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Long-term Cimzia therapy safe in patients with Crohn's disease
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Long-term treatment with Cimzia in patients with Crohn’s disease did not increase overall rates of adverse events, serious infections, malignancies and psoriasis compared with short-term use, according to retrospective study data, leading researchers to conclude the drug has a favorable long-term risk–benefit ratio.
Cimzia (certolizumab pegol, UCB) is a pegylated humanized antigen-binding fragment against tumor necrosis factor approved for moderate-to-severe Crohn’s disease in several countries.
“The aim of this retrospective pooled data analysis was to assess the safety of certolizumab pegol in patients with [Crohn’s disease] using data from UCB-sponsored and -conducted clinical trials,” Edward V. Loftus Jr., MD, from the Mayo Clinic in Rochester, Minn., and colleagues wrote. “These data allowed us to determine incidence rates of clinically important adverse events, a standard method for measuring safety across studies.”
The researchers evaluated data from five placebo-controlled trials, nine open-label studies and one dose-regimen study performed in 38 countries up to April 2014. Overall, 2,570 patients with moderate-to-severe Crohn’s disease were exposed to certolizumab pegol, with 4,378.1 patient-years of exposure.
They analyzed placebo controlled trial data (study durations, 6-38 weeks) and all exposed patients (study durations, 6-362 weeks) separately, and calculated adverse event incidence rates from the first dose through 70 days after the last dose. The mean duration of treatment was 254 days, and 5.8% of patients were treated for more than 7 years.
Placebo-controlled trial data showed similar adverse event incidence rates between treatment and placebo groups (31.35 vs. 24.33 per 100 patient-years). While there was an increased risk for serious infection in the treatment groups compared with placebo (RR = 1.57), incidence rates of serious infections (8.49 per 100 patient-years), malignancies (1.01 per 100 patient-years), psoriasis (1.01 per 100 patient-years) and psoriasiform dermatitis (0 per 100 patient-years) were low among those who received short-term treatment.
Data from all studies showed incidence rates of serious infections (6.47 per 100 patient-years), malignancies (0.8 per 100 patient-years), psoriasis (0.93 per 100 patient-years) and psoriasiform dermatitis (0.09 per 100 patient-years) remained low with long-term treatment.
Overall, the incidence rates for adverse events “were stable over time, suggesting that the risk of [adverse events] does not increase with longer exposure,” the researchers concluded. “The certolizumab pegol safety data described provides critical validation of the safety profile of certolizumab pegol for the treatment of [Crohn’s disease].” – by Adam Leitenberger
Disclosures: This study was funded by UCB. Loftus reports he has served as a consultant or advisory board member for AbbVie, Celgene, Genentech, Janssen Biotech, Immune Pharmaceuticals, MedImmune, Progentec Biosciences, Takeda, Theradiag, Seres Health, Sun Pharmaceuticals, Bristol-Myers Squibb and UCB; he also reports he has received research support from AbbVie, Amgen, Braintree, Bristol-Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Janssen Biotech, Pfizer, Receptos, Robarts Clinical Trials, Santarus, Shire, Takeda/Millenium, UCB and Warner Chilcott. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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