Assessment of corticosteroid-related quality of care measures for ulcerative colitis and Crohn’s disease in the United States: a claims data analysis

<p><b>Objective:</b> To evaluate corticosteroid (CS)-related quality of care indicators in patients with ulcerative colitis (UC) and Crohn’s disease (CD) in the US.</p> <p><b>Methods:</b> Adults diagnosed with UC or CD and prescription fills for an oral CS were identified from a large commercial US claims database (2005–2013). Quality indicators included prolonged CS use (≥60 days), use of CS-sparing therapy, and bone loss assessment. State-level variations in quality of care indicators were estimated using logistic regression models adjusting for age, gender, insurance plan type, and CD severity.</p> <p><b>Results:</b> Of the 25,063 UC and 22,155 CD patients receiving CS, 16.1% and 12.6%, respectively, were prolonged CS users. Among prolonged CS users, 52.5% of UC and 68.2% of CD patients used CS-sparing therapy. Bone loss assessment was observed in 11.0% of UC patients with prolonged CS use and 7.7% of newly diagnosed CD patients. Prolonged CS use was the lowest in Kentucky (odds ratio [OR] = 0.59) and the highest in Wisconsin (OR = 1.41) for UC patients; the lowest in North Carolina and New York (both OR = 0.71) and the highest in Utah (OR = 2.42) for CD patients. CS-sparing therapy use was the lowest in Delaware (OR = 0.42) and the highest in Michigan (OR = 0.83) for UC patients; it was significantly different only in South Carolina (OR = 0.57) for CD patients. Bone loss assessment rates were the highest in Arizona (OR = 1.83) for UC patients and were the lowest in Mississippi (OR = 0.52) and the highest in Texas (OR = 1.51) for CD patients.</p> <p><b>Limitations:</b> Information on disease severity was not available in the database.</p> <p><b>Conclusions:</b> Significant regional variations in all three quality indicators were observed across the US.</p

Changes in Practice Patterns of Clopidogrel in Combination with Proton Pump Inhibitors after an FDA Safety Communication

<div><p>Objectives</p><p>In 2009, the FDA issued a warning that omeprazole–a proton pump inhibitor (PPI)–reduces the antithrombotic effect of clopidogrel by almost half when taken concomitantly. This study aims to analyze the impact of the FDA Safety Communications on prescribing clopidogrel together with PPIs.</p><p>Methods</p><p>This retrospective study identified clopidogrel users from the Truven Health Analytics MarketScan Databases (01/2006–12/2012). Rates of clopidogrel-PPI combination therapy were estimated in 6-month intervals for patients with ≥1 clopidogrel prescription fill, then were analyzed pre- and post-safety communication (11/17/2009). Analyses were also conducted by grouping PPIs into CYP2C19 inhibitors (omeprazole and esomeprazole) and CYP2C19 non-inhibitors (pantoprazole, lansoprazole, dexlansoprazole, and rabeprazole).</p><p>Results</p><p>Overall, 483,074 patients met the selection criteria; of these, 157,248 used a clopidogrel-PPI combination. On average, 30.5% of patients in the pre- and 19.9% in the post-communication period used a clopidogrel-PPI combination therapy. Among clopidogrel users, the probability of using clopidogrel-PPI combinations fell by over 40% in the post-communication period (OR = 0.57; <i>p</i><0.001); the proportion of patients using esomeprazole fell from 12.9% to 5.3%, and the proportion using omeprazole fell from 10.1% to 6.3%. Among combination therapy users, the probability of patients using a combination with a CYP2C19 inhibitor decreased by 53% (OR = 0.47; <i>p</i><0.001); however, 31.5% of patients were still prescribed a clopidogrel-PPI combination therapy. Trends were similar for all and newly treated patients, regardless of clopidogrel indication and physician specialty.</p><p>Conclusions</p><p>The FDA Safety Communication resulted in a reduction in the number of patients undergoing combination therapy; however approximately one-third of patients still used combination therapy post-communication.</p></div

Systematic Review with Network Meta-Analysis: Comparative Efficacy of Biologics in the Treatment of Moderately to Severely Active Ulcerative Colitis

<div><p>Background</p><p>Biological therapies are increasingly used to treat ulcerative colitis (UC).</p><p>Aim</p><p>To compare the efficacy of biologics in adults with moderately-to-severely active UC, stratified by prior exposure to anti-tumour necrosis factor (anti-TNF) therapy.</p><p>Methods</p><p>A systematic literature review was undertaken to identify studies of biologics approved for UC. Network meta-analysis was conducted for endpoints at induction and maintenance.</p><p>Results</p><p>Seven studies were included in the meta-analysis of induction treatment for anti-TNF therapy-naïve patients. All biologics were more effective than placebo in inducing clinical response, clinical remission, and mucosal healing. Infliximab demonstrated a statistically significant improvement over adalimumab in clinical response (odds ratio [OR] [95% credible interval (CrI)]: 2.19 [1.35–3.55]), clinical remission (OR [95% CrI]: 2.81 [1.49–5.49]), and mucosal healing (OR [95% CrI]: 2.23 [1.21–4.14]); there were no other significant differences between biologics for induction efficacy. Five studies were included in the meta-analysis of maintenance treatment, two studies rerandomised responder patients at end of induction, and three followed the same patients ‘straight through’. To account for design differences, the number of responders at end of induction was assumed to be equivalent to the number rerandomised. Vedolizumab showed significantly different durable clinical response from comparators (OR [95% CrI] infliximab 3.18 [1.14–9.20], golimumab 2.33 [1.04–5.41], and adalimumab 3.96 [1.67–9.84]). In anti-TNF therapy-experienced patients, only vedolizumab and adalimumab could be compared. At induction, no significant differences in efficacy were seen. During maintenance, vedolizumab showed significantly improved rates of mucosal healing versus adalimumab (OR [95% CrI]: 6.72 [1.36–41.0]).</p><p>Conclusions</p><p>This study expands the understanding of comparative efficacies of biologic treatments for UC, encompassing outcomes and populations not previously studied. All biologic treatments were effective for UC during induction. Vedolizumab demonstrated possible clinical benefits in the maintenance setting versus all comparators, irrespective of prior anti-TNF exposure and after adjusting for differences in study design.</p></div

Among clopidogrel users, proportion of patients using clopidogrel-PPI combination therapy over time.

<p>Notes: ^a Total number of patient-semesters pre-safety communication = 272,113; post-safety communication = 1,593,625. ^b Percentages add up to more than 100% because more than 1 PPI could be prescribed in the same semester. ^c * indicates that the results are significant at the 5% level (two-sided alpha). ^d Protonix was first released as a generic, pantoprazole, in August 2007. Abbreviations: CI, confidence interval; PPI, proton pump inhibitor; S, semester.</p

Real-world effectiveness, adherence and persistence among patients with type 2 diabetes mellitus initiating dulaglutide treatment

<p><b>Objectives:</b> To assess glycemic effectiveness, adherence and persistence within 6 months of treatment initiation with dulaglutide, a once weekly GLP-1 receptor agonist, in a US real-world setting.</p> <p><b>Methods:</b> This retrospective claims analysis included adults (≥18 years) with T2DM from the HealthCore Integrated Research Database, who had HbA1c laboratory results around initiation and within 6 months after initiation. Glycemic control was assessed by change in HbA1c from pre-initiation to post-initiation. Patients were considered adherent if their proportion of days covered (PDC) was ≥0.80; persistence was measured as days of continuous therapy from initiation to 6 months after initiation with no gaps >45 days between fills.</p> <p><b>Results:</b> Of the 308 analyzed patients, the majority (<i>n</i> = 188; 61%) were adherent to dulaglutide (mean PDC 0.76; SD 0.26), with 115 patients (37%) discontinuing treatment. Mean persistence was 152 days/5 months. Mean HbA1c decreased from 8.49% (SD 1.70, median 8.20%) at baseline to 7.59% (SD 1.51, median 7.30%) at follow-up, corresponding to a mean HbA1c change of −0.90% (95% confidence interval [CI] −1.08 to −0.73; <i>p</i> < .01; median −0.70%). Patients who were adherent to or persistent with dulaglutide experienced larger reductions (−1.14% and −1.12% respectively), as did those without prior GLP-1 RA use (−1.03%). The proportion of patients with HbA1c <7% increased from 18% to 40%.</p> <p><b>Conclusions:</b> Dulaglutide was associated with a significant decrease in HbA1c levels 6 months after treatment initiation. Patients who adhered to or persisted with dulaglutide therapy, or were naïve to GLP-1 RA use, experienced greater decreases in HbA1c levels.</p

Included trials/treatments and important patient characteristics.

<p>Included trials/treatments and important patient characteristics.</p

Treatments and endpoints available for meta-analysis.

<p>Treatments and endpoints available for meta-analysis.</p

Forest plot of the odds ratios for biologics vs. placebo for anti-TNF therapy-naïve patients in maintenance studies.

<p>CrI, credible interval; TNF, tumour necrosis factor. Note: Adalimumab maintenance dose: 40 mg every other week; vedolizumab maintenance dose: 300 mg every 8 weeks; golimumab maintenance dose: 100 mg every 4 weeks; infliximab maintenance dose: 5 mg/kg intravenously every 8 weeks.</p

Forest plot of the odds ratios for biologics vs. placebo for anti-TNF therapy-naïve patients in induction studies.

<p>CrI, credible interval; TNF, tumour necrosis factor. Note: Adalimumab induction dose: 160 mg followed by 80 mg; vedolizumab induction dose: 300 mg; golimumab induction dose: 200 mg subcutaneous at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks; infliximab induction dose: 5 mg/kg intravenously at week 0, followed by 5 mg/kg at 2 and 6 weeks.</p

Comparative efficacy of biological agents for induction and maintenance therapy for anti-TNF therapy-experienced subpopulation.

<p>Comparative efficacy of biological agents for induction and maintenance therapy for anti-TNF therapy-experienced subpopulation.</p