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Study: Few patients with RA who miss doses of Actemra develop anti-drug antibodies
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Patients with rheumatoid arthritis who missed one or more subcutaneous injections of Actemra were unlikely to develop antibodies against the drug, according to research from Gerd R. Burmester, MD, and colleagues presented at the European League Against Rheumatism Annual European Congress of Rheumatology.
The researchers evaluated 366 patients in the BREVACTA phase 3 rheumatoid arthritis (RA) trial who missed one or more doses of Actemra (tocilizumab, Genentech) 162 mg scheduled every 2 weeks and 241 patients in the SUMMACTA phase 3 trial who missed one or more doses of subcutaneous tocilizumab 162 mg or intravenous tocilizumab every 4 weeks. An additional 219 patients in SUMMACTA who missed three or more consecutive doses were also included.
Gerd R. Burmester
Patient blood was analyzed for anti-drug antibodies (ADAs) at baseline and throughout the course of the study. After identification of ADAs, further analysis was conducted to reveal the neutralizing potential and immunoglobulin E (IgE) isotype.
Across all treatment arms, the number of patients who developed ADAs were low, according to the researchers. Five patients (1.4%) enrolled in BREVACTA who missed one or more dose of tocilizumab developed ADAs after restarting doses. Among the 241 patients who missed one or more dose and 219 patients in the SUMACTA trial who missed three or more consecutive doses, four patients (0.9%) developed ADAs when dosing was reinitiated. None of the patients who developed ADAs in either group experienced loss of efficacy or showed that the ADAs had neutralizing potential. Additionally, none of the patients who developed ADAs withdrew from the study.
“The incidence of anti-drug antibody development was overall low, with no impact on safety and efficacy, based on the results from approximately 1,465 patients who were treated with [tocilizumab subcutaneous] formulation for up to 2 years,” Burmester told Healio.com/Rheumatology. “Continued monitoring of immunogenicity, as well as its impact on safety and efficacy, will be performed in ongoing clinical studies with [tocilizumab]. Immunogenicity assessment will always need to be conducted as an important evaluation of any the biological therapy development.” – by Shirley Pulawski
Reference:
Burmester GR, et al. Paper #FRI0153. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.
Disclosures: Burmester reports grant/research support from Roche, Abbott, Pfizer, UCB, Merck Sharp & Dohme and Bristol-Myers Squibb and is a consultant for Roche, Chugai, Pfizer, UCB, and Bristol-Myers Squibb, Speakers bureau: Roche, Pfizer, Merck Sharp & Dohme, Abbott and Bristol-Myers Squibb. Please see the full study for a list of all other authors’ relevant financial disclosures.