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 Dec. 21 to the Effective Care portion of its Web site. Comments on the report are due by Jan. 19. http://www.effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/comment-draft-reports/?pageaction=displaydraftcommentform&topicid=203&productid=598&documenttype=draftReport 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 in adults, claiming that evidence revealed that the Schering Plough/Johnson & Johnson product was not as effective as Pfizer’s Enbrel. http://www.skinandallergynews.com/index.php?id=372&cHash=071010&tx_ttnews[tt_news]=17519
The draft report noted that about 520,000 adults in the U.S. have psoriatic arthritis, 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.
Key Questions
The comparative effectiveness study aimed to answer four key questions:
For patients with PsA, do drug therapies differ in their ability to reduce disease activity, to slow or limit progression of radiographic joint damage, or to maintain remission?
For patients with PsA, do drug therapies differ in their ability to improve patient reported symptoms, functional capacity or quality of life?
For patients with PsA, 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.
No Clinical Consensus
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 – e.g. oral DMARDs with corticosteroids, oral DMARDs with biologic DMARDs, triple combination of corticosteroids, oral DMARDs and biologic DMARDs. 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.
Contributing to the issue is the lack of trial evidence. "In patients with PsA, historically, few trials have been conducted with only minimal research before biologic agents were introduced; management options tended to be adopted from rheumatoid arthritis (RA) trial evidence," the draft report stated.
Starting from a base of 3,487 citations, researchers included 19 published articles reporting on 12 studies, including no head-to-head randomized controlled trials, no head-to-head nonrandomized controlled trials, 9 placebo-controlled trials, 2 meta-analyses or systematic reviews, and 1 observational study.
Report authors called for more comparative research to be done "to help clinicians and researchers arrive at stronger conclusions on the comparative efficacy, effectiveness, quality of life, and harms of medications for PsA," with a specific call for head-to-head randomized controlled trials to build the knowledge base.
Gregory Twachtman is a writer for "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.