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Malignancy rates may remain stable with long-term tocilizumab treatment
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Overall rates of malignancy remained stable in patients with rheumatoid arthritis treated with tocilizumab in the long-term, according to study results, and malignancy rates were similar to expected rates for patients with this form of arthritis.
Using five core, phase 3 placebo-controlled studies, researchers evaluated patients with rheumatoid arthritis (RA) randomized to receive either intravenous tocilizumab, placebo plus methotrexate/disease-modifying antirheumatic drugs or at least one dose of tocilizumab. Malignancy was analyzed during the study and adjudicated as malignant with medical reviews. Investigators used standardized incidence ratios (SIRs) from the Surveillance Epidemiology and End Results and International Agency for Research on Cancer GLOBOCON databases to compare the risk of malignancy to the expected malignancy in the general population.
Results showed 4,009 patients in the all-exposure tocilizumab group, with a mean treatment duration of 4 years and a total observation time of 16,120.1 patient-years (PY). Investigators noted the adjudicated rate of malignancy was 1.26/100 PY, which remained the same with time. For all malignancies combined, with the exclusion of non-melanoma cancer, the SIR for the U.S. population was 1.36. For non-U.S. populations, the SIR was 1.81.
The researchers wrote, “in contrast to those for the general populations; these higher rates are in line with those expected in patients with RA or in the geographic regions studied.” ‒ by Monica Jaramillo
Disclosures: Rubbert-Roth reports she receives grants and ad board/lecture fees from Roche, Pfizer, Chugai, Merck Sharp and Dohme, BMS and AbbVie. Please see the full study for a list of all other authors’ relevant financial disclosures.
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