BIOLOGICS VERSUS PLACEBO IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS: A SYSTEMATIC REVIEW AND META-ANALYSIS.
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 efficac... read morey and safety 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
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