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Tofacitinib more effectively treated RA patients’ symptoms than placebo
Tofacitinib, alone or with methotrexate, was more effective than placebo in significantly improving symptoms of patients with rheumatoid arthritis and also was superior to adalimumab for certain response criteria, according to meta-analysis results.
Researchers in Poland conducted a systematic literature search that included PubMed, EMBASE and Cochrane Central Register of Controlled Trials through May 3, 2013. The analysis included randomized controlled trials (RCTs) or abstracts published in peer-reviewed journals that evaluated tofacitinib compared with placebo or adalimumab for adults diagnosed with active rheumatoid arthritis (RA). Previously, all patients responded inadequately to methotrexate (MTX), disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor inhibitors.
Of 65 trials retrieved, nine RCTs comparing tofacitinib with placebo were identified, with eight included in the meta-analysis. Two studies also included a comparison with adalimumab. Five RCTs assessed tofacitinib’s efficacy in comparison with placebo, both given concomitantly with stable doses of MTX. Three studies compared tofacitinib with placebo without background MTX or other DMARDs.
After 12 weeks of treatment, tofacitinib provided improvement according to American College of Rheumatology 20% response criteria (ACR20) compared with placebo (P<.00001). Tofacitinib also showed superiority in achieving ACR50 response at week 12 vs. adalimumab (P=.003).
Researchers said no statistically significant differences in serious adverse events or treatment discontinuation because of adverse reactions were observed when comparing tofacitinib, adalimumab and placebo (P>.05).
“The findings … indicate that tofacitinib monotherapy or with background methotrexate provides early statistically significant and clinically important improvement in rheumatoid arthritis symptoms and has an acceptable safety profile compared to that of placebo,” the researchers concluded. “In addition, tofacitinib might provide an effective treatment option compared to intravenous or subcutaneous biological DMARDs, as suggested by the result of the comparison made regarding tofacitinib vs. adalimumab at ACR50 response rate.”
Disclosure: The researchers report no relevant financial disclosures.