| Popis: |
Alan Kivitz,1 Alicia M Ellis,2 Vishvesh Shende,3 Jérémy Lambert,4 Daljit Tatla2 1Altoona Center for Clinical Research, Duncansville, PA, USA; 2UCB Pharma, Raleigh, NC, USA; 3UCB Pharma, Slough, UK; 4UCB Pharma, Colombes, FranceCorrespondence: Daljit Tatla, UCB Pharma, 4000 Paramount Parkway, Morrisville, NC, USA, Tel +1 919 767-2518, Email daljit.tatla@ucb.comPurpose: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, key drivers of chronic inflammation. Bimekizumab must be injected subcutaneously and so patients require self-injection options that meet their preferences. This study evaluated safe and effective self-injection of bimekizumab by patients with psoriatic arthritis using the 1 mL safety syringe (SSy) or the 1 mL auto-injector (AI).Patients and Methods: The DV0004 devices study (NCT04109976) was a sub-study of BE VITAL, a multicenter, open-label extension of BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) in patients with active psoriatic arthritis. After receiving training, patients subcutaneously self-injected bimekizumab 160 mg at Baseline and Week 4. The primary and secondary endpoints were the proportion of patients self-injecting bimekizumab safely and effectively at Week 4 and Baseline, respectively. Patient self-injection experience was evaluated using the pain visual analog scale (VAS) and the Self-Injection Assessment Questionnaire (SIAQ).Results: Overall, 214 patients were randomized 1:1 at Baseline. All evaluable patients safely and effectively self-injected bimekizumab at Week 4 (SSy: n=105; AI: n=104) and Baseline (SSy: n=106; AI: n=106). Mean pain VAS scores were generally low at Week 4 (SSy: 11.0; AI: 11.4) and Baseline (SSy: 9.5; AI: 14.9). High mean pre- and post-injection SIAQ scores (≥ 6.7) were observed for both devices indicating a positive overall patient experience with self-injection. Self-injection was well tolerated with no reports of treatment-emergent adverse device effects (TEADEs), serious TEADEs or discontinuations due to TEADEs. Four non-device-related injection site reactions during the sub-study were reported in the parent study; all were mild, did not lead to discontinuation and resolved without treatment. All devices maintained their structural and functional integrity post-use.Conclusion: All patients self-injected subcutaneous bimekizumab safely and effectively using either device at Baseline and Week 4. Overall, patients reported a positive self-injection experience.Keywords: bimekizumab, clinical trial, patient experience, psoriatic arthritis, self-injection devices |
