4cps-009 efficacy, safety and economic impact of vedolizumab in ulcerative colitis and crohn’s disease

Background Treatments for ulcerative colitis (UC) and Crohn’s disease (CD) include conventional agents and tumour necrosis factor-alpha inhibitors (anti-TNFα). A substantial proportion of patients do not respond, are intolerant to both therapies or these drugs are contraindicated. Vedolizumab, a monoclonal antibody directed against α4β7-integrin that inhibits lymphocyte recruitment to the gastrointestinal tract, provides another therapeutic option. Purpose To assess the efficacy, safety and economic impact of vedolizumab treatment in UC and CD patients in clinical practice. Material and methods Retrospective, observational study of patients treated with intravenous vedolizumab from September 2015 to September 2017. Variables: age, sex, diagnosis, previous anti-TNFα therapy, duration, dose variation and analytical parameters: haemoglobin (Hb), C-reactive protein (CRP) and faecal calprotectine (FCP). Clinical response was measured by haemoglobin and CRP variation during induction and maintenance, and FCP reduction. Safety was assessed by reported treatment-emergent adverse events, and economic impact by drug patient-year cost. Results Forty-one patients, 63% men, mean age 46.6 years (19–76), were included. Indications: 16 patients (39%) UC and 19 (61%) CD. Most of the patients had previously been treated with anti-TNFα therapies (85%), mostly infliximab (88%), while 15% had never had biotherapy. Mean duration was 10.4 (1–30) months. Fourteen patients (34%) required a maintenance dose modification every 4 to 6 weeks instead of every 8 weeks. Mean Hb and CRP levels before vedolizumab administration were 13.3 mg/dl and 18.5 mg/L respectively, improving at the end of the induction in 0.2 mg/dl and 6.4 mg/L, and 0.3 mg/dl and 7.7 mg/L in the maintenance phase. Average FCP reduction was 22.4% from baseline levels to values at the end of the study. With regard to adverse events, 16 patients (39%) reported gastrointestinal events and seven (17%) arthralgias. Treatment was discontinued in two patients due to lack of efficacy. Estimated patient-year cost in our hospital was €18 259 the first year, and €14 202 the following year. Conclusion Vedolizumab provides an additional therapy for patients with an inadequate response or were intolerant to anti-TNFα. Effectiveness outcomes in our clinical setting were within the percentages presented in clinical trials either in induction or maintenance, showing a similar safety profile to other biological treatments and to that described in clinical trials. References and/or Acknowledgements Vedolizumab: EPAR-Summary for the public. EMA. No conflict of interest