Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort.

BACKGROUND & AIMS: Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn's disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. METHODS: This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn's disease with objective evidence of active inflammation at baseline (Harvey-Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan-Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. RESULTS: Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn's disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26-52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn's disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. CONCLUSIONS: Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn's disease.

Psychological and psychiatric morbidity in lichen sclerosus in a cohort recruited from a genitourinary medicine clinic.

Forty-five cases of lichen sclerosus (LS) were retrospectively found between 2000 and 2008 among those attending an associate university teaching hospital sexually transmitted infection (STI) clinic (genitourinary [GU] medicine clinic) and 26 responders of the 45, to a questionnaire about psychological morbidity and psychiatric morbidity, were evaluated. Sixteen percent of the patients were worried about the possibility of infecting their partners with the condition, despite counselling to the contrary. Twenty-seven percent felt that the condition's cosmetic appearance adversely affected libido. There was moderate to severe anxiety at one time or another in 58% while 27% experienced depression at one time or another; 19% admitted to insomnia as a result of the condition; 23% were stressed while 11.5% were worried about starting a new relationship. LS has a profound effect on mental health. Selected patients with LS may benefit from routine referral to a clinical psychologist, within the sexually transmitted disease setting to elaborate and institute coping strategies.