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Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis

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Abstract

Background

Ulcerative proctitis (UP), though associated with high symptom burden and poor quality of life, is excluded from most of the randomized controlled trials in UC, including the OCTAVE trials. We aimed to analyse the effectiveness of tofacitinib in UP, and compare it to that in left sided colitis (LSC) and pancolitis (PC).

Methods

This was a prospective cohort study. Patients with either steroid-dependent or refractory ulcerative colitis, who received tofacitinib, were divided into three groups based on the disease extent [UP, LSC and PC]. The primary outcome was comparison of proportion of patients in clinical remission in the three groups, at weeks 8, 16 and 48. Safety outcomes were reported using incidence rate per patient year of exposure.

Results

Clinical remission was achieved in 47%(15/32), 24%(23/94), and 43%(23/54) of patients at week 8, 56%(18/32), 37%(35/94), and 56%(30/54) of patients at week 16, and 59%(19/32), 38%(36/94), and 24%(13/54) of patients at week 48 in groups UP, LSC and PC, respectively. Corticosteroid-free clinical remission rates were significantly higher in patients in groups UP at week 48. Five (15%) patients with UP were primary non-responders to tofacitinib at week 16, while three (9%) patients had secondary loss of response at week 48. The probability of sustained clinical response was highest in patients with UP. Patients with UP had the lowest incidence of adverse effects.

Conclusion

The effectiveness of tofacitinib in inducing and maintaining clinical remission is greater in patients with UP compared to LSC and PC.

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Data availability

The data that support the findings of this study are available from the corresponding author, [AS], upon reasonable request.

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Authors and Affiliations

  1. Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, 141001, India

    Arshdeep Singh, Ramit Mahajan, Dharmatma Singh, Ramandeep Kaur & Ajit Sood

  2. Department of Internal Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

    Vandana Midha, Shreya Garg & Kirti Arora

  3. Department of Pharmacology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

    Kirandeep Kaur

  4. Research and Development Centre, Dayanand Medical College and Hospital, Ludhiana, Punjab, India

    Namita Bansal

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Contributions

Guarantor of article: AS. Specific author contributions—ArS: Conception and design of the study, acquisition of data, interpretation of data, drafting the article, revising it critically for important intellectual content, final approval of the version to be submitted. VM: Conceptualization, Supervision, Project administration, Drafting the article, revising it critically for important intellectual content, final approval of the version to be submitted. KK: Project administration, supervision, Revising the article critically for important intellectual content, final approval of the version to be submitted. RM: Revising the article critically for important intellectual content, final approval of the version to be submitted. DS: Acquisition of data, final approval of the version to be submitted. RK: Acquisition of data, final approval of the version to be submitted. SG: Revising the article critically for important intellectual content, final approval of the version to be submitted. KA: Revising the article critically for important intellectual content, final approval of the version to be submitted. NB: Interpretation of data, final approval of the version to be submitted. AS: Conception and design of the study, acquisition of data, interpretation of data, drafting the article, revising it critically for important intellectual content, final approval of the version to be submitted.

Corresponding author

Correspondence to Ajit Sood.

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Conflict of interest

Ajit Sood is on the advisory board of Janssen Pharmaceuticals (Asia–Pacific) and received honorarium for speaker events from Pfizer India and Takeda India. The remaining authors disclose no conflicts.

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Singh, A., Mahajan, R., Midha, V. et al. Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis. Dig Dis Sci 69, 1389–1402 (2024). https://doi.org/10.1007/s10620-024-08276-1

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