Most Patients With RA Can Self-Administer BI's Adalimumab Biosimilar, Study Reports

Boehringer Ingelheim’s adalimumab biosimilar, Cyltezo, which is approved though not yet launched in the United States and European Union, can be successfully self-administered—via auto-injector—by most patients with rheumatoid arthritis (RA).

That finding derives from a newly published paper in Expert Opinion that assessed real-life patient handling and self-injection of the biosimilar using the auto-injector device. The study, reported on by a research team led by Stanley Cohen, MD, included adult patients (aged 18 to 80 years) with moderate to severe rheumatoid arthritis (RA) at 19 sites in Poland and the United States.

The 7-week, phase 2, open-label, single-arm, interventional clinical trial in which patients self-injected 3 subcutaneous doses of the biosimilar with an auto-injector after having received training on how to use the device and having self-administered 1 training injection.

The injector device is pressed against the skin at a 90-degree angle, the user pushes an injection button confirmed by a clicking sound, and the duration of injection is approximately 10 seconds. Completion of the injection can be confirmed by inspecting the plunger in a viewer window. Injections were considered successful if the full content of the device was injected into the body.

In total, 77 patients were included in the study and completed 218 self-injections. Of those injections, 216 (99.1%) were successful as reported by both site personnel and patients. In the 2 cases of unsuccessful injections, the reported cause was that the device’s button could not be depressed by the patient. As no technical issues were identified with the device, the failure was deemed to be user error in both cases. The 2 patients with failed attempts were able to successfully administer a second injection.

The study’s authors say that, as the auto-injector presentation of the biosimilar is easy to use, there may be less unintentional nonadherence among patients receiving therapy with the biosimilar.

Reference

Cohen S, Klimiuk PA, Krahnke T, Assudani D. Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE-RL). [Published online May 15, 2018.] Expert Opinion. doi: 10.1080/17425247.2018.1472572.