P344 Real-world effectiveness of tofacitinib in ulcerative colitis: a multi-centre study

Ungaro, Ryan C.; Fenster, Marc; Dimopoulos, Christina; Patel, Amit; Deepak, Parakkal; Syal, Gaurav; Yarur, Andrés; Hirten, Robert; Christophi, George P.; Khatiwada, Aava; Lin, Bixuan; Colombel, J F; Ha, Christina; Weisshof, Roni; Beniwal-Patel, Poonam; Cohen, Benjamin L.; Pekow, Joel

doi:10.1093/ecco-jcc/jjy222.468

Cited by 15 publications

(28 citation statements)

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“…Multivariable analysis in this work revealed that patient's treatment naive status (OR 4.50, 95% CI 1.64-12.37) and a higher albumin (OR 2.63, 95% CI 1.02-6.80) were associated with a greater chance of achieving clinical response at week 8, whereas the concomitant use of corticosteroids at the start of tofacitinib treatment (OR 0.22, 95% CI 0.08-0.58), male gender (adjusted hazard ratio 0.25, 95% CI 0.08-0.83) and pancolitis were associated with a lower chance of achieving week 8 response 17 . In the same study, prior exposure to two biologic classes had lower rates (16.7%) of endoscopic healing at 6 months compared to bio-naive patients (87.1%) and those with exposure to one biologic agent (57.1%).…”

Section: Predictors Of Response and Remissionmentioning

confidence: 96%

“…The copyright holder for this preprint this version posted April 30, 2021. ; https://doi.org/10.1101/2021.04.27.21256170 doi: medRxiv preprint weas reported in 8% of patients. Tofacitinib use in biologic naive population was quantified in studies, comprising of 257 (59%) patients 17 . Tofacitinib dose was either 5 or 10 mg twice daily, according to investigator's protocol (Supplementary table 2).…”

Section: Characteristics Of Patients Across Studiesmentioning

confidence: 99%

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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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Section: Predictors Of Response and Remissionmentioning

confidence: 96%

Section: Characteristics Of Patients Across Studiesmentioning

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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“…The real‐world effectiveness of tofacitinib was confirmed in three retrospective studies 14–16 and a recent prospective trial 17 …”

Section: Efficacy ‐ Which Uc Patients Are Candidates For Jak Inhibitors?mentioning

confidence: 90%

Is tofacitinib a game‐changing drug for ulcerative colitis?

Magro

Estevinho

2020

UEG Journal

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The increasing knowledge on ulcerative colitis’ pathophysiology has contributed to the expansion of the therapeutic arsenal for this condition. However, to date, 25–40% of patients with ulcerative colitis remain primary or secondary non-responders to therapy, and up to 10% need to eventually undergo a colectomy. Janus kinase inhibitors block cytokine signalling involved in the pathogenesis of several inflammatory conditions. Tofacitinib is the first drug of this class approved for moderate-to-severely active ulcerative colitis in patients for whom disease worsened and those who did not improve with conventional therapy (aminosalicylates, corticosteroids and immunosuppressants) or monoclonal antibodies. We aimed to review the main aspects and concerns related to the current use of tofacitinib and to explore its future application.

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“…In the phase II trial, IBDQ was completed at baseline (day 1), with total scores being similar across all treatment groups, ranging from 123.2 to 134.5 52. At week 8, mean IBDQ total scores had dose-proportionally improved compared to baseline measurements across all five treatment groups (week 8 range 149.6–175.4), with the improvement being significantly higher over placebo (p = 0.001) only for those patients who received tofacitinib 15 mg twice daily.…”

Section: Therapeutic Efficacy Of Tofacitinib In Ucmentioning

confidence: 99%

“…In another cohort study from six centers in the USA, Ungaro et al retrospectively reviewed the data of 123 patients with active UC who received tofacitinib 10 mg twice daily for at least 8 weeks 52. A minority (28.5%) of patients were biologic naïve, whilst 40.7% had been exposed to both anti-TNFα and VDZ.…”

Section: Therapeutic Efficacy Of Tofacitinib In Ucmentioning

confidence: 99%

<p>Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data</p>

Varyani¹,

Argyriou²,

Phillips³

et al. 2019

DDDT

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Recent advances in the understanding of the pathophysiology of ulcerative colitis (UC) have led to the expansion of our therapeutic arsenal. Conventional treatment options, including aminosalicylates, corticosteroids, thiopurines, and calcineurin inhibitors, fail to control the disease in a significant proportion of patients. Approximately 25–50% of the patients treated with tumor necrosis factor antibodies (anti-TNFα) are primary and secondary non-responders to therapy. Tofacitinib is a novel orally administered small synthetic molecule that inhibits a homologous family of enzymes, termed Janus kinases that modulate multiple key cytokines involved in the pathogenesis of UC. Phase II and III trials showed promising results in UC, leading the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve its administration for the induction and maintenance of remission in moderate-to-severe UC. Herein, we review tofacitinib for the management of UC, its mechanism of action pharmacokinetic properties, efficacy, and safety.

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P344 Real-world effectiveness of tofacitinib in ulcerative colitis: a multi-centre study

Cited by 15 publications

References 0 publications

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

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

Is tofacitinib a game‐changing drug for ulcerative colitis?

<p>Profile of Tofacitinib in the Treatment of Ulcerative Colitis: An Evidence-Based Review of Recent Data</p>

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