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Go-dact: a phase 3b randomised, double-blind, placebo-controlled trial of golimumab plus methotrexate (mtx) versus placebo plus mtx in improving dactylitis in mtx-naive patients with psoriatic arthritis

Annals of Rheumatic Diseases Mar 23, 2020

Vieira-Sousa E, Alves P, Rodrigues AM, et al. - A phase 3b randomised, double-blind, placebo-controlled trial was carried out to evaluate the efficacy of golimumab in combination with methotrexate (MTX) vs MTX monotherapy in psoriatic arthritis (PsA) dactylitis in 11 Portuguese rheumatology centres. Researchers randomized individuals with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) to golimumab or placebo, both in combination with MTX.  For 24 weeks, 21-one individuals received golimumab plus MTX and 23 MTX monotherapy. The primary outcome included Dactylitis Severity Score (DSS) change from baseline to week 24. The DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score were considered as secondary outcomes. For the treatment of PsA dactylitis, it was reported that combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy.

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