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PDT with daylight effective in clearing AKs of the face, scalp
Photodynamic therapy (PDT) using daylight was as effective as PDT with an artificial light source in clearing grade I actinic keratoses (AKs) of the face and scalp after 3 months, but was associated with less pain and less severe side effects in a small Italian study.
In addition, most of the patients preferred the treatment with daylight photodynamic therapy (DL-PDT), reported Dr. Maria Concetta Fargnoli of the University of L’Aquila (Italy) and her associates (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:1926-32).
The prospective intrapatient study compared the effects of DL-PDT with conventional PDT (c-PDT) at 3 months in 35 patients with multiple grade I AKs of the face and scalp in September and October 2013. Patients were treated with c-PDT on one side of the face and DL-PDT on the other side. For c-PDT, light therapy was administered after methyl aminolevulinate (MAL) cream was applied to the treatment area and occluded. For DL-PDT, MAL cream was applied to the treatment area, left uncovered for 30 minutes in the dark; patients then exposed these areas to daylight for 2 hours, between 11 a.m. and 3 p.m., after which the cream was wiped off.
At 3 months, the complete response rate of grade I AKs was 87% for DL-PDT and 91% for c-PDT, which was not a significant difference. It was less effective for grade II and III AKs in the study, though, and at 6 months, the recurrence rate for grade I AKs treated with DL-PDT was higher (17%) than for those treated with c-PDT (12%), with a P value less than .05.
Treatment with DL-PDT was associated with significantly less pain and less severe adverse events, with less erythema, crusting, and pustular eruption 2 days after treatment. In addition, 88% of the patients were more satisfied with DL-PDT, the authors said.
“Our study confirms that DL-PDT using MAL is an effective, safe, and convenient alternative for the treatment of grade I AKs ,” they concluded. “Interestingly, clinical response for AK I was significantly moderated by outdoor temperature, increasing at higher temperatures.”
The authors had no conflicts of interest. Dr. Fargnoli received a research grant from Galderma, Italy, but Galderma played no role in the study, according to the study’s disclosure statement. Galderma manufactures the MAL cream product used in the study.
Photodynamic therapy (PDT) using daylight was as effective as PDT with an artificial light source in clearing grade I actinic keratoses (AKs) of the face and scalp after 3 months, but was associated with less pain and less severe side effects in a small Italian study.
In addition, most of the patients preferred the treatment with daylight photodynamic therapy (DL-PDT), reported Dr. Maria Concetta Fargnoli of the University of L’Aquila (Italy) and her associates (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:1926-32).
The prospective intrapatient study compared the effects of DL-PDT with conventional PDT (c-PDT) at 3 months in 35 patients with multiple grade I AKs of the face and scalp in September and October 2013. Patients were treated with c-PDT on one side of the face and DL-PDT on the other side. For c-PDT, light therapy was administered after methyl aminolevulinate (MAL) cream was applied to the treatment area and occluded. For DL-PDT, MAL cream was applied to the treatment area, left uncovered for 30 minutes in the dark; patients then exposed these areas to daylight for 2 hours, between 11 a.m. and 3 p.m., after which the cream was wiped off.
At 3 months, the complete response rate of grade I AKs was 87% for DL-PDT and 91% for c-PDT, which was not a significant difference. It was less effective for grade II and III AKs in the study, though, and at 6 months, the recurrence rate for grade I AKs treated with DL-PDT was higher (17%) than for those treated with c-PDT (12%), with a P value less than .05.
Treatment with DL-PDT was associated with significantly less pain and less severe adverse events, with less erythema, crusting, and pustular eruption 2 days after treatment. In addition, 88% of the patients were more satisfied with DL-PDT, the authors said.
“Our study confirms that DL-PDT using MAL is an effective, safe, and convenient alternative for the treatment of grade I AKs ,” they concluded. “Interestingly, clinical response for AK I was significantly moderated by outdoor temperature, increasing at higher temperatures.”
The authors had no conflicts of interest. Dr. Fargnoli received a research grant from Galderma, Italy, but Galderma played no role in the study, according to the study’s disclosure statement. Galderma manufactures the MAL cream product used in the study.
Photodynamic therapy (PDT) using daylight was as effective as PDT with an artificial light source in clearing grade I actinic keratoses (AKs) of the face and scalp after 3 months, but was associated with less pain and less severe side effects in a small Italian study.
In addition, most of the patients preferred the treatment with daylight photodynamic therapy (DL-PDT), reported Dr. Maria Concetta Fargnoli of the University of L’Aquila (Italy) and her associates (J Eur Acad Dermatol Venereol. 2015 Oct;29[10]:1926-32).
The prospective intrapatient study compared the effects of DL-PDT with conventional PDT (c-PDT) at 3 months in 35 patients with multiple grade I AKs of the face and scalp in September and October 2013. Patients were treated with c-PDT on one side of the face and DL-PDT on the other side. For c-PDT, light therapy was administered after methyl aminolevulinate (MAL) cream was applied to the treatment area and occluded. For DL-PDT, MAL cream was applied to the treatment area, left uncovered for 30 minutes in the dark; patients then exposed these areas to daylight for 2 hours, between 11 a.m. and 3 p.m., after which the cream was wiped off.
At 3 months, the complete response rate of grade I AKs was 87% for DL-PDT and 91% for c-PDT, which was not a significant difference. It was less effective for grade II and III AKs in the study, though, and at 6 months, the recurrence rate for grade I AKs treated with DL-PDT was higher (17%) than for those treated with c-PDT (12%), with a P value less than .05.
Treatment with DL-PDT was associated with significantly less pain and less severe adverse events, with less erythema, crusting, and pustular eruption 2 days after treatment. In addition, 88% of the patients were more satisfied with DL-PDT, the authors said.
“Our study confirms that DL-PDT using MAL is an effective, safe, and convenient alternative for the treatment of grade I AKs ,” they concluded. “Interestingly, clinical response for AK I was significantly moderated by outdoor temperature, increasing at higher temperatures.”
The authors had no conflicts of interest. Dr. Fargnoli received a research grant from Galderma, Italy, but Galderma played no role in the study, according to the study’s disclosure statement. Galderma manufactures the MAL cream product used in the study.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Key clinical point: Photodynamic therapy using daylight was as effective as PDT with an artificial light source in clearing grade I actinic keratoses of the face and scalp after 3 months, but was associated with less pain and less severe side effects, and was more acceptable to patients.
Major finding: At 3 months, the complete response rate of grade I AKs treated with daylight photodynamic therapy was 87% vs. 91% among those treated with conventional PDT (P = .16).
Data source: A prospective intrapatient, left-right study compared the effects of daylight PDT with methyl aminolevulinate cream and conventional PDT at 3 months in 35 patients with grade I AKs. c-PDT was also combined with application of the MAL cream.
Disclosures: The authors had no financial conflicts of interest. Dr. Fargnoli received a research grant from Galderma, Italy, but Galderma played no role in the study, according to the study’s disclosure statement. Galderma manufactures the MAL cream product used in the study.
Filler approved for lip augmentation
The Food and Drug Administration has approved a Juvederm product for lip augmentation, according to the manufacturer.
In an Oct. 1 press release, Allergan announced that Juvederm Ultra XC had been approved for “injection into the lips and perioral area for lip augmentation in adults over the age of 21.”
The product is described as a smooth gel formulation made up of a modified form of hyaluronic acid; it also contains lidocaine. In clinical studies, 79% of participants “showed a meaningful improvement in lip fullness” 3 months after treatment, the company said, and more than 78% “reported an improvement in their overall satisfaction with the look and feel of their lips” 1 year after treatment.
The Food and Drug Administration has approved a Juvederm product for lip augmentation, according to the manufacturer.
In an Oct. 1 press release, Allergan announced that Juvederm Ultra XC had been approved for “injection into the lips and perioral area for lip augmentation in adults over the age of 21.”
The product is described as a smooth gel formulation made up of a modified form of hyaluronic acid; it also contains lidocaine. In clinical studies, 79% of participants “showed a meaningful improvement in lip fullness” 3 months after treatment, the company said, and more than 78% “reported an improvement in their overall satisfaction with the look and feel of their lips” 1 year after treatment.
The Food and Drug Administration has approved a Juvederm product for lip augmentation, according to the manufacturer.
In an Oct. 1 press release, Allergan announced that Juvederm Ultra XC had been approved for “injection into the lips and perioral area for lip augmentation in adults over the age of 21.”
The product is described as a smooth gel formulation made up of a modified form of hyaluronic acid; it also contains lidocaine. In clinical studies, 79% of participants “showed a meaningful improvement in lip fullness” 3 months after treatment, the company said, and more than 78% “reported an improvement in their overall satisfaction with the look and feel of their lips” 1 year after treatment.
Filler approved for lip augmentation
The Food and Drug Administration has approved a Juvederm product for lip augmentation, according to the manufacturer.
In an Oct. 1 press release, Allergan announced that Juvederm Ultra XC had been approved for “injection into the lips and perioral area for lip augmentation in adults over the age of 21.”
The product is described as a smooth gel formulation made up of a modified form of hyaluronic acid; it also contains lidocaine. In clinical studies, 79% of participants “showed a meaningful improvement in lip fullness” 3 months after treatment, the company said, and more than 78% “reported an improvement in their overall satisfaction with the look and feel of their lips” 1 year after treatment.
The Food and Drug Administration has approved a Juvederm product for lip augmentation, according to the manufacturer.
In an Oct. 1 press release, Allergan announced that Juvederm Ultra XC had been approved for “injection into the lips and perioral area for lip augmentation in adults over the age of 21.”
The product is described as a smooth gel formulation made up of a modified form of hyaluronic acid; it also contains lidocaine. In clinical studies, 79% of participants “showed a meaningful improvement in lip fullness” 3 months after treatment, the company said, and more than 78% “reported an improvement in their overall satisfaction with the look and feel of their lips” 1 year after treatment.
The Food and Drug Administration has approved a Juvederm product for lip augmentation, according to the manufacturer.
In an Oct. 1 press release, Allergan announced that Juvederm Ultra XC had been approved for “injection into the lips and perioral area for lip augmentation in adults over the age of 21.”
The product is described as a smooth gel formulation made up of a modified form of hyaluronic acid; it also contains lidocaine. In clinical studies, 79% of participants “showed a meaningful improvement in lip fullness” 3 months after treatment, the company said, and more than 78% “reported an improvement in their overall satisfaction with the look and feel of their lips” 1 year after treatment.
FDA approves nivolumab-ipilimumab combination for melanoma
Nivolumab, a programmed death receptor-1 (PD-1)–blocking antibody, has been approved for use in combination with ipilimumab for treating people with BRAF V600 wild-type, unresectable or metastatic melanoma.
Approval was based on demonstration of an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival (PFS) in an international, multicenter, double-blind, randomized, two-arm, active-controlled trial in patients who were previously untreated for unresectable or metastatic, BRAF V600 wild-type melanoma, according to a Sept. 30 statement issued by the Food and Drug Administration.
Nivolumab, marketed as Opdivo Injection by Bristol-Myers Squibb, was approved in 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, a BRAF inhibitor. Ipilimumab, approved in 2011 and marketed as Yervoy by BMS, is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody indicated for treating unresectable or metastatic melanoma.
“Combined nivolumab (anti–PD-1) and ipilimumab (anti–CTLA-4) mediated inhibition results in enhanced T-cell function that is greater than the effects of either antibody alone, and results in improved antitumor responses in metastatic melanoma,” the updated nivolumab prescribing information states.
This is the first FDA approval of a cancer treatment regimen that includes two immuno-oncology agents, according to the company’s statement announcing the approval.
The phase II CheckMate 069 study enrolled 142 patients, including 109 patients with BRAF V600 wild-type melanoma, randomized in a 2:1 ratio to receive the combination or ipilimumab plus placebo; their median age was 66 years; 84% had an ECOG performance score of 0, and 15% had a score of 1. The overall response rate was 60% among those on the combination therapy vs. 11% among those on ipilimumab alone – a 49% improvement (P less than .001), according to the FDA.
Nine of the 43 patients with an objective response (ranging from 3 to 7 months) in the combination therapy group “have progressed after response, died, or received subsequent therapy,” the FDA said. Among the 34 patients who continued to have a response at the last analysis, 14 had responses that had lasted from at least 6 months to less than 9 months. The remaining 20 patients had responses that had lasted at least 9 months.
The estimated median PFS was 8.9 months in the combination group vs. 4.7 months in the ipilimumab-only arm, a 60% reduced risk (P less than .002)
Serious adverse reactions, adverse reactions resulting in permanent discontinuation or a delayed dose, and grade 3 or 4 adverse reaction were higher among those treated with the combination. Colitis, diarrhea, pyrexia, and pneumonitis were the most common serious adverse reactions among those on the combination.
The recommended dose and schedule is as follows, according to the FDA: 1 mg/kg of nivolumab administered as an IV infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for four doses. “The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.”
Both indications for nivolumab were approved as accelerated approvals, based on the “tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the prescribing information.
Serious adverse events associated with this therapy should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch.
Nivolumab, a programmed death receptor-1 (PD-1)–blocking antibody, has been approved for use in combination with ipilimumab for treating people with BRAF V600 wild-type, unresectable or metastatic melanoma.
Approval was based on demonstration of an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival (PFS) in an international, multicenter, double-blind, randomized, two-arm, active-controlled trial in patients who were previously untreated for unresectable or metastatic, BRAF V600 wild-type melanoma, according to a Sept. 30 statement issued by the Food and Drug Administration.
Nivolumab, marketed as Opdivo Injection by Bristol-Myers Squibb, was approved in 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, a BRAF inhibitor. Ipilimumab, approved in 2011 and marketed as Yervoy by BMS, is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody indicated for treating unresectable or metastatic melanoma.
“Combined nivolumab (anti–PD-1) and ipilimumab (anti–CTLA-4) mediated inhibition results in enhanced T-cell function that is greater than the effects of either antibody alone, and results in improved antitumor responses in metastatic melanoma,” the updated nivolumab prescribing information states.
This is the first FDA approval of a cancer treatment regimen that includes two immuno-oncology agents, according to the company’s statement announcing the approval.
The phase II CheckMate 069 study enrolled 142 patients, including 109 patients with BRAF V600 wild-type melanoma, randomized in a 2:1 ratio to receive the combination or ipilimumab plus placebo; their median age was 66 years; 84% had an ECOG performance score of 0, and 15% had a score of 1. The overall response rate was 60% among those on the combination therapy vs. 11% among those on ipilimumab alone – a 49% improvement (P less than .001), according to the FDA.
Nine of the 43 patients with an objective response (ranging from 3 to 7 months) in the combination therapy group “have progressed after response, died, or received subsequent therapy,” the FDA said. Among the 34 patients who continued to have a response at the last analysis, 14 had responses that had lasted from at least 6 months to less than 9 months. The remaining 20 patients had responses that had lasted at least 9 months.
The estimated median PFS was 8.9 months in the combination group vs. 4.7 months in the ipilimumab-only arm, a 60% reduced risk (P less than .002)
Serious adverse reactions, adverse reactions resulting in permanent discontinuation or a delayed dose, and grade 3 or 4 adverse reaction were higher among those treated with the combination. Colitis, diarrhea, pyrexia, and pneumonitis were the most common serious adverse reactions among those on the combination.
The recommended dose and schedule is as follows, according to the FDA: 1 mg/kg of nivolumab administered as an IV infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for four doses. “The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.”
Both indications for nivolumab were approved as accelerated approvals, based on the “tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the prescribing information.
Serious adverse events associated with this therapy should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch.
Nivolumab, a programmed death receptor-1 (PD-1)–blocking antibody, has been approved for use in combination with ipilimumab for treating people with BRAF V600 wild-type, unresectable or metastatic melanoma.
Approval was based on demonstration of an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival (PFS) in an international, multicenter, double-blind, randomized, two-arm, active-controlled trial in patients who were previously untreated for unresectable or metastatic, BRAF V600 wild-type melanoma, according to a Sept. 30 statement issued by the Food and Drug Administration.
Nivolumab, marketed as Opdivo Injection by Bristol-Myers Squibb, was approved in 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, a BRAF inhibitor. Ipilimumab, approved in 2011 and marketed as Yervoy by BMS, is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody indicated for treating unresectable or metastatic melanoma.
“Combined nivolumab (anti–PD-1) and ipilimumab (anti–CTLA-4) mediated inhibition results in enhanced T-cell function that is greater than the effects of either antibody alone, and results in improved antitumor responses in metastatic melanoma,” the updated nivolumab prescribing information states.
This is the first FDA approval of a cancer treatment regimen that includes two immuno-oncology agents, according to the company’s statement announcing the approval.
The phase II CheckMate 069 study enrolled 142 patients, including 109 patients with BRAF V600 wild-type melanoma, randomized in a 2:1 ratio to receive the combination or ipilimumab plus placebo; their median age was 66 years; 84% had an ECOG performance score of 0, and 15% had a score of 1. The overall response rate was 60% among those on the combination therapy vs. 11% among those on ipilimumab alone – a 49% improvement (P less than .001), according to the FDA.
Nine of the 43 patients with an objective response (ranging from 3 to 7 months) in the combination therapy group “have progressed after response, died, or received subsequent therapy,” the FDA said. Among the 34 patients who continued to have a response at the last analysis, 14 had responses that had lasted from at least 6 months to less than 9 months. The remaining 20 patients had responses that had lasted at least 9 months.
The estimated median PFS was 8.9 months in the combination group vs. 4.7 months in the ipilimumab-only arm, a 60% reduced risk (P less than .002)
Serious adverse reactions, adverse reactions resulting in permanent discontinuation or a delayed dose, and grade 3 or 4 adverse reaction were higher among those treated with the combination. Colitis, diarrhea, pyrexia, and pneumonitis were the most common serious adverse reactions among those on the combination.
The recommended dose and schedule is as follows, according to the FDA: 1 mg/kg of nivolumab administered as an IV infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for four doses. “The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.”
Both indications for nivolumab were approved as accelerated approvals, based on the “tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials,” according to the prescribing information.
Serious adverse events associated with this therapy should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch.
New FDA approval for adalimumab: Hidradenitis suppurativa
The approval of adalimumab has been expanded to include the treatment of moderate to severe hidradenitis suppurativa.
Approval is based on the results of two phase III studies, PIONEER Iand PIONEER II; this is the first product approved for treating hidradenitis suppurativa, according to the manufacturer, AbbVie. AbbVie markets adalimumab as Humira.
The studies compared adalimumab to placebo in 633 adults with Hurley Stage II or III disease with at least three abscesses or inflammatory nodules. In both studies, more patients treated with adalimumab (40 mg a week) had a clinical response at week 12, based on the Hidradenitis Suppurativa Clinical Response (at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline): 42% vs. 26% in one study, and 59% vs. 28% in the second study, according to the updated prescribing information.
This is the ninth approved indication for adalimumab, a tumor necrosis factor blocker approved for treating rheumatoid arthritis in 2002. Other Food and Drug Administration–approved indications include psoriatic arthritis, plaque psoriasis, and Crohn’s disease.
The prescribing information for adalimumab includes a boxed warning about the risk of serious infections and reports of malignancies in people treated with adalimumab and other TNF blockers; it is approved with a Medication Guide that explains the potential serious risks associated with treatment to patients.
Serious adverse events associated with adalimumab should be reported to the FDA MedWatch program.
The approval of adalimumab has been expanded to include the treatment of moderate to severe hidradenitis suppurativa.
Approval is based on the results of two phase III studies, PIONEER Iand PIONEER II; this is the first product approved for treating hidradenitis suppurativa, according to the manufacturer, AbbVie. AbbVie markets adalimumab as Humira.
The studies compared adalimumab to placebo in 633 adults with Hurley Stage II or III disease with at least three abscesses or inflammatory nodules. In both studies, more patients treated with adalimumab (40 mg a week) had a clinical response at week 12, based on the Hidradenitis Suppurativa Clinical Response (at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline): 42% vs. 26% in one study, and 59% vs. 28% in the second study, according to the updated prescribing information.
This is the ninth approved indication for adalimumab, a tumor necrosis factor blocker approved for treating rheumatoid arthritis in 2002. Other Food and Drug Administration–approved indications include psoriatic arthritis, plaque psoriasis, and Crohn’s disease.
The prescribing information for adalimumab includes a boxed warning about the risk of serious infections and reports of malignancies in people treated with adalimumab and other TNF blockers; it is approved with a Medication Guide that explains the potential serious risks associated with treatment to patients.
Serious adverse events associated with adalimumab should be reported to the FDA MedWatch program.
The approval of adalimumab has been expanded to include the treatment of moderate to severe hidradenitis suppurativa.
Approval is based on the results of two phase III studies, PIONEER Iand PIONEER II; this is the first product approved for treating hidradenitis suppurativa, according to the manufacturer, AbbVie. AbbVie markets adalimumab as Humira.
The studies compared adalimumab to placebo in 633 adults with Hurley Stage II or III disease with at least three abscesses or inflammatory nodules. In both studies, more patients treated with adalimumab (40 mg a week) had a clinical response at week 12, based on the Hidradenitis Suppurativa Clinical Response (at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline): 42% vs. 26% in one study, and 59% vs. 28% in the second study, according to the updated prescribing information.
This is the ninth approved indication for adalimumab, a tumor necrosis factor blocker approved for treating rheumatoid arthritis in 2002. Other Food and Drug Administration–approved indications include psoriatic arthritis, plaque psoriasis, and Crohn’s disease.
The prescribing information for adalimumab includes a boxed warning about the risk of serious infections and reports of malignancies in people treated with adalimumab and other TNF blockers; it is approved with a Medication Guide that explains the potential serious risks associated with treatment to patients.
Serious adverse events associated with adalimumab should be reported to the FDA MedWatch program.
FDA approves ReShape intragastric balloon device
The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.
The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30-40 kg/m2 and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m2 (or at least 30 kg/m2 in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m2 (or at least 35 kg/m2 in people with at least one obesity-related comorbidity).
The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.
The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m2; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.
After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.
Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.
The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.”
While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.
“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.
The ReShape device has been available in Europe since 2007.
Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.
The AGA Center for GI Innovation and Technology is committed to supporting the development of new devices and their introduction to the market in a safe and efficient manner. The center has been working with the FDA for the past several years to help the agency determine how to assess obesity devices.
“It is gratifying to see that the FDA continues to facilitate technologies to address significant public health concerns,” said chair of the center, Dr. Michael L. Kochman, FACP, AGAF. “The AGA Center for GI Innovation and Technology’s obesity-focused meeting, held in conjunction with the FDA, and the annual AGA Tech Summits have helped inform the discussion surrounding the new and novel devices in the obesity and metabolism space.”
The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.
The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30-40 kg/m2 and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m2 (or at least 30 kg/m2 in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m2 (or at least 35 kg/m2 in people with at least one obesity-related comorbidity).
The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.
The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m2; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.
After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.
Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.
The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.”
While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.
“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.
The ReShape device has been available in Europe since 2007.
Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.
The AGA Center for GI Innovation and Technology is committed to supporting the development of new devices and their introduction to the market in a safe and efficient manner. The center has been working with the FDA for the past several years to help the agency determine how to assess obesity devices.
“It is gratifying to see that the FDA continues to facilitate technologies to address significant public health concerns,” said chair of the center, Dr. Michael L. Kochman, FACP, AGAF. “The AGA Center for GI Innovation and Technology’s obesity-focused meeting, held in conjunction with the FDA, and the annual AGA Tech Summits have helped inform the discussion surrounding the new and novel devices in the obesity and metabolism space.”
The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.
The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30-40 kg/m2 and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m2 (or at least 30 kg/m2 in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m2 (or at least 35 kg/m2 in people with at least one obesity-related comorbidity).
The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.
The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m2; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.
After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.
Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.
The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.”
While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.
“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.
The ReShape device has been available in Europe since 2007.
Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.
The AGA Center for GI Innovation and Technology is committed to supporting the development of new devices and their introduction to the market in a safe and efficient manner. The center has been working with the FDA for the past several years to help the agency determine how to assess obesity devices.
“It is gratifying to see that the FDA continues to facilitate technologies to address significant public health concerns,” said chair of the center, Dr. Michael L. Kochman, FACP, AGAF. “The AGA Center for GI Innovation and Technology’s obesity-focused meeting, held in conjunction with the FDA, and the annual AGA Tech Summits have helped inform the discussion surrounding the new and novel devices in the obesity and metabolism space.”
FDA: Extra steps for cleaner scopes
Addressing recent outbreaks of serious, sometimes fatal infections associated with duodenoscopes, the Food and Drug Administration has issued recommendations for taking extra steps to improve the reprocessing of these devices, which “may further help reduce the risk of infection transmission,” the agency said in an August 4 statement.
The extra measures are microbiological culturing, ethylene oxide sterilization, the use of a liquid chemical sterilant processing system, and repeated high-level disinfection. “Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices,” according to the FDA’s statement announcing the measures.
The statement acknowledges that some health care facilities will not be able to implement one or more of these steps, so “it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks.”
And while it is not possible to completely eliminate the risk of transmitting infections, “the benefits of these devices continue to outweigh the risks in appropriately selected patients,” the statement adds. These recommendations and the statement regarding the risk-benefit profile of these devices, used to perform endoscopic retrograde cholangiopancreatography, reflect comments of panelists at a meeting of the FDA’s s gastroenterology and urology devices panel on May 14 and 15, in which AGA participated, to address recent concerns about duodenoscopes and several outbreaks in U.S. hospitals of serious infections related to the devices.
The FDA’s statement is available here.
Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088.
Addressing recent outbreaks of serious, sometimes fatal infections associated with duodenoscopes, the Food and Drug Administration has issued recommendations for taking extra steps to improve the reprocessing of these devices, which “may further help reduce the risk of infection transmission,” the agency said in an August 4 statement.
The extra measures are microbiological culturing, ethylene oxide sterilization, the use of a liquid chemical sterilant processing system, and repeated high-level disinfection. “Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices,” according to the FDA’s statement announcing the measures.
The statement acknowledges that some health care facilities will not be able to implement one or more of these steps, so “it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks.”
And while it is not possible to completely eliminate the risk of transmitting infections, “the benefits of these devices continue to outweigh the risks in appropriately selected patients,” the statement adds. These recommendations and the statement regarding the risk-benefit profile of these devices, used to perform endoscopic retrograde cholangiopancreatography, reflect comments of panelists at a meeting of the FDA’s s gastroenterology and urology devices panel on May 14 and 15, in which AGA participated, to address recent concerns about duodenoscopes and several outbreaks in U.S. hospitals of serious infections related to the devices.
The FDA’s statement is available here.
Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088.
Addressing recent outbreaks of serious, sometimes fatal infections associated with duodenoscopes, the Food and Drug Administration has issued recommendations for taking extra steps to improve the reprocessing of these devices, which “may further help reduce the risk of infection transmission,” the agency said in an August 4 statement.
The extra measures are microbiological culturing, ethylene oxide sterilization, the use of a liquid chemical sterilant processing system, and repeated high-level disinfection. “Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices,” according to the FDA’s statement announcing the measures.
The statement acknowledges that some health care facilities will not be able to implement one or more of these steps, so “it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks.”
And while it is not possible to completely eliminate the risk of transmitting infections, “the benefits of these devices continue to outweigh the risks in appropriately selected patients,” the statement adds. These recommendations and the statement regarding the risk-benefit profile of these devices, used to perform endoscopic retrograde cholangiopancreatography, reflect comments of panelists at a meeting of the FDA’s s gastroenterology and urology devices panel on May 14 and 15, in which AGA participated, to address recent concerns about duodenoscopes and several outbreaks in U.S. hospitals of serious infections related to the devices.
The FDA’s statement is available here.
Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program at 800-332-1088.
Intestinal obstruction risk increased in some childhood cancer survivors
Childhood cancer survivors are at an increased risk for developing an intestinal obstruction requiring surgery (IOS) 5 or more years after the initial cancer diagnosis, according to a study based on data from the Childhood Cancer Survivor Study.
The risk was greater among those who had a pelvic or abdominal tumor and had been exposed to pelvic or abdominal radiotherapy, reported the authors, who pointed out that no study has “rigorously” investigated the incidence of intestinal obstruction in childhood cancer survivors. The study appeared online in the Journal of Clinical Oncology (2015 Aug 10 doi: 10.1200/JCO.2015.61.5070).
The subjects in the study had been diagnosed with cancer before age 21 years between 1970 and 1986 and were followed longitudinally in the CCSS. The sample included 12,316 childhood cancer survivors who had survived at least 5 years from the time they were diagnosed with cancer and 4,023 of their siblings.
The cumulative incidence of “late” IOS (occurring at least 5 years after the cancer diagnosis) was 5.8% among those who had an abdominopelvic tumor and 1% among those who had other types of cancer, compared with 0.3% among siblings, who served as controls in the study. After adjusting for year of diagnosis, age at diagnosis, cancer type, radiotherapy, surgery, and other confounding factors, the risk of late IOS was significantly increased among those who had an abdominopelvic tumor (3.6 times greater) and those who had received abdominal/pelvic radiotherapy (2.4 times greater). Mortality was also almost twofold higher among those who developed late IOS when adjusted for the same factors, but there was no association with chemotherapy, cyclophosphamide equivalent dose, or platinum agent score and late IOS.
“The risk of IOS extends for decades beyond cancer diagnosis, implying the need for long-term vigilance, especially among survivors with abdominal or pelvic tumors and survivors who have undergone treatment with abdominal or pelvic surgery or radiotherapy,” concluded lead author Dr. Arin Madenci of Boston Children’s Hospital and his coauthors.
“Widespread awareness of the signs and symptoms of IOS will facilitate timely presentation and effective management of this complication. Although prevention of IOS is not currently possible, education of survivors of cancer, their families, and their health care providers is critical,” they added.
The study was supported by grants from the National Cancer Institute and Cancer Center Support (Centers of Research Excellence) and by the American Lebanese Syrian Associated Charities. Dr. Madenci and nine other authors had no disclosures. The remaining three authors had disclosures that included receiving honoraria, travel, and expenses from Sandoz, holding stock or other ownership in Pfizer and Novartis, serving as a consultant or advisor to United Therapeutics, and having an immediate family member with stock or other ownership in several pharmaceutical companies.
Childhood cancer survivors are at an increased risk for developing an intestinal obstruction requiring surgery (IOS) 5 or more years after the initial cancer diagnosis, according to a study based on data from the Childhood Cancer Survivor Study.
The risk was greater among those who had a pelvic or abdominal tumor and had been exposed to pelvic or abdominal radiotherapy, reported the authors, who pointed out that no study has “rigorously” investigated the incidence of intestinal obstruction in childhood cancer survivors. The study appeared online in the Journal of Clinical Oncology (2015 Aug 10 doi: 10.1200/JCO.2015.61.5070).
The subjects in the study had been diagnosed with cancer before age 21 years between 1970 and 1986 and were followed longitudinally in the CCSS. The sample included 12,316 childhood cancer survivors who had survived at least 5 years from the time they were diagnosed with cancer and 4,023 of their siblings.
The cumulative incidence of “late” IOS (occurring at least 5 years after the cancer diagnosis) was 5.8% among those who had an abdominopelvic tumor and 1% among those who had other types of cancer, compared with 0.3% among siblings, who served as controls in the study. After adjusting for year of diagnosis, age at diagnosis, cancer type, radiotherapy, surgery, and other confounding factors, the risk of late IOS was significantly increased among those who had an abdominopelvic tumor (3.6 times greater) and those who had received abdominal/pelvic radiotherapy (2.4 times greater). Mortality was also almost twofold higher among those who developed late IOS when adjusted for the same factors, but there was no association with chemotherapy, cyclophosphamide equivalent dose, or platinum agent score and late IOS.
“The risk of IOS extends for decades beyond cancer diagnosis, implying the need for long-term vigilance, especially among survivors with abdominal or pelvic tumors and survivors who have undergone treatment with abdominal or pelvic surgery or radiotherapy,” concluded lead author Dr. Arin Madenci of Boston Children’s Hospital and his coauthors.
“Widespread awareness of the signs and symptoms of IOS will facilitate timely presentation and effective management of this complication. Although prevention of IOS is not currently possible, education of survivors of cancer, their families, and their health care providers is critical,” they added.
The study was supported by grants from the National Cancer Institute and Cancer Center Support (Centers of Research Excellence) and by the American Lebanese Syrian Associated Charities. Dr. Madenci and nine other authors had no disclosures. The remaining three authors had disclosures that included receiving honoraria, travel, and expenses from Sandoz, holding stock or other ownership in Pfizer and Novartis, serving as a consultant or advisor to United Therapeutics, and having an immediate family member with stock or other ownership in several pharmaceutical companies.
Childhood cancer survivors are at an increased risk for developing an intestinal obstruction requiring surgery (IOS) 5 or more years after the initial cancer diagnosis, according to a study based on data from the Childhood Cancer Survivor Study.
The risk was greater among those who had a pelvic or abdominal tumor and had been exposed to pelvic or abdominal radiotherapy, reported the authors, who pointed out that no study has “rigorously” investigated the incidence of intestinal obstruction in childhood cancer survivors. The study appeared online in the Journal of Clinical Oncology (2015 Aug 10 doi: 10.1200/JCO.2015.61.5070).
The subjects in the study had been diagnosed with cancer before age 21 years between 1970 and 1986 and were followed longitudinally in the CCSS. The sample included 12,316 childhood cancer survivors who had survived at least 5 years from the time they were diagnosed with cancer and 4,023 of their siblings.
The cumulative incidence of “late” IOS (occurring at least 5 years after the cancer diagnosis) was 5.8% among those who had an abdominopelvic tumor and 1% among those who had other types of cancer, compared with 0.3% among siblings, who served as controls in the study. After adjusting for year of diagnosis, age at diagnosis, cancer type, radiotherapy, surgery, and other confounding factors, the risk of late IOS was significantly increased among those who had an abdominopelvic tumor (3.6 times greater) and those who had received abdominal/pelvic radiotherapy (2.4 times greater). Mortality was also almost twofold higher among those who developed late IOS when adjusted for the same factors, but there was no association with chemotherapy, cyclophosphamide equivalent dose, or platinum agent score and late IOS.
“The risk of IOS extends for decades beyond cancer diagnosis, implying the need for long-term vigilance, especially among survivors with abdominal or pelvic tumors and survivors who have undergone treatment with abdominal or pelvic surgery or radiotherapy,” concluded lead author Dr. Arin Madenci of Boston Children’s Hospital and his coauthors.
“Widespread awareness of the signs and symptoms of IOS will facilitate timely presentation and effective management of this complication. Although prevention of IOS is not currently possible, education of survivors of cancer, their families, and their health care providers is critical,” they added.
The study was supported by grants from the National Cancer Institute and Cancer Center Support (Centers of Research Excellence) and by the American Lebanese Syrian Associated Charities. Dr. Madenci and nine other authors had no disclosures. The remaining three authors had disclosures that included receiving honoraria, travel, and expenses from Sandoz, holding stock or other ownership in Pfizer and Novartis, serving as a consultant or advisor to United Therapeutics, and having an immediate family member with stock or other ownership in several pharmaceutical companies.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Some childhood cancer survivors are at a significantly increased risk of developing an intestinal obstruction requiring surgery (IOS), which should be considered in their long-term follow-up.
Major finding: The cumulative incidence of IOS occurring at least 5 years after the cancer diagnosis was 5.8% among those who had an abdominopelvic tumor and 1% among those who did not have an abdominopelvic tumor, compared with 0.3% among sibling controls in the study, and late IOS was associated with increased mortality.
Data source: A retrospective cohort study involving 12,316 childhood cancer survivors who had survived at least 5 years and 4,023 of their siblings, who served as controls, from the Childhood Cancer Survivor Study.
Disclosures: The study was supported by National Cancer Institute and Cancer Center Support (Centers of Research Excellence) grants, and by the American Lebanese Syrian Associated Charities. Dr. Madenci and nine other authors had no disclosures. The remaining three authors had disclosures that included receiving honoraria, travel, and expenses from Sandoz, holding stock or other ownership in Pfizer and Novartis, serving as a consultant or advisor to United Therapeutics, and having an immediate family member with stock or other ownership in several pharmaceutical companies.
Orbera intragastric balloon approved for weight loss in obese adults
Another endoscopically delivered intragastric balloon indicated as a weight loss aid in obese adults has been approved by the Food and Drug Administration.
The Orbera intragastric balloon has been approved as a treatment for weight loss, in obese adults, with a body mass index between 30 and 40 kg/m2, the manufacturer, Apollo Endosurgery, announced on Aug. 6. It is intended for obese adults who are considering invasive surgery or for whom invasive surgery is not appropriate, when diet and exercise or pharmaceutical interventions have not worked, the statement said.
During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later. The company will provide patients with an individualized weight-loss program for patients for 1 year, starting from the time of balloon placement.
The approval of this device follows the approval of the ReShape intragastric balloon for obese adults, for up to 6 months, announced by the FDA on July 28. ReShape was the first such device to be approved in the United States.
The results of the pivotal U.S. 12-month multicenter trial of the Orbera balloon in more than 250 obese adults with a BMI of 30-40 kg/m2 were reported at the Digestive Disease Week meeting in May, by Dr. Barham K. Abu Dayyeh of the Mayo Clinic in Rochester, Minn. For more than 2 years, patients were randomized to a 12-month behavioral modification program, with or without endoscopic placement of the balloon, which was removed at 6 months. Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months.
At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001). In addition, the total body weight loss was significantly higher in the balloon group at 3, 6, 9, and 12 months, and the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P less than .001), he said at the meeting. The majority of excess weight loss achieved at 6 months was also maintained at 12 months.
Serious adverse events were reported in 7% of controls and almost 10% of the balloon group, which included eight early removals for intolerance, one gastric outlet obstruction, one laryngospasm during placement, one case of severe abdominal cramping, and one case of severe dehydration. Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. There were no deaths during the study.
The Orbera balloon has been available in more than 80 countries, according to the manufacturer.
More information is available on the FDA website.
Another endoscopically delivered intragastric balloon indicated as a weight loss aid in obese adults has been approved by the Food and Drug Administration.
The Orbera intragastric balloon has been approved as a treatment for weight loss, in obese adults, with a body mass index between 30 and 40 kg/m2, the manufacturer, Apollo Endosurgery, announced on Aug. 6. It is intended for obese adults who are considering invasive surgery or for whom invasive surgery is not appropriate, when diet and exercise or pharmaceutical interventions have not worked, the statement said.
During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later. The company will provide patients with an individualized weight-loss program for patients for 1 year, starting from the time of balloon placement.
The approval of this device follows the approval of the ReShape intragastric balloon for obese adults, for up to 6 months, announced by the FDA on July 28. ReShape was the first such device to be approved in the United States.
The results of the pivotal U.S. 12-month multicenter trial of the Orbera balloon in more than 250 obese adults with a BMI of 30-40 kg/m2 were reported at the Digestive Disease Week meeting in May, by Dr. Barham K. Abu Dayyeh of the Mayo Clinic in Rochester, Minn. For more than 2 years, patients were randomized to a 12-month behavioral modification program, with or without endoscopic placement of the balloon, which was removed at 6 months. Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months.
At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001). In addition, the total body weight loss was significantly higher in the balloon group at 3, 6, 9, and 12 months, and the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P less than .001), he said at the meeting. The majority of excess weight loss achieved at 6 months was also maintained at 12 months.
Serious adverse events were reported in 7% of controls and almost 10% of the balloon group, which included eight early removals for intolerance, one gastric outlet obstruction, one laryngospasm during placement, one case of severe abdominal cramping, and one case of severe dehydration. Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. There were no deaths during the study.
The Orbera balloon has been available in more than 80 countries, according to the manufacturer.
More information is available on the FDA website.
Another endoscopically delivered intragastric balloon indicated as a weight loss aid in obese adults has been approved by the Food and Drug Administration.
The Orbera intragastric balloon has been approved as a treatment for weight loss, in obese adults, with a body mass index between 30 and 40 kg/m2, the manufacturer, Apollo Endosurgery, announced on Aug. 6. It is intended for obese adults who are considering invasive surgery or for whom invasive surgery is not appropriate, when diet and exercise or pharmaceutical interventions have not worked, the statement said.
During a 20- to 30-minute procedure, the deflated Orbera silicone balloon is placed in the stomach via an endoscopic procedure under a mild sedative, where it is then filled with saline until it is about the size of a grapefruit, according to the company. The patient usually can go home on the same day; the balloon is deflated and removed 6 months later. The company will provide patients with an individualized weight-loss program for patients for 1 year, starting from the time of balloon placement.
The approval of this device follows the approval of the ReShape intragastric balloon for obese adults, for up to 6 months, announced by the FDA on July 28. ReShape was the first such device to be approved in the United States.
The results of the pivotal U.S. 12-month multicenter trial of the Orbera balloon in more than 250 obese adults with a BMI of 30-40 kg/m2 were reported at the Digestive Disease Week meeting in May, by Dr. Barham K. Abu Dayyeh of the Mayo Clinic in Rochester, Minn. For more than 2 years, patients were randomized to a 12-month behavioral modification program, with or without endoscopic placement of the balloon, which was removed at 6 months. Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months.
At 6 months, the mean percent total body weight loss was about 10% in the balloon group, vs. 4% in the control group, a significant difference (P less than .001). In addition, the total body weight loss was significantly higher in the balloon group at 3, 6, 9, and 12 months, and the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P less than .001), he said at the meeting. The majority of excess weight loss achieved at 6 months was also maintained at 12 months.
Serious adverse events were reported in 7% of controls and almost 10% of the balloon group, which included eight early removals for intolerance, one gastric outlet obstruction, one laryngospasm during placement, one case of severe abdominal cramping, and one case of severe dehydration. Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. There were no deaths during the study.
The Orbera balloon has been available in more than 80 countries, according to the manufacturer.
More information is available on the FDA website.
FDA reports two PML cases in patients with MS treated with fingolimod
For the first time, progressive multifocal leukoencephalopathy has been reported in patients with multiple sclerosis who are being treated with fingolimod but have not been treated with an immunosuppressant, according to a Food and Drug Administration warning issued on Aug. 4.
Two cases have been reported; one is a definite case and the second is considered a probable case. A European case of progressive multifocal leukoencephalopathy (PML) in a patient on fingolimod previously described by the FDA in 2013 was not “conclusively linked” to the drug because the patient had been treated with an immunosuppressant drug that can cause PML and had been treated with intravenous corticosteroids during treatment with fingolimod, the statement said.
PML is a rare, serious, potentially fatal brain infection caused by the JC (John Cunningham) virus, which is present in most people, but can cause PML in patients who are immunosuppressed or are on immunosuppressive drugs. Symptoms of PML may include clumsiness of limbs, progressive weakness on one side of the body, confusion, vision disturbances, as well as changes in thinking, memory, and orientation. Clinicians who suspect that a patient on fingolimod may have PML should stop treatment and evaluate the patient for a diagnosis of PML, according to the FDA warning, which advises people on fingolimod to contact their health care professionals immediately “if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.”
Symptoms in the patient with definite PML, a 54-year old who had had MS for 13-14 years and had been treated with fingolimod for about 2.5 years, included instability while walking, clumsiness, inattention, somnolence, and mental sluggishness. JC viral DNA was present in the cerebrospinal fluid and MRI findings were characteristic of PML. The probable case was in a 49-year-old who had been treated with fingolimod for about 4 years, and had no symptoms, but had new MRI lesions consistent with PML and a CSF test that was positive for JC viral DNA.
To diagnose PML, “an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended,” according to the prescribing information for natalizumab (Tysabri), an intravenously administered treatment for MS that increases the risk of PML.
Fingolimod, taken once a day by mouth, is a sphingosine 1-phosphate receptor modulator marketed as Gilenya by Novartis. It was approved in 2010 and is indicated for treating relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
The fingolimod prescribing information and Medication Guide are being updated to include information about the two cases.
Possible cases of PML associated with fingolimod should be reported to the FDA’s MedWatch program website or by calling 1-800-332-1088.
For the first time, progressive multifocal leukoencephalopathy has been reported in patients with multiple sclerosis who are being treated with fingolimod but have not been treated with an immunosuppressant, according to a Food and Drug Administration warning issued on Aug. 4.
Two cases have been reported; one is a definite case and the second is considered a probable case. A European case of progressive multifocal leukoencephalopathy (PML) in a patient on fingolimod previously described by the FDA in 2013 was not “conclusively linked” to the drug because the patient had been treated with an immunosuppressant drug that can cause PML and had been treated with intravenous corticosteroids during treatment with fingolimod, the statement said.
PML is a rare, serious, potentially fatal brain infection caused by the JC (John Cunningham) virus, which is present in most people, but can cause PML in patients who are immunosuppressed or are on immunosuppressive drugs. Symptoms of PML may include clumsiness of limbs, progressive weakness on one side of the body, confusion, vision disturbances, as well as changes in thinking, memory, and orientation. Clinicians who suspect that a patient on fingolimod may have PML should stop treatment and evaluate the patient for a diagnosis of PML, according to the FDA warning, which advises people on fingolimod to contact their health care professionals immediately “if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.”
Symptoms in the patient with definite PML, a 54-year old who had had MS for 13-14 years and had been treated with fingolimod for about 2.5 years, included instability while walking, clumsiness, inattention, somnolence, and mental sluggishness. JC viral DNA was present in the cerebrospinal fluid and MRI findings were characteristic of PML. The probable case was in a 49-year-old who had been treated with fingolimod for about 4 years, and had no symptoms, but had new MRI lesions consistent with PML and a CSF test that was positive for JC viral DNA.
To diagnose PML, “an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended,” according to the prescribing information for natalizumab (Tysabri), an intravenously administered treatment for MS that increases the risk of PML.
Fingolimod, taken once a day by mouth, is a sphingosine 1-phosphate receptor modulator marketed as Gilenya by Novartis. It was approved in 2010 and is indicated for treating relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
The fingolimod prescribing information and Medication Guide are being updated to include information about the two cases.
Possible cases of PML associated with fingolimod should be reported to the FDA’s MedWatch program website or by calling 1-800-332-1088.
For the first time, progressive multifocal leukoencephalopathy has been reported in patients with multiple sclerosis who are being treated with fingolimod but have not been treated with an immunosuppressant, according to a Food and Drug Administration warning issued on Aug. 4.
Two cases have been reported; one is a definite case and the second is considered a probable case. A European case of progressive multifocal leukoencephalopathy (PML) in a patient on fingolimod previously described by the FDA in 2013 was not “conclusively linked” to the drug because the patient had been treated with an immunosuppressant drug that can cause PML and had been treated with intravenous corticosteroids during treatment with fingolimod, the statement said.
PML is a rare, serious, potentially fatal brain infection caused by the JC (John Cunningham) virus, which is present in most people, but can cause PML in patients who are immunosuppressed or are on immunosuppressive drugs. Symptoms of PML may include clumsiness of limbs, progressive weakness on one side of the body, confusion, vision disturbances, as well as changes in thinking, memory, and orientation. Clinicians who suspect that a patient on fingolimod may have PML should stop treatment and evaluate the patient for a diagnosis of PML, according to the FDA warning, which advises people on fingolimod to contact their health care professionals immediately “if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.”
Symptoms in the patient with definite PML, a 54-year old who had had MS for 13-14 years and had been treated with fingolimod for about 2.5 years, included instability while walking, clumsiness, inattention, somnolence, and mental sluggishness. JC viral DNA was present in the cerebrospinal fluid and MRI findings were characteristic of PML. The probable case was in a 49-year-old who had been treated with fingolimod for about 4 years, and had no symptoms, but had new MRI lesions consistent with PML and a CSF test that was positive for JC viral DNA.
To diagnose PML, “an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended,” according to the prescribing information for natalizumab (Tysabri), an intravenously administered treatment for MS that increases the risk of PML.
Fingolimod, taken once a day by mouth, is a sphingosine 1-phosphate receptor modulator marketed as Gilenya by Novartis. It was approved in 2010 and is indicated for treating relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
The fingolimod prescribing information and Medication Guide are being updated to include information about the two cases.
Possible cases of PML associated with fingolimod should be reported to the FDA’s MedWatch program website or by calling 1-800-332-1088.
