Abstract Background Biologics have revolutionized the treatment of Crohn’s disease (CD); however, high costs limit access. Biosimilars offer a potential cost-effective alternative, but switching from the reference product (RP) may raise patients concerns regarding efficacy and thus patients’ acceptance. This study evaluates the impact of switching from ustekinumab RP to biosimilar AVT04 on real-world effectiveness, safety, physicians’ efforts, patient-reported outcomes (PROs) and quality of life (QoL), and identifies factors influencing successful implementation. Methods The CONZULT study is a prospective, observational study of approximately 250 patients with moderate-to-severe CD in stable clinical remission on ustekinumab RP, enrolled across 37 centres in Germany. After switch to AVT04 patients were eligible for inclusion, and their routine clinical assessments have been observed for one year. Disease activity indices (Harvey-Bradshaw Index HBI, PRO-2, Bowel Urgency Questionnaire BUQ) and PROs (EQ-5D-5L, SF-36, SIBDQ) were evaluated. Patient and physician perceptions of the switch, satisfaction with the pre-filled syringe, and physician workload were documented. Results The interim analysis included 238 patients (mean age 47.3 ±15.1 years, median time since CD diagnosis 12.27 7.10-22.47 years) from 28 centres. 48.1% were male. Baseline data were collected at the first visit (V1), with the first follow-up visit (V2) at a median of 70.0 (56.0-91.0) days after AVT04 initiation. Switching to AVT04 maintained treatment effectiveness: no significant changes in disease activity (PRO-2; HBI; BUQ see Table 1) between V1 and V2 were observed. QoL remained largely unchanged (SIBDQ; SF-36 see Table 1). Physicians spent a median of 10 9.0-15.0 minutes explaining the switch initially. According to physicians’ perception, 88.2% of patients expressed no concerns. However, 23.6% of patients had concerns about switching treatments. The main concerns were reduced efficacy (17.6%) and increased risk for adverse reactions (9.7%). The majority of patients (84.7%) were satisfied or very satisfied with the AVT04 device and 89.1% considered it easy or very easy to use after switching from the RP. In total, 38 adverse drug reactions (ADR) with causal relationship to AVT04 (5.0%) were reported, none serious. Conclusion These findings show that switching to AVT04 does not compromise clinical effectiveness or safety and is generally well-received by both patients and physicians. Although patient concerns exist (reported by 23.6% in this study), the switch was well adopted by patients and physicians. Conflict of interest: Hoffmann, Jörg: research grants: none speaker: Abbvie, Falk, Hexal/Sandoz, Johnson & Johnson, Pfizer, Takeda advisory boards: Amgen, BMS, Lilly, Galapagos, Hexal, Pfizer, Stadapharm, Takeda clinical studies: Abbvie, Pfizer, Takeda, Johnson & Johnson, Genentech, Amgen, Lilly, Stadapharm membership: DCCV, DGVS, DGIM, DGEM, DEGUM Fischbach, Wolfgang: Stadapharm GmbH Dignass, Axel: Personal Fees: AbbVie, Alfasigma, CED Service GmbH, Celltrion, Dr. Falk Pharma, Falk Foundation, Ferring, Fresenius Kabi, Gilead, High5MD, J & J, Lilly, Materia Prima, MSD, Pfizer, Pharmacosmos, Sandoz, Stada, Streamed-Up, Takeda, Tillotts, Vifor Pharma Grant Abbvie, J & J, Takeda Non-financial support Abbvie, J & J, Takeda Other: Abivax, AbbVie, Alfasigma, Dr Falk Pharma, Fewrring, J & J, Pfizer Numrich, Ruben: Employee at STADAPHARM GmbH Furlan, Fabricio: Employee of STADA Arzneimittel AG
Hoffmann et al. (Thu,) studied this question.