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Using Healthcare Databases to Replicate Trial Findings for Supplemental Indications: Adalimumab in Patients with Ulcerative Colitis
Using Healthcare Databases to Replicate Trial Findings for Supplemental Indications: Adalimumab in Patients with Ulcerative Colitis
- Source :
- Clinical pharmacology and therapeutics. 108(4)
- Publication Year :
- 2020
-
Abstract
- Regulators wish to understand whether real world evidence can be used for secondary indications of biologics. Using the secondary indication of adalimumab for ulcerative colitis (UC) as an example, we aimed to replicate the ULTRA-2 randomized controlled trial finding on the effectiveness of adalimumab in patients with UC using realworld data analyses. Adalimumab, a TNF-alpha receptor inhibitor initially approved for Crohn's disease, was approved for moderate to severe UC in 2012. The ULTRA-2 trial had shown improved remission against placebo in patients with UC. Using claims data (2006-2012), we conducted a cohort study of patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of infliximab using propensity score matching. The coprimary end points were corticosteroid (CS) discontinuation within 8 weeks and 1 year of treatment. We computed hazard ratios (HRs) and 95% confidence intervals (CIs). We identified 398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users. Adalimumab users were 28% more likely to achieve CS-discontinuation compared with nonusers over 1 year (HR = 1.28; 95% CI 0.94-1.73). However, unlike in ULTRA-2, this effect was not observed in the first 8 weeks (HR = 0.79; 95% CI 0.65-0.97). Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment. In summary, our results highlight opportunities and some limitations of database analysis to identify treatment effects for secondary indications.
- Subjects :
- musculoskeletal diseases
Adult
Male
medicine.medical_specialty
Time Factors
Databases, Factual
Placebo
030226 pharmacology & pharmacy
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
Adalimumab
Medicine
Humans
Pharmacology (medical)
skin and connective tissue diseases
Randomized Controlled Trials as Topic
Pharmacology
Evidence-Based Medicine
business.industry
Hazard ratio
Remission Induction
Middle Aged
medicine.disease
Ulcerative colitis
Infliximab
Discontinuation
Treatment Outcome
030220 oncology & carcinogenesis
Colitis, Ulcerative
Female
Tumor Necrosis Factor Inhibitors
business
Cohort study
medicine.drug
Subjects
Details
- ISSN :
- 15326535
- Volume :
- 108
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Clinical pharmacology and therapeutics
- Accession number :
- edsair.doi.dedup.....e9151acf0e9377088f2f012de9f37220