Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE® -RL)

Expert Opinion on Drug Delivery
Stanley CohenDeepak Assudani

Abstract

This study examined the patient handling experience and self-injection success of patients with rheumatoid arthritis (RA) administering BI 695501 using an AI. This Phase II, 7-week, open-label, interventional study (NCT02636907) included adult patients with moderately to severely active RA not adequately controlled by DMARDs, with no experience of self-injecting with AI/pen. Patients self-injected BI 695501 via AI every 2 weeks in the AI Assessment Period (AAP). Training was given on first injection; AI handling events were recorded. Percentage of self-injection success was the primary end point. Patients could enter a 42-week pre-filled syringe (PFS) safety extension. The AAP was completed by 73/77 patients. In total, 216/218 (99.1%) self-injections on Days 15, 29, and 43, were successful. Nine (11.7%) patients had drug-related adverse events (AEs). Two patients reported four serious AEs (SAEs), none drug-related. Overall (in the AAP and PFS extension), 28 (36.4%) patients had drug-related AEs; nine patients had SAEs, one was considered drug-related. Five (6.5%) patients reported injection-site reactions in the AAP; 13 (18.1%) in the PFS extension. After training, almost all patients were successfully able to self-administer B...Continue Reading

References

Mar 22, 2001·The New England Journal of Medicine·E H Choy, G S Panayi
May 23, 2012·Expert Review of Clinical Immunology·Bart J F van den BemtCornelia H M van den Ende

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Citations

Dec 24, 2018·Expert Opinion on Biological Therapy·Mercedes Gimeno-GraciaFernando Gomollón
Sep 21, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Martin SchipperusAnouchka Seesaghur

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