Real-world outcomes of 54-week vedolizumab therapy and response durability after treatment discontinuation in ulcerative colitis: results from a multicenter prospective POLONEZ study.

Background

Vedolizumab is a gut-selective anti-lymphocyte trafficking agent used to treat ulcerative colitis (UC) and Crohn's disease.

Objectives

We aimed to evaluate the effectiveness, safety, and durability of the therapeutic effect of vedolizumab after treatment discontinuation in a real-world cohort of patients with UC treated in Poland.

Design

This was a multicenter, prospective study involving patients with moderate to severely active UC from 12 centers in Poland who qualified for reimbursed treatment with vedolizumab between February and November 2019.

Methods

The primary endpoints were clinical response (⩾2-point improvement from baseline on partial Mayo score) and clinical remission (partial Mayo score 0-1), including steroid-free remission, at week 54. Other outcomes included response durability at 26 weeks after treatment discontinuation, identification of predictors of response and remission, and safety assessment.

Results

In all, 100 patients with UC were enrolled (55 biologic naïve and 45 biologic exposed). At baseline, 68% of patients were on corticosteroids and 45% on immunomodulators. Clinical response was observed in 62% of patients, clinical remission in 50%, and steroid-free remission in 42.6% at week 54. Within 26 weeks after treatment discontinuation, 37% of patients who maintained response by week 54 relapsed. The decreased number of liquid stools and rectal bleeding and endoscopic response at week 14 were predictive factors for response at week 54. Time from diagnosis ranging 2-5 years, decreased stool frequency, and non-concomitant use of corticosteroids at baseline and at week 14 were predictive factors for remission at week 54. Partial Mayo score < 3 with no subscale score > 1 at week 54 was a predictive factor for durable response after treatment discontinuation. The rate of serious adverse events related to treatment was 3.63 per 100 patient-years.

Conclusion

Vedolizumab is effective and safe in UC treatment in Polish patients. However, the relapse rate after the treatment cessation was high.

Registration

ENCePP (EUPAS34119).

Informations de copyright

© The Author(s), 2023.

Déclaration de conflit d'intérêts

Piotr Eder received lecture fees and/or travel grants from Takeda, Ferring, Astellas, Pfizer, and Janssen. Maria Kłopocka has received payment for lectures from Janssen, Takeda, Ferring, Alfa-Sigma, and Pharmabest and travel/accommodation/meeting expenses from Ferring, Janssen, Takeda, Alfa-Sigma, and Pharmabest. Renata Talar-Wojnarowska received lecture fees and/or travel grants from Abbvie, Alfasigma, Astellas, Ferring, Janssen, Pfizer, and Takeda. Rafał Filip served as a speaker for Gramineer International AB, Egis, Ferring, Janssen, and Takeda; received investigational grants from Gramineer International AB, and Egis; and received support for traveling and congress assistance from MSD, Abbvie, Egis, Takeda, and Ferring. Katarzyna Waszak received payment for travel/accommodation/meeting expenses from Janssen-Cilag, Pfizer, Pro.Med.CS, Samsung Bioepis, and Takeda Pharma. Kamila Stawczyk-Eder received travel grants and lecture fees from Janssen, Pfizer, and Takeda. Ariel Liebert received payment for lectures from Janssen, Takeda, Egis, Abbvie, and Pharmabest, and travel/accommodation/meeting expenses from Janssen, Takeda, Egis, and Abbvie. Hubert Zatorski gave scientific advice to Takeda. Anna Solarska-Półchłopek received lecture fees and travel grants from Janssen. Aleksandra Kaczka received lecture fee(s)/travel/accommodation/meeting expenses from Takeda, Janssen-Cilag, Biogen, Astellas, and Alfa-Sigma. Krzysztof Wojciechowski and Szymon Drygała are permanent employees of Takeda Pharma sp. z o.o. Krzysztof Wojciechowski is now an employee of: Independent Public Health Care Center in Tarczyn, Warszawska 42, Tarczyn, Poland. Edyta Zagórowicz received lecture fees from Janssen, Sandoz, Ferring, and Pfizer; consultancy fees from Pfizer, Janssen, and Takeda; and other compensations from Takeda and Janssen. The remaining authors disclose no conflicts of interest.