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Cancer risk greater in CD patients treated with adalimumab, immunomodulators
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Combination adalimumab and immunomodulator therapy in patients with Crohn’s disease was associated with an increased risk for nonmelanoma skin cancer and other cancers, according to recent study data.
Mark T. Osterman, MD, University of Pennsylvania, Perelman School of Medicine, and colleagues performed a pooled analysis of data from 1,594 patients with Crohn’s disease (CD) who participated in clinical trials of anti-tumor necrosis factor (anti-TNF) agent adalimumab. Expected malignancy rates in the general population were sourced from the Surveillance, Epidemiology, and End Results (2000 to 2007) registry and a 1977-1978 National Cancer Institute survey, which were compared with malignancy rates in patients who underwent adalimumab monotherapy (n=900) or combination therapy (n=694).
Mark T. Osterman
Monotherapy malignancy rates were compared with those in combination therapy patients, and malignancy was defined as treatment emergent, occurring during therapy or up to 70 days after last dose. Relative risks were calculated with and without adjusting for age, sex, race, weight, smoking status, disease duration, baseline Crohn’s Disease Activity Index score, baseline corticosteroid use, and prior anti-TNF therapy.
Monotherapy patients showed no increased risk for nonmelanoma skin cancer (NMSC; standardized incidence ratio=1.2; 95% CI, 0.39-2.8) or other malignancies (SIR=0.63; 95% CI, 0.17-1.62) compared with the general population. Combination therapy patients, however, had a greater rate of NMSC malignancies (SIR=4.59; 95% CI, 2.51-7.7) and an increase in non-NMSC malignancies (SIR=3.04; 95% CI, 1.66-5.1) compared with the general population. Combination therapy patients also had a higher NMSC risk (adjusted RR=3.46; 95% CI, 1.08-11.06) and an increased risk for malignances other than NMSC (aRR=2.82; 95% CI, 1.07-7.44) vs. monotherapy patients.
“These data suggest that the increased risk likely is attributable to the immunomodulator therapy,” the researchers wrote. “Importantly, for most patients, particularly younger patients, the absolute increase in risk of cancer is small and must be weighed against the potential benefits of combination therapy on the course of CD.”
"For patients who are on step-up combination therapy in the setting of ineffective or incompletely effective thiopurine therapy, the potential risks of malignancy should be weighed against the potential benefits of increasing anti-TNF drug levels and suppressing antibody formation when deciding upon continuation or discontinuation of the thiopurine," Osterman told Healio.com.
Disclosure: See the study for a full list of relevant financial disclosures.
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