Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study

Abstract

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD). Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn’s disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL). Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn’s disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn’s disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn’s disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn’s disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn’s disease and ulcerative colitis patients ( p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52. Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

Real‐world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease

“…Drug persistence was high with 95.5% of patients remaining on treatment after 6 months, and 88.5% after 12 months. These numbers are in line with those reported for IV vedolizumab treatment, ranging from 60–95% after 12 months 25–27 …”

“…These numbers are in line with those reported for IV vedolizumab treatment, ranging from 60-95% after 12 months. [25][26][27] Our evaluation of the outcome of the switch included thorough investigations of clinical disease activity, applying two activity indices for CD (patient-based HBI and PRO2-CD) and two for UC (SCCAI and PRO2-UC), analysed by both median values and by proportions of patients in remission. All of these analyses corroborated the faecal calprotectin data, showing either unchanged disease activity levels after the switch in both CD and UC patients, or as in the case of SCCAI levels, a statistically significant improvement.…”

Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients: A Nationwide Dutch Registry Study

“…However, in these studies, not all patients were anti-TNF-experienced, and the primary outcome was clinical remission defined as a partial Mayo score <2. 15,16 In one German cohort, with patient characteristics and inclusion criteria similar to this cohort, a lower corticosteroid-free clinical remission rate was found (22%). 17 Few real-world studies described effectiveness of tofacitinib up to 52 weeks of treatment.…”

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

“… 10 According to the systematic reviews of the available real-world experience studies with vedolizumab, which were published in 2018, clinical response rates at week 52 were at the level of 48% (two studies, CI was not calculated) and 52% (16 studies, 95% CI: 37–65%), while clinical remission was achieved in 39% (two studies, CI was not calculated) and in 42% of patients (corticosteroid-free clinical remission assessed in nine studies, 95% CI: 31–53%). 22 , 23 In the more recent long-term real-world studies, the observed clinical response rate was 49% in a Swedish cohort 24 and 45% in an Israeli cohort. 25 In the abovementioned cohort studies, clinical remission rates were 47% and 33%, respectively.…”

“…This percentage was similar to that of other studies, where the discontinuation rate after 3-month therapy varied between 18%, 23.5%, and 26% of UC patients. 24 , 25 , 35 …”