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
- psoriatic arthritis
- outcomes research
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Handling editor Josef S Smolen
Contributors All authors were involved in drafting, revising and approved the final version of this manuscript. Substantial contributions for study conception and design were made by
EVS, HC, PA, FMM, AMR, IBM and JEF; RMR and EVS for data analysis; EVS, RMR, PT, AMR, FMM, HC, IBM and JEF for data interpretation; and EVS, PA, AMR, FT, JTC, AB, SP, FPS, JG, RA, TV, PP, CC, HS, JB, GS, CR, LT, PAR and JEF for acquisition of study data.
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.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval This trial was approved by the Portuguese Ethics Committee for Clinical Research (CEIC), National Authority of Medicines and Health Products (INFARMED) and National Data Protection Committee (CNPD).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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