BIOLOGICS VERSUS PLACEBO IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS: A SYSTEMATIC REVIEW AND META-ANALYSIS.
Alkofide, Maha.
2014
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Abstract: Several meta-analyses have addressed the comparative effectiveness of biologics to placebo for moderate to severe plaque psoriasis treatment. However, with the introduction of ustekinumab and the withdrawal of other biologics, the efficacy and tolerability of currently approved biologics in various psoriasis-related outcomes has yet to be assessed. Our aim was to compare the efficacy and... read moresafety of currently approved biologics to placebo in patients with moderate to severe psoriasis. We hypothesized that biologics are superior to placebo in efficacy and have a favorable safety profile. To collect relevant data we searched MEDLINE and Cochrane Central Register of Controlled Trials (CENTRAL) from inception through December 2013. Our study selection included: Peer-reviewed, English-language randomized controlled trials in patients with moderate to severe psoriasis comparing biologics to placebo. Two authors extracted data on study population, interventions, outcome measures, adverse events, and study methodology. Twenty-three trials satisfied our eligibility criteria. Random-effects model meta-analyses, meta-regression, subgroup analyses, and multivariate meta-analyses were performed. Participants on biologics had a summary odds ratio (OR) of 26.8 (95% CI= 18.8-38.4) for achieving 75% improvement in psoriasis area and severity index (PASI 75). This effect was consistent regardless of follow-up duration. All types of biologics were effective compared to placebo. For PASI 75 outcome, ustekinumab OR= 50.9 (95% CI= 36.4-71.2), infliximab OR= 33.6 (95% CI= 7.0-160), adalimumab OR= 26.6 (95% CI= 17.8-39.7), and etanercept OR= 16.9 (95% CI= 12.2-23.3). Similar effects were seen with physician's global assessment (PGA) score of 0 or 1 (OR= 25.7, 95% CI = 19.3-34.3) and dermatology life quality index (DLQI) score of 0 or 1 (OR= 25.3, 95% CI = 9.84-33.4). The proportions of patients with serious adverse events were similar between groups. Withdrawals due to adverse events were similar across groups, however withdrawals due to lack of efficacy were higher with placebo. There are several limitations to our study including: different outcome definitions and reporting bias, high heterogeneity, and publication bias. We concluded that biologics improved psoriasis control compared to placebo in PASI and non-PASI related outcomes. However, the need for trials comparing long-term efficacy and safety of biologics are warranted.
Thesis (M.S.)--Tufts University, 2014.
Submitted to the Dept. of Clinical & Translational Science.
Advisor: Ethan Balk.
Committee: Alice Gottlieb, Norma Terrin, and Jessica Paulus.
Keyword: Health sciences.read less - ID:
- kd17d4613
- Component ID:
- tufts:20208
- To Cite:
- DCA Citation Guide EndNote
