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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

Authors :
Marleen G H van de Sande
Dominique Baeten
Michael T. Nurmohamed
Arno W R van Kuijk
Leonieke J J van Mens
Henriëtte M. de Jong
Marc R. Kok
Rheumatology
ACS - Atherosclerosis & ischemic syndromes
AII - Inflammatory diseases
Clinical Immunology and Rheumatology
Graduate School
Amsterdam Gastroenterology Endocrinology Metabolism
Source :
Arthritis Research and Therapy, 21(1):208. BioMed Central, Arthritis Research & Therapy, Vol 21, Iss 1, Pp 1-6 (2019), Arthritis research & therapy, 21(1). BioMed Central, Arthritis Research & Therapy, de Jong, H M Y, van Mens, L J J, Nurmohamed, M T, Kok, M R, van Kuijk, A W R, Baeten, D L P & van de Sande, M G H 2019, ' 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 ', Arthritis Research and Therapy, vol. 21, no. 1, 208 . https://doi.org/10.1186/s13075-019-1998-4
Publication Year :
2019

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 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.

Details

Language :
English
ISSN :
14786354
Volume :
21
Issue :
1
Database :
OpenAIRE
Journal :
Arthritis research & therapy
Accession number :
edsair.doi.dedup.....3d574a77fcbf3c49e9b50ce1e44566d2