Medical therapies for heavy menstrual bleeding in women with uterine fibroids: a retrospective analysis of a large commercially insured population in the USA.

OBJECTIVES: To report patterns and patient characteristics associated with initiation of and persistence with medical therapies for uterine fibroid-related heavy menstrual bleeding. DESIGN: Retrospective cohort study. SETTING: US commercial insurance claims database. POPULATION: 41 561 women aged 18-54 years with uterine fibroids and heavy menstrual bleeding who initiated medical therapies from January 2000 through December 2013. METHOD: Multinomial logistic regression was used to assess patient characteristics associated with initiation and persistence. Cox proportional hazards regression was used on propensity score-matched cohorts to examine change from index medication. MAIN OUTCOMES MEASURES: Initiation of and persistence with four first-line medical therapies: short- and long-acting reversible contraceptive steroids, leuprolide acetate, and tranexamic acid. RESULTS: Most women (79.4%) took short-acting reversible contraceptive steroids as first-line therapy (index medication), whereas 9.5%, 8.5%, and 2.7% used long-acting reversible contraceptive steroids, leuprolide acetate, and tranexamic acid, respectively. During follow-up, 16 594 women (39.9%) switched to nonindex medication (18.4%) or procedural treatment (81.6%). In comparison with women taking short-acting steroids, those receiving long-acting steroids were less likely to switch [hazard ratio (HR) 0.84, 95% CI 0.79-0.91], whereas women taking leuprolide acetate (HR 2.44, 95% CI 2.27-2.62) or tranexamic acid (HR 1.44, 95% CI 1.26-1.65) were more likely to switch. Older age, emergency department visits, anaemia, and inflammatory disease diagnoses at baseline were associated with increased probability of discontinuing the index medication or switching to another therapy. CONCLUSIONS: Women with uterine fibroid-related heavy menstrual bleeding were more likely to persist with their initial therapy of long-acting reversible contraceptive steroid compared with other medical options. TWEETABLE ABSTRACT: 80% women with fibroid-related heavy menstrual bleeding use SARC, but LARC users are more persistent.

Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis.

BACKGROUND: Real-world comparative benefits and risks of infliximab (IFX) and adalimumab (ADA) in patients with ulcerative colitis (UC) are unclear. AIM: To evaluate the comparative effectiveness and safety of IFX and ADA in patients with UC who were new users of anti-TNF agents. METHODS: Using an administrative claims database (Optum Labs Data Warehouse), we identified patients who received first anti-TNF (IFX, ADA) prescription after a 12-month period without any anti-TNF treatment (baseline), and with a minimum 6-month follow-up after anti-TNF initiation. Primary outcome measures were: all-cause and UC-related hospitalisation, abdominal surgery, corticosteroid use >60 days after starting anti-TNF, and serious infections. We performed 2:1 propensity-score matched Cox proportional hazard analysis, and inverse probability-of-treatment weight (IPTW) analysis, accounting for healthcare utilisation, comorbidities and use of UC-related medication. RESULTS: We included 1400 new users of anti-TNF agents (age, 43 ± 15 years; 52% males), from 2006 to 2014. On propensity-score matched analysis, there was no significant difference in the risk of UC-related hospitalisation [IFX vs. ADA; adjusted hazard ratio (aHR), 1.04; 95% confidence interval (CI) 0.71-1.51], corticosteroid use (aHR, 0.85; 95% CI, 0.68-1.06) and serious infections (aHR, 0.62; 95% CI, 0.29-1.34) between IFX- and ADA-treated patients; the number of surgical events was very small. On IPTW analysis, risk of corticosteroid use was significantly lower in IFX - as compared to ADA - treated patients (aHR, 0.82; 95% CI, 0.68-0.99). Results were stable on multiple sensitivity analyses. CONCLUSIONS: In a large retrospective cohort of patients with UC who were new users of anti-TNF agents, IFX-treated patients may have lower corticosteroid use than ADA-treated patients, but risk of hospitalisation and serious infections were comparable.