Abstract
BackgroundMethotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse.ObjectiveIn order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods).ResultsIn terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1–60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5–5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1–14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% (mean ± s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time.LimitationsMeta-analyses for efficacy and safety, respectively, employed non-identical selection criteria.ConclusionsThese meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes.
Highlights
Rationale used for decades to treat psoriasis, surprisingly little systematic review of the use of methotrexate (MTX) in psoriasis has been carried out
We extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data
Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice
Summary
Rationale used for decades to treat psoriasis, surprisingly little systematic review of the use of methotrexate (MTX) in psoriasis has been carried out. A recent meta-analysis, comparing several systemic psoriasis treatments, did include methotrexate [1]. This study reported comparative efficacy of methotrexate, mostly to biologics, while no attempt was made to derive an estimate of PASI75 results versus placebo for methotrexate across clinical trials. If comparable dose ranges are employed, safety outcomes reported in other common chronic inflammatory conditions will be informative for psoriasis, even if the pathogenesis of the underlying condition treated differs. We performed a second, extended, meta-analysis to include studies on psoriasis and psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, palmoplantar psoriasis, as well as sero-negative spondyl-arthropathy. The co-morbidity spectrum of these patient populations will be not identical to psoriasis patients, including studies on these related indications in a meta-analysis vastly increases the sample size relevant for safety outcomes.
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