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

Abstract

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.

Editorial: real‐world safety of tofacitinib in ulcerative colitis

“…Real‐world studies can help to further characterise the benefit‐risk profile of tofacitinib for UC in routine clinical practice and to identify previously unrecognised safety concerns. We had reported on the real‐world effectiveness and safety of tofacitinib for UC 8 . With the exception of a slight increase in herpes zoster events, in this systematic review and meta‐analysis tofacitinib showed an acceptable safety profile, consistent with the profile reported in the OCTAVE programme.…”

“…With the exception of a slight increase in herpes zoster events, in this systematic review and meta‐analysis tofacitinib showed an acceptable safety profile, consistent with the profile reported in the OCTAVE programme. The herpes zoster pooled incidence rate per 100 patient‐years (IR) reported to be 6.9 (95% CI 4.5‐9.3) was higher than the herpes zoster IR reported in the global OCTAVE programme of 4.1 (95% CI 3.1‐5.2) 2,8 . This may be related to the high complexity and refractoriness of patients receiving tofacitinib in real life, with nearly 90% of patients having prior biological exposure and approximately two‐thirds having previously failed with both an anti‐TNF and vedolizumab 8 .…”

“…The herpes zoster pooled incidence rate per 100 patient‐years (IR) reported to be 6.9 (95% CI 4.5‐9.3) was higher than the herpes zoster IR reported in the global OCTAVE programme of 4.1 (95% CI 3.1‐5.2) 2,8 . This may be related to the high complexity and refractoriness of patients receiving tofacitinib in real life, with nearly 90% of patients having prior biological exposure and approximately two‐thirds having previously failed with both an anti‐TNF and vedolizumab 8 . In the OCTAVE trials, nearly half of patients were anti‐TNF‐naïve and prior treatment with vedolizumab was not allowed 2 .…”

Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis

“…Taxonera et al 43 have recently conducted a similar meta-analysis investigating the effectiveness and safety of tofacitinib. However, our work differs in a few substantial ways.…”

Efficacy, Safety and Future Perspectives of JAK Inhibitors in the IBD Treatment

“…The remission was achieved by 34.3% of the patients taking 5 mg, while doubling the dose helped to maintain the remission in 40.6% of the patients compared to 11.1% with placebo ( p < 0.001 for both groups). Results of the recent meta-analysis by Taconera et al [ 19 ] showed that a remission was reached in as many as 47% of patients with UC at weeks 12–16, response in 64.2% at weeks 12–16, corticosteroid-free remission in 44.3% at weeks 12–16, and mucosal healing in 48.3% at week 8. These outcomes are in line with data gathered in clinical trials.…”