Intest Res.  2021 Oct;19(4):386-397. 10.5217/ir.2020.00080.

Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)

• Hisamatsu T
• Kim HJ
• Motoya S
• Suzuki Y
• Ohnishi Y
• Fujii N
• Matsushima N
• Zheng R
• Marano CW

• KMID: 2521602
• DOI: http://doi.org/10.5217/ir.2020.00080

Abstract

Background/Aims
We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Methods
This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.
Results
Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.
Conclusions
UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.

Keyword

East-Asian; Ulcerative colitis; Subgroup analysis; UNIFI; Ustekinumab

Figure

• 

  Fig. 1 Study design and patient disposition. (A) Induction study and (B) maintenance study. UST, ustekinumab; SFU, safety follow-up; IV, intravenous; SC, subcutaneous; q12w, every 12 weeks; q8w, every 8 weeks.

• 

  Fig. 2 Primary endpoint and key clinical outcomes in induction study (overall and East-Asian population). aExcludes patients whose mucosal healing statues cannot be determined at week 8 due to an unevaluable biopsy (i.e., a biopsy that was collected, but could not be assessed due to sample preparation or technical errors). Overall population: n=316, 316, 315 and East-Asian population: n=44, 44, and 45 for placebo, ustekinumab (UST) 130 mg and UST 6 mg/kg, respectively.

• 

  Fig. 3 Primary and major secondary endpoints in maintenance study (overall and East-Asian population). aAnalyzed among patients with remission at maintenance baseline. Overall population: n=45, 40, 38 and East-Asian population: n=8, 3, and 3 for placebo, ustekinumab (UST) 90 mg every 12 weeks (q12w) and UST 90 mg every 8 weeks (q8w), respectively.

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