The association of timing of disease-modifying drug initiation and relapse in patients with multiple sclerosis using electronic health records

Abstract

Objective: A large, US de-identified electronic health record (EHR) database (Optum-Humedica de-identified Electronic Health Record dataset) was used to evaluate whether earlier disease-modifying drug (DMD) treatment initiation was associated with improved outcomes in multiple sclerosis (MS).

Methods: Newly diagnosed patients from 1 January 2008 to 30 August 2014 (International Classification of Diseases, Ninth Revision, Clinical Modification code: 340.xx; first MS diagnosis = index date) with healthcare activity 1 year pre- and 2 years post-index, and who initiated DMD treatment during the 2 year follow-up period, were included. Patients were categorized as Early or Late Initiators (initiated DMD treatment ≤90 or >90 days following index, respectively). Relapse was determined by the presence of an MS-related hospitalization or an outpatient encounter with MS diagnosis and corticosteroid prescription within 7 days.

Results: A total of 4732 patients met the inclusion criteria: 2042 (43.2%) were Early Initiators and 2690 (56.8%) were Late Initiators. Similar baseline mean age (46.9 years for both cohorts) and Charlson Comorbidity Index scores (Early Initiators: 0.3, Late Initiators: 0.32) were observed. Average time to treatment was 20.9 ± 27.6 days for Early Initiators and 346.3 ± 181.1 days for Late Initiators. A significantly higher proportion of Late Initiators (n = 609; 22.6%) had a relapse during the 2 years following MS diagnosis compared with Early Initiators (n = 403; 19.7%; p = .0158). After controlling for covariates using multivariable logistic regression, late initiation of DMD treatment was associated with greater likelihood of relapse compared with early initiation (odds ratio 1.189; 95% CI: 1.031–1.371; p = .0172).

Conclusions: Later initiation of DMD treatment (i.e. >90 days after MS diagnosis) in patients with MS was associated with a greater likelihood of relapse compared with earlier initiation. Early initiation of DMD treatment following a diagnosis of MS may have an effect on long-term outcomes.

Keywords:

• Disease-modifying drugs
• Electronic health record (EHR)
• Multiple sclerosis
• Timing
• Treatment initiation

Acknowledgments

The authors thank Natalie Edwards of Health Services Consulting Corporation, Boxborough, MA, USA (supported by EMD Serono, Inc., Rockland, MA, USA [a business of Merck KGaA, Darmstadt, Germany]) for editorial assistance in drafting the manuscript, collating the comments of authors, and assembling tables and figures.

Previous presentation: Results of this study were previously presented in poster form at the 2015 National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, National Harbor, MD, USA, 29 September–1 October 2015.

Transparency

Declaration of funding

This study was supported by EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany), which also funded editorial assistance in the preparation of this article.

Author contributions: F.A.C., D.O. and A.L.P. were responsible for the study design, analysis plan, interpretation of results, and development of the manuscript. F.A.C. and D.O. were responsible for statistical analyses. All authors approved the final version of the manuscript.

Declaration of financial/other relationships

F.A.C. and D.O. have disclosed that they are employees of Genesis Research, which received funding from EMD Serono, Inc. to conduct the analyses. A.L.P. has disclosed that she is an employee of EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany). The authors received no funding for their participation in the writing of the manuscript.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.