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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
  1. Leonieke J J van Mens1,2,
  2. Henriëtte M de Jong1,2,
  3. Inka Fluri1,2,
  4. Michael T Nurmohamed2,3,
  5. Marleen G H van de Sande1,2,
  6. Marc Kok4,
  7. Arno W R van Kuijk2,5,
  8. Dominique Baeten1,2
  1. 1 Clinical Immunology and Rheumatology, Amsterdam UMC, AMC/University of Amsterdam, Amsterdam, The Netherlands
  2. 2 Amsterdam Rheumatology and immunology Center, Amsterdam, The Netherlands
  3. 3 Clinical Immunology and Rheumatology, Amsterdam UMC, VU University, Amsterdam, The Netherlands
  4. 4 Rheumatology, Maasstad Ziekenhuis, Rotterdam, The Netherlands
  5. 5 Rheumatology, Jan van Breemen Research Institute | Reade, Amsterdam, The Netherlands
  1. Correspondence to Dr Dominique Baeten, Clinical Immunology and Rheumatology, Amsterdam UMC, AMC/University of Amsterdam, Amsterdam 1011 AA, The Netherlands; d.l.baeten{at}amc.uva.nl

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.

  • psoriatic arthritis
  • treatment
  • TNF inhibition
  • methotrexate
  • disease activity

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Footnotes

  • Handling editor Josef S Smolen

  • Contributors All authors were involved in drafting the article or revising it critically, and all authors approved the final version of the manuscript to be published. LJJvM, MTN, AWRvK and DB were involved in the study conception and design. LJJvM, HMdJ, IF, MGHvdS, MK and AWRvK were involved in the acquisition of study data. LJJvM, IF, HMdJ, MGHvdS, MK, AWRvK and CB were involved in the analysis and interpretation of the study data.

  • Funding This investigator-initiated study was supported by supply of study medication and an unrestricted grant from MSD.

  • 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.

  • Patient consent for publication Obtained.

  • Ethics approval The study was approved by the medical ethics committee of the Academic Medical Centre in Amsterdam.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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