ABSTRACT
OBJECTIVE: To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting. DESIGN: Retrospective cohort study using prospectively maintained clinical records. SETTING: Two UK tertiary inflammatory bowel disease (IBD) centres. PATIENTS: Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015. INTERVENTION: Vedolizumab, a monoclonal antibody to α-4 ß-7 integrins that selectively inhibit leucocyte migration into the gut. MAIN OUTCOME MEASURES: Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction ≥3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range. RESULTS: Fifty patients were included: 27 CD, 20 UC and 3 IBD-U (included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14. CONCLUSIONS: Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.
ABSTRACT
The use of pharmacoeconomic data in hospital formulary decisions was explored. Data were collected from pharmacist members of pharmacy and therapeutics (P&T) committees in 204 Florida hospitals. Participants were asked, via a cross-sectional telephone survey, to rate 10 factors used in making formulary decisions from 1 (most important) to 10 (least important). Participants were also asked about the usual sources of pharmacoeconomic data used by the P&T committee, the types of pharmacoeconomic analyses and humanistic outcome measures that have been used by the P&T committee to make formulary decisions, and the availability of someone with pharmacoeconomic skills to assist with the formulary decision-making. The average time spent collecting data was 19 minutes. Data were analyzed using descriptive statistics and correlation analysis. Eighty-six percent of the participants indicated that pharmacoeconomic data were used all the time or very often when formulary decisions were made, with only 6% stating that these data were rarely or never used. Pharmacoeconomic data were rated by 63% of participants to be very important in formulary decisions. The usual sources of pharmacoeconomic data listed by participants are inhouse data (75%), published literature (57%), and pharmaceutical industry studies (13%). Participants rated drug efficacy, toxicity, and side effects as the most important and avoiding use of home infusions as the least important factors in making hospital formulary decisions. About 70% of the hospitals had someone with pharmacoeconomic skills on staff, while 4% reported consulting with an external pharmacoeconomics expert. Most P&T committees in Florida hospitals relied on pharmacoeconomic data to assist them in making formulary decisions.
