Background Vedolizumab (VDZ) has demonstrated efficacy and safety in moderate-severe Crohn’s Disease (CD) in GEMINI registration trials. Nevertheless, the patient profile in actual clinical practice differs from that included in controlled studies so additional data are needed. The primary objective of our study was to evaluate the effectiveness, safety and durability of VDZ in active moderate-severe CD in real clinical practice. Methods Unicentric retrospective observational study. All patients treated in our center with VDZ with moderate-severe CD were included. Effectiveness was assessed 16 weeks after treatment iniciation and at the last visit with available data. Remission (RmLE) and steroid-free response (RsLE) were considered to be the achievement of a Harvey-Bradshaw index (HBI) ≤4 or a decrease of at least 3 points from the previous HBI. To evaluate the durability of VDZ, a Kaplan-Meier survival curve was performed. In addition, adverse effects attributable to VDZ during follow-up were recorded. Results We included 26 patients whose clinical-demographic features are shown in Table 1. The median follow-up of patients was 52 weeks (IQR= 24–78). At 16 weeks after initiation of VDZ treatment, RmLE and RsLE were achieved in 19.2% and 69.2% of patients respectively. At the last follow-up visit, 27% of patients achieved RmLE with 61.5% presenting RsLE (Figure 1). The probability of retention of VDZ treatment at median follow-up was 57%, not differing significantly between bionaive patients from those with previous failure to other biologic treatments (Figures 2 and 3). There were no serious adverse effects or effects that required discontinuation of VDZ. Three mild adverse effects were documented in 11.5% of patients (arthralgia, dyspnea and a mild viral infection). Conclusion In our series of patients, VDZ proved effectiveness and safety in line with that described in other real clinical practice series. The durability of VDZ at one year in this series of refractory CD was also considerable and did not vary according to previous exposure to biologic agents.
Background Ustekinumab has proved its efficacy and safety in moderate-to-severe Crohn′s disease (CD). However, the real practice setting differs from clinical trials. Our aim was to evaluate the effectiveness and safety of ustekinumab in a cohort of real-life practice patients with CD mostly refractory to anti-TNF α agents. Methods Observational retrospective single-center study. All patients undergoing treatment with ustekinumab at the Digestive Diseases Department of the Regional University Hospital of Málaga and at least 16 weeks of follow-up after induction were included. The primary outcome was steroid-free clinical remission (Harvey-Bradshaw Index ≤4) at 24 and 52 weeks. Secondary objectives were combined biological remission (fecal calprotectin levels <250 mcg/g and C-reactive protein <10 mg/dl), safety and persistence of ustekinumab during the follow-up period. Results A total of 89 patients with CD treated with ustekinumab (59,6% women; median disease duration 10 years) were included. The median follow-up was 60 weeks and 55 patients reached one year of follow-up. A 39,3% of the patients had history of previous abdominal surgery and 27% had been treated with 2 or more biologics. A 25,8% and 12,4% of the patients were on steroids and immunosupresants at the induction. The percentages of steroid-free clinical remission at 24 and 52 weeks were 42% and 54% respectively (Figure 1). Combined biological remission at 24 and 52 weeks was achieved in 33% and 45% of the patients respectively. Ustekinumab persistence was 88% at 12 months of follow-up (Figure 2). There were 14 suspensions mainly due to lack of response. Only 13 adverse events were documented in 9 patients (11.5%), none of them serious. Figure 1. Steroid-free clinical and biological remission percentages of ustekinumab at 16,24,52,76 and 104 weeks. Figure 2. Kaplan-Meier curve showing the durability of ustekinumab throughout the follow-up period. Conclusion Ustekinumab was effective and safe in a high proportion of patients with CD that were resistant to conventional immunosuppressant and antitumor necrosis factor drugs in this real-life practice cohort.
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