Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study)

Abstract

Background: Vedolizumab, a humanized antibody targeting the α4β7 integrin, was proven to be effective in the treatment of moderate-to-severe ulcerative colitis (UC) in randomized clinical trials. The aim of the POLONEZ study is to determine the demographic and clinical characteristics of the patients with UC treated with vedolizumab within the scope of the National Drug Program in Poland and to assess the real-world effectiveness and safety of vedolizumab in the study population. Here we report the demographic and clinical characteristics of these patients. Methods: This prospective study included adult patients eligible for UC treatment with vedolizumab who were recruited from 12 centers in Poland between February and November 2019. Collected data included sex, age, disease duration, presence of extraintestinal manifestations or comorbidities, status of previous biologic treatment, and current concomitant treatment. Disease extent was determined according to the Montreal classification, and disease activity was measured with the Mayo Score. Results: A total of 100 (55 biologic-naïve and 45 biologic-exposed) patients were enrolled in the study (51% female, median age 35 years). Among biologic-exposed patients (mostly infliximab-treated), 57% had failed to respond to the therapy. The disease duration was significantly shorter in biologic-naïve (median 5 years) than in biologic-exposed (8 years, p = 0.004) or biofailure patients (7 years, p = 0.04). In the overall population the median Total Mayo Score was 10. Disease extent and activity were similar between the subgroups. Conclusions: Our study indicates that patients treated with vedolizumab in Poland receive the drug relatively early after UC diagnosis, but their disease is advanced. More than half of the patients had not been treated with biologic drugs before initiating vedolizumab. The study was registered in ENCePP database (EUPAS34119). Lay summary Characteristics of patients treated for ulcerative colitis with vedolizumab in Poland Treatment of moderate-to-severe ulcerative colitis (UC) with the integrin antagonist vedolizumab became available within the Polish National Drug Program (NDP) in 2018. In this study, for the first time, we provide detailed demographic and clinical characteristics of 100 patients (median age 35 years, 51% female) treated with vedolizumab in Poland, of whom 55 were biologic-naïve and 45 biologic-exposed. The median duration of disease was 6 years. The disease duration was shorter in biologic-naïve than in biologic-exposed patients. Most patients were affected by extensive colitis (52%) or left-sided colitis (42%). Median disease activity was 10 according to the Total Mayo Score. Sixty-eight patients received concomitant systemic corticosteroids and 45 patients received immunomodulators. Our findings indicate that Polish patients receiving vedolizumab have a high disease activity and are treated relatively early after UC diagnosis. This might be due to the criteria for inclusion of a patient in the NDP.

Nutritional Status Indicators as a Predictor of Achieving Remission at Week 14 during Vedolizumab Therapy in Patients with Ulcerative Colitis: A Pilot Study

“…Our study showed that patients naïve to previous biological therapies significantly more often achieved clinical remission at week 14 during vedolizumab induction therapy (70.0% vs. 27.3%; p = 0.023). The same results were observed in POLONEZ study performed by Cichoż-Lach et al This study, conducted prospectively, included adult UC patients eligible for UC treatment with vedolizumab who were recruited from 12 centers in Poland and showed that among biologic-exposed patients (mostly infliximab-treated), 57% had failed to respond to the therapy [ 11 ].…”

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

“…As detailed baseline characteristics of Polish patients showed, at the time of enrollment in the NDP, this population had a more severe disease activity, a higher percentage of biologic-naïve patients, and received the first dose of vedolizumab earlier after UC diagnosis than those described in other European real-world cohorts. 14 The obtained treatment results, which may be impacted by the abovementioned differences, complement the data of clinical trials in relation to a larger patient population and daily clinical practice.…”

“…Baseline clinical characteristics of the study group were described previously. 14 BMI, body mass index; IQR, interquartile range. …”

“… 15 The disease activity was measured with the total Mayo score (range: 0–12, with higher scores indicating more active disease) at weeks 0 and 14. 14 , 16 , 17 Mucosal healing, defined by an endoscopic Mayo score of ⩽1, 17 was assessed at week 14. The partial Mayo score (range 0–9, total Mayo score without the endoscopic component) was used to assess the effectiveness of maintenance therapy at week 54.…”

“…The patient demographic and clinical characteristics at baseline have been published elsewhere. 14 Here, results during the visit at week 54 and response durability at 26 weeks after treatment discontinuation (week 80) are described.…”