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Long-term Tofacitinib Use Appears Safe, Effective

Long-term Tofacitinib Use Appears Safe, Effective

Mon, 06/22/2020 - 17:11

In patients with psoriatic arthritis, long-term tofacitinib (Xeljanz) appears to offer stable efficacy over 2.5 years, with a safety profile similar to that found in previous 6- and 12-month studies. These findings from an interim analysis were published online in the journal Rheumatology and Therapy.

“The safety and efficacy of tofacitinib 5 and 10 mg twice daily in patients with psoriatic arthritis appeared to be consistent with that observed in the qualifying studies, OPAL Broaden and OPAL Beyond,” researchers wrote. “Laboratory parameters generally remained consistent over time. Efficacy across various psoriatic arthritis disease domains and patient-reported outcomes was also maintained over time in those patients remaining in the study.”

Some 686 patients with psoriatic arthritis from phase 3 studies OPAL Broaden and OPAL Beyond entered the 3-year, open-label OPAL Balance extension study, researchers reported. Patients started with 5 mg of tofacitinib twice daily and adjusted to 10 mg twice daily 1 month later if there was no improvement. Certain concomitant medications, such as methotrexate and corticosteroids, were allowed.
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According to the interim analysis, 80% of patients experienced adverse events, 14% of which were serious, over 3 years. Nearly 9% of participants left the study because of adverse events. The following known tofacitinib adverse events were reported by fewer than 20 patients each: herpes zoster, serious infections requiring hospitalization, infections in patients with weakened immune systems, cancer, cardiovascular events, and embolisms.

Meanwhile, efficacy was maintained over 30 months of clinical and patient-reported outcome data, which showed a continuation of improvements observed in OPAL Broaden and OPAL Beyond, researchers reported.

“The results of this third interim analysis of the long-term extension study OPAL Balance support the long-term safety and efficacy of tofacitinib in patients with active psoriatic arthritis,” they concluded.

Jolynn Tumolo


Nash P, Coates LC, Kivitz AJ, et al. Safety and efficacy of tofacitinib in patients with active psoriatic arthritis: Interim analysis of OPAL Balance, an open-label, long-term extension study [published online ahead of print June 6, 2020]. Rheumatol Ther. doi:10.1007/s40744-020-00209-4

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