PSORIASIS

JAK Inhibitor Shows Long-term Efficacy for Plaque Psoriasis

June 5, 2018

A recent study found that tofacitinib, an oral Janus kinase inhibitor, had a similar safety profile to other phase 3 studies and remained efficacious over 54 months among patients with plaque psoriasis.

The open-label extension study included 2867 participants with moderate to severe chronic plaque psoriasis who completed phase 2/3 studies and received tofacitinib 10 mg twice a day for 3 months. Afterwards, investigators could adjust the dosage of tofacitinib to either 5 mg or 10 mg twice a day throughout the study period. Adverse events (AEs) were reported for up to 66 months and laboratory data was collected until month 54. The median treatment duration was 35.6 months. Primary efficacy endpoints included a 75% improvement on the Psoriasis Area and Severity Index (PASI75) and achieving clear or almost clear skin on the Physician’s Global Assessment (PGA response).
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During the follow-up period, 82.5% of participants reported AEs and 13.7% of participants reported serious AEs, with 13.9% discontinuing treatment due to AEs. Twenty-nine participants died. The incidence rate (patients with event/100 patient‐years) was 1.16 for serious infections, 0.67 for malignancies, and 0.26 for major adverse cardiovascular events. After initial changes in qualifying studies, the majority of laboratory parameters over 54 months were generally stable.

Overall, 52% to 62% of participants achieved a PGA response and 56% to 74% achieved PASI75 at each study visit through month 54.

“In patients with psoriasis, the safety profile of tofacitinib over 66 months was similar to previous reports in Phase 3 studies and efficacy was sustained through 54 months,” the researchers concluded.

Reference

Valenzuela F, Korman NJ, Bissonnette R, et al. Tofacitinib in patients with moderate to severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study [published online May 21, 2018]. Br J Dermatol. https://doi.org/10.1111/bjd.16798.