P0539 - Treatment Patterns Among Crohn’s Disease Patients Initiating Biologics: A Two-Year Pooled Analysis of Three United States Claims Databases

Sunday, October 24, 2021

3:30 PM – 7:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Award: Presidential Poster Award

Presenting Author(s)

EM

Erik Muser, PharmD, MPH

Janssen Scientific Affairs, LLC
Horsham, PA, United States

Award: Presidential Poster Award

Erik Muser, PharmD, MPH¹, Amanda Teeple, MPH¹, Janvi Sah, MS², Christopher Adams, MPH², Dexter Waters, MSPH¹, Zhijie Ding, PhD, MS¹, Cynthia Gutierrez, MPH²
¹Janssen Scientific Affairs, LLC, Horsham, PA; ²STATinMED Research, Ann Arbor, MI

Introduction: This study examined biologic treatment patterns among Crohn’s disease (CD) patients who initiated adalimumab (ADA), certolizumab pegol (CZP), infliximab (IFX), ustekinumab (UST), and vedolizumab (VDZ) over a 2-year follow-up.

Methods: This descriptive study used data pooled from IQVIA® PharMetrics®, IBM® MarketScan®, and Optum Clinformatics™ databases during September 2015 to February 2020. Patients aged 18-64 years were required to have ≥1 claim for CD and ≥1 claim for ADA, CZP, IFX, UST, VDZ (index date=date of biologic). Continuous enrollment was required 12 months before (baseline) and 24 months after (follow-up) index date. Patients without baseline biologic use were classified as bio-naïve and remaining patients as bio-experienced. Due to a small sample size CZP was not included in the analyses. Persistence was defined as proportion of patients that remained on index biologic without a gap >30 days for ADA, and >120 days for UST, IFX, and VDZ between run-out date of two biologic claims (gap ~2X the FDA labelled maintenance dosing interval). Patients that were non-persistent were classified as switchers (to another biologic), restarters (restarted index biologic), or true discontinuers (remaining patients) during follow-up. Among patients with ≥2 maintenance doses in year 1, dose titration including 50% dose escalation, 100% dose escalation, and 50% dose reduction from labelled dose (based upon mean maintenance dose) were evaluated for ADA, UST, and VDZ patients (IFX was not evaluated due to lack of weight information).

Results: 1,943 bio-naïve (ADA: 772; CZP: 31; IFX: 747; UST: 163; VDZ: 230) and 2,030 bio-experienced (ADA: 783; CZP: 95; IFX: 232; UST: 514; VDZ: 406) patients were identified. Persistence, over two years, was numerically highest for UST patients followed by IFX, VDZ, and ADA and trends were similar across bio-naïve and bio-experienced CD patients (Figure). Over 2 years of follow-up, 50% dose escalation and 50% dose reduction were numerically highest among ADA patients followed by UST and VDZ; Bio-naïve and bio-experienced patients followed a similar trend except for VDZ where bio-experienced patients had a slightly higher rate of dose escalation than bio-naïve patients (Table 1).

Discussion: Over 24 months of follow-up, unadjusted persistence was numerically highest in the UST cohort while dose titration was numerically highest in ADA patients with generally consistent trends in the bio-naïve and bio-experienced subsets.

Figure: Figure. Persistence Among Crohn’s Disease Patients Using Biologics Over 2 Years of Follow-Up*

*Variable gap definition: ADA 30 days; IFX, UST, VDZ: 120 days.

	Doses	Bio-Naïve	Bio-Experienced
Adalimumab	Sample Size	723	677
50% Dose Escalation	≥60 mg/2 weeks	14%	13%
100% Dose Escalation	≥80 mg/2 weeks	4%	2%
50% Dose Reduction	≤20 mg/ 2 weeks	3%	2%

Ustekinumab	Sample Size	156	486
50% Dose Escalation	≥135 mg/8 weeks	12%	12%
100% Dose Escalation	≥180 mg/8 weeks	4%	2%
50% Dose Reduction	≤45 mg/8 weeks	0%	1%

Vedolizumab	Sample Size	194	302
50% Dose Escalation	≥450mg/8 weeks	5%	8%
100% Dose Escalation	≥600 mg/8 weeks	1%	2%
50% Dose Reduction	≤150 mg/ 8 weeks	1%	1%

Table: Overall Dose Titration Among Crohn's Disease Patients Using Biologics Over 2 Years of Follow-up

Disclosures:

Erik Muser: Janssen Scientific Affairs, LLC – Employee. Johnson & Johnson – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Amanda Teeple: Janssen Scientific Affairs LLC – Employee. Johnson & Johnson – Stockholder/Ownership Interest (excluding diversified mutual funds).

Janvi Sah: STATinMED Research – Employee.

Christopher Adams: STATinMED Research – Employee.

Dexter Waters: Janssen Scientific Affairs – Employee.

Zhijie Ding: Janssen Scientific Affairs, LLC – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Cynthia Gutierrez: STATinMED Research – Employee.

Erik Muser, PharmD, MPH¹, Amanda Teeple, MPH¹, Janvi Sah, MS², Christopher Adams, MPH², Dexter Waters, MSPH¹, Zhijie Ding, PhD, MS¹, Cynthia Gutierrez, MPH². P0539 - Treatment Patterns Among Crohn’s Disease Patients Initiating Biologics: A Two-Year Pooled Analysis of Three United States Claims Databases, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.