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

Elsa Vieira-Sousa, Pedro Alves, Ana M Rodrigues, Filipa Teixeira, Jose Tavares-Costa, Alexandra Bernardo, Sofia Pimenta, Fernando M Pimentel-Santos, João Lagoas Gomes, Renata Aguiar, Patrícia Pinto, Taciana Videira, Cristina Catita, Helena Santos, Joana Borges, Graça Sequeira, Célia Ribeiro, Lídia Teixeira, Pedro Ávila-Ribeiro, Fernando M Martins, Helena Canhão, Iain B McInnes, Ruy M Ribeiro, João Eurico Fonseca, Elsa Vieira-Sousa, Pedro Alves, Ana M Rodrigues, Filipa Teixeira, Jose Tavares-Costa, Alexandra Bernardo, Sofia Pimenta, Fernando M Pimentel-Santos, João Lagoas Gomes, Renata Aguiar, Patrícia Pinto, Taciana Videira, Cristina Catita, Helena Santos, Joana Borges, Graça Sequeira, Célia Ribeiro, Lídia Teixeira, Pedro Ávila-Ribeiro, Fernando M Martins, Helena Canhão, Iain B McInnes, Ruy M Ribeiro, João Eurico Fonseca

Abstract

Objectives: To assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.

Methods: Multicentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.

Results: Twenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.

Conclusions: The combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.

Trial registration number: NCT02065713.

Keywords: anti-TNF; methotrexate; outcomes research; psoriatic arthritis.

Conflict of interest statement

Competing interests: EVS, FPS, JLG, LT, PAR and HC received grants from MSD. JEF received grants or personal fees from MSD, Abbvie, Biogen, Janssen, Lilly, Novartis, Pfizer, Roche, UCB and Sanofi. IBM received grants or personal fees from Celgene, Janssen, Novartis, Boerhinger Ingelheim, BMS, Abbvie, Lilly, GSK, Pfizer and UCB.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
GO-DACT trial consort flow diagram.
Figure 2
Figure 2
Changes from baseline to week 24 in DSS (A), psoriasis disease activity (D) and composite disease activity indices (E). Proportion of responders at week 24 of DSS 20, 50 and 70 (B), LDI 20, 50 and 70 (C) and response indices (F). ACR, American College of Rheumatology response index; BSA, body surface area; CDAI, clinical disease activity index; CPDAI, composite psoriatic disease activity index; DSS, Dactylitis Severity Score; DAPSA, disease activity in psoriatic arthritis; DAS28 4v, Disease Activity Score four variables; LDI, Leeds Dactylitis Index; MDA, minimal disease activity; MTX, methotrexate; NAPSI, Nail Psoriasis Severity Index; PASDAS: Psoriatic Arthritis Disease Activity Score; PASI: Psoriasis Area and Severity Index; PsAJAI, Psoriatic Arthritis Joint Activity Index; PsARC, Psoriatic Arthritis Response Criteria; SDAI, simplified disease activity index. *p

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