Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi ) Across Multiple Indications (EASE PAIN)

Rheumatol Ther. 2026 Apr 10. doi: 10.1007/s40744-026-00846-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Injection site pain (ISP) is a frequent concern with subcutaneous adalimumab therapy and may negatively affect treatment adherence and patient satisfaction. AVT02 is a high-concentration, low-volume (40 mg/0.4 mL), citrate-free biosimilar of reference product (RP) adalimumab (40 mg/0.8 mL; citrate-containing). The EASE PAIN study evaluated the real-world impact of switching from adalimumab RP or another biosimilar to AVT02 on ISP and patient-reported outcomes over 180 days.

METHODS: The EASE PAIN study (NCT05913817) was a national, observational, prospective phase IV study with a 6-month follow-up. The study enrolled Canadian 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 already decided to switch them from a high-volume RP or alternative adalimumab biosimilar to low-volume 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, injection site reactions (ISR) via a checklist (bleeding, burning, erythema, itching, soreness, swelling), 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. Healthcare utilization was measured as per the frequency, type, and volume of medical services accessed.

RESULTS: The intention-to-treat (ITT) population comprised 324 participants. Following the first administration of AVT02, mean ISP VAS scores improved by - 19.9 ± 26.1 mm compared with baseline. Adherence rate was 93.4% overall. More than 74.4% of patients reported being mostly or completely satisfied with treatment, and 76.9% of the participants perceived AVT02 as less painful as measured by the 5-Likert scale. Moreover, a lower number of patients experienced ISRs after their first dose of AVT02 (36 patients; 12.4%) compared with their last dose of high-volume adalimumab (124 patients; 42.3%). Quality-of-life scores remained stable throughout follow-up. No clinically meaningful changes were observed in disease activity or healthcare utilization.

CONCLUSIONS: In this real-world Canadian study, switching from adalimumab RP or alternative biosimilar to AVT02 was associated with reductions in ISP and reactions while maintaining high adherence, patient satisfaction, quality of life, and disease control across multiple indications.

TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov: NCT05913817.

PMID:41963765 | DOI:10.1007/s40744-026-00846-1