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Randomized Controlled Trial
. 2019 May;78(5):610-616.
doi: 10.1136/annrheumdis-2018-214746. Epub 2019 Feb 26.

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

Leonieke J J van Mens  1   2 , Henriëtte M de Jong  1   2 , Inka Fluri  1   2 , Michael T Nurmohamed  2   3 , Marleen G H van de Sande  1   2 , Marc Kok  4 , Arno W R van Kuijk  2   5 , Dominique Baeten  6   2
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Free article
Randomized Controlled Trial

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

Leonieke J J van Mens et al. Ann Rheum Dis. 2019 May.
Free article

Abstract

Objectives: 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.

Methods: 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.

Results: 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, ACR20/50/70, disease measures and patient-reported outcomes. The occurrence rates of adverse event and treatment-emergent adverse event were similar in both arms.

Conclusions: In patients with early PsA, DAS remission at week 22 was almost doubled with golimumab+MTX versus MTX alone. This double-blind, randomised, placebo-controlled study supports the concept that early initiation of TNFi in patients with PsA favours remission.

Trial registration number: NCT01871649.

Keywords: TNF inhibition; disease activity; methotrexate; psoriatic arthritis; treatment.

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Conflict of interest statement

Competing interests: DB is currently an employee of UCB Pharma. LJJvM, IF and HMdJ have nothing to disclose. MGHvdS has been an advisor for Abbvie and Novartis, and received research grants from Janssen, Eli Lily and Novartis. The department of MK is supported by Novartis, Abbvie, Pfizer, Roche, Lilly and BMS, and MK has been an advisor for Novartis and Abbvie. MTN received research grants, consultation and/or speaking fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi and UCB Pharma. AWRvK received speaker fees from Celgene, Novartis, Eli Lilly and Janssen, and received research support from MSD and Janssen.

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