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. 2019 May 28;9(5):e027456.
doi: 10.1136/bmjopen-2018-027456.

Real-world treatment persistence of golimumab in the management of immune-mediated rheumatic diseases in Europe: a systematic literature review

Affiliations

Real-world treatment persistence of golimumab in the management of immune-mediated rheumatic diseases in Europe: a systematic literature review

Karin Luttropp et al. BMJ Open. .

Abstract

Objectives: To summarise real-world data from studies reporting golimumab persistence in European immune-mediated rheumatic disease (IMRD) populations and to report pooled estimates.

Design: Systematic literature review.

Data sources: Relevant literature was identified through searching Medline and Embase via Ovid as well as the conference databases of European League Against Rheumatism and American College of Rheumatology-Association of Rheumatology Health Professionals.

Eligibility criteria: We screened records using predefined patients, interventions, comparators, outcomes and study design criteria. Eligible studies included reports of persistence among adult IMRD patients in Europe receiving treatment with subcutaneous golimumab. Clinical trials, randomised controlled trials, literature reviews, editorials, guidelines and studies with <20 patients receiving golimumab were excluded.

Data extraction and synthesis: Following double screening by two independent reviewers, 27 studies out of 578 identified records were selected for inclusion and subsequent data extraction. Persistence was most commonly reported at 12and 24 months; hence, pooled persistence estimates were calculated for these two time points and reported according to indication.

Results: Persistence ranged between 58.1% (psoriatic arthritis (PsA) patients regardless of treatment line) and 75.7% (biological-naïve rheumatoid arthritis patients) at 12 months; at 24 months, the range was 43% (axial spondyloarthritis (AxSpA) patients regardless of treatment line) and 69.6% (biological-naïve PsA patients). On the basis of data from 12 studies, persistence with golimumab treatment was either significantly higher or not significantly different from other tumour necrosis factor inhibitors (TNFi).

Conclusions: Golimumab persistence at 24 months approximates 50%, with a lower persistence among AxSpA (43%) patients. However, as the number of studies in these populations was low, they warrant further research. In 12 studies comparing various TNFi treatments, golimumab was shown to have significantly better or equal persistence to its comparators.

Keywords: drug survival; golimumab; real-world evidence (RWE); rheumatology; treatment persistence.

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Conflict of interest statement

Competing interests: KL, MD and NJ are employees of ICON PLC. FC, MG, SS and AK are employees of Merck Sharp & Dohme, Lucerne, Switzerland. SK and CMB are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.

Figures

Figure 1
Figure 1
Selection process flowchart for identification of studies to be included in the literature review. ACR, American College of Rheumatology; ARHP, Association of Rheumatology Health Professionals; EULAR, European League Against Rheumatism.
Figure 2
Figure 2
Number of studies reporting persistence at various time points. Results are reported by indication. (A) Immune-mediated rheumatic disease; (B) rheumatoid arthritis; (C) axial spondyloarthritis and (D) psoriatic arthritis.
Figure 3
Figure 3
Pooled persistence data at 12 and 24 months, by treatment line (where available). Results are reported by disease. (A) IMRD populations (persistence data not reported for individual diagnoses); (B) rheumatoid arthritis populations; (C) axial spondyloarthritis populations and (D) psoriatic arthritis populations. IMRD, immune-mediated rheumatic disease; GLM, golimumab; n, number of studies included.
Figure 4
Figure 4
Pooled mean survival time (months) for patients with mixed or unknown treatment history receiving golimumab (GLM) treatment. (A) Psoriatic arthritis patient populations and (B) rheumatoid arthritis patient populations.
Figure 5
Figure 5
Effect size of differences in persistence between golimumab (GLM) and comparators, expressed as HRs. All HR calculations were made using GLM persistence data as reference. (A) GLM versus adalimumab; (B) GLM versus certolizumab pegol; (C) GLM versus etanercept and (D) GLM versus infliximab. HR>1 indicates that comparator persistence is lower than reference (GLM) treatment persistence.

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