Tofacitinib versus a second anti-TNF drug after first anti-TNF failure to treat active rheumatoid arthritis

Abstract

Background: Rheumatoid arthritis is chronic inflammatory disease which could produce destruction of the joints, deformity in the joint zones and disability in the patient's daily life. So it’s important to treat correctly these patients. Biological therapy has greatly improved the treatment of RA, since the appearance of anti-TNF they have been the most used. Unfortunately, one-third of patients with rheumatoid arthritis show inadequate response to TNF inhibitors. Nowadays, there isn’t guidance on choosing the next treatment in these cases. The scientific literature supports both steps, the switching, to choose a second anti-TNF drug; or change to therapeutic target. Tofacitinib is an oral Janus kinase inhibitor, a new therapeutic target, for the treatment of active rheumatoid arthritis. Objectives: The objective of our study is to compare the efficacy of tofacitinib versus a second anti-TNF after a first failure of anti-TNF in the treatment of patients with active rheumatoid arthritis. Design: Multicentric, open and randomized controlled clinical trial with parallel groups. Methods: A total of 376 patients enrolled in this study will be randomized in two groups (group A and group B). The group A, with 188 patients, will receive two oral pills of tofacitinib (5mg and 5mg); and the second group, group B with 188 patients will receive an injections of anti-TNF drug. The efficacy of the treatment (primary outcome) will be the proportion of patients with a good or moderate DAS28 response on the EULAR scale in the 6th month of treatment. Secondary outcomes will also be seen in month 3 and 12, as well as SDAI, CDAI, HAQ and possible adverse effects.

Participants: Patients with active rheumatoid arthritis with insufficient response to first anti- TNF drug, reflected in DAS28-ESR with >3.2, with stable dose of methotrexate within 4 weeks

of enrollment