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Study: Malignancy rates remain stable over time with Xeljanz
The rate of malignancy development in patients receiving Xeljanz remained stable over time as exposure to the Janus kinase inhibitor increased, according to recently published data.
Patients with active, moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate or non-biologic or biologic disease-modifying anti-rheumatic drugs (DMARDs) were enrolled in phase 2 and 3 international studies. Patients with a history of malignancy were excluded; however, patients who developed a malignancy discontinued Xeljanz (tofacitinib, Pfizer) but continued follow-up.
Jeffrey R. Curtis
Of 5,671 patients who received tofacitinib in a trial, 4,204 were treated for more than 1 year, 3,084 were treated for more than 2 years and 1,948 were treated for more than 3 years. Median overall exposure was 2.35 years. Additionally, tofacitinib was received as monotherapy in 657 patients (47.2%) enrolled in phase 2 studies and 1,361 patients (35.9%) enrolled in phase 3 trials, whereas 2,435 (64.1%) received tofacitinib in combination with non-biological DMARDs.
Of 107 malignancies, lung cancer was the most common in 24 patients, followed by breast cancer in 18 patients, lymphoma in 10 patients and gastric cancer in six patients, excluding nonmelanoma skin cancer (NMSC). Statistical analysis showed no association between duration of tofacitinib treatment and overall malignancy risk, according to the researchers.
Of patients with lung cancer, five were diagnosed within 6 months of treatment initiation, 14 of 24 were current smokers, six were former smokers and four were nonsmokers. The standardized incidence ratio (SIR) was 2.19 for all studies. In patients with breast cancer, the SIR ratio was 0.78 and in lymphoma, the SIR was 2.64 after adjusting for age and sex.
Incidents of NMSC were reported in 66 patients, including 44 incidents of basal cell carcinoma in 39 patients and 38 incidents of squamous cell carcinoma in 33 patients. Of all malignancies, 18 deaths occurred.
The rates of malignancies in patients treated with tofacitinib were similar to rates seen in patients with RA, according to the researchers. - by Shirley Pulawski
Disclosures: Curtis reports grants and personal fees from Genentech, UCB, Janssen, Corrona, Amgen, Pfizer, BMS, Crescendo, AbbVie, outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.