In Third and Fourth Line in RA, Tofacitinib Monotherapy Proves Similar in Efficacy to Anti-TNFs Plus Methotrexate

A recent study assessed tofacitinib versus anti–tumor necrosis factor (anti-TNF) agents using data from the Corrona registry, a large, prospective, observational database of patients with rheumatoid arthritis (RA) in more than 174 practices in 41 US states. 
The Center for Biosimilars Staff
November 27, 2019
The introduction of Janus kinase (JAK) inhibitors into the treatment landscape for inflammatory diseases has the potential to significantly change how patients with rheumatoid arthritis (RA) are treated, and stakeholders are currently grappling with such issues as the drugs’ cost effectiveness and benefits relative to the standard of care: anti–tumor necrosis factor (anti-TNF) therapies and their biosimilars.

A recent study, published in Rheumatology and Therapy, assessed one such JAK inhibitor, tofacitinib (Xeljanz), versus anti-TNF agents using data from the Corrona registry, a large, prospective, observational database of patients with RA in more than 174 practices in 41 US states. The researchers characterized the comparative effectiveness of tofacitinib versus anti-TNF agents both as monotherapy and in combination with methotrexate.

The study included data from 8014 patients who had received an anti-TNF for RA from 2001 and 558 who had received tofacitinib since 2012, with or without concomitant methotrexate, up to November 2016. Outcomes were compared among treatments and by lines of therapy.

Patients who had 6 months of follow-up included 402 patients receiving tofacitinib (238 of whom used the drug as monotherapy) and 6241 patients receiving an anti-TNF agent (1889 of whom used a biologic as monotherapy). Those receiving tofacitinib had a longer RA duration, and a greater proportion of patients in this group had previously received biologics compared with those in the anti-TNF use group.

In patients receiving anti-TNFs as second-line therapy, the rate of low disease activity (LDA) and/or remission based on the Clinical Disease Activity Index was higher among those who took methotrexate than among those receiving monotherapy (59.0% vs 49.0%; odds ratio [OR], 1.50; 95% CI, 1.19-1.88). In the third line, combination therapy also led to better outcomes than monotherapy in terms of LDA and remission (43.1% vs 36.9%; OR, 1.30; 95% CI, 1.02-1.64).

However, for those receiving tofacitinib in the third and fourth lines, LDA/remission rates were not significantly different between those receiving monotherapy and combination therapy (32.1% vs 30.2%; OR, 1.09; 95% CI, 0.61-to 1.95).

When the authors restricted anti-TNF data to an observation period starting with the approval date of tofacitinib and matched line of therapy (using a combined third and fourth line), rates of LDA/remission were similar among patients receiving anti-TNFs in combination with methotrexate and those receiving tofacitinib as monotherapy (33.8% vs 29.9%; OR, 1.21; 95% CI, 0.74-1.97). No differences were observed for LDA/remission between patients starting anti-TNFs in combination with methotrexate and those starting tofacitinib in combination with methotrexate in the third and fourth line (38.7% vs 36.0%; OR, 1.12; 95% CI, 0.65-1.93).

In clinical practice, write the authors, anti-TNF agents see an improvement in their efficacy with the addition of methotrexate in the second and third line, but in the third and fourth line, patients are likely to achieve similar efficacy outcomes with tofacitinib as monotherapy and anti-TNFs or tofacitinib in combination with methotrexate.

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