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Tofacitinib o Adalimumab versus Placebo para Artritis Psoriásica

Mease P, Hall S, FitzGerald O, van der Heijde D, Merola J F, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik K S. - N Engl J Med 2017; 377:1537-50. DOI: 10.1056/NEJMoa1615975

In the Phase 3 OPAL Broaden trial of patients with active psoriatic arthritis (PsA) with inadequate response to ≥1 csDMARD, superior efficacy was observed in patients treated with tofacitinib (TOF) compared with those given placebo.

Patients were randomised to: 5 mg TOF BID, 10 mg TOF BID, 40 mg adalimumab administered subcutaneously q2W, or placebo with a switch to 5 mg TOF at Month 3. Adalimumab was used as an active control in the study.

A variety of primary and secondary endpoints were used to test the efficacy of TOF. Primary endpoints, at Month 3, were ACR20 response rates and change from baseline HAQ-DI score. Secondary endpoints included: ACR 50/70 response rates, PASI75 and DAS-28 CRP score.

Both 5 mg and 10 mg TOF doses showed significantly greater ACR20 response and HAQ-DI change from baseline score at Month 3 compared with placebo. AEs were more frequent with TOF compared with placebo. Rates of non-progression of joint damage were similar in all treatment groups over the 12-month study period.

Conclusions suggest that further research is needed to assess the long-term efficacy and safety of TOF in patients with PsA.

Keywords: JAK, Tofacitinib, Clinical, Phase 3

Access original article via Pubmed

Upload date: November 2017

Translated by: Igor Kos

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