VISIBLE-OLE: Long-term data of vedolizumab in UC and CD

Vedolizumab is an efficacious and safe long-term therapy for patients with ulcerative colitis (UC) or Crohn’s disease (CD), according to findings of the VISIBLE open-label extension study. The data appeared to be somewhat stronger for patients with UC than those with CD.

Vedolizumab targets α4β7 integrin, a protein that plays a role in gut inflammation. The agent is approved for the treatment of moderate-to-severe UC and CD. In the phase 3 VISIBLE 1 and 2 trials, the subcutaneous formulation of this agent was tested in patients with UC or CD [1,2]. Following these studies, participants could enter the VISIBLE open-label extension study (NCT02620046). Participants who completed 52 weeks of therapy in VISIBLE 1 or 2 (randomised responders) and those without clinical response at week 6 but with a response at week 14 (non-randomised responders) received subcutaneously administered vedolizumab, 108 mg every 2 weeks. Dose escalation to weekly administration was optional in case of disease worsening. Dr Edward Loftus (Mayo Clinic, MN, USA) presented the data at 168 weeks of follow-up [3]. “Patients with missing data or those who escalated to weekly dosing were imputed as non-response, irrespective of clinical status,” he emphasised.

At baseline of the open-label extension study, the clinical remission rates were 55.0%, 91.3%, and 77.1% for the randomised responders with UC (n=124) who had received placebo, subcutaneous vedolizumab, and intravenous vedolizumab, respectively. At week 168, the corresponding rates were 40.0%, 56.5%, and 62.9%. For the non-randomised responders with UC the clinical remission rates were 57.0% at baseline and 29.9% at week 168.

The baseline clinical remission rates for randomised responders with CD (n=226) were 60.3% for participants on placebo and 62.0% for those on subcutaneous vedolizumab. At week 168, the corresponding rates were 32.4% and 37.3%, respectively. In total, 57.6% of the non-randomised responders with CD (n=118) had achieved clinical remission at baseline of the open-label extension study. This rate dropped to 27.1% at week 168.

Notably, 22.2% of the patients with UC achieved clinical remission 2 months after escalating the dose of vedolizumab. For patients with CD, the corresponding rate was 38.1%. Finally, Dr Loftus mentioned that no new safety signals were observed with longer follow-up.

“The VISIBLE open-label extension study showed that the clinical benefit of subcutaneously administered vedolizumab was maintained in the long-term,” concluded Dr Loftus. “These results support the use of subcutaneous vedolizumab in patients with UC or CD who are in need of long-term maintenance therapy.”

1. Sandborn WJ, et al. Gastroenterology. 2020 Feb;158(3):562-572.e12.
2. Vermeire S, et al. J Crohns Colitis. 2022 Jan 28;16(1):27-38.
3. Loftus EV, et al. Persistence of treatment effect in patients with ulcerative colitis and Crohn’s disease: long-term results from the VISIBLE OLE study. Abstract Su1859, Digestive Disease Week 2025, 3–6 May 2025, San Diego, USA.

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Posted on 21 May 202521 May 2025