Treatment with either low- or high-dose vedolizumab results in high rates of clinical remission in children with moderate-to-severe ulcerative colitis (UC), regardless of weight, according to the phase III KEPLER trial presented at ESPGHAN 2026.
During the maintenance phase, nearly half of the participants (47.3 percent) treated with vedolizumab achieved the primary endpoint of clinical remission* (per modified Mayo [mMayo] score) at week 54, with similar proportions in either the low- or high-dose groups (51.1 percent and 43.5 percent, respectively). [ESPGHAN 2026, abstract OP012]
Moreover, a consistently high percentage of patients treated with either dose of vedolizumab had clinical remission at week 54, regardless of prior anti-TNF** status (50 percent [anti-TNF naïve] and 43.2 percent [anti-TNF exposed]) or weight (52.6 percent [10 to <30 kg] and 45.9 percent [≥30 kg]).
In terms of weight, patients in the low-dose group had a slightly higher rate of clinical remission than those in the high-dose group (55.6 percent vs 50 percent [10 to <30 kg] and 50 percent vs 41.7 percent [≥30 kg]).
This finding was consistent with a previous study, GEMINI 1, which showed similar clinical remission rates in adult patients with ulcerative colitis, said study author Dr Caterina Strisciuglio from the Department of Paediatrics and Paediatric Gastroenterology at the University of Rzeszów, Rzeszów, Poland.
The KEPLER trial included 120 children and adolescents aged 2–17 years with moderate-to-severe UC who had an inadequate response to conventional treatments (such as steroids and immunomodulators and/or TNF antagonists). Participants were given intravenous vedolizumab every 8 weeks for a 14-week induction period. Of these, 93 who achieved a clinical response at week 14 were then randomized in a 1:1 ratio to receive either low- (n=47) or high-dose (n=46) vedolizumab based on body weight or anti-TNF exposure for a 54-week maintenance therapy.
Additional efficacy endpoints
Clinical remission by PUCAI*** score of <10 was achieved by 78.7 percent in the low-dose group compared with 60.9 percent in the high-dose group, while more patients in the low-dose group achieved corticosteroid-free remission at week 54 (56.5 percent vs 27.8 percent).
Endoscopic remission, defined as a decrease in Mayo endoscopic score response by ≥1 point, was achieved by 57.5 percent of patients in the low-dose group and 43.5 percent of those in the high-dose group at week 14, which was sustained through week 54 (36.2 percent and 30.4 percent, respectively).
Safety
Treatment-emergent adverse events (TEAEs) associated with vedolizumab occurred in 12.5 percent of the patients, of which a few serious TEAEs were reported (4.2 percent).
No clinically meaningful differences in TEAEs, serious TEAEs, or any AEs of special interest were observed between the low- and high-dose groups or weight groups, Strisciuglio noted.
“Vedolizumab was well tolerated, with no new safety signals identified. The safety profile was consistent with vedolizumab use in adults with UC,” said Strisciuglio.
“Overall, both low- and high-dose vedolizumab were effective for children and adolescents with UC, regardless of patient weight (<30 to ≥30 kg),” she concluded.