Table 4.
Real-world evidence with tofacitinib for ulcerative colitis.
| Publication | Population | Treatment with tofacitinib | Outcome in the UC population | Result |
|---|---|---|---|---|
| Weisshof16 | 53 UC, 4 CD, 1 pouchitis 93% previously failing anti-TNF 81% previously failed VDZ 47% concomitant steroids | 5 or 10 mg BID for ≥8 weeks | Clinical response at Week 8: symptomatic improvement but not resolution | 36% |
| Clinical remission at Week 8: complete resolution of clinical symptoms | 33% | |||
| Lair-Mehiri17 | 37 UC 100% previously failed anti-TNF 97% previously failed VDZ | 10 mg BID | Steroid-free clinical remission at Week 24: total Mayo score ≤2 without any sub-score >1 | 32% |
| Clinical response at Week 24: decrease in the total Mayo score with ≥3 points and ≥30%, and decrease in rectal bleeding sub-score ≥1 point or absolute rectal bleeding sub-score ≤1 | 41% | |||
| Survival without colectomy at Week 24 | 77% | |||
| Patel18 | 123 UC 29% bio-naïve 41% previously failed anti-TNF and VDZ | 10 mg BID for ≥8 weeks | Clinical response at Week 8: >50% reduction in symptoms | 48% [61%]* |
| Clinical remission at Week 8: not further defined | 11% [14%]* | |||
| Endoscopic healing within 6 months: Mayo endoscopic sub-score ≤1 or absence of erosions/ulcerations | 30% [65%]* | |||
| Clark-Snustad19 | 24 UC | 5 or 10 mg BID for ≥4 weeks | Median drop in SCCAI by Week 4 | 7.18 to 4.53 [p = 0.009] |
| Median drop in endoscopic sub-score by Week 4 | 2.21 to 1.25 [p = 0.36] | |||
| Kolar20 | 24 UC 75% bio-exposed 41% concomitant steroids | 10 mg BID for ≥8 weeks | Mucosal healing at Week 8: Mayo endoscopic sub-score ≤1 | 53% |
| Honap21 | 25 UC 96% previously failing anti-TNF 56% previously failing VDZ | Not available | Median drop in SCCAI by Week 8 [in 15 patients] | 8 to 2 [p <0.0001] |
| Median drop in faecal calprotectin by Week 8 [in 15 patients] | 451 to 95 µg/g [p <0.0001] | |||
| Berinstein22 | 4 acute severe UC | 10 mg TID for 3 days In combination with methylprednisolone [n = 3] or budesonide [n = 1] | Clinical remission: not further specified | 75% |
BID, twice daily; CD, Crohn’s disease; SCCAI, Simple Clinical Colitis Activity Index; TID, three times daily; TNF, tumour necrosis factor; UC, ulcerative colitis; VDZ, vedolizumab.
* Non-responder imputation [as observed].