Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate

Annals of the Rheumatic Diseases
Leonieke J J van MensDominique Baeten

Abstract

Early initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior to MTX alone in inducing remission in PsA. This investigator-initiated, multicentre, double-blind, randomised, placebo-controlled trial included 51 MTX and bDMARD-naive patients with PsA fulfilling the CASPAR criteria and with active disease at baseline (≥3 swollen joint count/tender joint count). Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm). MTX was started 15 mg/week and increased to 25 mg/week over 8 weeks. The primary endpoint was percentage of patients achieving Disease Activity Score (DAS) remission (<1.6) at week 22. Safety was assessed throughout the study. The primary efficacy endpoint was achieved by 81% in the TNFi arm versus 42 % in the MTX arm (p=0.004). This difference in DAS remission was already observed at week 8. A significant difference in favour of the golimumab+MTX arm at week 22 was also observed for other response criteria such as MDA, ACR2...Continue Reading

Associated Clinical Trials

References

Jul 13, 2004·Arthritis and Rheumatism·Philip J MeaseWayne Tsuji
Jan 29, 2005·Annals of the Rheumatic Diseases·C AntoniUNKNOWN IMPACT 2 Trial Investigators
Oct 4, 2005·Arthritis and Rheumatism·Philip J MeaseUNKNOWN Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group
Jul 28, 2006·Arthritis and Rheumatism·William TaylorUNKNOWN CASPAR Study Group
Jan 17, 2009·Annals of the Rheumatic Diseases·L C CoatesP S Helliwell
Feb 22, 2012·Rheumatology·Gabrielle H KingsleyDavid L Scott
Jan 9, 2015·Arthritis Research & Therapy·Hanna W van SteenbergenAnnette H M van der Helm-van Mil
Oct 1, 2015·The New England Journal of Medicine·Philip J MeaseUNKNOWN FUTURE 1 Study Group
Feb 19, 2017·Annals of the Rheumatic Diseases·Philippe CarronUNKNOWN CRESPA investigator group
Oct 19, 2017·The New England Journal of Medicine·Dafna GladmanKeith S Kanik

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