Direct switch from TNFi to tofacitinib shows ‘acceptable’ safety in psoriatic arthritis
Key takeaways:
- Efficacy was similar between patients on tofacitinib and those who switched from adalimumab.
- Switching from adalimumab brought no increases in treatment-emergent adverse events.
For patients with psoriatic arthritis, switching directly from adalimumab to tofacitinib with no washout period presents no increased safety risks, according to data published in Arthritis Research & Therapy.
“This work is an extension of previous work on the effect of tofacitinib in patients with psoriatic arthritis,” Dafna D. Gladman, MD, of the department of medicine at the University of Toronto, told Healio. “The purpose of the current study was to determine the efficacy and safety outcomes of patients who were originally treated with tofacitinib and those who were originally treated with adalimumab, but later switched to tofacitinib. This was particularly relevant since there have not been many studies who looked at direct switches from one agent to another.”
To examine the safety and efficacy of switching directly from adalimumab (Humira, AbbVie) to tofacitinib (Xeljanz, Pfizer) in PsA, Gladman and colleagues conducted a post-hoc analysis of data from a phase 3 study that tested the two drugs against each other, as well as long-term extension data in which adalimumab-treated patients switched to tofacitinib.
The analysis included 180 adults with PsA, 50.6% of whom switched in the long-term extension study from adalimumab 40 mg once every two weeks to receiving tofacitinib 5 mg twice per day. The other 89 participants received the tofacitinib regimen throughout both studies.
Efficacy — measured via ACR20/50/70, Psoriasis Area Severity Index, Psoriatic Arthritis Disease Activity Score, the Health Assessment Questionnaire Disability Index and other metrics — was similar between both groups during the phase 3 study, according to the researchers. Responses were maintained and largely similar between the groups through month 3 of the long-term extension study.
The analysis showed that, among switchers, those who responded in an efficacy outcome during the long-term extension were mostly those who also responded during the initial study.
Meanwhile, throughout the study and the long-term extension, incidences of treatment-emergent adverse events, serious adverse events and serious infections were overall similar between treatment groups. Switching directly from adalimumab to the tofacitinib regimen demonstrated an “acceptable” safety profile, the researchers wrote.
“This analysis demonstrated that both patients who continued on tofacitinib and those who switched from adalimumab to tofacitinib demonstrated similar efficacy, and the safety profile was maintained,” Gladman said. “This suggests that clinicians can safely switch their psoriatic arthritis patients from adalimumab to tofacitinib without any loss of efficacy or safety concerns.”
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