Tofacitinib ‘real-world’ effectiveness in active UC

Tofacitinib is relatively effective in ulcerative colitis (UC) patients in real practice, even in a highly refractory cohort of patients from the prospectively maintained ENEIDA registry [1]. Only 12% of patients not in remission at week 8 reached remission at week 16.

Clinical activity and effectiveness were defined in terms of partial Mayo score (PMS). Included were 113 UC patients who were exposed to tofacitinib for a median of 44 weeks. After 8 weeks, response and remission rates were 60% and 31%, respectively; these rates were still similar at week 16 (see Figure). Higher PMS at week 4 (OR 0.2; 95% CI 0.1–0.4) was associated with a reduced odds of achieving remission after 8 weeks. Higher PMS at week 4 (OR 0.5; 95% CI 0.3–0.7) and higher PMS at week 8 (OR 0.2; 95% CI 0.1–0.5) were associated with a lower chance of remission after 16 weeks. Of patients not in remission at week 4 and week 8, 20% and 12% achieved remission after 16 weeks. Noteworthy, 65% of patients in remission at week 8 relapsed within the next year.

Figure. Short-term effectiveness of tofacitinib in ulcerative colitis (last-observation-carried-forward method) [1]



Primary failure was the main reason for a total of 45 patients (40%) to discontinue tofacitinib over time. Only PMS at week 8 was associated with discontinuation (HR 1.5; 95% CI 1.3–1.6). Eighteen patients had adverse events, of which 4 were hypercholesterolaemia. No thromboembolic events were reported.

Early ‘real-world’ experience with tofacitinib in 4 UK tertiary centres resulted in similar efficacy and safety outcomes as had been reported in the pivotal OCTAVE clinical trials [2]. Response and remission rates were 73% (81/111) and 56% (62/111) respectively at week 8, and 48% (39/82) and 39% (32/82) respectively at week 26. Steroid-free remission was reached by 47% (52/111) and 37% (30/82) at week 8 and 26. There were 6 serious infections.

1. 
   
   1. Chaparro M, et al. ECCO-IBD 2020, OP29.
   2. Chee D, et al. ECCO-IBD 2020, DOP69.

 



Posted on 14 April 202012 November 2020