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.

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.

• Authors: 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
• Journal: Arthritis research & therapy (Arthritis Res Ther) Vol. 21 Issue 1 Pg. 208 (09 14 2019) ISSN: 1478-6362 [Electronic] England
• PMID: 31521192 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• Tumor Necrosis Factor Inhibitors
• golimumab
• Methotrexate

Topics

• Antibodies, Monoclonal (administration & dosage)
• Antirheumatic Agents (administration & dosage)
• Arthritis, Psoriatic (diagnosis, drug therapy)
• Disease Progression
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Male
• Methotrexate (administration & dosage)
• Middle Aged
• Remission Induction (methods)
• Time Factors
• Treatment Outcome
• Tumor Necrosis Factor Inhibitors (therapeutic use)