Review raises no new safety concerns with Xeljanz for RA

No new safety concerns were raised after a review of adverse events in patients being treated for rheumatoid arthritis with Xeljanz.

Post-marketing spontaneous reports covering 18 months after the approval of Xeljanz (tofacitinib citrate, Pfizer) were analyzed in relation to adverse events (AEs).

Of 2,496 case reports, 6,295 AEs were reported. Most AEs (83.4%) were non-serious. Of the 1,043 serious AEs, 21.8% were related to infections. 8.7 were related to gastrointestinal disorders, 3.55% were neoplasm events and 0.6% were hepatobiliary disorders.

Serious infections numbered 5.1 per 100 patient years at the first month, 6.2 per 100 patient years at 2 months and 2.48 per 100 patient years at the 6-month interval.

Pneumonia was present in 33 patients, urinary tract infection in 26 patients, sepsis in 15 patients, diverticulitis in 11 patients and herpes zoster infections in 10 patients. Tuberculosis was reactivated in two patients, disseminated herpes zoster in one patient, histoplasmosis in one patient, cytomegalovirus gastritis/esophagitis in one patient and an unspecified opportunistic infection in one patient.

Lymphoma was reported in six patients, bladder cancer in three patients, brain neoplasm in three patients, malignant lung neoplasm in two patients, basal cell carcinoma in two patients and unspecified malignancy in two patients; however, most case reports lacked sufficient information to assess causality, according to the researchers.

No significant change in reported rates for gastrointestinal and hepatobiliary AEs with tofacitinib were noted. Of the 91 serious AEs reported, diarrhea was the most common (11 patients) followed by nausea, vomiting, hemorrhage and hematochezia. – by Shirley Pulawski

Reference:

Cohen S, et al. Paper #465. Presented at: American College of Rheumatology Annual Meeting. Nov. 14-19, 2014; Boston.

Disclosure:The authors are affiliated with Pfizer.