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Biologic Therapy Sequencing in Ulcerative Colitis: A Real-World Observational Study of Second-Line Therapy After Vedolizumab
AIBD 2023
Background:
Biologics have revolutionized the management of ulcerative colitis (UC). Nonetheless, some patients do not experience an adequate response to first-line biologic treatment and switch to a second-line biologic. The objective of this real-world observational study was to assess rates of response to second-line anti-tumor necrosis factor α (anti-TNFα) treatment in patients with UC who had previously received first-line treatment with the α4β7 integrin (anti-lymphocyte trafficking) antagonist vedolizumab.
Methods:
This retrospective study included biologic-naïve adult patients with moderate to severe UC who were treated at a large, multi-center, private gastroenterology practice. Patients who received vedolizumab as a first-line biologic between January 2018 and May 2020 were identified through electronic medical records. Eligible patients who discontinued vedolizumab treatment and switched to a second-line anti-TNFα treatment were followed for up to 12 months after switching or until discontinuation of anti-TNFα treatment. The primary endpoint was the proportion of patients who received anti-TNFα treatment who had a clinical response (defined as a ≥2-point reduction in partial Mayo score from baseline). A key secondary endpoint was the proportion of patients who received anti-TNFα treatment who had clinical remission (defined as a partial Mayo score of < 2). Both endpoints were assessed at 3, 6, 9, and 12 months after second-line treatment initiation.
Results:
In total, 260 patients with moderate to severe UC received first-line vedolizumab. Treatment was discontinued after a median (interquartile range [IQR]) duration of 7.5 months (5–14) in 53 patients (20.4%) who then received a second-line anti-TNFα treatment. The second-line anti-TNFα treatments received following vedolizumab discontinuation were infliximab (n=39, 73.6%) and adalimumab (n=14, 26.4%). Median (IQR) disease duration in the anti-TNFα treatment cohort was 5 years (2–10). Of all patients who received a second-line anti-TNFα treatment, 28/53 patients (52.8%) at 3 months, 17/53 (32.1%) at 6 months, 18/53 (34.0%) at 9 months, and 14/53 (26.4%) at 12 months had a clinical response. Among these patients, 14/53 (26.4%) at 3 months, 10/53 (18.9%) at 6 months, 13/53 (24.5%) at 9 months, and 11/53 (20.8%) at 12 months had clinical remission. In the 12 months following treatment initiation, 27/53 patients (51.0%) discontinued anti-TNFα treatment, primarily due to the development of antibodies. Accounting for treatment discontinuations, 28/45 patients (62.2%) at 3 months, 17/35 (48.6%) at 6 months, 18/28 (64.3%) at 9 months, and 14/26 (53.8%) at 12 months had a clinical response. Among patients still receiving anti-TNFα treatment, 14/45 (31.1%) at 3 months, 10/35 (28.6%) at 6 months, 13/28 (46.4%) at 9 months, and 11/26 (42.3%) at 12 months had clinical remission.
Conclusions:
The majority of patients who received an anti-TNFα treatment following discontinuation of vedolizumab as a first-line biologic had a clinical response at 3 months. Response rates declined between 3 and 6 months, then remained relatively stable up to 12 months. Clinical remission was achieved in approximately 25% of patients and was stable across the 12-month period. These findings suggest that anti-TNFα treatments can be used in patients with UC following failure of vedolizumab as a first-line biologic.
