Real-World Effectiveness and Safety of Tofacitinib in Crohn’s Disease and IBD-U: A Multicenter Study From the TROPIC Consortium

Fenster, Marc; Alayo, Quazim A.; Khatiwada, Aava; Wang, Wenfei; Dimopoulos, Christina; Gutierrez, Alexandra; Ciorba, Matthew A.; Christophi, George P.; Hirten, Robert; Ha, Christina; Beniwal-Patel, Poonam; Cohen, Benjamin L.; Syal, Gaurav; Yarur, Andrés; Patel, Anish; Colombel, Jean–Frédéric; Pekow, Joel; Ungaro, Ryan C.; Rubin, David T.; Deepak, Parakkal

doi:10.1016/j.cgh.2020.10.025

Cited by 25 publications

(18 citation statements)

References 8 publications

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“…Our study reports that CTB was well-tolerated and resulted in clinical and endoscopic improvement in some patients with refractory CD. These results build the growing body of literature demonstrating the potential role of CTB in CD 10,11 and are important for treating providers, as the majority of patients fail to achieve endoscopic remission on current therapy.…”

Section: Discussionsupporting

confidence: 55%

“…This clinical response rate is similar to the tofacitinib induction trials (69.8%) 3 and higher than a recently published retrospective study (46.6%) that also included a refractory population. 11 In our study, 54.5% of patients achieved endoscopic improvement on tofacitinib. These preliminary results suggest that CTB may be effective at reducing clinical and endoscopic disease activity in some patients not in remission that are currently on biologic therapy.…”

Section: Discussionmentioning

confidence: 47%

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Safety and Efficacy of Tofacitinib in Combination With Biologic Therapy for Refractory Crohn’s Disease

Lee

Singla

Harper

et al. 2021

Inflammatory Bowel Diseases

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Background The majority of patients with Crohn’s disease (CD) will not achieve endoscopic remission on current therapy. Addition of tofacitinib to biologics may improve remission rates. Methods We retrospectively assessed safety and clinical and endoscopic effectiveness of off-label tofacitinib and biologics for CD. Results We identified 19 patients treated with tofacitinib and a biologic for refractory CD between 2017 and 2019. Tofacitinib was added for luminal disease on colonoscopy (n = 13), luminal disease on capsule (n = 3), and pyoderma gangrenosum (n = 3). The mean age was 41.2 years (28–62), mean disease was duration 16.9 years (6–36), and prior exposure to biologics was a median of 4 (1–6). Mean treatment duration was 9.6 months (SD, 3.3). Adverse events (AEs) were reported in 36.8% of patients, most commonly minor infection or CD flare, and no patients had a serious AE; 80.0% (n = 8) achieved clinical response, and 60.0% (n = 6) achieved clinical remission based on Harvey-Bradshaw Index. Endoscopic improvement occurred in 54.5% (n = 6), endoscopic remission in 18.2% (n = 2), and endoscopic healing in 18.2% (n = 2) of patients. Mean Simple Endoscopic Score in CD significantly improved from 13.6 ± 5.2 to 6.5 ± 4.0 after treatment (P < .01). Conclusions In patients treated with tofacitinib in combination with a biologic, no new safety signals were observed. Combination tofacitinib and a biologic was effective in achieving clinical and endoscopic improvement in some patients with severe, refractory CD, although a larger sample size is needed to further assess the efficacy and long-term safety of this treatment strategy.

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Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 47%

Safety and Efficacy of Tofacitinib in Combination With Biologic Therapy for Refractory Crohn’s Disease

Lee

Singla

Harper

et al. 2021

Inflammatory Bowel Diseases

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“…In 2020, Fenster et al conducted a retrospective cohort study to examine the real-world efficacy and safety of the off-label use of tofacitinib in patients with CD or unclassified IBD (IBD-U) [ 17 ]. Seventy-six patients with CD and IBD-U, 98.7% of whom had previously been treated with biologic therapy and 48.7% of whom had failed at least two biologic therapies, were followed for a median of 7.6 months.…”

Section: Tofacitinib In CDmentioning

confidence: 99%

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

Kim

2021

IJMS

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For a significant proportion of patients with inflammatory bowel disease (IBD), primary non-response and secondary loss of response to treatment remain significant issues. Anti-tumor necrosis factor therapies have been licensed for use in IBD. Other disease-related pathways have been targeted as well, including the interleukin 12/23 axis and lymphocyte tracking. However, the need for parenteral administration and the associated costs of dispensing and monitoring all biologics remain a burden on healthcare systems and patients. Janus kinase inhibitors are small-molecule drugs that can be administered orally and are relatively inexpensive, thus offering an additional option for treating IBD. They have been shown to be effective in patients with ulcerative colitis (UC), but they are less effective in those with Crohn’s disease (CD). Nonetheless, given the immune-system-based mechanism of these drugs, their safety profile remains a cause for concern. This article provides an overview of Janus kinase (JAK) inhibitors and new trends in the treatment of IBD.

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“…LC, a frequent and dangerous disease, caused numerous clinical contacts due to its complications ( Fenster et al, 2020 ). This process brought about a progressive loss of liver function, such as catabolism of toxins and drugs, metabolism of carbohydrates, lipids and proteins.…”

Section: The Roles Of Interleukin-35 In Liver Diseasesmentioning

confidence: 99%

The Role of IL-35 in the Pathophysiological Processes of Liver Disease

Lian

et al. 2021

Front. Pharmacol.

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It is known that liver diseases have several characteristics of massive lipid accumulation and lipid metabolic disorder, and are divided into liver inflammation, liver fibrosis, liver cirrhosis (LC), and hepatocellular carcinoma (HCC) in patients. Interleukin (IL)-35, a new-discovered cytokine, can protect the liver from the environmental attack by increasing the ratio of Tregs (T regulatory cells) which can increase the anti-inflammatory cytokines and inhibit the proliferation of immune cellular. Interestingly, two opposite mechanisms (pro-inflammatory and anti-inflammatory) have connection with the ultimate formation of liver diseases, which suggest that IL-35 may play crucial function in the process of liver diseases through immunosuppressive regulation. Besides, some obvious advantages also imply that IL-35 can be considered as a new therapeutic target to control the progression of liver diseases, while its mechanism of function still needs further research.

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Real-World Effectiveness and Safety of Tofacitinib in Crohn’s Disease and IBD-U: A Multicenter Study From the TROPIC Consortium

Cited by 25 publications

References 8 publications

Safety and Efficacy of Tofacitinib in Combination With Biologic Therapy for Refractory Crohn’s Disease

Safety and Efficacy of Tofacitinib in Combination With Biologic Therapy for Refractory Crohn’s Disease

The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment

The Role of IL-35 in the Pathophysiological Processes of Liver Disease

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