Subcutaneous vedolizumab maintenance attains clinical remission in ulcerative colitis
Patients with ulcerative colitis (UC) who received a subcutaneous (SC) formulation of vedolizumab as maintenance therapy achieved clinical remission at 52 weeks, according to the VISIBLE 1* trial presented at AIBD 2020.
“[Although] the safety and efficacy of [intravenous (IV)] vedolizumab … [are] well established for both induction and maintenance treatment of UC, … for chronic diseases that require long-term maintenance treatment, some patients may [still] prefer self-administered SC dosing as a less time-intensive and more convenient treatment option,” said Dr Natália Queiroz from the University of Sao Paulo, Brazil, who presented the study on behalf of the investigators.
This phase III, double-blind, double-dummy trial involved 216 patients with moderate-to-severe UC who received induction therapy with vedolizumab IV 300 mg at weeks 0 and 2 and were then randomized to receive vedolizumab SC 108 mg Q2W + placebo IV Q8W (n=106), vedolizumab IV 300 mg Q8W + placebo SC Q2W (n=54), or placebo SC Q2W + placebo IV Q8W (n=56) from week 6. Statistical tests were only performed between vedolizumab SC and placebo arms. [AIBD 2020, session VI; Gastroenterology 2020;158:562-572]
At week 52, a significantly higher percentage of patients on vedolizumab SC maintenance achieved clinical remission, defined as a total Mayo score of ≤2 and no individual subscore of >1, compared with placebo (46.2 percent vs 14.3 percent; p<0.001).
Significantly more patients on vedolizumab SC than placebo experienced endoscopic improvement (56.6 percent vs 21.4 percent; p<0.001) and durable clinical response (64.2 percent vs 28.6 percent; p<0.001) at week 52.
The rate of durable clinical remission at week 52 was numerically higher in the vedolizumab SC compared with the placebo arm (15.1 percent vs 5.4 percent; p=0.076), though this finding did not reach statistical significance, noted Queiroz.
Eleven patients in the vedolizumab SC arm experienced injection-site reactions (ISRs), which were of mild-to-moderate intensity and did not lead to treatment discontinuation. “The ISR rate (10.4 percent) is in line with other SC IBD treatments and was not treatment limiting,” Queiroz noted.
No cases of Clostridium difficile infection or deaths were reported.
Of note, overall [efficacy and] safety findings were comparable between the vedolizumab SC and IV treatment arms, said Queiroz.
“Patients receiving vedolizumab SC retained their improvements in partial Mayo scores in the maintenance phase, with scores improving further over time, while patients receiving placebo showed worsening over time,” said the investigators.
“The new vedolizumab SC formulation … was effective and generally safe as maintenance therapy for patients with moderately to severely active UC who responded to therapy with vedolizumab IV … Vedolizumab SC will [also] provide patients with an additional option for maintaining clinical response to vedolizumab,” they concluded.
*VISIBLE 1: Efficacy and safety of vedolizumab subcutaneously (SC) as maintenance therapy in ulcerative colitis