Injection Site Pain and Adherence in Patients Switching from Reference Adalimumab to AVT02 - Ease Pain Trial (Full Analysis)

Objectives AVT02, a biosimilar to reference product (RP) adalimumab, is formulated at high concentration and with citrate-free excipients. The EASE PAIN trial is a Phase IV study in Canada evaluating the impact of switching from RP or an alternative adalimumab biosimilar to AVT02 on patient outcomes.[1-3] The primary objective examines the impact of switching on injection site pain (ISP) across patients in Canada. Secondary objectives include describing the impact of switching on patient perception of change in ISP, injection site reaction (ISR), treatment Adherence, patient satisfaction, quality of life, disease activity, and healthcare utilization. Methods The study enrolled patients with gastrointestinal conditions (Crohn’s disease [CD], ulcerative colitis [UC]), rheumatological conditions (rheumatoid arthritis [RA], ankylosing spondylitis [AS], psoriatic arthritis [PsA]), or dermatological conditions (hidradenitis suppurativa [HS], psoriasis [PsO]). Participants were eligible if their treating physician had decided to switch them from low-concentration RP or alternative adalimumab biosimilar to AVT02. The study assessed ISP measured via the Visual Analog Scale (VAS), adherence via the compliance rate, patient satisfaction and perception of change in pain via the Likert scale, quality of life based on EQ-5D-5L, and disease activity via the patient and physician global assessment scores for participants up to Day 180 after switching. Results The intention-to-treat (ITT) population comprised 324 participants. Following the first administration of AVT02, injection site VAS pain score decreased by an average of −19.9 ± 26.13 across the whole population. Supporting this, 76% of the participants perceived AVT02 as less painful as measured by the 5-Likert scale. Moreover, a significantly lower number of patients experienced ISRs after their first dose of AVT02 (36 patients; 12.4%) compared with their last dose of low-concentration adalimumab (124 patients; 42.3%). Adherence rate was 93.4% overall. The ITT population maintained a high patient satisfaction (more than 74.4% reported being ‘mostly or completely satisfied’) and a high quality of life score (EQ-5D-5L score of >82 on a scale of 1-100) after switching from RP to AVT02. There were generally no changes in patient and physician reported outcomes nor in healthcare utilization. Conclusion The results of this study demonstrate that switching from RP or alternative biosimilar adalimumab to AVT02 leads to decreased ISP across all indications, fewer numbers of ISRs, and a maintenance of high adherence rates, patient satisfaction, and quality of life among patients. References [1.] Sacristán JA. PLoS One 2020;15:e0234705. [2.] Kuek A. Postgraduate Medical Journal 2007;83:251. [3.] Feldman SR. BioDrugs 2021;35:735-748.