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Meta‐analysis results do not reflect the real safety of biologics in psoriasis *
Author(s) -
Afach S.,
Chaimani A.,
Evrenoglou T.,
Penso L.,
Brouste E.,
Sbidian E.,
Le Cleach L.
Publication year - 2021
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.19244
Subject(s) - psoriasis , medicine , dermatology , meta analysis , medline , chemistry , biochemistry
Summary Background In reported systematic reviews and meta‐analyses of randomized controlled trials ( RCT s) assessing treatments for psoriasis, the proportion of serious adverse events ( SAE s) did not differ between treatments and placebo. Including cases of psoriasis worsening as SAE s may explain the lack of difference. Objectives This systematic review and meta‐analysis aimed to explore this possibility. Methods Among the 140 RCT s included in the Living Network Cochrane Review (last search on 8 May 2019), we selected those comparing a biologic treatment against placebo. The primary outcome was the numbers of SAE s in the treatment and placebo arms after excluding cases of psoriasis worsening. Secondary outcomes were the number of adverse events ( AE s) of special interest. The trial was registered on PROSPERO ( CRD 42019124495). Results We analysed 51 RCT s. Of these, 21 included at least one anti‐tumour necrosis factor ( TNF )‐α arm, 15 one anti‐interleukin ( IL )‐17 arm, 11 one anti‐ IL ‐23 arm and nine one anti‐ IL ‐12/23 arm. With cases of psoriasis worsening included, the risk of occurrence of SAE s between biologic treatments and placebo did not differ: risk ratio ( RR ) 1·09, 95% confidence interval ( CI ) 0·88–1·36. After excluding cases of psoriasis worsening, the RR became significant ( RR 1·30, 95% CI 1·02–1·65). By drug class, the RR s were for anti‐ TNF ‐α, 1·68 (95% CI 1·11–2·54; no missing data); anti‐ IL ‐17, 1·28 (95% CI 0·88–1·85; no missing data); anti‐ IL ‐23, 0·95 (95% CI 0·59–1·52; no missing data) and anti‐ IL ‐12/23, 1·18 (95% CI 0·72–1·94; no missing data). We were unable to examine potential differences in AE s of special interest between biologic treatments and placebo arms because of the small number of events. Conclusions On excluding cases of worsening psoriasis, the risk of occurrence of SAE s is higher in the biologic than in the placebo arm. Given the rare events, we could not highlight whether this higher risk of SAE s was related to AE s of special interest. Reporting of SAE s in clinical trials has to be changed to provide more transparency through the separate reporting of disease flares leading to hospital admission and other SAE s.