Long-Term Safety of Certolizumab Confirmed for RA, axSpA, PsA

The long-term safety of certolizumab pegol (CZP) is comparable to previous safety reports for all its indications, according to study results published in RMD Open.

The study included data from 49 UCB Pharma-funded clinical trials, including 27 in rheumatoid arthritis (RA), 1 in axial spondyloarthritis (axSpA), 1 in psoriatic arthritis (PsA), 5 in psoriasis (PSO), and 15 in Crohn disease (CD). An external expert committee medically reviewed the serious adverse events (SAEs) of interest, including infections, malignancies, autoimmunity/hypersensitivity events, major adverse cardiovascular events (MACE), gastrointestinal perforations, psoriasis events, and laboratory abnormalities.

The researchers then calculated incidence rates (IRs) per 100 patient-years (PY) and used WHO/GLOBOCAN/SEER databases to calculate standardized mortality and malignancy rates.

A total of 11,317 patients treated with CZP contributed 21,695 PY of CZP exposure; the maximum exposure time was 7.8 years.

The results indicated that the most common SAEs were infections (IR, 3.62 per 100 PY). Malignancies had an IR of 0.82 per 100 PY, including an IR of 0.06 per 100 PY for lymphoma.

The IRs for MACE and GI perforations were 0.47 and 0.08 per 100 PY, respectively. Patients with RA had the highest rate of MACE while patients with CD had the highest rate of GI perforations. Patients with PSO had the lowest rates of SAE.

The researchers noted that the incidence of deaths and malignancies aligned with the expected general population data.

“The RA data reported are consistent with the previous pooled CZP safety update, and overall data are in line with post-marketing data for CZP and other biologic medications,” the researchers wrote.

Disclosures: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Curtis JR, Mariette X, Gaujoux-Viala C, et al. Long-term safety of certolizumab pegol in rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis and Crohn’s disease: a pooled analysis of 11 317 patients across clinical trials [published online May 31, 2019]. RMD Open. doi:10.1136/rmdopen-2019-000942