Abstract Background Ustekinumab biosimilar has been approved for the treatment of Crohn’s Disease (CD). While clinical trial data are available from studies conducted in psoriasis populations, there is a paucity of real-world evidence evaluating the efficacy and safety associated with switching from originator ustekinumab or initiating biosimilar in ustekinumab-naïve patients. Methods This bicentric retrospective study included two groups: (a) CD patients who switched from originator ustekinumab (Stelara) to a biosimilar (SB17 Pyzchiva® or AVT04 Uzpruvo®); and (b) ustekinumab-naive patients starting a biosimilar. Inclusion required at least three months of follow-up, while those with ulcerative colitis, postoperative CD prophylaxis, or combination therapy were excluded. The primary outcome for switchers was drug persistence; for naive patients, short-term clinical response at 3–4 months. Clinical, biochemical, and safety data were collected at baseline, 3–4 months, and 6 months. Results A total of 74 patients were included, forty-one patients were UST-switch, and 30 patients were UST-naive. In the UST-switch cohort, 37 patients switched to ustekinumab SB17 (Pyzchiva ®) and 4 patients to AVT04 (Uzpruvo®). No differences were observed in the mean IHB pre-switch and 3 months after the switch (2.4 vs 2.2, Δ -0.2 95% CI -1.3-1; p = 0.8) nor at 6 months follow-up (2.4 vs 2.1, Δ -0.2 95% CI -1.4-1; p = 0.7). Trough levels pre-switch and 3 months after the switch were comparable (5 vs 6.2, Δ -1.3 95% CI -3.1-0.48). Fecal calprotectin was comparable at baseline and 3 months post-switch (181.7 vs 148.7; Δ -33.1 95% CI -148.6-82.4; p = 0.6). At 6 months post-switch, the Ustekinumab biosimilar persistence was 94.5% (95% CI 81-98.7) (figure 1A). One dermatological adverse event was detected 2.4%). For UST-initiation cohort, all patients initiated SB17 (Pyzchiva ®). At 3-4 months, 21 patients (70%) achieved steroid-free clinical remission and 24 patients (80%) steroid-free clinical response. At 6 months, 16 patients (80%) achieved steroid-free clinical remission, and 18 patients (90%) achieved steroid-free clinical response. No difference was observed in the fecal calprotectin from baseline and at 3-4 months (224.8 vs 223.6; Δ 1.23; 95% CI -232.5-234.9). No adverse event was observed. Conclusion Administration of the ustekinumab biosimilar appears to be both safe and effective when initiated in UST-naive patients or following switch from originator ustekinumab in CD patients. Conflict of interest: Fuentes-Valenzuela, Esteban: Esteban Fuentes-Valenzuela has received education funding from AbbVie, Alfa Sigma Pfizer, Takeda, DrFalk Pharma, Kern Pharma and Janssen and served as speaker for Janssen Chivato Martín Falquina, Irene: I have received financial support from AbbVie, Kern, Takeda, and Janssen for postgraduate courses and attendance at scientific conferences. Olmos Jerez, Jose Antonio: No conflict of interest Lopez Martin, Maria Del Carmen: No conflict of interest Calvache Rodriguez, Almudena: No conflict of interest Gil Santana, Marina: No conflict of interest Somoza Fernández, Beatriz: No conflict of interest Castaño Milla, Carlos: No conflict of interest Bejerano Dominguez, Alicia: No conflict of interest
Fuentes-Valenzuela et al. (Thu,) studied this question.