SPARTAN (SPondyloArthritis Research & Treatment Network): Annual Meeting

NEW YORK – For the first time, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis is preparing evidence-based treatment recommendations for the diagnosis and management of the comorbidities associated with psoriatic arthritis.

"I am really excited that we are taking the initiative to treat and manage the psoriatic arthritis [PsA] patient as a whole," reported Dr. Elaine Husni, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. The guidelines are meant to be a "platform on which to raise awareness" and foster education.

An initial set of guidelines on comorbidities was drafted at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Dr. Husni led the consensus group and fielded questions about key recommendations.

The first of these recommendations, which will undergo a process of discussion and review prior to formal adoption, states that all patients with PsA should be evaluated for cardiovascular (CV) disease. The consensus group labeled this recommendation "strong" even while conferring it with grade D evidence.

"The grade D was based on the fact that there are no outcomes data specifically in patients with psoriatic arthritis," observed Dr. Alexis R. Ogdie-Beatty, director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia. A member of the consensus group, Dr. Ogdie-Beatty suggested that benefit from CV screening is still a reasonable expectation "given the growing evidence that patients with PsA are at increased risk."

Similar "strong" recommendations but grade D evidence were given for screening for ophthalmic complications and inflammatory bowel disease. In these cases, there is good evidence for an association with PsA but limited evidence that screening will lead to improved outcome. The exception was obesity for which the group gave a B rating to the evidence for benefit from diagnosis and treatment.

Screening for diabetes was also included among recommendations, but it was given a "weak" rating and a grade D for supportive evidence.

Most of the other recommendations involved screening for various infections, such as hepatitis C virus (HCV), HIV, and tuberculosis, prior to initiating immunosuppressant therapies, particularly biologics. The level of evidence for these recommendations typically ranged between B and C even though all were given strong recommendations.

The consensus recommendations are not expected to include much detail about the specific management of comorbidities. The reason is concern about their applicability across various settings of care. It was thought that GRAPPA, as an international organization, should accommodate different types of practice. For example, the group cautioned against outlining steps of CV risk management, which may be managed by rheumatologists in some areas of the world but by specialists in others.

"We want to stay away from being minicardiologists," Dr. Husni explained. She indicated that the goal of the recommendations is to simply identify the specific types of comorbidity screening that should be considered "core recommendations" in the approach to PsA.

However, there is interest in creating a table regarding the use of specific medications for PsA treatment in the context of comorbidities. In a color-coded draft presented at the GRAPPA and SPARTAN meeting, some examples included caution in the use of NSAIDs in patients with CV disease, a need for monitoring when using cyclosporine in patients with chronic kidney disease, and a preference for etanercept over other tumor necrosis factor inhibitors in patients with HCV infection.

Overall, recommendations for comorbidities were identified as an important step in defining optimal care for PsA. According to Dr. Ogdie-Beatty, "the most important point may be to raise awareness." As these recommendations wend their way through an approval process at the organizational level, Dr. Ogdie-Beatty expressed hope that the final wording is specific enough to encourage attention to comorbidities without restricting a variety of valid approaches.

Dr. Husni reported a financial relationship with Celgene. Dr. Ogdie-Beatty had no potential conflicts of interest to report.

NEW YORK – For the first time, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis is preparing evidence-based treatment recommendations for the diagnosis and management of the comorbidities associated with psoriatic arthritis.

"I am really excited that we are taking the initiative to treat and manage the psoriatic arthritis [PsA] patient as a whole," reported Dr. Elaine Husni, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. The guidelines are meant to be a "platform on which to raise awareness" and foster education.

An initial set of guidelines on comorbidities was drafted at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Dr. Husni led the consensus group and fielded questions about key recommendations.

The first of these recommendations, which will undergo a process of discussion and review prior to formal adoption, states that all patients with PsA should be evaluated for cardiovascular (CV) disease. The consensus group labeled this recommendation "strong" even while conferring it with grade D evidence.

"The grade D was based on the fact that there are no outcomes data specifically in patients with psoriatic arthritis," observed Dr. Alexis R. Ogdie-Beatty, director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia. A member of the consensus group, Dr. Ogdie-Beatty suggested that benefit from CV screening is still a reasonable expectation "given the growing evidence that patients with PsA are at increased risk."

Similar "strong" recommendations but grade D evidence were given for screening for ophthalmic complications and inflammatory bowel disease. In these cases, there is good evidence for an association with PsA but limited evidence that screening will lead to improved outcome. The exception was obesity for which the group gave a B rating to the evidence for benefit from diagnosis and treatment.

Screening for diabetes was also included among recommendations, but it was given a "weak" rating and a grade D for supportive evidence.

Most of the other recommendations involved screening for various infections, such as hepatitis C virus (HCV), HIV, and tuberculosis, prior to initiating immunosuppressant therapies, particularly biologics. The level of evidence for these recommendations typically ranged between B and C even though all were given strong recommendations.

The consensus recommendations are not expected to include much detail about the specific management of comorbidities. The reason is concern about their applicability across various settings of care. It was thought that GRAPPA, as an international organization, should accommodate different types of practice. For example, the group cautioned against outlining steps of CV risk management, which may be managed by rheumatologists in some areas of the world but by specialists in others.

"We want to stay away from being minicardiologists," Dr. Husni explained. She indicated that the goal of the recommendations is to simply identify the specific types of comorbidity screening that should be considered "core recommendations" in the approach to PsA.

However, there is interest in creating a table regarding the use of specific medications for PsA treatment in the context of comorbidities. In a color-coded draft presented at the GRAPPA and SPARTAN meeting, some examples included caution in the use of NSAIDs in patients with CV disease, a need for monitoring when using cyclosporine in patients with chronic kidney disease, and a preference for etanercept over other tumor necrosis factor inhibitors in patients with HCV infection.

Overall, recommendations for comorbidities were identified as an important step in defining optimal care for PsA. According to Dr. Ogdie-Beatty, "the most important point may be to raise awareness." As these recommendations wend their way through an approval process at the organizational level, Dr. Ogdie-Beatty expressed hope that the final wording is specific enough to encourage attention to comorbidities without restricting a variety of valid approaches.

Dr. Husni reported a financial relationship with Celgene. Dr. Ogdie-Beatty had no potential conflicts of interest to report.

NEW YORK – For the first time, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis is preparing evidence-based treatment recommendations for the diagnosis and management of the comorbidities associated with psoriatic arthritis.

"I am really excited that we are taking the initiative to treat and manage the psoriatic arthritis [PsA] patient as a whole," reported Dr. Elaine Husni, director of the Arthritis and Musculoskeletal Center at the Cleveland Clinic. The guidelines are meant to be a "platform on which to raise awareness" and foster education.

An initial set of guidelines on comorbidities was drafted at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Dr. Husni led the consensus group and fielded questions about key recommendations.

The first of these recommendations, which will undergo a process of discussion and review prior to formal adoption, states that all patients with PsA should be evaluated for cardiovascular (CV) disease. The consensus group labeled this recommendation "strong" even while conferring it with grade D evidence.

"The grade D was based on the fact that there are no outcomes data specifically in patients with psoriatic arthritis," observed Dr. Alexis R. Ogdie-Beatty, director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia. A member of the consensus group, Dr. Ogdie-Beatty suggested that benefit from CV screening is still a reasonable expectation "given the growing evidence that patients with PsA are at increased risk."

Similar "strong" recommendations but grade D evidence were given for screening for ophthalmic complications and inflammatory bowel disease. In these cases, there is good evidence for an association with PsA but limited evidence that screening will lead to improved outcome. The exception was obesity for which the group gave a B rating to the evidence for benefit from diagnosis and treatment.

Screening for diabetes was also included among recommendations, but it was given a "weak" rating and a grade D for supportive evidence.

Most of the other recommendations involved screening for various infections, such as hepatitis C virus (HCV), HIV, and tuberculosis, prior to initiating immunosuppressant therapies, particularly biologics. The level of evidence for these recommendations typically ranged between B and C even though all were given strong recommendations.

The consensus recommendations are not expected to include much detail about the specific management of comorbidities. The reason is concern about their applicability across various settings of care. It was thought that GRAPPA, as an international organization, should accommodate different types of practice. For example, the group cautioned against outlining steps of CV risk management, which may be managed by rheumatologists in some areas of the world but by specialists in others.

"We want to stay away from being minicardiologists," Dr. Husni explained. She indicated that the goal of the recommendations is to simply identify the specific types of comorbidity screening that should be considered "core recommendations" in the approach to PsA.

However, there is interest in creating a table regarding the use of specific medications for PsA treatment in the context of comorbidities. In a color-coded draft presented at the GRAPPA and SPARTAN meeting, some examples included caution in the use of NSAIDs in patients with CV disease, a need for monitoring when using cyclosporine in patients with chronic kidney disease, and a preference for etanercept over other tumor necrosis factor inhibitors in patients with HCV infection.

Overall, recommendations for comorbidities were identified as an important step in defining optimal care for PsA. According to Dr. Ogdie-Beatty, "the most important point may be to raise awareness." As these recommendations wend their way through an approval process at the organizational level, Dr. Ogdie-Beatty expressed hope that the final wording is specific enough to encourage attention to comorbidities without restricting a variety of valid approaches.

Dr. Husni reported a financial relationship with Celgene. Dr. Ogdie-Beatty had no potential conflicts of interest to report.

NEW YORK – Unexpectedly and conflicting with previous reports, a careful analysis of a relatively large series of patients with psoriatic arthritis mutilans found that most had axial involvement.

In a series of 56 patients with psoriatic arthritis (PsA) mutilans drawn from 610 consecutive patients with PsA, 65% had evidence of axial disease on the most recent radiograph. Of these, 57% had radiographic sacroiliitis, which was bilateral in 80%.

"This proportion far exceeds the typical 25% incidence of axial disease reported in the literature," according to Dr. Deepak Jadon, a specialist registrar in rheumatology at the Royal National Hospital for Rheumatic Diseases, Bath, England.

The proportion of confirmed PsA mutilans cases, at 9%, was also higher than the 5% typically reported, according to Dr. Jadon, who presented these findings at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Referral to a specialty clinic may explain the higher rate, but PsA mutilans could only be ruled out, because of inadequate radiographs, in 483 of the 610 patients, so the actual proportion could be even higher.

In 35 of the patients with PsA mutilans, defined as osteolysis involving at least 50% of the visualized articular surface on both sides of the joints, serial radiographs confirmed that this disease is progressive. In this series, 37% of the patients had PsA mutilans at the time of the first radiograph, but the rest developed PsA mutilans over the course of follow-up.

Of this second group, 84% had received a disease-modifying antirheumatic drug (DMARD) prior to developing PsA mutilans, an observation that "suggests DMARDs may not prevent the onset of this condition," Dr. Jadon reported, cautioning that there are other potential explanations.

Using a random-effects model, "different patterns of progression were observed in the feet and hands," Dr. Jadon reported. In both groups, the most common pattern was an initial surge of activity followed by a tapering of rate of progression. However, a second surge of activity in the hands was not observed in the feet.

When compared to unaffected PsA patients, those with PsA mutilans were on average younger (33 vs. 40 years; P = .039) and more likely to have nail dystrophy (83% vs. 45%; P = .0002). The severity of nail dystrophy appeared to correlate with the severity of joint involvement.

The most commonly affected joints in this series were the metatarsophalangeal joint of the big toe, the proximal interphalangeal joint of the thumb, and the metacarpophalangeal joint of the index finger. While many patients had monoarticular involvement at the time of diagnosis, 80% of patients in this series had polyarticular disease on the most recent radiograph.

Not surprisingly, functional limitations were significantly greater for patients with PsA mutilans on standardized health assessment questionnaire (HAQ) when compared with patients with PsA (P = .048). The differences involved functions affecting both the hands, such as those relevant to grip strength, and the feet.

Data from this series did not provide any insight on treatment efficacy. Biologic use in those with serial radiographs, which included a sizeable number of patients managed before the biologic era, was too infrequent to infer effect on disease progression. However, the frequent exposure to DMARDs in patients with documented progression suggests benefits may be limited.

Dr. Jadon suggested that prospective data for PsA mutilans, which is widely regarded as the least common but most severe form of PsA, are now needed to determine which treatments have the greatest potential to improve long-term outcome.

Dr. Jadon reported no potential conflicts of interest.

NEW YORK – Unexpectedly and conflicting with previous reports, a careful analysis of a relatively large series of patients with psoriatic arthritis mutilans found that most had axial involvement.

In a series of 56 patients with psoriatic arthritis (PsA) mutilans drawn from 610 consecutive patients with PsA, 65% had evidence of axial disease on the most recent radiograph. Of these, 57% had radiographic sacroiliitis, which was bilateral in 80%.

"This proportion far exceeds the typical 25% incidence of axial disease reported in the literature," according to Dr. Deepak Jadon, a specialist registrar in rheumatology at the Royal National Hospital for Rheumatic Diseases, Bath, England.

The proportion of confirmed PsA mutilans cases, at 9%, was also higher than the 5% typically reported, according to Dr. Jadon, who presented these findings at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Referral to a specialty clinic may explain the higher rate, but PsA mutilans could only be ruled out, because of inadequate radiographs, in 483 of the 610 patients, so the actual proportion could be even higher.

In 35 of the patients with PsA mutilans, defined as osteolysis involving at least 50% of the visualized articular surface on both sides of the joints, serial radiographs confirmed that this disease is progressive. In this series, 37% of the patients had PsA mutilans at the time of the first radiograph, but the rest developed PsA mutilans over the course of follow-up.

Of this second group, 84% had received a disease-modifying antirheumatic drug (DMARD) prior to developing PsA mutilans, an observation that "suggests DMARDs may not prevent the onset of this condition," Dr. Jadon reported, cautioning that there are other potential explanations.

Using a random-effects model, "different patterns of progression were observed in the feet and hands," Dr. Jadon reported. In both groups, the most common pattern was an initial surge of activity followed by a tapering of rate of progression. However, a second surge of activity in the hands was not observed in the feet.

When compared to unaffected PsA patients, those with PsA mutilans were on average younger (33 vs. 40 years; P = .039) and more likely to have nail dystrophy (83% vs. 45%; P = .0002). The severity of nail dystrophy appeared to correlate with the severity of joint involvement.

The most commonly affected joints in this series were the metatarsophalangeal joint of the big toe, the proximal interphalangeal joint of the thumb, and the metacarpophalangeal joint of the index finger. While many patients had monoarticular involvement at the time of diagnosis, 80% of patients in this series had polyarticular disease on the most recent radiograph.

Not surprisingly, functional limitations were significantly greater for patients with PsA mutilans on standardized health assessment questionnaire (HAQ) when compared with patients with PsA (P = .048). The differences involved functions affecting both the hands, such as those relevant to grip strength, and the feet.

Data from this series did not provide any insight on treatment efficacy. Biologic use in those with serial radiographs, which included a sizeable number of patients managed before the biologic era, was too infrequent to infer effect on disease progression. However, the frequent exposure to DMARDs in patients with documented progression suggests benefits may be limited.

Dr. Jadon suggested that prospective data for PsA mutilans, which is widely regarded as the least common but most severe form of PsA, are now needed to determine which treatments have the greatest potential to improve long-term outcome.

Dr. Jadon reported no potential conflicts of interest.

NEW YORK – Unexpectedly and conflicting with previous reports, a careful analysis of a relatively large series of patients with psoriatic arthritis mutilans found that most had axial involvement.

In a series of 56 patients with psoriatic arthritis (PsA) mutilans drawn from 610 consecutive patients with PsA, 65% had evidence of axial disease on the most recent radiograph. Of these, 57% had radiographic sacroiliitis, which was bilateral in 80%.

"This proportion far exceeds the typical 25% incidence of axial disease reported in the literature," according to Dr. Deepak Jadon, a specialist registrar in rheumatology at the Royal National Hospital for Rheumatic Diseases, Bath, England.

The proportion of confirmed PsA mutilans cases, at 9%, was also higher than the 5% typically reported, according to Dr. Jadon, who presented these findings at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network (SPARTAN). Referral to a specialty clinic may explain the higher rate, but PsA mutilans could only be ruled out, because of inadequate radiographs, in 483 of the 610 patients, so the actual proportion could be even higher.

In 35 of the patients with PsA mutilans, defined as osteolysis involving at least 50% of the visualized articular surface on both sides of the joints, serial radiographs confirmed that this disease is progressive. In this series, 37% of the patients had PsA mutilans at the time of the first radiograph, but the rest developed PsA mutilans over the course of follow-up.

Of this second group, 84% had received a disease-modifying antirheumatic drug (DMARD) prior to developing PsA mutilans, an observation that "suggests DMARDs may not prevent the onset of this condition," Dr. Jadon reported, cautioning that there are other potential explanations.

Using a random-effects model, "different patterns of progression were observed in the feet and hands," Dr. Jadon reported. In both groups, the most common pattern was an initial surge of activity followed by a tapering of rate of progression. However, a second surge of activity in the hands was not observed in the feet.

When compared to unaffected PsA patients, those with PsA mutilans were on average younger (33 vs. 40 years; P = .039) and more likely to have nail dystrophy (83% vs. 45%; P = .0002). The severity of nail dystrophy appeared to correlate with the severity of joint involvement.

The most commonly affected joints in this series were the metatarsophalangeal joint of the big toe, the proximal interphalangeal joint of the thumb, and the metacarpophalangeal joint of the index finger. While many patients had monoarticular involvement at the time of diagnosis, 80% of patients in this series had polyarticular disease on the most recent radiograph.

Not surprisingly, functional limitations were significantly greater for patients with PsA mutilans on standardized health assessment questionnaire (HAQ) when compared with patients with PsA (P = .048). The differences involved functions affecting both the hands, such as those relevant to grip strength, and the feet.

Data from this series did not provide any insight on treatment efficacy. Biologic use in those with serial radiographs, which included a sizeable number of patients managed before the biologic era, was too infrequent to infer effect on disease progression. However, the frequent exposure to DMARDs in patients with documented progression suggests benefits may be limited.

Dr. Jadon suggested that prospective data for PsA mutilans, which is widely regarded as the least common but most severe form of PsA, are now needed to determine which treatments have the greatest potential to improve long-term outcome.

Dr. Jadon reported no potential conflicts of interest.

NEW YORK – Improvements in clinical trial design for psoriasis, psoriatic arthritis, and other inflammatory diseases are being credited to a decision to enlist patients as full partners, not just advisors or consultants, in research initiatives.

"Rheumatologists, I think, have been leaders is recognizing that patients can bring an expertise to clinical research that is unique and ensure that study endpoints are relevant to outcomes important to them," reported Dr. William Tillett, a research fellow in the department of rheumatology at the Royal National Hospital for Rheumatic Diseases in Bath, England.

The value of patient research partners (PRP) was a recurring theme at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network. GRAPPA, in particular, has been fostering research collaborations with patients since 2006.

"It has been an evolution. Patients were initially enlisted to sit in when trial designs were being discussed. Now, we are talking about full partnership so that they are involved at the inception with equal partnership that includes veto power and author credit," Dr. Tillett explained.

At the GRAPPA meeting, an afternoon symposium was devoted to optimal strategies for fostering collaboration with PRPs, which builds on work already initiated with a group called Patient Involvement for Outcome Measures in PsA (PIOMPsA). In turn, PIOMPsA, formed 2 years ago, was largely modeled on PRP initiatives led by OMERACT (Outcomes Measurement in Rheumatology).

"OMERACT has been involving patients in clinical research design for about 10 years," reported Dr. Philip J. Mease, director of rheumatology research at Swedish Medical Center, Seattle. "The idea of making patients full-blown partners is more recent, but I think there is increasing appreciation for what the right patients can contribute to improve study design."

The initiatives are spreading through rheumatology and other inflammatory diseases. At the GRAPPA meeting, updates on patient initiatives to influence clinical research were presented not only from the work of PIOMPsA and OMERACT but also from the International Dermatology Outcomes Measures (IDEOM) consortium. Created in collaboration with the National Psoriasis Foundation (NPF), IDEOM is bringing clinicians and patients together to define standard outcome measures.

"There are no really good measures to evaluate relative severity of psoriasis from the patient’s perspective," reported Dr. Alice Gottlieb, professor of dermatology at Tufts Medical Center, Boston. Tools traditionally used in clinical trials, such as the Psoriasis Area Severity Index (PASI) "are not practical in the clinic" and do not necessarily reflect the impact of psoriasis on quality of life when used as a study endpoint, she said.

PIOMPsA has now conducted several meetings, including one held in conjunction with OMERACT in Budapest, Hungary, in early May 2014. Like IDEOM, PIOMPsA has been focused on developing consensus on core symptoms of its target inflammatory disease. This is critical because the ability of clinical trials to generate relevant data is dependent on first defining meaningful endpoints, according to Dr. Tillett, who presented the PIOMPsA deliberations at the GRAPPA meeting.

In Budapest, for example, a vote was taken on whether to add fatigue to a list of core symptoms for PsA that includes impaired physical function, skin lesions, and joint pain. Fatigue was added to the list by a vote in which 70% supported it as a core PsA symptom, said Dr. Tillett, who recently published on the goals and underlying concepts of PIOMPsA (Curr. Rheumatol. Rep. 2014;16:418).

According to Dr. Tillett and Dr. Mease, PRPs are an answer to the repeatedly reported disconnect between physicians and patients in rating disease severity. By involving patients with interest in clinical research and collaborative skills, treatment trials have the potential to generate data more useful to practical patient management.

"It will be very difficult to show objectively that patient-aided trial design leads to better studies, but this is a reasonable expectation. I think that the contributions we have already seen from these collaborations bear this out," said Dr. Tillett, who expects the concept to spread to other fields of medicine.

Dr. Tillett reported financial relationships with AbbVie and Amgen. Dr. Mease reported financial relationships with AbbVie, Amgen, Biogen Idec, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen Pharmaceuticals, Lilly, Merck & Co, Novartis, Pfizer, UCB Pharma, and Vertex. Dr. Gottlieb reported financial relationships with Abbott, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Centocor, Novo Nordisk, Teva, and UCB.

NEW YORK – Improvements in clinical trial design for psoriasis, psoriatic arthritis, and other inflammatory diseases are being credited to a decision to enlist patients as full partners, not just advisors or consultants, in research initiatives.

"Rheumatologists, I think, have been leaders is recognizing that patients can bring an expertise to clinical research that is unique and ensure that study endpoints are relevant to outcomes important to them," reported Dr. William Tillett, a research fellow in the department of rheumatology at the Royal National Hospital for Rheumatic Diseases in Bath, England.

The value of patient research partners (PRP) was a recurring theme at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network. GRAPPA, in particular, has been fostering research collaborations with patients since 2006.

"It has been an evolution. Patients were initially enlisted to sit in when trial designs were being discussed. Now, we are talking about full partnership so that they are involved at the inception with equal partnership that includes veto power and author credit," Dr. Tillett explained.

At the GRAPPA meeting, an afternoon symposium was devoted to optimal strategies for fostering collaboration with PRPs, which builds on work already initiated with a group called Patient Involvement for Outcome Measures in PsA (PIOMPsA). In turn, PIOMPsA, formed 2 years ago, was largely modeled on PRP initiatives led by OMERACT (Outcomes Measurement in Rheumatology).

"OMERACT has been involving patients in clinical research design for about 10 years," reported Dr. Philip J. Mease, director of rheumatology research at Swedish Medical Center, Seattle. "The idea of making patients full-blown partners is more recent, but I think there is increasing appreciation for what the right patients can contribute to improve study design."

The initiatives are spreading through rheumatology and other inflammatory diseases. At the GRAPPA meeting, updates on patient initiatives to influence clinical research were presented not only from the work of PIOMPsA and OMERACT but also from the International Dermatology Outcomes Measures (IDEOM) consortium. Created in collaboration with the National Psoriasis Foundation (NPF), IDEOM is bringing clinicians and patients together to define standard outcome measures.

"There are no really good measures to evaluate relative severity of psoriasis from the patient’s perspective," reported Dr. Alice Gottlieb, professor of dermatology at Tufts Medical Center, Boston. Tools traditionally used in clinical trials, such as the Psoriasis Area Severity Index (PASI) "are not practical in the clinic" and do not necessarily reflect the impact of psoriasis on quality of life when used as a study endpoint, she said.

PIOMPsA has now conducted several meetings, including one held in conjunction with OMERACT in Budapest, Hungary, in early May 2014. Like IDEOM, PIOMPsA has been focused on developing consensus on core symptoms of its target inflammatory disease. This is critical because the ability of clinical trials to generate relevant data is dependent on first defining meaningful endpoints, according to Dr. Tillett, who presented the PIOMPsA deliberations at the GRAPPA meeting.

In Budapest, for example, a vote was taken on whether to add fatigue to a list of core symptoms for PsA that includes impaired physical function, skin lesions, and joint pain. Fatigue was added to the list by a vote in which 70% supported it as a core PsA symptom, said Dr. Tillett, who recently published on the goals and underlying concepts of PIOMPsA (Curr. Rheumatol. Rep. 2014;16:418).

According to Dr. Tillett and Dr. Mease, PRPs are an answer to the repeatedly reported disconnect between physicians and patients in rating disease severity. By involving patients with interest in clinical research and collaborative skills, treatment trials have the potential to generate data more useful to practical patient management.

"It will be very difficult to show objectively that patient-aided trial design leads to better studies, but this is a reasonable expectation. I think that the contributions we have already seen from these collaborations bear this out," said Dr. Tillett, who expects the concept to spread to other fields of medicine.

Dr. Tillett reported financial relationships with AbbVie and Amgen. Dr. Mease reported financial relationships with AbbVie, Amgen, Biogen Idec, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen Pharmaceuticals, Lilly, Merck & Co, Novartis, Pfizer, UCB Pharma, and Vertex. Dr. Gottlieb reported financial relationships with Abbott, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Centocor, Novo Nordisk, Teva, and UCB.

NEW YORK – Improvements in clinical trial design for psoriasis, psoriatic arthritis, and other inflammatory diseases are being credited to a decision to enlist patients as full partners, not just advisors or consultants, in research initiatives.

"Rheumatologists, I think, have been leaders is recognizing that patients can bring an expertise to clinical research that is unique and ensure that study endpoints are relevant to outcomes important to them," reported Dr. William Tillett, a research fellow in the department of rheumatology at the Royal National Hospital for Rheumatic Diseases in Bath, England.

The value of patient research partners (PRP) was a recurring theme at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network. GRAPPA, in particular, has been fostering research collaborations with patients since 2006.

"It has been an evolution. Patients were initially enlisted to sit in when trial designs were being discussed. Now, we are talking about full partnership so that they are involved at the inception with equal partnership that includes veto power and author credit," Dr. Tillett explained.

At the GRAPPA meeting, an afternoon symposium was devoted to optimal strategies for fostering collaboration with PRPs, which builds on work already initiated with a group called Patient Involvement for Outcome Measures in PsA (PIOMPsA). In turn, PIOMPsA, formed 2 years ago, was largely modeled on PRP initiatives led by OMERACT (Outcomes Measurement in Rheumatology).

"OMERACT has been involving patients in clinical research design for about 10 years," reported Dr. Philip J. Mease, director of rheumatology research at Swedish Medical Center, Seattle. "The idea of making patients full-blown partners is more recent, but I think there is increasing appreciation for what the right patients can contribute to improve study design."

The initiatives are spreading through rheumatology and other inflammatory diseases. At the GRAPPA meeting, updates on patient initiatives to influence clinical research were presented not only from the work of PIOMPsA and OMERACT but also from the International Dermatology Outcomes Measures (IDEOM) consortium. Created in collaboration with the National Psoriasis Foundation (NPF), IDEOM is bringing clinicians and patients together to define standard outcome measures.

"There are no really good measures to evaluate relative severity of psoriasis from the patient’s perspective," reported Dr. Alice Gottlieb, professor of dermatology at Tufts Medical Center, Boston. Tools traditionally used in clinical trials, such as the Psoriasis Area Severity Index (PASI) "are not practical in the clinic" and do not necessarily reflect the impact of psoriasis on quality of life when used as a study endpoint, she said.

PIOMPsA has now conducted several meetings, including one held in conjunction with OMERACT in Budapest, Hungary, in early May 2014. Like IDEOM, PIOMPsA has been focused on developing consensus on core symptoms of its target inflammatory disease. This is critical because the ability of clinical trials to generate relevant data is dependent on first defining meaningful endpoints, according to Dr. Tillett, who presented the PIOMPsA deliberations at the GRAPPA meeting.

In Budapest, for example, a vote was taken on whether to add fatigue to a list of core symptoms for PsA that includes impaired physical function, skin lesions, and joint pain. Fatigue was added to the list by a vote in which 70% supported it as a core PsA symptom, said Dr. Tillett, who recently published on the goals and underlying concepts of PIOMPsA (Curr. Rheumatol. Rep. 2014;16:418).

According to Dr. Tillett and Dr. Mease, PRPs are an answer to the repeatedly reported disconnect between physicians and patients in rating disease severity. By involving patients with interest in clinical research and collaborative skills, treatment trials have the potential to generate data more useful to practical patient management.

"It will be very difficult to show objectively that patient-aided trial design leads to better studies, but this is a reasonable expectation. I think that the contributions we have already seen from these collaborations bear this out," said Dr. Tillett, who expects the concept to spread to other fields of medicine.

Dr. Tillett reported financial relationships with AbbVie and Amgen. Dr. Mease reported financial relationships with AbbVie, Amgen, Biogen Idec, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen Pharmaceuticals, Lilly, Merck & Co, Novartis, Pfizer, UCB Pharma, and Vertex. Dr. Gottlieb reported financial relationships with Abbott, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Centocor, Novo Nordisk, Teva, and UCB.

NEW YORK – For the skin component of psoriatic arthritis, consensus about how high to set the bar for disease control continues to elude experts, judging from a debate about the value of "clear" or "almost clear" as the most acceptable treatment endpoints.

Current therapies in psoriatic arthritis (PsA) are sufficiently effective to support a treat-to-target approach for both skin lesions and joint inflammation, but there is lack of consensus about which metrics should be employed to define any specific target for skin lesions, according to Dr. Joel Gelfand, medical director of the clinical studies unit in the department of dermatology at the University of Pennsylvania, Philadelphia. He noted that even if the goal is the absence of skin involvement, no one agrees on what method should be used to document this endpoint.

"No one in clinical practice uses PASI," maintained Dr. Gelfand, referring to the Psoriasis and Area and Severity Index, which is one of the most widely accepted standards for judging efficacy in treatment trials. Speaking at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network, Dr. Gelfand said most objective scoring systems, such as PASI, are too labor intensive. Clinicians tend to use their own system for documenting relative control of skin lesions in the medical record.

Evaluating disease control without applying a reproducible, broadly used metric has numerous potential problems, according to Dr. Gelfand. Most importantly, it prevents objective evaluation of whether treatment targets are being met. This obscures efforts to document benefit relative to either clinical goals or optimal care. Dr. Gelfand made the analogy to the treatment goals created for blood pressure, blood glucose, or cholesterol, where the targets are clear and a change in treatment is warranted if the target is not reached.

This point of view resonated with the audience of dermatologists, rheumatologists, and PsA patients attending the meeting. In an electronic audience poll, there was nearly 100% agreement that a treat-to-target approach is appropriate for skin lesions but no strong consensus on what the target should be. In the poll attempting to define consensus, 32% agreed with a target of less than 3% body surface area (BSA) while 48% agreed the BSA target should be less than 1%. It is notable that dermatologists were more likely to accept a less rigorous BSA than rheumatologists. The majority of patients agreed the target should be less than 1% BSA, although this group represented less than 10% of the audience.

Not surprisingly, health-related quality of life studies show measurable differences between "clear" and "almost clear" skin lesions in PsA patients whether measured by PASI, BSA, or other measures, according to Dr. Gelfand, but he cautioned that it is important to be realistic about goals. He suggested that a target that exposes patients to unacceptable side effects is the wrong target, and this may be the source of dissension among experts.

Asked for a comment, Dr. Wolf-Henning Boehncke, professor and chair of the department of dermatology at the University of Geneva agreed in principle with the treat-to-target approach. However, Dr. Boehncke, who is the current president of GRAPPA, also emphasized simple and practical assessment tools and achievable endpoints.

"We must define targets that are reasonable," Dr. Boehncke said. While complex patient assessment tools are not likely to be widely used by clinicians, unrealistic targets can be counterproductive if they are not considered in the overall context of tolerability and patient satisfaction.

Dr. Gelfand has or has had financial relationships with AbbVie, Amgen, Celgene, Eli Lilly, Genentech, Janssen, Merck, Novartis, and Pfizer.

NEW YORK – For the skin component of psoriatic arthritis, consensus about how high to set the bar for disease control continues to elude experts, judging from a debate about the value of "clear" or "almost clear" as the most acceptable treatment endpoints.

Current therapies in psoriatic arthritis (PsA) are sufficiently effective to support a treat-to-target approach for both skin lesions and joint inflammation, but there is lack of consensus about which metrics should be employed to define any specific target for skin lesions, according to Dr. Joel Gelfand, medical director of the clinical studies unit in the department of dermatology at the University of Pennsylvania, Philadelphia. He noted that even if the goal is the absence of skin involvement, no one agrees on what method should be used to document this endpoint.

"No one in clinical practice uses PASI," maintained Dr. Gelfand, referring to the Psoriasis and Area and Severity Index, which is one of the most widely accepted standards for judging efficacy in treatment trials. Speaking at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network, Dr. Gelfand said most objective scoring systems, such as PASI, are too labor intensive. Clinicians tend to use their own system for documenting relative control of skin lesions in the medical record.

Evaluating disease control without applying a reproducible, broadly used metric has numerous potential problems, according to Dr. Gelfand. Most importantly, it prevents objective evaluation of whether treatment targets are being met. This obscures efforts to document benefit relative to either clinical goals or optimal care. Dr. Gelfand made the analogy to the treatment goals created for blood pressure, blood glucose, or cholesterol, where the targets are clear and a change in treatment is warranted if the target is not reached.

This point of view resonated with the audience of dermatologists, rheumatologists, and PsA patients attending the meeting. In an electronic audience poll, there was nearly 100% agreement that a treat-to-target approach is appropriate for skin lesions but no strong consensus on what the target should be. In the poll attempting to define consensus, 32% agreed with a target of less than 3% body surface area (BSA) while 48% agreed the BSA target should be less than 1%. It is notable that dermatologists were more likely to accept a less rigorous BSA than rheumatologists. The majority of patients agreed the target should be less than 1% BSA, although this group represented less than 10% of the audience.

Not surprisingly, health-related quality of life studies show measurable differences between "clear" and "almost clear" skin lesions in PsA patients whether measured by PASI, BSA, or other measures, according to Dr. Gelfand, but he cautioned that it is important to be realistic about goals. He suggested that a target that exposes patients to unacceptable side effects is the wrong target, and this may be the source of dissension among experts.

Asked for a comment, Dr. Wolf-Henning Boehncke, professor and chair of the department of dermatology at the University of Geneva agreed in principle with the treat-to-target approach. However, Dr. Boehncke, who is the current president of GRAPPA, also emphasized simple and practical assessment tools and achievable endpoints.

"We must define targets that are reasonable," Dr. Boehncke said. While complex patient assessment tools are not likely to be widely used by clinicians, unrealistic targets can be counterproductive if they are not considered in the overall context of tolerability and patient satisfaction.

Dr. Gelfand has or has had financial relationships with AbbVie, Amgen, Celgene, Eli Lilly, Genentech, Janssen, Merck, Novartis, and Pfizer.

NEW YORK – For the skin component of psoriatic arthritis, consensus about how high to set the bar for disease control continues to elude experts, judging from a debate about the value of "clear" or "almost clear" as the most acceptable treatment endpoints.

Current therapies in psoriatic arthritis (PsA) are sufficiently effective to support a treat-to-target approach for both skin lesions and joint inflammation, but there is lack of consensus about which metrics should be employed to define any specific target for skin lesions, according to Dr. Joel Gelfand, medical director of the clinical studies unit in the department of dermatology at the University of Pennsylvania, Philadelphia. He noted that even if the goal is the absence of skin involvement, no one agrees on what method should be used to document this endpoint.

"No one in clinical practice uses PASI," maintained Dr. Gelfand, referring to the Psoriasis and Area and Severity Index, which is one of the most widely accepted standards for judging efficacy in treatment trials. Speaking at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the Spondyloarthritis Research & Treatment Network, Dr. Gelfand said most objective scoring systems, such as PASI, are too labor intensive. Clinicians tend to use their own system for documenting relative control of skin lesions in the medical record.

Evaluating disease control without applying a reproducible, broadly used metric has numerous potential problems, according to Dr. Gelfand. Most importantly, it prevents objective evaluation of whether treatment targets are being met. This obscures efforts to document benefit relative to either clinical goals or optimal care. Dr. Gelfand made the analogy to the treatment goals created for blood pressure, blood glucose, or cholesterol, where the targets are clear and a change in treatment is warranted if the target is not reached.

This point of view resonated with the audience of dermatologists, rheumatologists, and PsA patients attending the meeting. In an electronic audience poll, there was nearly 100% agreement that a treat-to-target approach is appropriate for skin lesions but no strong consensus on what the target should be. In the poll attempting to define consensus, 32% agreed with a target of less than 3% body surface area (BSA) while 48% agreed the BSA target should be less than 1%. It is notable that dermatologists were more likely to accept a less rigorous BSA than rheumatologists. The majority of patients agreed the target should be less than 1% BSA, although this group represented less than 10% of the audience.

Not surprisingly, health-related quality of life studies show measurable differences between "clear" and "almost clear" skin lesions in PsA patients whether measured by PASI, BSA, or other measures, according to Dr. Gelfand, but he cautioned that it is important to be realistic about goals. He suggested that a target that exposes patients to unacceptable side effects is the wrong target, and this may be the source of dissension among experts.

Asked for a comment, Dr. Wolf-Henning Boehncke, professor and chair of the department of dermatology at the University of Geneva agreed in principle with the treat-to-target approach. However, Dr. Boehncke, who is the current president of GRAPPA, also emphasized simple and practical assessment tools and achievable endpoints.

"We must define targets that are reasonable," Dr. Boehncke said. While complex patient assessment tools are not likely to be widely used by clinicians, unrealistic targets can be counterproductive if they are not considered in the overall context of tolerability and patient satisfaction.

Dr. Gelfand has or has had financial relationships with AbbVie, Amgen, Celgene, Eli Lilly, Genentech, Janssen, Merck, Novartis, and Pfizer.