Tu1895 TOFACITINIB INDUCES CLINICAL AND ENDOSCOPIC REMISSION IN BIOLOGIC REFRACTORY ULCERATIVE COLITIS PATIENTS: A REAL-WORLD BELGIUM COHORT STUDY

Cremer, Anneline; Lobatón, Triana; Vieujean, Sophie; Bossuyt, Peter; Rahier, Jean–François; Baert, Filip; Dewit, Olivier; Macken, Elisabeth; Somers, Michael J.; Vijverman, A; Deflandre, J; Hootegem, Philippe Van; Mana, Fazia; Willandt, Barbara; Caenepeel, Philip; Humblet, Evelien; D’Heygere, F; Verreth, Annelies; Nawar, A. El; Coenegrachts, J; Dewit, Sophie; Coninck, Steven De; Schoofs, Nele; Delen, Stefan; Dutré, Joris; Thienpont, Clara; Branden, S Vanden; Staessen, Dirk; Franchimont, Denis

doi:10.1016/s0016-5085(20)33682-9

Cited by 1 publication

(4 citation statements)

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“…Of the 202 citations identified with the search strategy, 17 studies including 1162 patients with UC were eligible to be included in this review. [5][6][7][11][12][13][14][15][16][17][18][19][20][21][22][23][24] (Supplementary Table 1). Six studies were reported as full-text articles, and 11 were conference proceedings.…”

Section: Resultsmentioning

confidence: 99%

“…Eleven studies 5, 6, 11-13, 15, 19, 20, 22-24 reported clinical remission rates (n = 755) (Supplementary Table 1). Remission was achieved in 34.7% of patients at week 8 (95% CI, 24.4-45.1; 9 studies 6, 11-13, 15, 19, 20 ,22 ,24 ) and in 47% at weeks 12 to 16 (95% CI, 40.3-53.6; 8 studies 5,6,11,13,15,19,22,23 ; Fig. 1).…”

Section: Primary Endpoint: Clinical Remissionmentioning

confidence: 96%

“…Mucosal healing was reported in 6 studies 5,7,12,15,18,19 (n = 252; Figure 3). Mucosal healing was achieved in 41.9% of patients at week 8 (95% CI, 18.1-65.6; range, 23.1%-54.2%; 3 studies 12,15,18 ) and in 35.1% of patients at weeks 12 to 16 (95% CI, 11.5-58.7; range, 9.1%-64.9%; 4 studies 5-7, 15, 19 ).…”

Section: Mucosal Healingmentioning

confidence: 99%

“…The need for prolonged induction according to label was reported in 5 studies. 5,13,15,17,22 A prolonged induction course for up to 16 weeks with tofacitinib 10 mg twice daily was required in 43.2% of patients (95% CI, 37.2-49.2; range, 36%-56%). Outcomes of patients needing prolonged induction were not reported separately.…”

Section: Tofacitinib-prolonged Induction and Dose Escalation Ratesmentioning

confidence: 99%

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Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With Meta-Analysis

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Alba

2021

Inflammatory Bowel Diseases

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Background Knowledge of the real-world effectiveness and safety of tofacitinib for ulcerative colitis (UC) is relevant to confirm the benefit observed in clinical trials. Methods This systematic review and meta-analysis evaluated the real-world effectiveness of tofacitinib for moderate to severely active UC. The primary outcome was clinical remission evaluated at week 8, weeks 12 to 16, and month 6. Secondary outcomes were response, corticosteroid-free remission, mucosal healing, colectomy, and safety. Results Seventeen studies with a total of 1162 patients with UC were included. Remission (11 studies) was achieved in 34.7% of patients at week 8 (95% confidence interval [CI], 24.4%-45.1%), 47% at weeks 12 to 16 (95% CI, 40.3%-53.6%), and 38.3% at month 6 (95% CI, 29.2%-47.5%) at month 6 duplicated. Response was achieved in 62.1%, 64.2%, 50.8%, and 41.8% of patients at week 8, weeks 12 to 16, month 6, and month 12, respectively. Corticosteroid-free remission (5 studies) was achieved in 38.4%, 44.3%, 33.6%, and 31% of patients at week 8, weeks 12 to 16, month 6, and month 12, respectively. Mucosal healing was achieved in 48.3% and 45.3% of patients at week 8 and weeks 12 to 16, respectively. Patients who were biologic-naïve (11.6%) had a significantly higher rate of response at week 8 (1.38; 95% CI, 1.03-1.84). The incidence rates of serious adverse events and herpes zoster was 8.9 and 6.9 per 100 patient-years, respectively. Conclusions This meta-analysis of real-world studies confirms the effectiveness of tofacitinib in a highly refractory population of patients with moderate to severely active UC. Tofacitinib showed an acceptable safety profile. These findings were consistent with clinical trials and further support the use of tofacitinib in UC.

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