Direct switch from TNFi to tofacitinib shows ‘acceptable’ safety in psoriatic arthritis
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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.
“There are no available data from randomized controlled trials in PsA assessing clinical outcomes in patients who have directly switched from [TNF inhibitors] to tofacitinib, and whether they maintain or achieve disease control with an acceptable safety profile,” Dafna D. Gladman, MD, of the department of medicine at the University of Toronto, and colleagues wrote.
“Given the different mechanisms of action of these treatments, and the long half-life of adalimumab (15 to 19 days), it is possible that directly switching from adalimumab to tofacitinib with no washout period could result in a short period of overlapping immunomodulatory effects,” they added. “However, to maintain disease control, it may be preferable to avoid a washout period, as discontinuing DMARD treatment can lead to rapid increase in PsA symptoms.”
To examine the safety and efficacy of switching directly from adalimumab (Humira, AbbVie) to tofacitinib (Xeljanz, Pfizer) in PsA, Dafna 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.
“Overall, efficacy and safety outcomes were generally similar between the two groups, suggesting that patients with PsA can be directly switched from adalimumab to tofacitinib without any washout period,” Gladman and colleagues wrote. “... These results suggest that patients with PsA can be directly switched from [adalimumab] to tofacitinib without any washout period.”
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