Evidence Called Insufficient For Comparing PsA Drugs

Gregory Twachtman is a writer for “The Pink Sheet.” This news organization and “The Pink Sheet” are owned by Elsevier.

A comparative effectiveness study on drug therapies used to treat psoriatic arthritis in adults determined that evidence is insufficient to draw any conclusions.

“Overall, the data are quite limited and the evidence is insufficient to draw firm conclusions on comparative efficacy, effectiveness, and harms of either oral or biologic DMARDs [disease-modifying antirheumatic drugs] in this condition,” the draft report stated. AHRQ uploaded the draft report to the Effective Care portion of its Web site. The draft did not identify the lead investigators of the study.

AHRQ's findings come soon after the U.K.'s National Institute for Clinical Excellence rejected Simponi for the treatment of active and progressive psoriatic arthritis (PsA) in adults, claiming that evidence revealed that the Schering Plough/Johnson & Johnson product was not as effective as Pfizer's Enbrel.

The draft report noted that about 520,000 U.S. adults have PsA, with treatments aimed primarily at controlling pain and inflammation and, ultimately, at slowing or arresting the progression of joint destruction.

The study compared a variety of oral and biologic DMARDs, including Simponi (golimumab) and Enbrel (etanercept), as well as Sanofi-Synthelabo's Plaquenil (hydroxychloroquine), Sanofi-Aventis' Arava (leflunomide), methotrexate, sulfasalazine, Abbott's Humira (adalimumab), UCB's Cimzia (certolizumab) and J&J's Remicade (infliximab). Humira, Enbrel, Simponi, and Remicade are approved by FDA to be used in patients with PsA.

The comparative effectiveness study for PsA aimed to answer four key questions:

▸ Do drug therapies differ in their ability to reduce disease activity, to slow or limit progression of radiographic joint damage, or to maintain remission?

▸ Do drug therapies differ in their ability to improve patient-reported symptoms, functional capacity, or quality of life?

▸ Do drug therapies differ in harms, tolerability, adherence, or adverse effects?

▸ What are the comparative benefits and harms of drug therapies for PsA in subgroups of patients based on stage of disease, history of prior therapy, demographics, concomitant therapies, or comorbidities?

The limited evidence that surfaced during research addressed the first three questions but nothing could be found on the fourth.

The draft report noted that experts “have not arrived at consensus about the comparative effectiveness of corticosteroids, oral DMARDs, and biologic DMARDs for treating PsA. More importantly, it is unclear how the effectiveness and safety of different types of combination therapy compare. In addition, there is debate about how early in the disease process combination therapy should be initiated and whether patients will respond to a biologic agent if they have previously failed a different biologic agent.”

The draft report added that questions remain about the risks of these agents. There is also limited understanding of the benefits and risks regarding subpopulations, including ethnic minorities, the elderly, pregnant women, and patients with other comorbidities.

Gregory Twachtman is a writer for “The Pink Sheet.” This news organization and “The Pink Sheet” are owned by Elsevier.

A comparative effectiveness study on drug therapies used to treat psoriatic arthritis in adults determined that evidence is insufficient to draw any conclusions.

“Overall, the data are quite limited and the evidence is insufficient to draw firm conclusions on comparative efficacy, effectiveness, and harms of either oral or biologic DMARDs [disease-modifying antirheumatic drugs] in this condition,” the draft report stated. AHRQ uploaded the draft report to the Effective Care portion of its Web site. The draft did not identify the lead investigators of the study.

AHRQ's findings come soon after the U.K.'s National Institute for Clinical Excellence rejected Simponi for the treatment of active and progressive psoriatic arthritis (PsA) in adults, claiming that evidence revealed that the Schering Plough/Johnson & Johnson product was not as effective as Pfizer's Enbrel.

The draft report noted that about 520,000 U.S. adults have PsA, with treatments aimed primarily at controlling pain and inflammation and, ultimately, at slowing or arresting the progression of joint destruction.

The study compared a variety of oral and biologic DMARDs, including Simponi (golimumab) and Enbrel (etanercept), as well as Sanofi-Synthelabo's Plaquenil (hydroxychloroquine), Sanofi-Aventis' Arava (leflunomide), methotrexate, sulfasalazine, Abbott's Humira (adalimumab), UCB's Cimzia (certolizumab) and J&J's Remicade (infliximab). Humira, Enbrel, Simponi, and Remicade are approved by FDA to be used in patients with PsA.

The comparative effectiveness study for PsA aimed to answer four key questions:

▸ Do drug therapies differ in their ability to reduce disease activity, to slow or limit progression of radiographic joint damage, or to maintain remission?

▸ Do drug therapies differ in their ability to improve patient-reported symptoms, functional capacity, or quality of life?

▸ Do drug therapies differ in harms, tolerability, adherence, or adverse effects?

▸ What are the comparative benefits and harms of drug therapies for PsA in subgroups of patients based on stage of disease, history of prior therapy, demographics, concomitant therapies, or comorbidities?

The limited evidence that surfaced during research addressed the first three questions but nothing could be found on the fourth.

The draft report noted that experts “have not arrived at consensus about the comparative effectiveness of corticosteroids, oral DMARDs, and biologic DMARDs for treating PsA. More importantly, it is unclear how the effectiveness and safety of different types of combination therapy compare. In addition, there is debate about how early in the disease process combination therapy should be initiated and whether patients will respond to a biologic agent if they have previously failed a different biologic agent.”

The draft report added that questions remain about the risks of these agents. There is also limited understanding of the benefits and risks regarding subpopulations, including ethnic minorities, the elderly, pregnant women, and patients with other comorbidities.

Gregory Twachtman is a writer for “The Pink Sheet.” This news organization and “The Pink Sheet” are owned by Elsevier.

A comparative effectiveness study on drug therapies used to treat psoriatic arthritis in adults determined that evidence is insufficient to draw any conclusions.

“Overall, the data are quite limited and the evidence is insufficient to draw firm conclusions on comparative efficacy, effectiveness, and harms of either oral or biologic DMARDs [disease-modifying antirheumatic drugs] in this condition,” the draft report stated. AHRQ uploaded the draft report to the Effective Care portion of its Web site. The draft did not identify the lead investigators of the study.

AHRQ's findings come soon after the U.K.'s National Institute for Clinical Excellence rejected Simponi for the treatment of active and progressive psoriatic arthritis (PsA) in adults, claiming that evidence revealed that the Schering Plough/Johnson & Johnson product was not as effective as Pfizer's Enbrel.

The draft report noted that about 520,000 U.S. adults have PsA, with treatments aimed primarily at controlling pain and inflammation and, ultimately, at slowing or arresting the progression of joint destruction.

The study compared a variety of oral and biologic DMARDs, including Simponi (golimumab) and Enbrel (etanercept), as well as Sanofi-Synthelabo's Plaquenil (hydroxychloroquine), Sanofi-Aventis' Arava (leflunomide), methotrexate, sulfasalazine, Abbott's Humira (adalimumab), UCB's Cimzia (certolizumab) and J&J's Remicade (infliximab). Humira, Enbrel, Simponi, and Remicade are approved by FDA to be used in patients with PsA.

The comparative effectiveness study for PsA aimed to answer four key questions:

▸ Do drug therapies differ in their ability to reduce disease activity, to slow or limit progression of radiographic joint damage, or to maintain remission?

▸ Do drug therapies differ in their ability to improve patient-reported symptoms, functional capacity, or quality of life?

▸ Do drug therapies differ in harms, tolerability, adherence, or adverse effects?

▸ What are the comparative benefits and harms of drug therapies for PsA in subgroups of patients based on stage of disease, history of prior therapy, demographics, concomitant therapies, or comorbidities?

The limited evidence that surfaced during research addressed the first three questions but nothing could be found on the fourth.

The draft report noted that experts “have not arrived at consensus about the comparative effectiveness of corticosteroids, oral DMARDs, and biologic DMARDs for treating PsA. More importantly, it is unclear how the effectiveness and safety of different types of combination therapy compare. In addition, there is debate about how early in the disease process combination therapy should be initiated and whether patients will respond to a biologic agent if they have previously failed a different biologic agent.”

The draft report added that questions remain about the risks of these agents. There is also limited understanding of the benefits and risks regarding subpopulations, including ethnic minorities, the elderly, pregnant women, and patients with other comorbidities.