Treatment with either low- or high-dose vedolizumab yields 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 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 the low- and 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 achieved 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 among adult patients with UC, 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 (steroids, immunomodulators, and/or TNF antagonists). Participants received intravenous vedolizumab every 8 weeks during a 14-week induction period. Of these, 93 who achieved a clinical response at week 14 were 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, defined as a 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. At week 54, more patients in the low-dose group achieved corticosteroid-free remission (56.5 percent vs 27.8 percent).
Endoscopic remission, defined as a decrease in Mayo endoscopic score by ≥1 point, was achieved by 57.5 percent of patients in the low-dose group and 43.5 percent in the high-dose group at week 14, and this response 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 patients, of which a few were serious (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 that observed with vedolizumab use in adults with UC,” said Strisciuglio.
“Overall, both low- and high-dose vedolizumab were effective in children and adolescents with UC, regardless of patient weight (<30 to ≥30 kg),” she concluded.