Anakinra for Rheumatoid Arthritis: A Systematic Review

↵* Methodological quality was defined using the system described by Tugwell, et al³⁰ as follows: Platinum: A published systematic review that has at least 2 individual controlled trials each satisfying the following: Sample size of at least 50 per group — if these do not find a statistically significant difference, they are adequately powered for a 20% relative difference in the relevant outcome. Blinding of patients and assessors for outcomes. Handling of withdrawals > 80% followup [imputations based on methods such as last observation carried forward (LOCF) are acceptable]. Concealment of treatment allocation. Gold: At least 1 randomized clinical trial meeting all the following criteria for the major outcome(s) as reported: Sample sizes of at least 50 per group — if these do not find a statistically significant difference, they are adequately powered for a 20% relative difference in the relevant outcome. Blinding of patients and assessors for outcomes. Handling of withdrawls > 80% followup (imputations based on methods such as LOCF are acceptable). Concealment of treatment allocation. Silver: A randomized trial that does not meet the above criteria. Silver ranking would also include evidence from at least 1 study of non-randomized cohorts that did and did not receive the therapy, or evidence from at least one high quality case-control study. A randomized trial with a “head-to-head” comparison of agents would be considered silver level ranking unless a reference were provided to a comparison of one of the agents to placebo showing at least a 20% relative difference. Bronze: The bronze ranking is given to evidence if a least 1 high quality case series without controls (including simple before/after studies in which patients act as their own control) or if the conclusion is derived from expert opinion based on clinical experience without reference to any of the foregoing (for example, argument from physiology, bench research, or first principles). ACR: American College of Rheumatology; HAQ: Health Assessment Questionnaire; VAS: visual analog scale; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; SD/SE: standard deviation/error.