Supplementary Material for: Comparative efficacy of mesalazine and ozanimod following induction treatment in mesalazine-exposed advanced therapy-naïve in adult ulcerative colitis patients

Introduction: Both mesalazine and ozanimod are oral treatment options for patients with moderately active ulcerative colitis (UC).
Methods: Comparative-analysis comparing efficacy endpoints of an 8-week non-inferiority induction study (TP0503) with 3.2 g/day mesalazine (n=321) to the True North 10-week induction study of 1 mg/day Ozanimod (n=281). We compared the efficacy of oral mesalazine (Asacol) as monotherapy and ozanimod (Zeposia) as add-on therapy to mesalazine, without concomitant corticosteroids, following induction treatment in mesalazine-exposed, but immunomodulator and advanced therapy-naïve UC patients. Endpoints from the non-inferiority study were re-calculated using the definitions from the True North study. Results: The two cohorts had similar age (45 ± 14 years vs 44 ± 13.5 years) and baseline disease severity (total Mayo score; 8.5 ± 0.8 vs 8.6 ± 1.1) for mesalazine and ozanimod-treated patients, respectively. No differences were observed in patients achieving clinical response [reduction from baseline in the 3-component Mayo score (sum of RBS, SFS, and MES) of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS ≤1] (58% vs 58%; p=0.917) and clinical remission [rectal bleeding subscore (RBS) = 0, stool frequency subscore (SFS) ≤1 (and decreases of ≥1 point from baseline SFS), and MES ≤1] (22% vs 28%; p=0.074) treated with mesalazine (at 8-weeks) and ozanimod (at 10-weeks), respectively. A higher percentage of patients treated with ozanimod achieved endoscopic improvement [MES ≤1 without friability] compared to mesalazine (38% vs 29%, p=0.018). Conclusion: A similar effect on clinical efficacy was observed between patients treated with mesalazine and those treated with ozanimod patients, among individuals previously exposed to mesalazine or steroids.