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Abstract Number: 483

An Evaluation of Literature On Discontinuation Rates of Biologics in Rheumatoid Arthritis

Setareh A. Williams1, Victoria Porter2, Victoria Zarotsky3, Sujatha Sundaram4, Elisabeth Nyman5, Cassie K. Gregson6 and Paul S. J. Miller6, 1AstraZeneca LP, Wilmington, DE, 2OptumInsight, Mastic Beach, NY, 3OptumInsight, Calabasas, CA, 4OptumInsight, Hanover, NH, 5AstraZeneca, Mölndal, Sweden, 6AstraZeneca, Macclesfield, United Kingdom

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Anti-TNF therapy and rheumatoid arthritis (RA)

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy

Session Type: Abstract Submissions (ACR)

Background/Purpose: To assess reasons for biologic discontinuation or switching in the treatment of rheumatoid arthritis (RA).

Methods: A text mining strategy was developed to identify, from the biomedical information published through July 2011, data relevant to discontinuation or switching due to adverse events (AEs) or lack of efficacy or patient preference. Searches encompassed Medline, ACR and EULAR conference abstracts, and > 20,000 selected full-text documents. The abstracts of the identified documents were manually assessed to determine whether they reported on the incidence/duration of and/or reasons for discontinuing/switching therapy. Expert opinions including non‑systematic reviews, case studies, and editorials and commentaries were excluded.

Results: 234 full-text articles and 45 meeting abstracts were identified as reporting on discontinuation due to AEs/lack of efficacy. Fourteen articles/abstracts reporting on discontinuation due to patient preference were identified. Sixty-one articles on discontinuation due to AEs/lack of efficacy met inclusion criteria (4 systematic reviews/meta-analyses, 17 randomized controlled trials, 7 registry studies, 21 prospective studies, and 12 observational studies), and 9 studies on patient preference met inclusion criteria (3 registry studies, 4 retrospective analyses, 1 cross-sectional, and 1 prospective study). AEs accounted for 5% to 40% of discontinuations within the 1st year of therapy. Injection/infusion site reactions were the most common discontinuation-related AE, most frequently reported with infliximab use and in patients with history of allergic reactions. Discontinuation due to lack of efficacy varied from 1% to 52% in studies with a 6-month follow-up duration and from 17% to 47% per year over a 10-year period. Patients were more likely to start on a 2nd biologic if their 1st biologic was discontinued due to lack of efficacy than if discontinued due to AEs. Patient preference accounted for 4% to 29% of the total discontinuations. Infliximab, followed by etanercept, were the most widely evaluated biologics. Limited data on withdrawal rates were available for 2ndgeneration and non-TNF inhibitor biologics.

Conclusion: Despite the availability of 9 RA biologics, a substantial proportion of patients discontinue treatment largely due to AEs or lack of efficacy. Heterogeneity in RA disease is well-known; hence, new therapies with different mechanisms of action may help mitigate this issue. Treatments offering equivalent efficacy to that of currently available biologics that can be sustained over longer time periods would benefit RA patients with inadequate response to available treatments.


Disclosure:

S. A. Williams,

AstraZeneca,

1,

AstraZeneca,

3;

V. Porter,

OptumInsight,

3,

AstraZeneca,

2;

V. Zarotsky,

OptumInsight,

3,

AstraZeneca,

2;

S. Sundaram,

OptumInsight,

5,

AstraZeneca,

2;

E. Nyman,

AstraZeneca,

3,

AstraZeneca,

1;

C. K. Gregson,

AstraZeneca,

1,

AstraZeneca,

3;

P. S. J. Miller,

AstraZeneca,

1,

AstraZeneca,

3.

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