Among patients with rheumatoid arthritis who had previously been treated with methotrexate, the effectiveness and safety of tofacitinib was not demonstrably different than that of non-TNF biologics, according to findings published in Arthritis Research & Therapy.
“Most RA patients initiate therapy with methotrexate, which is the cornerstone RA drug,” Sasha Bernatsky, MD, PhD, FRCPC, of the Research Institute of McGill University Health Center, told Healio Rheumatology. “However past research suggests that about two-thirds of RA patients will require additional drugs. Several therapeutic options are available, including new Janus kinase (JAK) inhibitors, such as tofacitinib.”
To directly compare the effectiveness and safety of tofacitinib (Xeljanz, Pfizer) to a variety of treatments, including disease-modifying antirheumatic drugs (DMARDs), TNF inhibitors and non-TNF biologics in patients with RA who had already received methotrexate, the researchers conducted a retrospective cohort study the MarketScan Commercial Claims and Encounters database, and the MarketScan Medicare Supplemental and Coordination of Benefits database.
Among patients with RA who had previously been treated with methotrexate, the effectiveness and safety of tofacitinib was not demonstrably different than that of non-TNF biologics, according to researchers.
Bernatsky and colleagues included 21,832 patients with RA who had received methotrexate and were newly prescribed tofacitinib, biologics and DMARDs other than methotrexate between Jan. 1, 2011, and Dec. 30, 2014. Treatments were designated effective if they met all the following criteria at 1 year following the date of first prescription: high adherence, no biologic or tofacitinib switch or addition, no DMARD switch or addition, no increase in dose or frequency of index drug, no more than one glucocorticoid joint injection and no new or increased oral glucocorticoid dose. The primary safety measure was serious infection requiring hospitalization.
Among the participants, 0.8% were treated with tofacitinib, 24.7% received DMARDs other than methotrexate, 61.2% received TNF inhibitors and 13.3% were treated with non-TNF biologics.
According to the researchers, tofacitinib was effective in 15.4% of its cases, compared with 11.1% for DMARDs, 18.6% for TNF inhibitors and 19.8% for non-TNF biologics. In their adjusted analysis, the researchers concluded that tofacitinib and non-TNF biologics had similar effectiveness, while DMARDs were less effective.
“With respect to hospitalized infections, comparing tofacitinib to non-TNF biologics, we did not see any clear differences,” Bernatsky said. “Our study also highlights well-known factors associated with higher risk of infection like past and current oral glucocorticoids, previous biologic drug use, and current use of methotrexate.”
According to Bernatsky, the findings are consistent with current RA guidelines recommending tofacitinib as an alternative to biologic drugs when a patient remains in moderate- or high-disease activity after a first-line DMARD. However, she noted that said findings are not definitive, noting that she and her colleagues analyzed a relatively small sample of tofacitinib users.
“In our analyses, patients using biologics or tofacitinib could be also taking one or more DMARD, including methotrexate,” Bernatsky said. “In the safety analysis, patients were allowed to change therapy during follow-up. Then, we found that approximately half of the tofacitinib exposure was represented by patients who had initially started the cohort with a biologic therapy. However, in a sensitivity that we censored patients after they stopped/switched their initial therapy, the estimates were similar.” – by Jason Laday
Disclosure: Bernatsky reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.