Real-world Effectiveness of Tofacitinib for Moderate to Severe Ulcerative Colitis: A Multicentre UK Experience

Honap, Sailish; Chee, Desmond; Chapman, Thomas; Patel, Mehul; Kent, Alexandra; Ray, Shuvra; Sharma, Esha; Kennedy, James; Cripps, Sarah; Walsh, Alissa J.; Goodhand, James; Ahmad, Tariq; Satsangi, Jack; Irving, Peter M; Kennedy, Nicholas A.

doi:10.1093/ecco-jcc/jjaa075

Cited by 95 publications

(128 citation statements)

References 36 publications

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“…Further, in a British multicenter retrospective observational cohort study from 4 centers which included 134 UC patients, 83% of the patients had previously received at least one biologic. Overall, 74% of patients responded to tofacitinib at week 8, and steroid-free clinical remission was observed in 44% of the patients at week 26 [15]. In addition, a French cohort study on the real-world effectiveness and safety of tofacitinib in 38 patients was published: steroid-free clinical remission was observed in 34% of the patients at week 48 [16].…”

Section: Discussionmentioning

confidence: 99%

Tofacitinib in Treatment-Refractory Moderate to Severe Ulcerative Colitis: Real-World Experience from a Retrospective Multicenter Observational Study

Hoffmann

Globig

Thomann

et al. 2020

JCM

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(1) Background: Tofacitinib is approved in Europe for the treatment of adults with moderately to severely active ulcerative colitis since 2018. Real-world efficacy and safety data are currently scarce. (2) Methods: We performed a retrospective multicenter study at three German tertiary outpatient clinics for inflammatory bowel diseases and included all patients who started tofacitinib therapy between August 2018 and March 2020. The primary endpoint was a combined endpoint of steroid-free clinical remission, steroid-free clinical response, or clinical response at week 8. Secondary endpoints were biochemical response at week 8, as well as steroid-free clinical remission, steroid-free clinical response or clinical response at week 24, respectively, adverse events by week 24, and need for colectomy by the end of follow-up. (3) Results: Thirty-eight patients with moderate-to-severe ulcerative colitis were included. Eleven patients (28.9%) achieved steroid-free clinical remission at week 8. Fifty-three percent of the patients were primary non-responders at week 8. Three severe adverse events (pneumonia, hospitalization for aggravation of ulcerative colitis, emergency colectomy due to colon perforation), and 12 adverse events were documented by week 8 of therapy. By the end of follow-up, seven patients (18.4%) had undergone colectomy.

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Section: Discussionmentioning

confidence: 99%

Tofacitinib in Treatment-Refractory Moderate to Severe Ulcerative Colitis: Real-World Experience from a Retrospective Multicenter Observational Study

Hoffmann

Globig

Thomann

et al. 2020

JCM

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“…Other reasons for treatment discontinuation were adverse events (AE) in 20% of patients (44/241, 95% CI 13-30%) (Supplementary figure 3c), need for colectomy 19 % (29/147, 95% CI 6-47%) and patient request (0.8%, 3/370) (Table 3). Median time to discontinuation of therapy was 9 weeks 19,23,24 .…”

Section: Treatment Discontinuationmentioning

confidence: 99%

“…Descriptors of tofacitinib efficacy outcomes across real-world studies. 675 676 Clinical response Decrease of ≥2 points38,39 , 3 PMS/ decrease >30% from baseline40,20,24 Decrease ≥1 point on RBS 38 /absolute RBS=0/1 from baseline36,20 Reduction in SSCAI of 323…”

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confidence: 99%

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

Lucaciu

Plevris

et al. 2021

Preprint

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Background and aims Evidence on the outcomes of tofacitinib therapy in real world ulcerative colitis (UC) patients is needed, as a number of these patients would not match the inclusion criteria for clinical trials. We have therefore summarised data derived from observational, real-world evidence (RWE) studies on the effectiveness and safety of tofacitinib in moderate to severe ulcerative colitis (UC) patients. Methods We searched the PubMed, EMBASE, Scopus, Web of Science and Cochrane databases for observational studies on the use of tofacitinib in UC patients, published between 30/05/2018 and 24/01/2021. Pooled induction (8-14 weeks) and maintenance (16-26 weeks) clinical response and remission rates were calculated, as well as the proportion of reported adverse events using random effects models. Results Nine studies were included, comprising 830 patients, of which 81% were previously treated with anti-TNF and 57% with vedolizumab. Induction of clinical response and remission were achieved in 51% (95% CI 41-60%) and 37% (26-45%) of patients, after a median follow-up of 8 weeks. At the end of a median follow-up of 24 weeks, maintenance of clinical response and remission were met in 40% (31-50%) and 29% (23-36%) of patients, respectively. Thirty-two percent of the patients had at least one adverse event, the most commonly reported being mild infection (13%) and worsening of UC, requiring colectomy (13%). A third of the patients (35%) discontinued tofacitinib, most frequently due to primary non-response (51%). Conclusions Tofacitinib is a safe and effective therapy in real-world UC patients, as previously reported by clinical trials.

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“…No data on dosing or interval of anti‐TNFα agents were available 14 . Three tofacitinib studies included were randomised clinical trials 10,26 and two were real‐life cohorts 24,25 . In these studies different treatment induction doses were used (range 0.5‐15 mg), but maintenance regimens were similar in all studies (5 mg or 10 mg twice daily) 10,24‐26 .…”

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: effect of inflammatory bowel disease therapy on lipid levels

Sleutjes

Lennep

Boersma

et al. 2021

Aliment Pharmacol Ther

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Summary Background Increase in lipid levels associated with the treatment of inflammatory bowel disease (IBD) has previously been reported. However, it is unknown if this effect is similar for all IBD drug classes. Aim To precisely assess the effect of different IBD drug classes on lipid profiles Methods We performed a systematic literature search of randomised controlled trials and observational cohort studies that assessed lipid levels before and after induction (≤10 weeks) and maintenance (>10 weeks) of IBD treatment. Data of 11 studies (1663 patients) were pooled using random effects models. The influence of patient and disease characteristics on treatment effects on total cholesterol levels was analysed in 6 studies (1211 patients) for which individual data were available, using linear mixed models. Results A statistically significant increase in total cholesterol was observed after induction treatment with corticosteroids (+1.19 mmol/L, 95% confidence interval [CI95] +0.52 to +2.59), and tofacitinib (+0.66 mmol/L, CI95 +0.42 to +0.79), but not after anti−TNFα treatment (−0.11 mmol/L, CI95 −0.26 to +0.36 mmol/L). Similar differences were observed after maintenance treatment. Treatment effects were significantly related to age, but not with other factors. Lipid changes were inversely correlated with but not modified by CRP changes. Conclusions Increase in total cholesterol levels was strongest for corticosteroids followed by tofacitinib but was not observed for anti‐TNFα agents. Whether total cholesterol change associated with IBD treatment has an effect on cardiovascular risk requires further study.

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Real-world Effectiveness of Tofacitinib for Moderate to Severe Ulcerative Colitis: A Multicentre UK Experience

Cited by 95 publications

References 36 publications

Tofacitinib in Treatment-Refractory Moderate to Severe Ulcerative Colitis: Real-World Experience from a Retrospective Multicenter Observational Study

Tofacitinib in Treatment-Refractory Moderate to Severe Ulcerative Colitis: Real-World Experience from a Retrospective Multicenter Observational Study

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

Systematic review with meta‐analysis: effect of inflammatory bowel disease therapy on lipid levels

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