Draft Key Questions
Disposition of Comments Report
Archived: This report is greater than 3 years old. Findings may be used for research purposes, but should not be considered current.
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To examine the comparative effectiveness of biologic systemic agents versus nonbiologic systemic agents or phototherapy, on an individual drug level, for treatment of chronic plaque psoriasis (CPP) and to determine patient and disease characteristics that modify outcomes of interest.
Medline, the Cochrane Central Register of Controlled Trials, and Web of Science from inception to June 2012, with no language restrictions.
Randomized controlled trials (RCTs) and observational studies were included in our review if they compared treatment with Food and Drug Administration-approved biologic systemic agents with either an approved nonbiologic systemic agent or phototherapy in adult patients with CPP and provided data on at least one prespecified outcome. Using predefined criteria, data on study design and population, interventions, quality, and outcomes were extracted. No quantitative analyses were performed and all data were qualitatively synthesized. The strength of evidence (SOE) for individual outcome was rated, when possible, as insufficient (I), low (L), moderate (M), or high (H). The applicability of the body of evidence was described.
Five RCTs and four observational studies directly compared therapies from the specified classes. An additional five studies provided data on the transition of patients from one therapy to another. Studies generally reported short-term outcomes (median of 24 weeks) in small (<200 subjects) international patient populations. Compared with methotrexate, adalimumab improved health-related quality of life (HRQoL) [SOE: L], Psoriasis Area and Severity Index (PASI) [SOE: L], Physician's Global Assessment (PGA) score [SOE: L], and patient's assessment of disease severity score [SOE: L], while reducing pain [SOE: L] and pruritus [SOE: L] with no effect on infection rates [SOE: L]. Compared with acitretin, etanercept improved PASI [SOE: M] and compared with methotrexate, infliximab improved HRQoL [SOE: L], PASI [SOE: L], and PGA [SOE: L]. Compared with methotrexate, ustekinumab improved PGA [SOE:L]. Data were insufficient for any other comparisons and outcomes. Data from the post-hoc subgroup analysis of one RCT that compared treatment with adalimumab with treatment with methotrexate suggested that as disease severity improved, so did a patient's HRQoL. Data were insufficient to evaluate the impact of any other patient or disease characteristics on outcomes.
In patients with CPP, there were limited data directly comparing systemic biologic agents with either systemic nonbiolgic agents or with phototherapy on an individual drug level. Overall there is insufficient evidence to determine the comparative effectiveness of individual therapies, as compared with each other between the specified classes, with few exceptions. For the comparisons of adalimumab versus methotrexate, infliximab versus methotrexate, ustekinumab versus methotrexate, and etanercept versus acitretin, there is predominantly low strength of evidence favoring the individual biologic agent versus the nonbiologic agent. Additional trials directly comparing biologic systemic agents, systemic nonbiologic agents, and phototherapy are needed.