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Lymphoma rates in Xeljanz clinical trials for RA stable
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In a review of clinical trials of tofacitinib, lymphoma rates among patients with rheumatoid arthritis who received the drug were stable over time, with minimal differences in the baseline characteristics of those with and without lymphoma, according to findings published in Arthritis Care and Research.
“Safety events of special interest related to JAK involvement in immune function, including lymphoma, require close monitoring during the development of immunomodulatory agents,” Xavier Mariette, MD, PhD, of the Paris Sud University Hospitals, and colleagues wrote. “The efficacy and safety of tofacitinib for the treatment of RA have been reported in phase-1, phase-2, phase-3 and longterm extension studies with up to 105 months of observation.”
To analyze and characterize lymphoma events that have occurred in the RA clinical development program of tofacitinib (Xeljanz, Pfizer), the researchers reviewed 19 studies, representing 6,149 adult patients with active moderate-to-severe RA at baseline. The studies included two phase 1, nine phase 2, six phase 3 and two long-term extension trials. The studies included 19,406 patientyears of exposure, with a median treatment duration of 3.4 years.
Patients in the studies received tofacitinib in doses of 1 mg to 30 mg twice daily, or 20 mg once daily, either as monotherapy or in addition to conventional synthetic diseasemodifying antirheumatic drugs. Mariette and colleagues calculated the number of patients with lymphoma events per 100 patient-years, as well as standardized incidence ratios. They also performed a descriptive case–matched control analysis to determine potential risk factors for lymphoma.
Adjusted for age and sex, the standardized incidence ratio for lymphoma was 2.62 (95% CI, 1.58-4.09). Among the 19 lymphoma events, three were positive for EpsteinBarr virus, eight were negative, two were equivocal and six were untested. At baseline, more lymphoma cases than controls had a history of Sjögren’s syndrome, and were positive for anti-cyclic citrullinated protein and rheumatoid factor. In addition, the mean corticosteroid dose was higher for lymphoma cases compared with those in the control groups.
According to the researchers, there were 19 incidences of lymphoma (IR = 0.1; 95% CI, 0.06-0.15), with no increase with exposure time.
“[Incidence rates] and types of lymphoma observed during the tofacitinib RA clinical development program (with upward of 8 years of exposure) were consistent with expectations in the RA patient population as a whole and did not increase with exposure time,” Mariette and colleagues wrote. “Although efforts were made to ascertain the [EpsteinBarr virus] status of the lymphomas reported, the data do not allow a clear assessment to be made.” – by Jason Laday
Disclosure: Mariette reports honoraria from BristolMyers Squibb, GlaxoSmithKline, MedImmune, Pfizer, Sanofi and UCB. Please see the study for all other authors’ relevant financial disclosures.
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