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Nonmelanoma skin cancer incidence rates appear stable with Xeljanz treatment for RA

Overall nonmelanoma skin cancer incidence rates appeared to be stable in patients with rheumatoid arthritis who were treated with Xeljanz, according to a recent analysis of studies.

Jeffrey Curtis, MD, MPH, and colleagues pooled nonmelanoma skin cancer data from two phase 1, eight phase 2 and six phase 3 studies, along with two long-term extension studies. In the phase 1, phase 2 and extension studies, patients with rheumatoid arthritis (RA) received Xeljanz (tofacitinib, Pfizer) 5 mg or 10 mg twice daily as monotherapy or with disease-modifying anti-rheumatic drugs. In the phase 2 studies, patients received tofacitinib 1 mg to 30 mg twice daily or 20 mg once daily.

Jeffrey Curtis

The combined doses in all patient populations were used to calculate incidence rates per 100 patient years of exposure for first nonmelanoma skin cancer.

In all studies, there were 6,092 patients who received tofacitinib, with 15,103 patient-years of exposure. Eighty-three patients had at least one nonmelanoma skin cancer occurrence, including 39 cases of squamous cell carcinoma (SCC) and 52 cases of basal cell carcinoma (BCC). A history of nonmelanoma skin cancer before tofacitinib therapy was reported by five patients.

Incidence rates overall were 0.55 (95% CI, 0.45-0.69) for nonmelanoma skin cancer overall, 0.26 (95% CI, 0.19-0.35) for SCC and 0.35 (95% CI, 0.26-0.45) for BCC. Patients receiving tofacitinib 5 mg twice-daily had nonmelanoma skin cancer incidence rates of 0.61 (95% CI, 0.34-1.1) in the phase 1, 2 and 3 studies and 0.41 (95% CI, 0.26-0.66) in the extensions studies, while those receiving 10 mg twice daily had nonmelanoma skin cancer incidence rates of 0.47 (95% CI, 0.24-0.9) in the phase 1, 2 and 3 studies and 0.79 (95% CI, 0.6-1.05) in the extension studies.

Patients receiving background disease-modifying anti-rheumatic drugs had an incidence rate of 0.64 compared with 0.43 for patients receiving tofacitinib monotherapy. Patients who previously received tumor necrosis factor inhibitors had a higher rate of nonmelanoma skin cancer, with an incidence rate of 1.01 compared with 0.47 for those who had not received the therapy.

“[Nonmelanoma skin cancer incidence rates] appeared consistent with published estimates in patients with RA treated with [tumor necrosis factor inhibitors],” the researchers concluded.  – By Bruce Thiel

Reference:

Curtis J, et al. Paper #THU0174. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosures: Curtis reports receiving grant and research support from Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.