Treatment Patterns and Sequencing in Patients With Inflammatory Bowel Disease

Brady, Joanne E.; Stott-Miller, Marni; Mu, George; Perera, Sue

doi:10.1016/j.clinthera.2018.07.013

Cited by 43 publications

(27 citation statements)

References 27 publications

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“…The effectiveness and tolerability of biologic therapy was indicated by the persistence findings, which account for both treatment switches and discontinuations. In our analysis, over half of patients discontinued biologic treatment during their clinical course, and mean time to loss of biologic persistence was > 12 months, which is comparable to that reported in previous studies [12,18,[26][27][28][29]. The relatively low rate of intestinal complications (33%) and surgery (22%) following biologic introduction, and long mean time between first biologic introduction and first complication (of about 10 months) or first surgery (of just under 2 years) suggests a role of biologics in preventing CD complications and delaying the need for surgical intervention, as seen in other observational studies and clinical trials [30-32].…”

Section: Discussionsupporting

confidence: 88%

Imaging and treatment patterns in newly-diagnosed patients with Crohn’s disease: analysis of a Japanese claims database

Hirai

Uda

Ota

et al. 2019

Preprint

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Background: The biologics adalimumab, infliximab, and ustekinumab are approved to treat Crohn’s disease (CD) in Japan; they are recommended to induce/maintain remission in steroid-dependent/steroid-refractory CD. However, little is known about biologic use in real-world clinical practice, particularly in the initial treatment stage following endoscopic/radiographic diagnosis (intestinal inspection). Methods: This observational, retrospective, longitudinal cohort study assessed patients in the Japan Medical Data Center claims database who were diagnosed with CD from 2009–2019, and prescribed ≥ 1 biologic (adalimumab, infliximab, ustekinumab). Primary outcomes were type of first-line treatment prescribed on/within 6 months of first CD diagnosis, and time from first diagnosis to biologic introduction. Results: The study included 1346 patients with newly-diagnosed CD who were prescribed a biologic (adalimumab, n = 434; infliximab, n = 892; ustekinumab, n = 20). Most common first-line treatments were 5-aminosalicylic acid (5-ASA) monotherapy (26.8%), 5-ASA plus biologic (26.3%), and biologic monotherapy (12.9%). First-line steroids (monotherapy/in combination) were prescribed in 10.8% of patients. The first-line biologic prescription rate was lower in patients who had undergone intestinal inspection within 12 months before biologic introduction versus those who had not (5.3% vs 17.4% in monotherapy; 19.9% vs 65.4% in combination with other agents). Mean time from diagnosis to first biologic prescription was 4.1 months. Conclusions: The study demonstrated high use of biologics (particularly infliximab) and low use of steroids in initial treatment of Japanese patients with newly-diagnosed CD who received biologics during their treatment course. Biologic prescription was more common in patients who had not undergone prior intestinal inspection.

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Section: Discussionsupporting

confidence: 88%

Imaging and treatment patterns in newly-diagnosed patients with Crohn’s disease: analysis of a Japanese claims database

Hirai

Uda

Ota

et al. 2019

Preprint

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“…The American College of Gastroenterology (ACG) recommends treatment with biologic agents such as adalimumab (ADA), certolizumab pegol (CZP), infliximab (IFX), and vedolizumab (VDZ) for patients who fail to respond, lose response, or are intolerant to conventional treatment [1,10,11]. These treatments are prescribed to attain and maintain clinical remission, slow disease progression, and delay surgical interventions [12]. However, between one-third and one-half of patients do not respond to anti-tumor necrosis factor (anti-TNF) treatments, which necessitates the introduction of a second biologic.…”

Section: Introductionmentioning

confidence: 99%

“…Switching to other medications ranges from 11% to 35% [20]. Brady et al [12] noted that only one-third of CD patients remained on a biologic treatment over a 12-month follow-up period.…”

Section: Introductionmentioning

confidence: 99%

Persistence, Dose Titration, and Health Care Resource Utilization Among Crohn’s Disease Patients Treated With Ustekinumab: A Real-World Analysis in the United States

et al. 2020

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Introduction: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. This real-world study evaluated persistence, dose titration, health care resource utilization (HCRU) and associated costs, and medication use among CD patients treated with ustekinumab (UST) in several pooled US commercial database populations. Methods: CD patients aged C 18 years with medical or pharmacy claims for UST were selected from pooled data from 3 large, national commercial databases. The first observed medical or pharmacy claim for UST was the index date. Patients were required to have had C 1 medical claim with a CD diagnosis during the 12 months prior to the index date and continuous health plan enrollment for a minimum of 12 months prior to and 12 months after the index date. Comparisons of outcomes during the baseline and follow-up periods were conducted using inferential statistical tests. Results: A total of 214 eligible UST patients were selected. The majority (74.8%) were biologic experienced (mean age: 41 years), and 83.6% remained treatment persistent during the 12-month post-index period. Among discontinuers, 25.7% restarted UST, and 8.6% switched from UST in the 12-month observation period. The mean treatment duration was 329 days. Most patients (77%) used the recommended UST dose, as defined as being within a 20% dose variation from label (90 mg/ 8 weeks ± 20%), 17.9% experienced dose escalation, and 5.1% experienced dose reduction. Post-index immunomodulator and corticosteroid use reduced by 20% and 28%, respectively, as compared with pre-index use among CD patients using UST. Annual all-cause ER visits and inpatient stays decreased by 20.5% and 30.3%, respectively, with similar downward trends for annual CD-related HCRU. Conclusions: The majority of CD patients prescribed UST were biologic experienced, and persistence was high over the 1-year follow-up. UST treatment initiation was associated with reductions in ER visits, inpatient stays, and steroid and other medication use.

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“…Overall, 54.0% of patients with UC newly initiated on a biologic (adalimumab, certolizumab, golimumab, infliximab, natalizumab, ustekinumab or vedolizumab) were reported to remain on their first-line therapy at 1 year based on another analysis of the same US insurance claims database. 15 However, McDermott et al reported only 35.0% (n=8/23) of patients receiving adalimumab persisting at 1 year. 14 This Irish study might be linked to the low patient numbers, as only 23 out of 3000 patients were found to be patients with UC receiving adalimumab with a high percentage of previous biologic failure (20 of 23 patients had previously received infliximab).…”

Section: Discussionmentioning

confidence: 98%

“…Published studies report treatment persistence rates at 1 year for biologics ranging from 35.0% to 63.0% in patients with UC from Ireland, the USA and Canada. [13][14][15][16][17] A number of observational studies have explored treatment response in the three antitumour necrosis factor (anti-TNF) agents currently licensed for use in UC. These have included multicentre cohort studies of adalimumab and golimumab in Spain, 18 19 an observational study of golimumab in Italian primary IBD centres 20 and a retrospective analysis of the outcomes of infliximab treatment at a Japanese academic hospital.…”

Section: Introductionmentioning

confidence: 99%

Treatment persistence and colectomy-free outcomes in patients with ulcerative colitis receiving golimumab or adalimumab: a UK experience

Hoque

Puenpatom

Boccaletti³

et al. 2020

BMJ Open Gastroenterol

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ObjectiveTo examine real-world treatment persistence, colectomy-free survival and treatment switching patterns in UK patients with ulcerative colitis (UC) prescribed golimumab or adalimumab.DesignThis was a retrospective chart review study in adult patients diagnosed with UC using data from 16 National Health Service sites in the UK. Patient records were included in the study if they had initiated first or second-line adalimumab or golimumab between 1 March 2016 and 30 September 2017 (index date). Subjects were required for ≥6 months post treatment initiation. Demographics, clinical characteristics, treatment-related data and colectomy data were extracted over a follow-up period of 6–12 months. Treatment persistence rate was the primary outcome. Colectomy-free survival and treatment switching were secondary outcomes. Outcomes were compared between treatments using χ2 tests and Fisher’s exact test for categorical variables. The t-tests were used for continuous variables. Time-to-event variables were evaluated using Kaplan-Meier curves and log-rank tests.ResultsThe study included a total of 183 patients (96 (52.5%) prescribed adalimumab; 87 (47.5%) golimumab), and patients were mostly first line (79.8%). Demographic and clinical characteristics were generally similar between treatment groups. Persistence rates within 12 months were 64.6% for adalimumab and 64.4% for golimumab (p=0.681). Overall, 20.2% switched to other therapy within 1 year, with 8.2% golimumab and 12.0% adalimumab switching to another biologic. Of patients prescribed adalimumab, 14.6% had ≥1 dose change, mainly dose escalations. In the 12 months post treatment initiation, 8.2% of patients underwent colectomy, with no significant difference in colectomy-free survival by treatment, p=0.73.ConclusionThis study provides evidence of clinical outcomes and real-world persistence for adalimumab and golimumab in UC. The persistence rates of both therapies were above 64.0% at 12 months following treatment initiation. In addition, the 1-year colectomy-free survival was relatively similar between the two treatments.

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Treatment Patterns and Sequencing in Patients With Inflammatory Bowel Disease

Abstract: While current treatment options seem effective in a proportion of patients with UC and CD, others require multiple lines of therapy, suggesting anunmet need for alternative treatments in UC and CD to achieve disease control.

Cited by 43 publications

References 27 publications

Imaging and treatment patterns in newly-diagnosed patients with Crohn’s disease: analysis of a Japanese claims database

Imaging and treatment patterns in newly-diagnosed patients with Crohn’s disease: analysis of a Japanese claims database

Persistence, Dose Titration, and Health Care Resource Utilization Among Crohn’s Disease Patients Treated With Ustekinumab: A Real-World Analysis in the United States

Treatment persistence and colectomy-free outcomes in patients with ulcerative colitis receiving golimumab or adalimumab: a UK experience

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