| Objective. To evaluate the benefits and harms of combination of tumor necrosisfactor-alpha (TNF-α) inhibitor and methotrexate (MTX) compared with TNF-αinhibitor monotherapy in the treatment of ankylosing spondylitis (AS). Methods.Randomized controlled trials were identified from MEDLINE, EMBASE, CINAHL,CENTRAL and Clinical Trials Registry Platform (all up to November3,2013), aswell as from the reference sections of retrieved articles. The risk of bias was evaluatedin all included trials. Data were extracted by two reviewers independently using aspecially designed extraction form. The Cochrane Collaboration’s Review Manager5software was used for data analysis. Results. The search retrieved852titles, of which3original trials were included, involving187participants. The overall risk of bias islow in all three trials. All these three studies applied infliximab (IFX) and MTXcombination. Only one study was placebo controlled, and all of them examined smallsamples. The analysis showed no significant advantage of the IFX and MTXcombination versus IFX monotherapy. Two trials assessed Assessment of AnkylosingSpondylitis (ASAS)40and the pooled risk ratio (RR) was1.37and95%confidenceinterval (CI)0.84to2.23. The RR for ASAS20was1.16(0.88to1.52). Likewise,there were no significant difference between IFX+MTX combination group and IFXmonotherapy group in partial remission, Bath Ankylosing Spondylitis DiseaseActivity Index, Bath Ankylosing Spondylitis Functional Index, Magnetic resonanceimaging activity score and other secondary outcomes. Withdrawals for side effectsand for any reason were similar in IFX+MTX combination group and IFXmonotherapy group. RRs were1.89(0.71to5.02) and1.11(0.67to1.84), respectively.Conclusions. There is not enough evidence supporting any benefit of adding MTX toTNF-α inhibitor for the treatment of AS. |
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