Predictive factors of the clinical efficacy of ustekinumab in patients with refractory Crohn’s disease: tertiary centers experience in Japan

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

“…In most real-life studies, UST was used on anti-TNF-α failure or refractory patients [ 70 , 71 ]. In this specific clinical context, remission at 24 weeks and (when available) at 52 weeks ranged from 31% to 75% and 25% to 60%, respectively [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 ]. Moreover, mucosal healing (MH) and fecal calprotectin (FC) levels significantly improved under UST treatment [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , …”

“…Interestingly, the results comparison of studies conducted on different continents showed that UST acts similarly, namely between 24 and 52 weeks. The remission rate was about 25% in North America [ 32 , 34 ], 39% in South America [ 43 ], 25–60% in Europe [ 26 , 27 , 28 , 29 , 30 , 35 , 36 , 37 , 40 , 41 , 42 , 46 , 47 , 48 ], and 31–84% in Asia [ 31 , 38 , 39 , 45 ].…”

“…These findings were confirmed by a Canadian trial, which reported clinical remission in 59% of bio-experienced and 79% of bio-naïve CD patients [ 83 ]. In contrast, in a Brazilian trial, statistically significant differences were not observed in the remission rate recorded at one year between bio-experienced and bio-naïve CD patients treated with UST or VDZ (39.4 vs. 39.8: p = 0.96), respectively [ 45 ].…”

“…Other treatments are usually recommended for refractory patients or those with specific contraindications to anti-TNF-α drugs [ 108 ]. The real-life data for the use of UST in this setting are still scarce and limited by small sample sizes and large heterogeneity of therapy protocols/outcome definitions [ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 35 , 45 , 47 , 48 , 55 , 61 , 62 , 63 , 68 , 69 , 70 , 71 , 72 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , …”

“…Long-term data from the CERTIFI and UNITI-IM for CD, and UNIFI for UC, have proven the efficacy of UST for the induction and maintenance of remission in both IBDs, and the most favorable results were observed in naïve patients to biological drugs [ 21 , 22 , 23 , 24 , 25 ]. Numerous “real world” (RW) data that have emerged in recent years have confirmed the favorable clinical, endoscopic, and histological results in patients treated with UST, the safety of which has thus been strengthened [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 ]. The results of the first comparative study between UST and an anti-TNF-α have further supported this claim [ 60 ].…”