Usability validation of the Sensoready pen in patients with relapsing multiple sclerosis.

The Sensoready pen is intended for self-administration of subcutaneous 20 mg ofatumumab at home. This human factors summative study assessed the usability of the Sensoready pen in relapsing multiple sclerosis patients. 32 patients (injection-experienced [n = 17] and injection-naive [n = 15]) across five locations in the USA were asked to complete two simulated injections using the Sensoready pen. In the first and second simulated injections, 90.6 and 96.9% of patients, respectively, successfully delivered a full dose, while 81.3 and 84.4%, respectively, successfully performed the injection without any use errors. The Sensoready pen is safe and effective for its intended use by intended users and in the intended use environment. This pen has a low harm potential and high injection success rate in patients, even without prior training or experience.