Background: There is an increasing body of evidence showing that earlier use of biologics improves clinical outcomes in Crohn's disease (CD). Aim:To perform a systematic review and meta-analysis to assess the impact of early biologic use in the treatment of CD. Methods: PubMed and Embase databases were searched for English language papers and conference abstracts published through April 30, 2019. Studies were selected for inclusion if patients initiated biologics within 2 years of a CD diagnosis or if earlier biologics use (top-down) was compared with a conventional step-up strategy. Randomeffects meta-analyses were conducted to compare clinical remission (CR), relapse and endoscopic healing rates between early biologic treatment (<2 years of disease duration or top-down treatment strategy) and late/conventional treatment (biologic use after >2 years of disease duration or conventional step-up treatment strategy).Results: A total of 3069 records were identified, of which 47 references met the selection criteria for systematic review. A total of 18 471 patients were studied, with a median follow-up of 64 weeks (range 10-416). Meta-analysis found that early use of biologics was associated with higher rates of clinical remission (OR 2.10 [95% CI:1.69-2.60], n = 2763, P < 0.00001), lower relapse rates (OR 0.31 [95% CI: 0.14-0.68], n = 596, P = 0.003) and higher mucosal healing rates (OR 2.37 [95% CI: 1.78-3.16], n = 994, P < 0.00001) compared with late/conventional management. Conclusions:Early biologic treatment is associated with improved clinical outcomes in both adult and paediatric CD patients, not only in prospective clinical trials but also in real-world settings.

Background and Aims Bowel urgency and abdominal pain are impactful, yet underappreciated ulcerative colitis symptoms and not commonly assessed in clinical trials. We evaluated how these symptoms may improve with upadacitinib treatment and correlate with clinical and health-related quality of life (HRQOL) outcomes in the phase 2b U-ACHIEVE study. Methods Patients aged 18–75 years with moderately to severely active ulcerative colitis were randomised to receive placebo or upadacitinib (7.5, 15, 30, or 45 mg QD). Bowel urgency and abdominal pain were evaluated at baseline and Weeks 2, 4, 6, and 8. Week 8 correlations were evaluated between bowel urgency/abdominal pain with clinical (Mayo subscores, and high-sensitivity C-reactive protein and faecal calprotectin measurements) and HRQOL outcomes (Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey scores). Results A greater proportion of patients (N = 250) reported no bowel urgency and less abdominal pain with upadacitinib treatment compared to placebo, with improvements observed as early as 2 weeks. At Week 8, patients receiving the 45-mg QD dose had the greatest improvements versus placebo, with 46% reporting no bowel urgency (vs 9%; P ≤0.001) and 38% reporting no abdominal pain (vs 13%; P = 0.015). At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes. Conclusions Induction treatment with upadacitinib demonstrated significant reductions in bowel urgency and abdominal pain compared to placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.

From US payer perspectives, adoption of crisaborole results in modest pharmacy budget impact/savings.

Introduction Dose escalation is one of the treatment approaches studied and suggested in advanced therapies for Crohn’s disease (CD) and ulcerative colitis (UC). This study aimed to identify and characterize the dosing escalation patterns of advanced therapies in CD and UC. Methods Two systematic literature reviews (SLRs) were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE ® , Embase ® , and Cochrane Library were searched for articles published between January 2011 and October 2021 and limited to non-interventional studies in English language. Congress and bibliographic searches were also conducted. Articles were screened by two independent researchers. Dose escalation patterns were described and summarized considering the regional regulatory label recommendation (in North America [NA] or outside of North America [ONA]). Results Among 3190 CD and 2116 UC articles identified in the Ovid searches, 100 CD and 54 UC studies were included in the SLR, with more studies conducted ONA. Most studies reported an initial maintenance dose pattern aligned with the lower starting dose per local regulatory label; however, several ONA studies ( n = 13 out of 14) reported ustekinumab every 8 weeks as starting maintenance pattern in CD. In ONA studies, the median within-guideline escalation rates in CD and UC were 43% in ustekinumab (CD only), 33% and 32% for vedolizumab; 29% and 39% for adalimumab; and 14% and 10% for infliximab. Evidence regarding dose escalation patterns for tofacitinib, certolizumab pegol, and golimumab was limited. Some dose escalation patterns outside of label recommendations were observed including ustekinumab every 8 weeks to every 4 weeks and vedolizumab every 8 weeks to every 6 weeks. Conclusion Dose escalation strategies are widely documented in the literature. The reported dose escalation patterns and escalation rates vary by region and by CD and UC. Most escalation patterns reported were aligned with regulatory recommendations while some reported more diverse or aggressive dose escalation. Prospero Registration CRD42021289251. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02457-6.

Background As part of the IBD-DICE (Determinants, Incidence and Consequences of CS Excess) collaborative research programme, this study examined rates of CS use and excess use in patients with IBD over time and after initial diagnosis. Methods Using IBM® MarketScan®, a representative claims database including details of &gt;200 million individuals annually in the United States (US), we conducted a retrospective analysis of CS use from 2007 to 2018 in adult patients with IBD. Patients with conditions commonly associated with high levels of CS use (other than IBD) were excluded. CS use and excess were examined over calendar time in all patients (prevalent cohort), and in relation to the time of first IBD diagnosis in a newly diagnosed subset (incident cohort). Both a restrictive and a broader definition of CS use were examined. The restrictive definition only included claims for oral budesonide or prednisolone/prednisone with a pre-defined minimum daily equivalent dose of ≥17.5 mg, based on a typical tapering CS prescription for IBD. Under the broader definition, CS use was considered as any claim for oral prednisolone, prednisone, budesonide or methylprednisolone. Excess CS use was defined as either ≥2 CS courses in a 12-month period or ≥3 months of continuous CS use. Results The prevalent cohort (restrictive definition) included a total of 338,837 patients with 1,051,213 observation years. Rates of CS use ranged from 23.7% in 2007 to 19.3% in 2009 and plateaued in subsequent years (18.4%–21.1%). Rates of CS excess were higher from 2007 to 2009 (8.9%–11.5%) than in later years, and remained relatively stable from 2010 to 2018 (7.9%–8.6%). Similar patterns were seen with the broad definition of CS use, with CS excess rates of 15.2% in 2007 and 10.9%–11.8% from 2010 to 2018 (Figure 1). The incident cohort included 106,875 patients with 320,295 observation years. CS use was highest in the first year after diagnosis (24.2% and 29.4% with the restrictive and broad definitions, respectively) and decreased and plateaued by the second year after diagnosis (range: 10.8%–14.8% and 16.8%–21.0%, respectively). Similarly, CS excess was highest in the first year after diagnosis (11.7% and 14.6% with the restrictive and broad definitions, respectively) and decreased and levelled off by the second year after diagnosis (range: 3.6%–6.2% and 5.6%–8.6%, respectively) (Figure 2). Conclusion Despite advances in IBD treatment over the past decade and the adverse effects associated with CS, use of CS has not decreased substantially in the US in recent years. Levels of CS excess remain a concern, and may represent an opportunity for more optimised treatment and education, especially for newly diagnosed patients.

Introduction The aim of this work is to compare real-world outcomes of patients with rheumatoid arthritis (RA) receiving adalimumab (ADA) bio-originator (non-switchers) to those who had switched from ADA bio-originator to an ADA biosimilar (switchers) on the basis of the hypothesis that these outcomes would differ. Methods Data were drawn from the Adelphi RA Disease Specific Programme™, a point-in-time survey of physicians and their patients in Europe (France, Germany, Italy, Spain, UK) in 2020. Physicians completed a questionnaire for their next ten adult patients with RA, followed by four additional patients who had switched from ADA bio-originator to an ADA biosimilar (switchers). Physician- and patient-reported outcomes (PROs) for switchers and non-switchers were compared by propensity score matching. Results Three hundred and three rheumatologists provided data for 160 non-switchers and 225 switchers, 140 patients provided data; 51 non-switchers, 89 switchers. According to physician-reported disease activity, non-switchers were more likely to improve on their current ADA treatment than switchers (68%, n = 108 vs. 26%, n = 59 p < 0.001) and less likely to worsen (1%, n = 2 vs. 9%, n = 20; p < 0.01). Physician-reported patient adherence was significantly lower amongst switchers versus non-switchers (0.66 vs. 0.78, respectively; p = 0.04). More non-switchers than switchers were reported by their physicians to be consistent in taking their RA medicine ( p < 0.001). Compared with non-switchers, PRO measures indicated quality of life was worse (EQ-5D Visual Analogue Scale: 62.9 vs. 71.9; p < 0.001) and activity impairment was greater (Work Productivity Activity Index: 31.0 vs. 24.4; p = 0.02) for switchers, with trends for poorer health status and greater pain. Conclusions Non-medical switching in RA treatment may lead to unforeseen outcomes that should be considered by health decision-makers. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00526-w.

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