Analysis of the short-term efficacy of ustekinumab as the first-line treatment for Crohn′s disease / 中华消化杂志

ABSTRACT

Objective:To evaluate the short-term efficacy of ustekinumab (UST) as the first-line treatment of Crohn′s disease (CD).Methods:From October 1, 2020 to March 1, 2023, at the First Affiliated Hospital of Soochow University, 64 CD patients treated with UST as first-line biologics were enrolled. The patients were classified using the Montreal classification. Clinical and endoscopic response and remission were assessed by Crohn′s disease activity index (CDAI) and simple endoscopic score for crohn′s disease (SES-CD), respectively. Clinical response was defined as a reduction in CDAI score ≥70, and clinical remission was defined as a CDAI score <150; Endoscopic response was defined as ≥50% reduction from baseline in SES-CD score, and endoscopic remission was defined as SES-CD score ≤2. The clinical response rate and clinical remission rate at week 24 and week 48, as well as the endoscopic response rate and endoscopic remission rate at week 48 were observed in CD patients (only 21 patients with endoscopic prognostic results). Mann-Whitney rank sum test was used for statistical analysis.Results:Among 64 CD patients, there were 47 males and 17 females, with an age of (33.5±13.7) years old. According to Montreal classification, there were 3 cases (4.7%) of type A1 (≤16 years old), 44 cases (68.8%) of type A2 (17 to 40 years old), and 17 cases (26.6%) of type A3 (>40 years old); 43 cases (67.2%) of type L1 (terminal ileum type), 10 cases (15.6%) of type L2 (colonic type), 8 cases (12.5%) of type L3 (ileocolonic type), 1 case (1.6%) of type L4 (upper gastrointestinal type), 2 cases (3.1%) of type L1+ L4; 23 cases (35.9%) of type B1 (non-stricturing, non-penetrating), 34 cases (53.1%) of type B2 (stricturing), 2 cases (3.1%) of type B3 (penetrating), 5 cases (7.8%) of type B2+ B3; 44 cases (68.8%) complicated with perianal lesions. Among 56 CD patients with UST maintenance therapy once every 8 weeks, the CDAI scores at week 24 and 48 after treatment were both lower than that at week 0 (64.46(30.61, 123.30), 34.24(15.77, 64.83) vs. 353.40(290.40, 391.30)), and the CDAI score at week 48 after treatment was lower than that at week 24 after treatment, and the differences were statistically significant ( Z=-9.01, -9.13, and -3.14; P<0.001, <0.001, and =0.002). The clinical response rate was 100.0% (56/56) and the clinical remission rate was 91.1% (51/56) at week 24; the clinical response rate was 100.0% (56/56) and the clinical remission rate was 98.2% (55/56) at week 48. Among 39 CD patients complicated with perianal lesions, the closure rate of anal lesions at week 24 was 87.2% (34/39) and at week 48 was 100.0% (39/39). Among 8 CD patients who received UST maintenance therapy once every 12 weeks, the CDAI scores at week 24 and 48 were both lower than that at week 0 (100.40(71.20, 171.30), 38.49(18.25, 143.50) vs. 268.00(242.60, 364.90)), and the differences were statistically significant ( Z=-3.26 and -3.36; both P<0.001). At week 24, 7 CD patients achieved clinical response and 5 CD patients achieved clinical remission. At week 48, 8 CD patients achieved clinical response and 6 CD patients achieved clinical remission. Among 5 CD patients complicated with perianal lesions, 3 CD patients achieved perianal closure at week 24 and all 5 CD patients achieved closure of perianal lesions at week 48. Among 21 CD patients who underwent endoscopic evaluation, 16 CD patients received UST maintenance therapy once every 8 weeks, the SES-CD score at week 48 was lower than that at week 0 (4.00(3.00, 7.75) vs. 9.50(7.25, 10.75)), and the difference was statistically significant ( Z=-3.43, P<0.001), among them, 9 CD patients achieved endoscopic response and 2 CD patients achieved endoscopic remission; 5 CD patients received UST maintenance therapy once every 12 weeks, there was no statistically significant difference in the SES-CD score at week 48 compared with that at week 0 (4.00(1.50, 6.50) vs. 7.00(3.50, 10.00)) ( P>0.05), among them, 3 CD patients achieved endoscopic response and 1 CD patients achieved endoscopic remission. Conclusion:UST as the first-line treatment for CD patients can achieve clinical efficacy (response or remission), and the maintenance therapy is beneficial for endoscopic remission and closure of perianal lesions.