive patch, limited evidence suggests that obesity may reduce effectiveness, but “it’s still way better than barrier methods,” and for the contraceptive ring, no evidence suggests that obesity affects efficacy, she said.
For emergency contraception, evidence suggests that ulipristal is more effective than Plan B in women with high body mass index.
OTC contraceptive access
Pharmacy and OTC access are a good idea, Dr. Espy said.
“ACOG now supports both, which is great, and there are now a number of states where women can access contraception through the pharmacy. There are a lot of barriers there as well, and really the answer is OTC access,” she said. “There is a pill right now that is seeking [Food and Drug Administration] approval; it will be a progestin-only pill – the first one to be available over the counter, so I think this is something that we’ll see in the next 5-10 years.”
Additional future directions
One technology in development is a longer-acting injectable, such as a 6- or 9-month Depot-type shot.
Biodegradable implants also are in development. “What a cool idea – it just disappears in your arm, no need to remove it,” Dr. Espey said, adding that nonsurgical permanent sterilization is another possible advance, which would be “a holy grail.”
As for male contraception?
“I’ve been saying for about 25 years that in 5 years we’ll have a male contraceptive, so I’m not going to say it anymore with any kind of time frame, but it’s possible,” she said.
Dr. Espey reported having no financial disclosures.
NASHVILLE, TENN. – There’s some good news on the contraception and reproductive health front, according to a recent update from Eve Espey, MD.
The unintended pregnancy rate in the United States, including among adolescents and young women, is declining, and the U.S. abortion rate is at its lowest level since Roe v. Wade, she said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
A 2016 article based on 2008-2011 data showed that after hovering around 50% for nearly 3 decades, the unintended pregnancy rate dropped “for the first time in a very long period of time,” said Dr. Espey, professor and chair of the department of obstetrics & gynecology, division of family planning at the University of New Mexico, Albuquerque (N Engl J Med. 2016; 374[9]:843-52).
“It doesn’t look that impressive – it basically went down to 45%, but considering the scope and the number of women who are affected by unplanned pregnancy, this is actually a huge public health achievement,” she said. “And I think ... in the next cycles of the [Center for Disease Control and Prevention’s] National Survey of Family Growth ... we’ll hopefully continue to see this and potentially more [decline].”
As for abortion rates, an increase occurred following Roe v. Wade, but rates are now down to pre-Roe levels.
“One of the things that we know about the abortion rate is that the most important determinant ... is access to contraceptives,” Dr. Espey said, noting that both the abortion and unintended pregnancy rate declines are attributable to better and more consistent use of contraceptives, increased abstinence as teens are waiting longer to have sex, and the “meteoric rise in long-acting reversible contraceptive (LARC) use.”
Importantly, while improvements in public health have traditionally only impacted upper-class white women, a reduction is finally occurring in disparities with women of color, but those disparities still remain,” she added. “Just like we’re focusing so much on this relative to maternal mortality, the same kinds of disparities occur in access to reproductive health.”
Dr. Espey also provided updates on other aspects of contraception.
IUDs and other LARC methods
The use of LARCs increased from 2% of contraceptive types used by reproductive-aged women in 2002 to 12% in 2012. The majority of that change was in IUD use, with a small increase in implant use, she said, noting that the latest data from the 2015-2017 cycle of the National Survey of Family Growth shows that the rate is now up to 16%.
“The rise has been nothing that I ever imagined that I would see, certainly in my professional career,” she said.
The huge impact of LARCs on the unintended pregnancy rate is attributable to consistent effectiveness over time, compared with an increasing failure rate over time with short-acting contraceptive methods, she said, explaining that while the failure rate with oral contraceptives is about 8%-9% over the first 3 years, it increases to 53% at 8 years.
It’s a matter of looking at both “typical use” effectiveness and continuation rates: LARCs have continuation rates of about 75%-85%; Depot-Provera, for example, has a 25%-30% continuation rate at 1 year, she noted.
Dr. Espey also attributed the gains to improved access via the Affordable Care Act’s contraceptive mandate, which has been shown in numerous studies to have improved access and consistency of contraceptive use, but which is “currently being chipped away,” and to the federal Title X program that covers family planning care for low income women, including undocumented women.
“These two programs have made a huge impact for us, and I hope that we as ob.gyns. will continue to support them,” she said.
Reproductive justice
Despite their effectiveness, it is important to remember that LARC methods are not right for everyone, Dr. Espey said.
“It’s not all about effectiveness. Women have many reasons for accessing contraception, and our job is not to reduce unintended pregnancy. ... The idea really is that we empower women. ... We should really give choices and trust women to make the best choices for them,” she explained.
Barriers to IUD removal also should be eliminated, she noted, explaining that a woman who wants her IUD removed a month after insertion should have that option.
She said she has “changed her language,” from asking why a woman wants an $800 IUD removed after a month to asking whether she would like to hear about ways to make it better or if she is “just ready to have it removed.”
For those not interested in a discussion about birth control, she suggested providing information about the bedsider.org site.
“This is a great resource for patients,” she said, noting that it is available in both English and Spanish.
U.S. Medical Eligibility Criteria and Selected Practice Recommendations on contraceptive use
The MEC contraceptive guidance, a regularly updated, evidence-based project of the CDC, provides “best practices” information on candidate selection, or the “who” of contraceptive selection (who is a candidate for a particular method), Dr. Espy said, noting that it’s a “handy resource” for in-office use.
The SPR is more of a “how-to” guide that provides specifics on contraceptive use, such as when a woman can rely on the pill for contraception after she starts taking it, or how a woman should be followed after IUD placement, she said.
A free CDC app provides access to both.
Emergency contraception
The best overall emergency contraceptive method is the copper IUD, but often it is less accessible than oral methods, of which ulipristal acetate (ella), is the best choice, Dr. Espy said.
“Ulipristal is kind of a best-kept secret. It’s a selective estrogen-receptor modulator – it actually works better and longer than Plan B (levonorgestrel). What’s great about Plan B is that you can get it over the counter, but ulipristal delays ovulation longer,” she explained.
Contraceptives and obesity
Oral contraceptive efficacy is “so much more about adherence,” than about weight, she said.
With respect to the contraceptive patch, limited evidence suggests that obesity may reduce effectiveness, but “it’s still way better than barrier methods,” and for the contraceptive ring, no evidence suggests that obesity affects efficacy, she said.
For emergency contraception, evidence suggests that ulipristal is more effective than Plan B in women with high body mass index.
OTC contraceptive access
Pharmacy and OTC access are a good idea, Dr. Espy said.
“ACOG now supports both, which is great, and there are now a number of states where women can access contraception through the pharmacy. There are a lot of barriers there as well, and really the answer is OTC access,” she said. “There is a pill right now that is seeking [Food and Drug Administration] approval; it will be a progestin-only pill – the first one to be available over the counter, so I think this is something that we’ll see in the next 5-10 years.”
Additional future directions
One technology in development is a longer-acting injectable, such as a 6- or 9-month Depot-type shot.
Biodegradable implants also are in development. “What a cool idea – it just disappears in your arm, no need to remove it,” Dr. Espey said, adding that nonsurgical permanent sterilization is another possible advance, which would be “a holy grail.”
As for male contraception?
“I’ve been saying for about 25 years that in 5 years we’ll have a male contraceptive, so I’m not going to say it anymore with any kind of time frame, but it’s possible,” she said.
Dr. Espey reported having no financial disclosures.
EXPERT ANALYSIS FROM ACOG 2019
FDA expands Doptelet approval to ITP patients with thrombocytopenia
The Food and Drug Administration has approved a supplemental New Drug Application expanding the indication of avatrombopag (Doptelet) to include treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous therapy, according to Dova Pharmaceuticals.
FDA approval was based on results of a phase 3 trial in which a majority of patients who received avatrombopag achieved a platelet count of at least 50,000 per mcg after 8 days of therapy. In addition, efficacy was superior to patients in the placebo group in the maintenance of platelet counts during the 6-month treatment period.
Avatrombopag – an oral, thrombopoietin receptor agonist administered with food – was previously indicated for the treatment of chronic liver disease in adult patients who are scheduled to undergo a procedure. The most common adverse reactions in patients with ITP include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Find the full press release on the Dova Pharmaceuticals website.
The Food and Drug Administration has approved a supplemental New Drug Application expanding the indication of avatrombopag (Doptelet) to include treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous therapy, according to Dova Pharmaceuticals.
FDA approval was based on results of a phase 3 trial in which a majority of patients who received avatrombopag achieved a platelet count of at least 50,000 per mcg after 8 days of therapy. In addition, efficacy was superior to patients in the placebo group in the maintenance of platelet counts during the 6-month treatment period.
Avatrombopag – an oral, thrombopoietin receptor agonist administered with food – was previously indicated for the treatment of chronic liver disease in adult patients who are scheduled to undergo a procedure. The most common adverse reactions in patients with ITP include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Find the full press release on the Dova Pharmaceuticals website.
The Food and Drug Administration has approved a supplemental New Drug Application expanding the indication of avatrombopag (Doptelet) to include treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous therapy, according to Dova Pharmaceuticals.
FDA approval was based on results of a phase 3 trial in which a majority of patients who received avatrombopag achieved a platelet count of at least 50,000 per mcg after 8 days of therapy. In addition, efficacy was superior to patients in the placebo group in the maintenance of platelet counts during the 6-month treatment period.
Avatrombopag – an oral, thrombopoietin receptor agonist administered with food – was previously indicated for the treatment of chronic liver disease in adult patients who are scheduled to undergo a procedure. The most common adverse reactions in patients with ITP include headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Find the full press release on the Dova Pharmaceuticals website.
JAK inhibitors are the ‘near future’ of alopecia areata treatment
MILAN – Janus kinase (JAK) inhibitors have clear science supporting their use in alopecia areata, and an increasing number of positive studies demonstrate their efficacy in regrowing hair, Brett King, MD, PhD, said at the World Congress of Dermatology.
Although not yet specifically approved for , said Dr. King, associate professor of dermatology at Yale University, New Haven, Conn.
“JAK inhibitors are very much within our reach for the treatment of severe alopecia areata,” Dr. King said in an oral presentation on therapeutic advances for alopecia. “We need to follow the science,” he added. “We would not be here telling a story about JAK inhibitors and these other agents without very bright scientists, so we really have to applaud the people who made this the focus of their research.”
JAK science
The science supporting JAK inhibitors can be traced back to a 2014 report by Angela M. Christiano, PhD,, Raphael Clynes, of Columbia University, New York, and others showing that alopecia areata is driven by cytotoxic T lymphocytes, and is reversed by inhibition of the JAK/STAT pathway in mouse models of disease (Nat Med. 2014 Sep;20[9]:1043-9). Those investigators also reported near-complete regrowth of hair in three patients who received oral ruxolitinib, an inhibitor of JAK1 and JAK2, hinting at the potential clinical importance of this targeted approach.
As Dr. King explained, secretion of interleukin (IL)-15 from the hair follicle endothelial cell activates CD8+NKG2D+ T cells leading to secretion of interferon (IFN)-gamma, which has a receptor on the hair follicle epithelial cell, activating that cell to secrete more IL-15.
“IL-15 and IFN-gamma both signal through the JAK/STAT pathway,” he said. “There are over 50 cytokines that signal through the JAK/STAT pathway, including IFN-gamma and IL-15, and on binding their receptor at the cell surface, they pass the baton, if you will, to the JAK enzymes, of which there are 4 members – JAK1, 2, 3 and tyrosine kinase 2. These enzymes subsequently pass the baton to STAT, and STAT translocates to the nucleus, where transcription occurs and disease happens. So we have an opportunity then with a small molecule JAK inhibitor to mediate disease, such that if we give this person a JAK inhibitor, they should regrow hair.”
JAK data
A number of studies of JAK inhibitors support that science, including an open-label study of 66 patients treated with the JAK1/3 inhibitor tofacitinib twice daily (JCI Insight. 2016 Sep 22;1[15]:e89776). About one-third experienced a 50% or greater improvement from baseline, as measured by the severity of alopecia tool (SALT) score over 3 months of treatment, with adverse events limited to grade 1-2 infections, according to the authors, which included Dr. King.
Around the same time, results of an open-label study with ruxolitinib, a JAK1/2 inhibitor, were published showing that 9 of 12 patients had complete or near complete scalp hair regrowth over 6 months of treatment, he said.
In a subsequent retrospective study of 90 patients treated with tofacitinib, about 66%-70% of patients experienced regrowth of hair, depending on the dose received. However, that study also showed that hair regrowth was unlikely in patients with complete or near complete scalp hair loss for 10 years or more, Dr. King said. An additional study showed that tofacitinib may be effective in adolescents as in adults, or even more effective, he added, while another found that low-dose ruxolitinib was as effective as higher dose ruxolitinib for the treatment of severe alopecia areata.
News earlier in 2019 surrounded the results of two randomized, double-blind placebo controlled trials, reported at the annual American Academy of Dermatology meeting in Washington, DC, showing efficacy for investigational oral JAK-targeted agents, a JAK 1/2 inhibitor (CTP-543), and a TYK2/JAK1 inhibitor (PF-06700841) and a JAK3 inhibitor (PF-06651600).
“I think this really is the near future of alopecia areata treatment,” Dr. King said.
No success yet for topical JAKs
One area where JAK inhibitors have not shined yet is in topical formulations. In a pilot study of tofacitinib 2% ointment, only 1 of 10 patients had significant scalp hair growth, while a study of topical ruxolitinib was stopped early and results have not yet been reported, according to Dr. King. “As dermatologists, we’re always interested in topical therapy for skin disease, but I’m not sure that alopecia areata is a disease for which topical JAK inhibitors will be effective,” he said.
Dr. King reported disclosures related to Aclaris Therapeutics, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly, Pfizer, Regeneron, and Sanofi Genzyme.
MILAN – Janus kinase (JAK) inhibitors have clear science supporting their use in alopecia areata, and an increasing number of positive studies demonstrate their efficacy in regrowing hair, Brett King, MD, PhD, said at the World Congress of Dermatology.
Although not yet specifically approved for , said Dr. King, associate professor of dermatology at Yale University, New Haven, Conn.
“JAK inhibitors are very much within our reach for the treatment of severe alopecia areata,” Dr. King said in an oral presentation on therapeutic advances for alopecia. “We need to follow the science,” he added. “We would not be here telling a story about JAK inhibitors and these other agents without very bright scientists, so we really have to applaud the people who made this the focus of their research.”
JAK science
The science supporting JAK inhibitors can be traced back to a 2014 report by Angela M. Christiano, PhD,, Raphael Clynes, of Columbia University, New York, and others showing that alopecia areata is driven by cytotoxic T lymphocytes, and is reversed by inhibition of the JAK/STAT pathway in mouse models of disease (Nat Med. 2014 Sep;20[9]:1043-9). Those investigators also reported near-complete regrowth of hair in three patients who received oral ruxolitinib, an inhibitor of JAK1 and JAK2, hinting at the potential clinical importance of this targeted approach.
As Dr. King explained, secretion of interleukin (IL)-15 from the hair follicle endothelial cell activates CD8+NKG2D+ T cells leading to secretion of interferon (IFN)-gamma, which has a receptor on the hair follicle epithelial cell, activating that cell to secrete more IL-15.
“IL-15 and IFN-gamma both signal through the JAK/STAT pathway,” he said. “There are over 50 cytokines that signal through the JAK/STAT pathway, including IFN-gamma and IL-15, and on binding their receptor at the cell surface, they pass the baton, if you will, to the JAK enzymes, of which there are 4 members – JAK1, 2, 3 and tyrosine kinase 2. These enzymes subsequently pass the baton to STAT, and STAT translocates to the nucleus, where transcription occurs and disease happens. So we have an opportunity then with a small molecule JAK inhibitor to mediate disease, such that if we give this person a JAK inhibitor, they should regrow hair.”
JAK data
A number of studies of JAK inhibitors support that science, including an open-label study of 66 patients treated with the JAK1/3 inhibitor tofacitinib twice daily (JCI Insight. 2016 Sep 22;1[15]:e89776). About one-third experienced a 50% or greater improvement from baseline, as measured by the severity of alopecia tool (SALT) score over 3 months of treatment, with adverse events limited to grade 1-2 infections, according to the authors, which included Dr. King.
Around the same time, results of an open-label study with ruxolitinib, a JAK1/2 inhibitor, were published showing that 9 of 12 patients had complete or near complete scalp hair regrowth over 6 months of treatment, he said.
In a subsequent retrospective study of 90 patients treated with tofacitinib, about 66%-70% of patients experienced regrowth of hair, depending on the dose received. However, that study also showed that hair regrowth was unlikely in patients with complete or near complete scalp hair loss for 10 years or more, Dr. King said. An additional study showed that tofacitinib may be effective in adolescents as in adults, or even more effective, he added, while another found that low-dose ruxolitinib was as effective as higher dose ruxolitinib for the treatment of severe alopecia areata.
News earlier in 2019 surrounded the results of two randomized, double-blind placebo controlled trials, reported at the annual American Academy of Dermatology meeting in Washington, DC, showing efficacy for investigational oral JAK-targeted agents, a JAK 1/2 inhibitor (CTP-543), and a TYK2/JAK1 inhibitor (PF-06700841) and a JAK3 inhibitor (PF-06651600).
“I think this really is the near future of alopecia areata treatment,” Dr. King said.
No success yet for topical JAKs
One area where JAK inhibitors have not shined yet is in topical formulations. In a pilot study of tofacitinib 2% ointment, only 1 of 10 patients had significant scalp hair growth, while a study of topical ruxolitinib was stopped early and results have not yet been reported, according to Dr. King. “As dermatologists, we’re always interested in topical therapy for skin disease, but I’m not sure that alopecia areata is a disease for which topical JAK inhibitors will be effective,” he said.
Dr. King reported disclosures related to Aclaris Therapeutics, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly, Pfizer, Regeneron, and Sanofi Genzyme.
MILAN – Janus kinase (JAK) inhibitors have clear science supporting their use in alopecia areata, and an increasing number of positive studies demonstrate their efficacy in regrowing hair, Brett King, MD, PhD, said at the World Congress of Dermatology.
Although not yet specifically approved for , said Dr. King, associate professor of dermatology at Yale University, New Haven, Conn.
“JAK inhibitors are very much within our reach for the treatment of severe alopecia areata,” Dr. King said in an oral presentation on therapeutic advances for alopecia. “We need to follow the science,” he added. “We would not be here telling a story about JAK inhibitors and these other agents without very bright scientists, so we really have to applaud the people who made this the focus of their research.”
JAK science
The science supporting JAK inhibitors can be traced back to a 2014 report by Angela M. Christiano, PhD,, Raphael Clynes, of Columbia University, New York, and others showing that alopecia areata is driven by cytotoxic T lymphocytes, and is reversed by inhibition of the JAK/STAT pathway in mouse models of disease (Nat Med. 2014 Sep;20[9]:1043-9). Those investigators also reported near-complete regrowth of hair in three patients who received oral ruxolitinib, an inhibitor of JAK1 and JAK2, hinting at the potential clinical importance of this targeted approach.
As Dr. King explained, secretion of interleukin (IL)-15 from the hair follicle endothelial cell activates CD8+NKG2D+ T cells leading to secretion of interferon (IFN)-gamma, which has a receptor on the hair follicle epithelial cell, activating that cell to secrete more IL-15.
“IL-15 and IFN-gamma both signal through the JAK/STAT pathway,” he said. “There are over 50 cytokines that signal through the JAK/STAT pathway, including IFN-gamma and IL-15, and on binding their receptor at the cell surface, they pass the baton, if you will, to the JAK enzymes, of which there are 4 members – JAK1, 2, 3 and tyrosine kinase 2. These enzymes subsequently pass the baton to STAT, and STAT translocates to the nucleus, where transcription occurs and disease happens. So we have an opportunity then with a small molecule JAK inhibitor to mediate disease, such that if we give this person a JAK inhibitor, they should regrow hair.”
JAK data
A number of studies of JAK inhibitors support that science, including an open-label study of 66 patients treated with the JAK1/3 inhibitor tofacitinib twice daily (JCI Insight. 2016 Sep 22;1[15]:e89776). About one-third experienced a 50% or greater improvement from baseline, as measured by the severity of alopecia tool (SALT) score over 3 months of treatment, with adverse events limited to grade 1-2 infections, according to the authors, which included Dr. King.
Around the same time, results of an open-label study with ruxolitinib, a JAK1/2 inhibitor, were published showing that 9 of 12 patients had complete or near complete scalp hair regrowth over 6 months of treatment, he said.
In a subsequent retrospective study of 90 patients treated with tofacitinib, about 66%-70% of patients experienced regrowth of hair, depending on the dose received. However, that study also showed that hair regrowth was unlikely in patients with complete or near complete scalp hair loss for 10 years or more, Dr. King said. An additional study showed that tofacitinib may be effective in adolescents as in adults, or even more effective, he added, while another found that low-dose ruxolitinib was as effective as higher dose ruxolitinib for the treatment of severe alopecia areata.
News earlier in 2019 surrounded the results of two randomized, double-blind placebo controlled trials, reported at the annual American Academy of Dermatology meeting in Washington, DC, showing efficacy for investigational oral JAK-targeted agents, a JAK 1/2 inhibitor (CTP-543), and a TYK2/JAK1 inhibitor (PF-06700841) and a JAK3 inhibitor (PF-06651600).
“I think this really is the near future of alopecia areata treatment,” Dr. King said.
No success yet for topical JAKs
One area where JAK inhibitors have not shined yet is in topical formulations. In a pilot study of tofacitinib 2% ointment, only 1 of 10 patients had significant scalp hair growth, while a study of topical ruxolitinib was stopped early and results have not yet been reported, according to Dr. King. “As dermatologists, we’re always interested in topical therapy for skin disease, but I’m not sure that alopecia areata is a disease for which topical JAK inhibitors will be effective,” he said.
Dr. King reported disclosures related to Aclaris Therapeutics, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly, Pfizer, Regeneron, and Sanofi Genzyme.
EXPERT ANALYSIS FROM WCD2019
LARC prolongs interpregnancy intervals but doesn’t cut preterm birth risk
NASHVILLE, TENN. – when used between a first and second pregnancy, results of a retrospective cohort study suggest.
Of 35,754 women who had a first and second live birth between 2005 and 2015 and who received non-emergent care within 10 years of the first birth, 3,083 (9%) had evidence of interpregnancy LARC exposure and were significantly less likely to have short interpregnancy intervals than were 32,671 with either non-LARC contraceptive use or no record of contraceptive-related care (P less than .0001), Sara E. Simonsen, PhD, reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
Intervals in those with intrapartum LARC use were 12 months or less in 4% of women, 13-18 months in 8%, 19-24 months in 11%, and greater than 24 months in 13%.
However, preterm birth, which occurred in 7% of first births and 6% of second births, was not lower among those with LARC exposure vs. those with no contraceptive encounters after adjustment for interpregnancy interval and a number of demographic factors, including education, presence of father, mother’s age, Hispanic ethnicity, fetal anomalies, and preterm birth history (adjusted odds ratio, 1.13), said Dr. Simonsen, a certified nurse midwife at the University of Utah Hospital, Salt Lake City.
“Preterm birth, a live birth at less than 37 weeks’ gestation, is a major determinant of poor neonatal outcomes,” she and her colleagues wrote. “Short interpregnancy interval, defined as less than 18 months, is an important risk factor for preterm birth.”
Given the increasing number of U.S. women who use highly effective LARCs to space pregnancies, she and her colleagues performed a retrospective cohort study of electronic medical records from two large health systems and linked them with birth and fetal death records to explore the relationship between interpregnancy LARC and both interpregnancy interval and preterm birth in the subsequent pregnancy.
“We did find that women who used LARC between their pregnancies were less likely to have a short interpregnancy interval, but in adjusted models ... we found no association with intrapartum LARC use and preterm birth in the second birth,” Dr. Simonsen said during an e-poster presentation at the meeting.
In fact, preterm birth in the second birth was most strongly associated with a prior preterm birth – a finding consistent with the literature, she and her colleagues noted.
Although the findings are limited by the use of retrospective data not designed for research, the data came from a large population-based sample representing about 85% of Utah births, they said.
The findings suggest that while LARC use may not reduce preterm birth risk, it “may contribute favorably to outcomes to the extent that having optimal interpregnancy interval does,” they wrote.
“‘We feel that these findings support providers counseling women on the full range of contraception options in the postpartum and not pushing [intrauterine devices,]” Dr. Simonsen added.
The related topic of immediate postpartum LARC use was addressed by Eve Espey, MD, in a separate presentation at the meeting.
Dr .Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, reported that immediate postpartum insertion of an intrauterine device (IUD) is highly cost-effective despite an expulsion rate of between 10% and 30%. She also addressed the value of postpartum LARC for reducing rapid-repeat pregnancy rates.
Payment models for immediate postpartum LARC are “very cumbersome,” but at the university, a persistent effort over 4 years has led to success. Immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases, she said, adding that efforts are underway to help other hospitals “troubleshoot the issues.”
The lack of private insurance coverage for immediate postpartum LARC remains a challenge, but Dr. Espey said she remains “super enthusiastic” about its use.
“I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen,” she said, urging colleagues to advocate for that within their American College of Obstetricians and Gynecologists sections when possible.
Dr. Simonsen and Dr. Espey reported having no relevant disclosures.
NASHVILLE, TENN. – when used between a first and second pregnancy, results of a retrospective cohort study suggest.
Of 35,754 women who had a first and second live birth between 2005 and 2015 and who received non-emergent care within 10 years of the first birth, 3,083 (9%) had evidence of interpregnancy LARC exposure and were significantly less likely to have short interpregnancy intervals than were 32,671 with either non-LARC contraceptive use or no record of contraceptive-related care (P less than .0001), Sara E. Simonsen, PhD, reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
Intervals in those with intrapartum LARC use were 12 months or less in 4% of women, 13-18 months in 8%, 19-24 months in 11%, and greater than 24 months in 13%.
However, preterm birth, which occurred in 7% of first births and 6% of second births, was not lower among those with LARC exposure vs. those with no contraceptive encounters after adjustment for interpregnancy interval and a number of demographic factors, including education, presence of father, mother’s age, Hispanic ethnicity, fetal anomalies, and preterm birth history (adjusted odds ratio, 1.13), said Dr. Simonsen, a certified nurse midwife at the University of Utah Hospital, Salt Lake City.
“Preterm birth, a live birth at less than 37 weeks’ gestation, is a major determinant of poor neonatal outcomes,” she and her colleagues wrote. “Short interpregnancy interval, defined as less than 18 months, is an important risk factor for preterm birth.”
Given the increasing number of U.S. women who use highly effective LARCs to space pregnancies, she and her colleagues performed a retrospective cohort study of electronic medical records from two large health systems and linked them with birth and fetal death records to explore the relationship between interpregnancy LARC and both interpregnancy interval and preterm birth in the subsequent pregnancy.
“We did find that women who used LARC between their pregnancies were less likely to have a short interpregnancy interval, but in adjusted models ... we found no association with intrapartum LARC use and preterm birth in the second birth,” Dr. Simonsen said during an e-poster presentation at the meeting.
In fact, preterm birth in the second birth was most strongly associated with a prior preterm birth – a finding consistent with the literature, she and her colleagues noted.
Although the findings are limited by the use of retrospective data not designed for research, the data came from a large population-based sample representing about 85% of Utah births, they said.
The findings suggest that while LARC use may not reduce preterm birth risk, it “may contribute favorably to outcomes to the extent that having optimal interpregnancy interval does,” they wrote.
“‘We feel that these findings support providers counseling women on the full range of contraception options in the postpartum and not pushing [intrauterine devices,]” Dr. Simonsen added.
The related topic of immediate postpartum LARC use was addressed by Eve Espey, MD, in a separate presentation at the meeting.
Dr .Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, reported that immediate postpartum insertion of an intrauterine device (IUD) is highly cost-effective despite an expulsion rate of between 10% and 30%. She also addressed the value of postpartum LARC for reducing rapid-repeat pregnancy rates.
Payment models for immediate postpartum LARC are “very cumbersome,” but at the university, a persistent effort over 4 years has led to success. Immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases, she said, adding that efforts are underway to help other hospitals “troubleshoot the issues.”
The lack of private insurance coverage for immediate postpartum LARC remains a challenge, but Dr. Espey said she remains “super enthusiastic” about its use.
“I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen,” she said, urging colleagues to advocate for that within their American College of Obstetricians and Gynecologists sections when possible.
Dr. Simonsen and Dr. Espey reported having no relevant disclosures.
NASHVILLE, TENN. – when used between a first and second pregnancy, results of a retrospective cohort study suggest.
Of 35,754 women who had a first and second live birth between 2005 and 2015 and who received non-emergent care within 10 years of the first birth, 3,083 (9%) had evidence of interpregnancy LARC exposure and were significantly less likely to have short interpregnancy intervals than were 32,671 with either non-LARC contraceptive use or no record of contraceptive-related care (P less than .0001), Sara E. Simonsen, PhD, reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.
Intervals in those with intrapartum LARC use were 12 months or less in 4% of women, 13-18 months in 8%, 19-24 months in 11%, and greater than 24 months in 13%.
However, preterm birth, which occurred in 7% of first births and 6% of second births, was not lower among those with LARC exposure vs. those with no contraceptive encounters after adjustment for interpregnancy interval and a number of demographic factors, including education, presence of father, mother’s age, Hispanic ethnicity, fetal anomalies, and preterm birth history (adjusted odds ratio, 1.13), said Dr. Simonsen, a certified nurse midwife at the University of Utah Hospital, Salt Lake City.
“Preterm birth, a live birth at less than 37 weeks’ gestation, is a major determinant of poor neonatal outcomes,” she and her colleagues wrote. “Short interpregnancy interval, defined as less than 18 months, is an important risk factor for preterm birth.”
Given the increasing number of U.S. women who use highly effective LARCs to space pregnancies, she and her colleagues performed a retrospective cohort study of electronic medical records from two large health systems and linked them with birth and fetal death records to explore the relationship between interpregnancy LARC and both interpregnancy interval and preterm birth in the subsequent pregnancy.
“We did find that women who used LARC between their pregnancies were less likely to have a short interpregnancy interval, but in adjusted models ... we found no association with intrapartum LARC use and preterm birth in the second birth,” Dr. Simonsen said during an e-poster presentation at the meeting.
In fact, preterm birth in the second birth was most strongly associated with a prior preterm birth – a finding consistent with the literature, she and her colleagues noted.
Although the findings are limited by the use of retrospective data not designed for research, the data came from a large population-based sample representing about 85% of Utah births, they said.
The findings suggest that while LARC use may not reduce preterm birth risk, it “may contribute favorably to outcomes to the extent that having optimal interpregnancy interval does,” they wrote.
“‘We feel that these findings support providers counseling women on the full range of contraception options in the postpartum and not pushing [intrauterine devices,]” Dr. Simonsen added.
The related topic of immediate postpartum LARC use was addressed by Eve Espey, MD, in a separate presentation at the meeting.
Dr .Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, reported that immediate postpartum insertion of an intrauterine device (IUD) is highly cost-effective despite an expulsion rate of between 10% and 30%. She also addressed the value of postpartum LARC for reducing rapid-repeat pregnancy rates.
Payment models for immediate postpartum LARC are “very cumbersome,” but at the university, a persistent effort over 4 years has led to success. Immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases, she said, adding that efforts are underway to help other hospitals “troubleshoot the issues.”
The lack of private insurance coverage for immediate postpartum LARC remains a challenge, but Dr. Espey said she remains “super enthusiastic” about its use.
“I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen,” she said, urging colleagues to advocate for that within their American College of Obstetricians and Gynecologists sections when possible.
Dr. Simonsen and Dr. Espey reported having no relevant disclosures.
REPORTING FROM ACOG 2019
Immune modulators help anti-TNF agents battle Crohn’s disease, but not UC
Adding an immune modulator (IM) to anti–tumor necrosis factor (anti-TNF) initiation therapy benefits patients with Crohn’s disease (CD) but not those with ulcerative colitis (UC), according to a recent retrospective look at more than 1,000 cases.
The study showed that patients with CD who started combination therapy instead of monotherapy had lower rates of treatment ineffectiveness, experienced longer delays until hospitalization, and less often needed to switch their anti-TNF agent, reported lead author Laura E. Targownik, MD, of the University of Manitoba, in Winnipeg, Canada, and colleagues.
“Current guidelines on the medical management of IBD strongly support the use of IMs and anti-TNFs in combination over anti-TNF monotherapy,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, there is a sparsity of real-world data demonstrating the incremental benefits of combination therapy.”
The investigators noted that the SONIC trial, conducted in 2010, showed that patients treated with combination therapy were more likely to achieve corticosteroid-free remission at weeks 26 and 50; this became the basis of evidence leading multiple clinical guidelines to recommend combination therapy for patients with CD.
The present study involved 852 patients with CD and 303 with UC who began treatment with an anti-TNF agent during 2001-2016. Data were drawn from the Manitoba Inflammatory Bowel Disease (IBD) Epidemiology database.
The main outcome of interest was treatment ineffectiveness, which was defined by any of the following four events: acute, IBD-related hospital admission for more than 48 hours; resective intestinal surgery; corticosteroid use at least 14 days after initiating anti-TNF therapy, or, if corticosteroids were used within 16 weeks of anti-TNF initiation, then subsequent corticosteroid use occurring at least 16 weeks after initiation; or switching to a different anti-TNF agent. The investigators also looked for differences in effectiveness between two agents from each class: anti-TNF agents infliximab and adalimumab, and immunomodulators methotrexate and azathioprine.
Results showed that patients with CD had higher rates of ineffectiveness-free survival when treated with combination therapy instead of monotherapy at 1 year (74.2% vs. 68.6%) and 2 years (64.0% vs. 54.5%). Using a Cox proportional hazards model, this translated to a 38% reduced risk of treatment ineffectiveness (adjusted hazard ratio, 0.62).
“This suggests that the findings of the SONIC trial may extend to real-world clinical practice, even in patients who had previous IM exposure,” the investigators noted.
Combination therapy was also significantly associated with longer time to first IBD-related hospitalization (HR, 0.53) and the need to switch anti-TNF agent (HR, 0.63). However, no such relationships were found for time to resective surgery or corticosteroid use. Although combination therapy had no impact on the rate of primary treatment ineffectiveness in multivariable logistic regression, those who received anti-TNF therapy for more than 90 days had delayed secondary treatment ineffectiveness and fewer IBD-related hospitalizations. Choice of agent from either class had no influence on effectiveness of combination therapy.
In contrast with the above findings, combination therapy in patients with UC was less promising, which aligns with previous studies.
“[W]e were not able to demonstrate a significant advantage to combination therapy in persons with UC,” the investigators wrote. “In addition, all published cohort studies to date have not been able to confirm a significant benefit to combination therapy in UC. ... In light of the lower quality of prior evidence, combined with the results from our study, the indication for combination therapy in UC would appear to be weaker.”
“Further analyses in larger cohorts may clarify whether there is a clinically relevant benefit of combination therapy in persons with UC,” the investigators concluded. “Because of the discrepancy between our findings and those of a meta-analysis of cohort studies previously published on this topic, confirmation of our results is required in future studies.”
The investigators disclosed no funding or conflicts of interest.
SOURCE: Targownik LE et al. Clin Gastroenterol Hepatol. 2018 Nov 15. doi: 10.1016/j.cgh.2018.11.003.
Twenty years after the approval of the first anti–tumor necrosis factor (TNF) biologic agent for the treatment of inflammatory bowel disease (IBD), patients and providers are still learning how to optimize these medications. One optimization is the use of combination therapy (immunomodulator and anti-TNF). Immunomodulators are used independently for maintenance of remission of IBD, and they have been shown to reduce immunogenicity and improve efficacy when used in combination with an anti-TNF agent in prior short-term randomized controlled trials. However, use of combination therapy in the real-world is not universally practiced. Data are lacking on the risks and benefits of long-term use of these agents. Therefore, this article by Targownik et al. is very timely.
Importantly, a mixed group of patients who had previously been on azathioprine monotherapy and those newly starting this therapy at the time of anti-TNF initiation were included in this cohort (a group similar to what we see in real-world practice). Data on risk factors for disease complications, such as disease phenotype or severity, were not available. By contrast, none of the efficacy associations were improved in the smaller group of patients with ulcerative colitis on combination therapy.
As providers counsel patients on the benefits and risks of various IBD treatment choices, these data by Targownik et al. will inform decisions. Future research should incorporate additional means of biologic optimization, such as the use of therapeutic drug monitoring and/or risk factor–based selection of therapeutic agents, to better inform individualized treatment choices.
Millie D. Long MD, MPH, is an associate professor of medicine in the division of gastroenterology and hepatology; Inflammatory Bowel Diseases Center; vice chief for education; director, Gastroenterology and Hepatology Fellowship Program at the University of North Carolina at Chapel Hill. She has the following conflicts of interest: AbbVie, Takeda, Pfizer, UCB, Janssen, Salix, Prometheus, Target Pharmasolutions, and Valeant.
Twenty years after the approval of the first anti–tumor necrosis factor (TNF) biologic agent for the treatment of inflammatory bowel disease (IBD), patients and providers are still learning how to optimize these medications. One optimization is the use of combination therapy (immunomodulator and anti-TNF). Immunomodulators are used independently for maintenance of remission of IBD, and they have been shown to reduce immunogenicity and improve efficacy when used in combination with an anti-TNF agent in prior short-term randomized controlled trials. However, use of combination therapy in the real-world is not universally practiced. Data are lacking on the risks and benefits of long-term use of these agents. Therefore, this article by Targownik et al. is very timely.
Importantly, a mixed group of patients who had previously been on azathioprine monotherapy and those newly starting this therapy at the time of anti-TNF initiation were included in this cohort (a group similar to what we see in real-world practice). Data on risk factors for disease complications, such as disease phenotype or severity, were not available. By contrast, none of the efficacy associations were improved in the smaller group of patients with ulcerative colitis on combination therapy.
As providers counsel patients on the benefits and risks of various IBD treatment choices, these data by Targownik et al. will inform decisions. Future research should incorporate additional means of biologic optimization, such as the use of therapeutic drug monitoring and/or risk factor–based selection of therapeutic agents, to better inform individualized treatment choices.
Millie D. Long MD, MPH, is an associate professor of medicine in the division of gastroenterology and hepatology; Inflammatory Bowel Diseases Center; vice chief for education; director, Gastroenterology and Hepatology Fellowship Program at the University of North Carolina at Chapel Hill. She has the following conflicts of interest: AbbVie, Takeda, Pfizer, UCB, Janssen, Salix, Prometheus, Target Pharmasolutions, and Valeant.
Twenty years after the approval of the first anti–tumor necrosis factor (TNF) biologic agent for the treatment of inflammatory bowel disease (IBD), patients and providers are still learning how to optimize these medications. One optimization is the use of combination therapy (immunomodulator and anti-TNF). Immunomodulators are used independently for maintenance of remission of IBD, and they have been shown to reduce immunogenicity and improve efficacy when used in combination with an anti-TNF agent in prior short-term randomized controlled trials. However, use of combination therapy in the real-world is not universally practiced. Data are lacking on the risks and benefits of long-term use of these agents. Therefore, this article by Targownik et al. is very timely.
Importantly, a mixed group of patients who had previously been on azathioprine monotherapy and those newly starting this therapy at the time of anti-TNF initiation were included in this cohort (a group similar to what we see in real-world practice). Data on risk factors for disease complications, such as disease phenotype or severity, were not available. By contrast, none of the efficacy associations were improved in the smaller group of patients with ulcerative colitis on combination therapy.
As providers counsel patients on the benefits and risks of various IBD treatment choices, these data by Targownik et al. will inform decisions. Future research should incorporate additional means of biologic optimization, such as the use of therapeutic drug monitoring and/or risk factor–based selection of therapeutic agents, to better inform individualized treatment choices.
Millie D. Long MD, MPH, is an associate professor of medicine in the division of gastroenterology and hepatology; Inflammatory Bowel Diseases Center; vice chief for education; director, Gastroenterology and Hepatology Fellowship Program at the University of North Carolina at Chapel Hill. She has the following conflicts of interest: AbbVie, Takeda, Pfizer, UCB, Janssen, Salix, Prometheus, Target Pharmasolutions, and Valeant.
Adding an immune modulator (IM) to anti–tumor necrosis factor (anti-TNF) initiation therapy benefits patients with Crohn’s disease (CD) but not those with ulcerative colitis (UC), according to a recent retrospective look at more than 1,000 cases.
The study showed that patients with CD who started combination therapy instead of monotherapy had lower rates of treatment ineffectiveness, experienced longer delays until hospitalization, and less often needed to switch their anti-TNF agent, reported lead author Laura E. Targownik, MD, of the University of Manitoba, in Winnipeg, Canada, and colleagues.
“Current guidelines on the medical management of IBD strongly support the use of IMs and anti-TNFs in combination over anti-TNF monotherapy,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, there is a sparsity of real-world data demonstrating the incremental benefits of combination therapy.”
The investigators noted that the SONIC trial, conducted in 2010, showed that patients treated with combination therapy were more likely to achieve corticosteroid-free remission at weeks 26 and 50; this became the basis of evidence leading multiple clinical guidelines to recommend combination therapy for patients with CD.
The present study involved 852 patients with CD and 303 with UC who began treatment with an anti-TNF agent during 2001-2016. Data were drawn from the Manitoba Inflammatory Bowel Disease (IBD) Epidemiology database.
The main outcome of interest was treatment ineffectiveness, which was defined by any of the following four events: acute, IBD-related hospital admission for more than 48 hours; resective intestinal surgery; corticosteroid use at least 14 days after initiating anti-TNF therapy, or, if corticosteroids were used within 16 weeks of anti-TNF initiation, then subsequent corticosteroid use occurring at least 16 weeks after initiation; or switching to a different anti-TNF agent. The investigators also looked for differences in effectiveness between two agents from each class: anti-TNF agents infliximab and adalimumab, and immunomodulators methotrexate and azathioprine.
Results showed that patients with CD had higher rates of ineffectiveness-free survival when treated with combination therapy instead of monotherapy at 1 year (74.2% vs. 68.6%) and 2 years (64.0% vs. 54.5%). Using a Cox proportional hazards model, this translated to a 38% reduced risk of treatment ineffectiveness (adjusted hazard ratio, 0.62).
“This suggests that the findings of the SONIC trial may extend to real-world clinical practice, even in patients who had previous IM exposure,” the investigators noted.
Combination therapy was also significantly associated with longer time to first IBD-related hospitalization (HR, 0.53) and the need to switch anti-TNF agent (HR, 0.63). However, no such relationships were found for time to resective surgery or corticosteroid use. Although combination therapy had no impact on the rate of primary treatment ineffectiveness in multivariable logistic regression, those who received anti-TNF therapy for more than 90 days had delayed secondary treatment ineffectiveness and fewer IBD-related hospitalizations. Choice of agent from either class had no influence on effectiveness of combination therapy.
In contrast with the above findings, combination therapy in patients with UC was less promising, which aligns with previous studies.
“[W]e were not able to demonstrate a significant advantage to combination therapy in persons with UC,” the investigators wrote. “In addition, all published cohort studies to date have not been able to confirm a significant benefit to combination therapy in UC. ... In light of the lower quality of prior evidence, combined with the results from our study, the indication for combination therapy in UC would appear to be weaker.”
“Further analyses in larger cohorts may clarify whether there is a clinically relevant benefit of combination therapy in persons with UC,” the investigators concluded. “Because of the discrepancy between our findings and those of a meta-analysis of cohort studies previously published on this topic, confirmation of our results is required in future studies.”
The investigators disclosed no funding or conflicts of interest.
SOURCE: Targownik LE et al. Clin Gastroenterol Hepatol. 2018 Nov 15. doi: 10.1016/j.cgh.2018.11.003.
Adding an immune modulator (IM) to anti–tumor necrosis factor (anti-TNF) initiation therapy benefits patients with Crohn’s disease (CD) but not those with ulcerative colitis (UC), according to a recent retrospective look at more than 1,000 cases.
The study showed that patients with CD who started combination therapy instead of monotherapy had lower rates of treatment ineffectiveness, experienced longer delays until hospitalization, and less often needed to switch their anti-TNF agent, reported lead author Laura E. Targownik, MD, of the University of Manitoba, in Winnipeg, Canada, and colleagues.
“Current guidelines on the medical management of IBD strongly support the use of IMs and anti-TNFs in combination over anti-TNF monotherapy,” the investigators wrote in Clinical Gastroenterology and Hepatology. “However, there is a sparsity of real-world data demonstrating the incremental benefits of combination therapy.”
The investigators noted that the SONIC trial, conducted in 2010, showed that patients treated with combination therapy were more likely to achieve corticosteroid-free remission at weeks 26 and 50; this became the basis of evidence leading multiple clinical guidelines to recommend combination therapy for patients with CD.
The present study involved 852 patients with CD and 303 with UC who began treatment with an anti-TNF agent during 2001-2016. Data were drawn from the Manitoba Inflammatory Bowel Disease (IBD) Epidemiology database.
The main outcome of interest was treatment ineffectiveness, which was defined by any of the following four events: acute, IBD-related hospital admission for more than 48 hours; resective intestinal surgery; corticosteroid use at least 14 days after initiating anti-TNF therapy, or, if corticosteroids were used within 16 weeks of anti-TNF initiation, then subsequent corticosteroid use occurring at least 16 weeks after initiation; or switching to a different anti-TNF agent. The investigators also looked for differences in effectiveness between two agents from each class: anti-TNF agents infliximab and adalimumab, and immunomodulators methotrexate and azathioprine.
Results showed that patients with CD had higher rates of ineffectiveness-free survival when treated with combination therapy instead of monotherapy at 1 year (74.2% vs. 68.6%) and 2 years (64.0% vs. 54.5%). Using a Cox proportional hazards model, this translated to a 38% reduced risk of treatment ineffectiveness (adjusted hazard ratio, 0.62).
“This suggests that the findings of the SONIC trial may extend to real-world clinical practice, even in patients who had previous IM exposure,” the investigators noted.
Combination therapy was also significantly associated with longer time to first IBD-related hospitalization (HR, 0.53) and the need to switch anti-TNF agent (HR, 0.63). However, no such relationships were found for time to resective surgery or corticosteroid use. Although combination therapy had no impact on the rate of primary treatment ineffectiveness in multivariable logistic regression, those who received anti-TNF therapy for more than 90 days had delayed secondary treatment ineffectiveness and fewer IBD-related hospitalizations. Choice of agent from either class had no influence on effectiveness of combination therapy.
In contrast with the above findings, combination therapy in patients with UC was less promising, which aligns with previous studies.
“[W]e were not able to demonstrate a significant advantage to combination therapy in persons with UC,” the investigators wrote. “In addition, all published cohort studies to date have not been able to confirm a significant benefit to combination therapy in UC. ... In light of the lower quality of prior evidence, combined with the results from our study, the indication for combination therapy in UC would appear to be weaker.”
“Further analyses in larger cohorts may clarify whether there is a clinically relevant benefit of combination therapy in persons with UC,” the investigators concluded. “Because of the discrepancy between our findings and those of a meta-analysis of cohort studies previously published on this topic, confirmation of our results is required in future studies.”
The investigators disclosed no funding or conflicts of interest.
SOURCE: Targownik LE et al. Clin Gastroenterol Hepatol. 2018 Nov 15. doi: 10.1016/j.cgh.2018.11.003.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Systemic psoriasis treatments less often prescribed in elderly with psoriasis, despite comparable response rates
MILAN – an analysis of German and Swiss registry data shows.
There was an “imbalance” in the types of medications prescribed for older and younger patients in the registry, with biologics used more frequently in younger patients, according to investigator Matthias Augustin, MD, director of the Institute For Health Services Research in Dermatology and Nursing in Hamburg, Germany.
However, the efficacy of systemic treatments, including nonbiologic therapies, was comparable between older and younger patients, other than a few differences in response rates early in treatment that disappeared with longer follow-up, Dr. Augustin said at the World Congress of Dermatology. Coupled with evidence from the medical literature, results of this registry data analysis suggest there are “very few reasons” to avoid use of systemic drugs in elderly patients.
“I think we should create awareness and discuss possible reasons that deter dermatologists from prescribing systemic antipsoriatics in elderly patients,” he said.
Concerns about safety and drug interactions in the elderly may be one barrier to prescribing systemic therapy in this patient population: More data on this issue are needed, since the elderly are taking more medications than younger patients and have more contraindications, Dr. Augustin said. “I think this is a job for all registries for the future.”
Older individuals have typically been excluded from psoriasis clinical trials, making it difficult to extrapolate existing safety and efficacy data to those patients, he pointed out.
Accordingly, Dr. Augustin and coinvestigators evaluated prospectively collected data for patients with moderate to severe psoriasis who were included in either the German Psoriasis registry (PsoBest) or the Swiss Dermatology Network for Targeted Therapies (SDNTT). They split the cohort into a control group of those younger than 65 years (about 4,600 individuals) and those 65 years or older (about 740 individuals).
A few systemic drugs were used more frequently in the elderly, including apremilast and methotrexate, while most other drugs, including biologics, were used more frequently in younger patients, Dr. Augustin and colleagues found in their analysis. There were a few differences between the elderly and controls related to weight, smoking, and other factors, but not so pronounced that they would explain differences in the use of the systemic therapy.
Response rates to systemic therapies were generally comparable between the elderly and controls, as measured by Psoriasis Area Severity Index (PASI) 75 responses, PASI scores of 3 or less, and Dermatology Life Quality Index scores of one or less, he added.
One exception was methotrexate, which was more effective in the elderly after 3 and 6 months of treatment, but that difference was no longer apparent after 12 months of treatment, he said. Likewise, cyclosporine showed a higher response rate in younger patients at 3 months, but not at 6 or 12 months.
Based on the findings, “overall, we observed comparable responses between the controls and the elderly,” Dr. Augustin concluded.
The PsoBest registry is sponsored by CVderm, DDG, and BVDD, and “has been established and is operated in close cooperation with the involved pharmaceutical companies whose statutory pharmacovigilance requirements are taken into account,” according to a statement on the PsoBest website. The Swiss registry is supported by Janssen, AbbVie, Pfizer, Celgene, Lilly, and Novartis. The investigators did not report any disclosures.
MILAN – an analysis of German and Swiss registry data shows.
There was an “imbalance” in the types of medications prescribed for older and younger patients in the registry, with biologics used more frequently in younger patients, according to investigator Matthias Augustin, MD, director of the Institute For Health Services Research in Dermatology and Nursing in Hamburg, Germany.
However, the efficacy of systemic treatments, including nonbiologic therapies, was comparable between older and younger patients, other than a few differences in response rates early in treatment that disappeared with longer follow-up, Dr. Augustin said at the World Congress of Dermatology. Coupled with evidence from the medical literature, results of this registry data analysis suggest there are “very few reasons” to avoid use of systemic drugs in elderly patients.
“I think we should create awareness and discuss possible reasons that deter dermatologists from prescribing systemic antipsoriatics in elderly patients,” he said.
Concerns about safety and drug interactions in the elderly may be one barrier to prescribing systemic therapy in this patient population: More data on this issue are needed, since the elderly are taking more medications than younger patients and have more contraindications, Dr. Augustin said. “I think this is a job for all registries for the future.”
Older individuals have typically been excluded from psoriasis clinical trials, making it difficult to extrapolate existing safety and efficacy data to those patients, he pointed out.
Accordingly, Dr. Augustin and coinvestigators evaluated prospectively collected data for patients with moderate to severe psoriasis who were included in either the German Psoriasis registry (PsoBest) or the Swiss Dermatology Network for Targeted Therapies (SDNTT). They split the cohort into a control group of those younger than 65 years (about 4,600 individuals) and those 65 years or older (about 740 individuals).
A few systemic drugs were used more frequently in the elderly, including apremilast and methotrexate, while most other drugs, including biologics, were used more frequently in younger patients, Dr. Augustin and colleagues found in their analysis. There were a few differences between the elderly and controls related to weight, smoking, and other factors, but not so pronounced that they would explain differences in the use of the systemic therapy.
Response rates to systemic therapies were generally comparable between the elderly and controls, as measured by Psoriasis Area Severity Index (PASI) 75 responses, PASI scores of 3 or less, and Dermatology Life Quality Index scores of one or less, he added.
One exception was methotrexate, which was more effective in the elderly after 3 and 6 months of treatment, but that difference was no longer apparent after 12 months of treatment, he said. Likewise, cyclosporine showed a higher response rate in younger patients at 3 months, but not at 6 or 12 months.
Based on the findings, “overall, we observed comparable responses between the controls and the elderly,” Dr. Augustin concluded.
The PsoBest registry is sponsored by CVderm, DDG, and BVDD, and “has been established and is operated in close cooperation with the involved pharmaceutical companies whose statutory pharmacovigilance requirements are taken into account,” according to a statement on the PsoBest website. The Swiss registry is supported by Janssen, AbbVie, Pfizer, Celgene, Lilly, and Novartis. The investigators did not report any disclosures.
MILAN – an analysis of German and Swiss registry data shows.
There was an “imbalance” in the types of medications prescribed for older and younger patients in the registry, with biologics used more frequently in younger patients, according to investigator Matthias Augustin, MD, director of the Institute For Health Services Research in Dermatology and Nursing in Hamburg, Germany.
However, the efficacy of systemic treatments, including nonbiologic therapies, was comparable between older and younger patients, other than a few differences in response rates early in treatment that disappeared with longer follow-up, Dr. Augustin said at the World Congress of Dermatology. Coupled with evidence from the medical literature, results of this registry data analysis suggest there are “very few reasons” to avoid use of systemic drugs in elderly patients.
“I think we should create awareness and discuss possible reasons that deter dermatologists from prescribing systemic antipsoriatics in elderly patients,” he said.
Concerns about safety and drug interactions in the elderly may be one barrier to prescribing systemic therapy in this patient population: More data on this issue are needed, since the elderly are taking more medications than younger patients and have more contraindications, Dr. Augustin said. “I think this is a job for all registries for the future.”
Older individuals have typically been excluded from psoriasis clinical trials, making it difficult to extrapolate existing safety and efficacy data to those patients, he pointed out.
Accordingly, Dr. Augustin and coinvestigators evaluated prospectively collected data for patients with moderate to severe psoriasis who were included in either the German Psoriasis registry (PsoBest) or the Swiss Dermatology Network for Targeted Therapies (SDNTT). They split the cohort into a control group of those younger than 65 years (about 4,600 individuals) and those 65 years or older (about 740 individuals).
A few systemic drugs were used more frequently in the elderly, including apremilast and methotrexate, while most other drugs, including biologics, were used more frequently in younger patients, Dr. Augustin and colleagues found in their analysis. There were a few differences between the elderly and controls related to weight, smoking, and other factors, but not so pronounced that they would explain differences in the use of the systemic therapy.
Response rates to systemic therapies were generally comparable between the elderly and controls, as measured by Psoriasis Area Severity Index (PASI) 75 responses, PASI scores of 3 or less, and Dermatology Life Quality Index scores of one or less, he added.
One exception was methotrexate, which was more effective in the elderly after 3 and 6 months of treatment, but that difference was no longer apparent after 12 months of treatment, he said. Likewise, cyclosporine showed a higher response rate in younger patients at 3 months, but not at 6 or 12 months.
Based on the findings, “overall, we observed comparable responses between the controls and the elderly,” Dr. Augustin concluded.
The PsoBest registry is sponsored by CVderm, DDG, and BVDD, and “has been established and is operated in close cooperation with the involved pharmaceutical companies whose statutory pharmacovigilance requirements are taken into account,” according to a statement on the PsoBest website. The Swiss registry is supported by Janssen, AbbVie, Pfizer, Celgene, Lilly, and Novartis. The investigators did not report any disclosures.
REPORTING FROM WCD2019
Atopic dermatitis patients achieved freedom from itch on JAK inhibitor upadacitinib
MILAN – according to a report presented at the World Congress of Dermatology.
Compared with those in the placebo group, more patients receiving the selective Janus kinase 1 (JAK1) inhibitor achieved an itch-free state and maintained it over the 16 weeks of the phase 2b trial, said investigator Kristian Reich, MD, professor of translational research in inflammatory skin diseases at the University Medical Center Hamburg-Eppendorf (Germany).
These improvements in pruritus occurred early with upadacitinib and were pronounced at the highest dose studied, 30 mg daily, he commented. Treatment with upadacitinib also rapidly and significantly improved clinical signs of AD versus placebo, as previously reported primary endpoint data show.
“It’s a drug that works in eczema,” Dr. Reich said in an oral presentation. “We still do not fully understand what the exact relationship between itch and eczema is. Is there a neurogenic inflammation? Is there an epidermal pathology? But clearly with this drug, it does seem to reduce the itch, it does reduce the eczema, it does this early on, and the 30 mg does seem to be the right dose.”
Upadacitinib is a selective inhibitor of JAK1, a member of the signal transduction cascade for many cytokines implicated in AD, including interleukin-4, IL-13, IL-22, and others, Dr. Reich told attendees at the meeting.
In the phase 2b study, 167 patients with moderate to severe AD were randomized to placebo or upadacitinib at 7.5 mg, 15 mg, or 30 mg daily over a 16-week, double-blind period, followed by a 72-week, blinded extension. The mean age across these groups ranged from 39 to 42 years, and the mean time since onset of symptoms was 24-34 years.
Significantly improvements in Eczema Area and Severity Index (EASI) scores were seen as early as 2 weeks and were maintained throughout the 16-week, double-blind period, as previously shown. By 16 weeks, the mean percentage improvement in EASI score was 74.4% for upadacitinib 30 mg daily versus 23.0% for placebo (P less than .001).
In this more recent post hoc analysis of itch, the percentage of patients with a weekly rolling average pruritus Numerical Rating Scale (NRS) score of 0-1 was significantly higher in the upadacitinib groups, Dr. Reich said.
The placebo-adjusted difference in average pruritus NRS scores of 0-1 was highest in the 30-mg daily group, at 37.7% by week 16 (P less than .001).
Those itch scores correlated with the Patient Global Impression of Severity results, in that almost all patients rating their disease as absent or minimal by that scale also had a pruritus NRS score of 0 (81.6%) or 1 (10.5%), he said.
That link shows the important contribution of itch to the overall rating of disease severity by the patient. “Patients want to be able to say, ‘I have only minimal or absent disease,’ ” he said. “This will likely require that you really get the itch down, for example, to 0 or 1, using this pruritus numerical rating scale.”
Pruritus improvements in favor of upadacitinib were also seen when using Scoring AD itch and Patient-Oriented Eczema Measure (POEM) itch measures, Dr. Reich said. With POEM, 0% of placebo-treated patients had 0 days of itch in the past week, compared with 28.6% in the upadacitinib 30-mg daily group.
The risk-to-benefit profile of upadacitinib supports proceeding to phase 3 trials in patients with AD, according to Dr. Reich and coinvestigators.
Phase 3 trials of upadacitinib are underway in AD, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, according to a recent AbbVie press release. The Food and Drug Administration accepted a New Drug Application Accepted For Priority Review for upadacitinib treatment of moderate to severe RA, based on a phase 3 program including more than 4,900 patients, the company announced in February.
Support for the study was provided by AbbVie. Dr. Reich reported disclosures related to AbbVie, Affibody, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo Pharma, Eli Lilly, Medac Pharma, Merck, Novartis, Pfizer, Regeneron, Takeda, UCB, and XenoPort.
MILAN – according to a report presented at the World Congress of Dermatology.
Compared with those in the placebo group, more patients receiving the selective Janus kinase 1 (JAK1) inhibitor achieved an itch-free state and maintained it over the 16 weeks of the phase 2b trial, said investigator Kristian Reich, MD, professor of translational research in inflammatory skin diseases at the University Medical Center Hamburg-Eppendorf (Germany).
These improvements in pruritus occurred early with upadacitinib and were pronounced at the highest dose studied, 30 mg daily, he commented. Treatment with upadacitinib also rapidly and significantly improved clinical signs of AD versus placebo, as previously reported primary endpoint data show.
“It’s a drug that works in eczema,” Dr. Reich said in an oral presentation. “We still do not fully understand what the exact relationship between itch and eczema is. Is there a neurogenic inflammation? Is there an epidermal pathology? But clearly with this drug, it does seem to reduce the itch, it does reduce the eczema, it does this early on, and the 30 mg does seem to be the right dose.”
Upadacitinib is a selective inhibitor of JAK1, a member of the signal transduction cascade for many cytokines implicated in AD, including interleukin-4, IL-13, IL-22, and others, Dr. Reich told attendees at the meeting.
In the phase 2b study, 167 patients with moderate to severe AD were randomized to placebo or upadacitinib at 7.5 mg, 15 mg, or 30 mg daily over a 16-week, double-blind period, followed by a 72-week, blinded extension. The mean age across these groups ranged from 39 to 42 years, and the mean time since onset of symptoms was 24-34 years.
Significantly improvements in Eczema Area and Severity Index (EASI) scores were seen as early as 2 weeks and were maintained throughout the 16-week, double-blind period, as previously shown. By 16 weeks, the mean percentage improvement in EASI score was 74.4% for upadacitinib 30 mg daily versus 23.0% for placebo (P less than .001).
In this more recent post hoc analysis of itch, the percentage of patients with a weekly rolling average pruritus Numerical Rating Scale (NRS) score of 0-1 was significantly higher in the upadacitinib groups, Dr. Reich said.
The placebo-adjusted difference in average pruritus NRS scores of 0-1 was highest in the 30-mg daily group, at 37.7% by week 16 (P less than .001).
Those itch scores correlated with the Patient Global Impression of Severity results, in that almost all patients rating their disease as absent or minimal by that scale also had a pruritus NRS score of 0 (81.6%) or 1 (10.5%), he said.
That link shows the important contribution of itch to the overall rating of disease severity by the patient. “Patients want to be able to say, ‘I have only minimal or absent disease,’ ” he said. “This will likely require that you really get the itch down, for example, to 0 or 1, using this pruritus numerical rating scale.”
Pruritus improvements in favor of upadacitinib were also seen when using Scoring AD itch and Patient-Oriented Eczema Measure (POEM) itch measures, Dr. Reich said. With POEM, 0% of placebo-treated patients had 0 days of itch in the past week, compared with 28.6% in the upadacitinib 30-mg daily group.
The risk-to-benefit profile of upadacitinib supports proceeding to phase 3 trials in patients with AD, according to Dr. Reich and coinvestigators.
Phase 3 trials of upadacitinib are underway in AD, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, according to a recent AbbVie press release. The Food and Drug Administration accepted a New Drug Application Accepted For Priority Review for upadacitinib treatment of moderate to severe RA, based on a phase 3 program including more than 4,900 patients, the company announced in February.
Support for the study was provided by AbbVie. Dr. Reich reported disclosures related to AbbVie, Affibody, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo Pharma, Eli Lilly, Medac Pharma, Merck, Novartis, Pfizer, Regeneron, Takeda, UCB, and XenoPort.
MILAN – according to a report presented at the World Congress of Dermatology.
Compared with those in the placebo group, more patients receiving the selective Janus kinase 1 (JAK1) inhibitor achieved an itch-free state and maintained it over the 16 weeks of the phase 2b trial, said investigator Kristian Reich, MD, professor of translational research in inflammatory skin diseases at the University Medical Center Hamburg-Eppendorf (Germany).
These improvements in pruritus occurred early with upadacitinib and were pronounced at the highest dose studied, 30 mg daily, he commented. Treatment with upadacitinib also rapidly and significantly improved clinical signs of AD versus placebo, as previously reported primary endpoint data show.
“It’s a drug that works in eczema,” Dr. Reich said in an oral presentation. “We still do not fully understand what the exact relationship between itch and eczema is. Is there a neurogenic inflammation? Is there an epidermal pathology? But clearly with this drug, it does seem to reduce the itch, it does reduce the eczema, it does this early on, and the 30 mg does seem to be the right dose.”
Upadacitinib is a selective inhibitor of JAK1, a member of the signal transduction cascade for many cytokines implicated in AD, including interleukin-4, IL-13, IL-22, and others, Dr. Reich told attendees at the meeting.
In the phase 2b study, 167 patients with moderate to severe AD were randomized to placebo or upadacitinib at 7.5 mg, 15 mg, or 30 mg daily over a 16-week, double-blind period, followed by a 72-week, blinded extension. The mean age across these groups ranged from 39 to 42 years, and the mean time since onset of symptoms was 24-34 years.
Significantly improvements in Eczema Area and Severity Index (EASI) scores were seen as early as 2 weeks and were maintained throughout the 16-week, double-blind period, as previously shown. By 16 weeks, the mean percentage improvement in EASI score was 74.4% for upadacitinib 30 mg daily versus 23.0% for placebo (P less than .001).
In this more recent post hoc analysis of itch, the percentage of patients with a weekly rolling average pruritus Numerical Rating Scale (NRS) score of 0-1 was significantly higher in the upadacitinib groups, Dr. Reich said.
The placebo-adjusted difference in average pruritus NRS scores of 0-1 was highest in the 30-mg daily group, at 37.7% by week 16 (P less than .001).
Those itch scores correlated with the Patient Global Impression of Severity results, in that almost all patients rating their disease as absent or minimal by that scale also had a pruritus NRS score of 0 (81.6%) or 1 (10.5%), he said.
That link shows the important contribution of itch to the overall rating of disease severity by the patient. “Patients want to be able to say, ‘I have only minimal or absent disease,’ ” he said. “This will likely require that you really get the itch down, for example, to 0 or 1, using this pruritus numerical rating scale.”
Pruritus improvements in favor of upadacitinib were also seen when using Scoring AD itch and Patient-Oriented Eczema Measure (POEM) itch measures, Dr. Reich said. With POEM, 0% of placebo-treated patients had 0 days of itch in the past week, compared with 28.6% in the upadacitinib 30-mg daily group.
The risk-to-benefit profile of upadacitinib supports proceeding to phase 3 trials in patients with AD, according to Dr. Reich and coinvestigators.
Phase 3 trials of upadacitinib are underway in AD, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, according to a recent AbbVie press release. The Food and Drug Administration accepted a New Drug Application Accepted For Priority Review for upadacitinib treatment of moderate to severe RA, based on a phase 3 program including more than 4,900 patients, the company announced in February.
Support for the study was provided by AbbVie. Dr. Reich reported disclosures related to AbbVie, Affibody, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo Pharma, Eli Lilly, Medac Pharma, Merck, Novartis, Pfizer, Regeneron, Takeda, UCB, and XenoPort.
REPORTING FROM WCD2019
Survey: Patient-provider communication regarding dyspareunia disappoints
NASHVILLE, TENN. – Many women with endometriosis experience dyspareunia, but they are largely unsatisfied when it comes to discussions with health care providers about their symptoms, the results of an online survey suggest.
Of 638 women with self-reported endometriosis who responded to the survey, 81% said they always or usually experience pain during intercourse, 51% described their pain as severe, and 49% said they experience pain lasting more than 24 hours, Roberta Renzelli-Cain, DO, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“The results of our survey suggest that said Dr. Renzelli-Cain, director of the West Virginia National Center of Excellence in Women’s Health and an ob.gyn. at West Virginia University, Morgantown.
In fact, survey responses suggested that dyspareunia has a marked impact on quality of life; 69% of respondents said they find sexual intercourse unpleasant, 31% said they always or usually avoid intercourse, 44% strongly agreed that dyspareunia has affected their relationship with their spouse or partner, 63% said they worry that their spouse or partner will leave, and 63% said they feel depressed because of their dyspareunia, she and her colleagues found.
Most respondents (88%) discussed their symptoms with health care providers (HCPs), and 85% did so with their ob.gyn. Among the other HCPs who respondents spoke with about their dyspareunia were primary care physicians, nurse practitioners, emergency department doctors, fertility specialists, and pain specialists.
Among the reasons given for avoiding discussions with HCPs about painful intercourse were embarrassment (34% of respondents), thinking nothing would help (26%), the physician was a man (5%), and a feeling that the provider was not understanding (3%).
Overall, 18% of respondents said they received no advice from their HCPs regarding how to deal with their dyspareunia, and 39% found nothing that their HCPs suggested to be effective.
Advice given by HCPs included surgery, lubricant use, over-the-counter pain medication, and trying different sexual positions. The percentages of respondents receiving this advice, and the percentages who considered the advice effective, respectively, were 46%, 25% for surgery; 32%, 21% for lubricant use; 36%, 18% for OTC medication; and 21%, 14% for trying different sexual positions, the investigators said.
Importantly, 42% of respondent said they felt it would be easier to discuss dyspareunia if their HCP initiated the subject.
The findings are notable given that 6%-10% of women of childbearing age are affected by endometriosis, and about 30% of those women have related dyspareunia – a “challenging symptom associated with lower sexual functioning, as well as lower self-esteem, and body image,” the investigators wrote.
The 24-question English-language survey was conducted online among women aged 19 years or older who reported having endometriosis and dyspareunia. Participants were recruited via a social network for women with endometriosis (MyEndometriosisTeam.com) and invited by e-mail to participate.
Of the 32,865 invited participants, 361 U.S.-based women and 277 women from outside the United States completed the survey. Most (83%) were aged 19-29 years.
In this online survey, the majority of women reported suboptimal communication with HCPs when seeking help for dyspareunia, the investigators said, concluding that “these results were similar between the U.S.- and non-U.S.–based women, highlighting the need for better medical communication between patients and HCPs, and better advice for patients regarding dyspareunia.”
Dr. Renzelli-Cain reported having no relevant financial disclosures.
NASHVILLE, TENN. – Many women with endometriosis experience dyspareunia, but they are largely unsatisfied when it comes to discussions with health care providers about their symptoms, the results of an online survey suggest.
Of 638 women with self-reported endometriosis who responded to the survey, 81% said they always or usually experience pain during intercourse, 51% described their pain as severe, and 49% said they experience pain lasting more than 24 hours, Roberta Renzelli-Cain, DO, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“The results of our survey suggest that said Dr. Renzelli-Cain, director of the West Virginia National Center of Excellence in Women’s Health and an ob.gyn. at West Virginia University, Morgantown.
In fact, survey responses suggested that dyspareunia has a marked impact on quality of life; 69% of respondents said they find sexual intercourse unpleasant, 31% said they always or usually avoid intercourse, 44% strongly agreed that dyspareunia has affected their relationship with their spouse or partner, 63% said they worry that their spouse or partner will leave, and 63% said they feel depressed because of their dyspareunia, she and her colleagues found.
Most respondents (88%) discussed their symptoms with health care providers (HCPs), and 85% did so with their ob.gyn. Among the other HCPs who respondents spoke with about their dyspareunia were primary care physicians, nurse practitioners, emergency department doctors, fertility specialists, and pain specialists.
Among the reasons given for avoiding discussions with HCPs about painful intercourse were embarrassment (34% of respondents), thinking nothing would help (26%), the physician was a man (5%), and a feeling that the provider was not understanding (3%).
Overall, 18% of respondents said they received no advice from their HCPs regarding how to deal with their dyspareunia, and 39% found nothing that their HCPs suggested to be effective.
Advice given by HCPs included surgery, lubricant use, over-the-counter pain medication, and trying different sexual positions. The percentages of respondents receiving this advice, and the percentages who considered the advice effective, respectively, were 46%, 25% for surgery; 32%, 21% for lubricant use; 36%, 18% for OTC medication; and 21%, 14% for trying different sexual positions, the investigators said.
Importantly, 42% of respondent said they felt it would be easier to discuss dyspareunia if their HCP initiated the subject.
The findings are notable given that 6%-10% of women of childbearing age are affected by endometriosis, and about 30% of those women have related dyspareunia – a “challenging symptom associated with lower sexual functioning, as well as lower self-esteem, and body image,” the investigators wrote.
The 24-question English-language survey was conducted online among women aged 19 years or older who reported having endometriosis and dyspareunia. Participants were recruited via a social network for women with endometriosis (MyEndometriosisTeam.com) and invited by e-mail to participate.
Of the 32,865 invited participants, 361 U.S.-based women and 277 women from outside the United States completed the survey. Most (83%) were aged 19-29 years.
In this online survey, the majority of women reported suboptimal communication with HCPs when seeking help for dyspareunia, the investigators said, concluding that “these results were similar between the U.S.- and non-U.S.–based women, highlighting the need for better medical communication between patients and HCPs, and better advice for patients regarding dyspareunia.”
Dr. Renzelli-Cain reported having no relevant financial disclosures.
NASHVILLE, TENN. – Many women with endometriosis experience dyspareunia, but they are largely unsatisfied when it comes to discussions with health care providers about their symptoms, the results of an online survey suggest.
Of 638 women with self-reported endometriosis who responded to the survey, 81% said they always or usually experience pain during intercourse, 51% described their pain as severe, and 49% said they experience pain lasting more than 24 hours, Roberta Renzelli-Cain, DO, reported during a poster session at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
“The results of our survey suggest that said Dr. Renzelli-Cain, director of the West Virginia National Center of Excellence in Women’s Health and an ob.gyn. at West Virginia University, Morgantown.
In fact, survey responses suggested that dyspareunia has a marked impact on quality of life; 69% of respondents said they find sexual intercourse unpleasant, 31% said they always or usually avoid intercourse, 44% strongly agreed that dyspareunia has affected their relationship with their spouse or partner, 63% said they worry that their spouse or partner will leave, and 63% said they feel depressed because of their dyspareunia, she and her colleagues found.
Most respondents (88%) discussed their symptoms with health care providers (HCPs), and 85% did so with their ob.gyn. Among the other HCPs who respondents spoke with about their dyspareunia were primary care physicians, nurse practitioners, emergency department doctors, fertility specialists, and pain specialists.
Among the reasons given for avoiding discussions with HCPs about painful intercourse were embarrassment (34% of respondents), thinking nothing would help (26%), the physician was a man (5%), and a feeling that the provider was not understanding (3%).
Overall, 18% of respondents said they received no advice from their HCPs regarding how to deal with their dyspareunia, and 39% found nothing that their HCPs suggested to be effective.
Advice given by HCPs included surgery, lubricant use, over-the-counter pain medication, and trying different sexual positions. The percentages of respondents receiving this advice, and the percentages who considered the advice effective, respectively, were 46%, 25% for surgery; 32%, 21% for lubricant use; 36%, 18% for OTC medication; and 21%, 14% for trying different sexual positions, the investigators said.
Importantly, 42% of respondent said they felt it would be easier to discuss dyspareunia if their HCP initiated the subject.
The findings are notable given that 6%-10% of women of childbearing age are affected by endometriosis, and about 30% of those women have related dyspareunia – a “challenging symptom associated with lower sexual functioning, as well as lower self-esteem, and body image,” the investigators wrote.
The 24-question English-language survey was conducted online among women aged 19 years or older who reported having endometriosis and dyspareunia. Participants were recruited via a social network for women with endometriosis (MyEndometriosisTeam.com) and invited by e-mail to participate.
Of the 32,865 invited participants, 361 U.S.-based women and 277 women from outside the United States completed the survey. Most (83%) were aged 19-29 years.
In this online survey, the majority of women reported suboptimal communication with HCPs when seeking help for dyspareunia, the investigators said, concluding that “these results were similar between the U.S.- and non-U.S.–based women, highlighting the need for better medical communication between patients and HCPs, and better advice for patients regarding dyspareunia.”
Dr. Renzelli-Cain reported having no relevant financial disclosures.
REPORTING FROM ACOG 2019
Study explores link between inhaled corticosteroid for COPD and reduced lung cancer risk
recent research from the European Respiratory Journal has shown.
“The appropriate use of [inhaled corticosteroids] ICS in [chronic obstructive pulmonary disease] COPD patients is often debated and not all patients might benefit from the use of ICS. The clinical benefits and risk of use in an individual patient must be weighed by the physician,” wrote Adam J.N. Raymakers, MSc, PhD, of the University of British Columbia’s Collaboration for Outcomes Research and Evaluation (CORE), Vancouver, B.C., and colleagues.
“This study, however, indicates that potential benefits may accrue from ICS use in COPD patients in terms of reduced lung cancer risk, and that sustained use may be associated with reduced risk of lung cancer.”
Dr. Raymakers and colleagues did an analysis of 39,676 patients with COPD (mean age, 70.7 years; 53% female) who received ICS between 1997 and 2007 and linked those patients to a registry of cancer patients in British Columbia. The linked databases included the Medical Services Plan (MSP) payment information file, Discharge Abstract Database (DAD), PharmaNet data file, and the British Columbia Cancer Registry (BCCR). The researchers determined a patient had COPD if he or she received three or more prescriptions related to COPD, while ICS exposure was analyzed in the context of a patient’s ICS exposure, cumulative duration, cumulative dose, and weighted cumulative duration and dose.
The analysis revealed 372,075 prescriptions for ICS were dispensed and 71.2% of the patients were “distinct users” of ICS, with patients filling a median of eight prescriptions at mean 5.2 years of follow-up. Fluticasone propionate was the most common ICS prescribed at a dose of 0.64 mg per day, and patients had median 60 days of ICS supplied per person.
Overall, there were 994 cases of lung cancer (2.5%), and exposure to ICS was linked to a 30% reduction in lung cancer risk (hazard ratio, 0.70; 95% confidence interval, 0.61-0.80), while recency-weighted duration of ICS exposure was linked to a 26% reduction in lung cancer risk (HR, 0.74; 95% CI, 0.66-0.87). There was a 43% reduced risk of lung cancer per gram of ICS when the data were measured by recency-weighted cumulative dosage.
In a multivariate analysis, ICS use was associated with a 30% reduction in risk of non–small cell lung cancer (HR, 0.70; 95% CI, 0.60-0.82), which the researchers said suggests ICS provides a protective effect for patients against lung cancer. “These results highlight the importance of properly identifying which patients might be at the highest risk of lung cancer, to enhance the therapeutic benefits of ICS in these COPD patients,” they wrote.
This study received funding from the Canadian Institutes of Health Research. The authors report no conflicts of interest.
SOURCE: Raymakers A, et al. Eur Respir J. 2019. doi: 10.1183/13993003.01257-2018.
recent research from the European Respiratory Journal has shown.
“The appropriate use of [inhaled corticosteroids] ICS in [chronic obstructive pulmonary disease] COPD patients is often debated and not all patients might benefit from the use of ICS. The clinical benefits and risk of use in an individual patient must be weighed by the physician,” wrote Adam J.N. Raymakers, MSc, PhD, of the University of British Columbia’s Collaboration for Outcomes Research and Evaluation (CORE), Vancouver, B.C., and colleagues.
“This study, however, indicates that potential benefits may accrue from ICS use in COPD patients in terms of reduced lung cancer risk, and that sustained use may be associated with reduced risk of lung cancer.”
Dr. Raymakers and colleagues did an analysis of 39,676 patients with COPD (mean age, 70.7 years; 53% female) who received ICS between 1997 and 2007 and linked those patients to a registry of cancer patients in British Columbia. The linked databases included the Medical Services Plan (MSP) payment information file, Discharge Abstract Database (DAD), PharmaNet data file, and the British Columbia Cancer Registry (BCCR). The researchers determined a patient had COPD if he or she received three or more prescriptions related to COPD, while ICS exposure was analyzed in the context of a patient’s ICS exposure, cumulative duration, cumulative dose, and weighted cumulative duration and dose.
The analysis revealed 372,075 prescriptions for ICS were dispensed and 71.2% of the patients were “distinct users” of ICS, with patients filling a median of eight prescriptions at mean 5.2 years of follow-up. Fluticasone propionate was the most common ICS prescribed at a dose of 0.64 mg per day, and patients had median 60 days of ICS supplied per person.
Overall, there were 994 cases of lung cancer (2.5%), and exposure to ICS was linked to a 30% reduction in lung cancer risk (hazard ratio, 0.70; 95% confidence interval, 0.61-0.80), while recency-weighted duration of ICS exposure was linked to a 26% reduction in lung cancer risk (HR, 0.74; 95% CI, 0.66-0.87). There was a 43% reduced risk of lung cancer per gram of ICS when the data were measured by recency-weighted cumulative dosage.
In a multivariate analysis, ICS use was associated with a 30% reduction in risk of non–small cell lung cancer (HR, 0.70; 95% CI, 0.60-0.82), which the researchers said suggests ICS provides a protective effect for patients against lung cancer. “These results highlight the importance of properly identifying which patients might be at the highest risk of lung cancer, to enhance the therapeutic benefits of ICS in these COPD patients,” they wrote.
This study received funding from the Canadian Institutes of Health Research. The authors report no conflicts of interest.
SOURCE: Raymakers A, et al. Eur Respir J. 2019. doi: 10.1183/13993003.01257-2018.
recent research from the European Respiratory Journal has shown.
“The appropriate use of [inhaled corticosteroids] ICS in [chronic obstructive pulmonary disease] COPD patients is often debated and not all patients might benefit from the use of ICS. The clinical benefits and risk of use in an individual patient must be weighed by the physician,” wrote Adam J.N. Raymakers, MSc, PhD, of the University of British Columbia’s Collaboration for Outcomes Research and Evaluation (CORE), Vancouver, B.C., and colleagues.
“This study, however, indicates that potential benefits may accrue from ICS use in COPD patients in terms of reduced lung cancer risk, and that sustained use may be associated with reduced risk of lung cancer.”
Dr. Raymakers and colleagues did an analysis of 39,676 patients with COPD (mean age, 70.7 years; 53% female) who received ICS between 1997 and 2007 and linked those patients to a registry of cancer patients in British Columbia. The linked databases included the Medical Services Plan (MSP) payment information file, Discharge Abstract Database (DAD), PharmaNet data file, and the British Columbia Cancer Registry (BCCR). The researchers determined a patient had COPD if he or she received three or more prescriptions related to COPD, while ICS exposure was analyzed in the context of a patient’s ICS exposure, cumulative duration, cumulative dose, and weighted cumulative duration and dose.
The analysis revealed 372,075 prescriptions for ICS were dispensed and 71.2% of the patients were “distinct users” of ICS, with patients filling a median of eight prescriptions at mean 5.2 years of follow-up. Fluticasone propionate was the most common ICS prescribed at a dose of 0.64 mg per day, and patients had median 60 days of ICS supplied per person.
Overall, there were 994 cases of lung cancer (2.5%), and exposure to ICS was linked to a 30% reduction in lung cancer risk (hazard ratio, 0.70; 95% confidence interval, 0.61-0.80), while recency-weighted duration of ICS exposure was linked to a 26% reduction in lung cancer risk (HR, 0.74; 95% CI, 0.66-0.87). There was a 43% reduced risk of lung cancer per gram of ICS when the data were measured by recency-weighted cumulative dosage.
In a multivariate analysis, ICS use was associated with a 30% reduction in risk of non–small cell lung cancer (HR, 0.70; 95% CI, 0.60-0.82), which the researchers said suggests ICS provides a protective effect for patients against lung cancer. “These results highlight the importance of properly identifying which patients might be at the highest risk of lung cancer, to enhance the therapeutic benefits of ICS in these COPD patients,” they wrote.
This study received funding from the Canadian Institutes of Health Research. The authors report no conflicts of interest.
SOURCE: Raymakers A, et al. Eur Respir J. 2019. doi: 10.1183/13993003.01257-2018.
FROM THE EUROPEAN RESPIRATORY JOURNAL