Sustained remission with methotrexate monotherapy after 22-week induction treatment with TNF-alpha inhibitor and methotrexate in early psoriatic arthritis: an open-label extension of a randomized placebo-controlled trial

Henriëtte M Y de Jong, Leonieke J J van Mens, Michael T Nurmohamed, Marc R Kok, Arno W R van Kuijk, Dominique L P Baeten, Marleen G H van de Sande, Henriëtte M Y de Jong, Leonieke J J van Mens, Michael T Nurmohamed, Marc R Kok, Arno W R van Kuijk, Dominique L P Baeten, Marleen G H van de Sande

Abstract

Background: If TNF inhibitors are initiated in the early stages of psoriatic arthritis, this could potentially modulate disease and therefore allow us to discontinue the TNF inhibitor after achieving remission.

Objective: To investigate whether remission induced by tumour necrosis factor alpha inhibitor (TNFi) and methotrexate in patients with early psoriatic arthritis is sustained after withdrawal of TNFi.

Methods: Open-label extension of a recently published double-blind, randomized placebo-controlled trial. Patients with psoriatic arthritis fulfilling the CASPAR criteria and with active disease at baseline (swollen and tender joint count ≥ 3) were randomized to either golimumab and methotrexate or matched placebo and methotrexate. Patients in Disease Activity Score (DAS) remission at week 22 continued in the open-label extension on methotrexate monotherapy. The primary end point was the percentage of patients in DAS-CRP remission (DAS < 1.6) at week 50.

Results: Eight patients from the original placebo group and 18 patients from the original TNFi group continued in the extension phase. At week 50, 6 out of 8 (75%) patients from the original MTX (methotrexate) group versus 10 out of 18 (56%) patients from the original MTX+TNFi group were in DAS-CRP remission (p = 0.347). Considering the total study population, 6 out of 24 (25%) of the original MTX group versus 10 out of 26 (38.5%) of the original MTX+TNFi group were in DAS remission at week 50 (p = 0.308).

Conclusions: Remission achieved by initial combination treatment with TNFi and methotrexate in early psoriatic arthritis is maintained on methotrexate monotherapy in approximately half of the patients.

Trial registration: Registered at Clinicaltrials.gov with number NCT01871649 on June 7, 2013.

Keywords: Early psoriatic arthritis; Methotrexate; Remission; TNF inhibitor; Treatment withdrawal.

Conflict of interest statement

DB is currently an employee of UCB Pharma. LJJvM and HMdJ declare that they have no competing interest. 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.

Figures

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Fig. 1
The patient disposition and flow chart

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