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Cited by 3Multiple Sclerosis Research StudiesPharmacovigilance and Adverse Drug ReactionsInflammatory Bowel Disease

The Patient and Clinician Assessment of Gastrointestinal (GI) Related Adverse Events Associated with Oral Disease-Modifying Therapies in Multiple Sclerosis: A Qualitative Study

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Jivraj, Farah, Kang, Sha, Reedie, Scott, Kapadia, Shivani, Strzok, Sara, Elliott, Emma, Cano, Stefan, Rock, Marvin·2022·Advances in Therapy
DOI 10.1007/s12325-022-02250-xPMC PMC9438375
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Abstract

Current guidelines for relapsing-remitting multiple sclerosis (RRMS) call for treatment with disease-modifying therapies (DMTs) early in the disease to prevent relapses and accumulation of neurologic impairment and disability. However, patients taking certain oral DMTs may experience gastrointestinal (GI)-related adverse events (AEs), particularly at dose titration. We conducted qualitative research with healthcare professionals (HCPs) and patients in Canada to contextualize their experiences with three oral DMTs: dimethyl fumarate (Tecfidera ® ), fingolimod (Gilenya ® ), and teriflunomide (Aubagio ® ). The objectives of this study were to (1) gather qualitative data to better understand the patient and HCP experience of GI AEs in oral MS DMT treatment in Canada and (2) determine to what extent two patient-reported outcome (PRO) instruments used in recent oral DMT trials capture what is important to patients regarding GI AEs in oral MS DMT treatment (content validity) and to provide qualitative data to help interpret PRO scores. This was a qualitative, non-interventional, descriptive, cross-sectional study comprising HCP and patient interviews conducted in English and French, using a 1:1 semi-structured interview approach. Patients reported 16 unique GI AE concepts related to oral DMTs. The most commonly reported symptoms were diarrhea, indigestion, and nausea. While patients acknowledged the negative impact associated with GI-related AEs, most characterized the treatment experience as positive, focusing on preference for oral administration, perceived efficacy of DMTs in terms of lack of MS relapses, slowed progression of their disease, and improvement in MS symptoms. Results supported the content validity (relevance, comprehension, and comprehensiveness) of the two PROs assessed. HCP feedback reinforced patient perspectives on both GI concepts and the two PRO instruments. Outcomes of these research activities include experiential data on the symptom and impact experience of oral DMTs in MS from both patients and HCPs that contribute to the process of determining therapeutic value.

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  1. [1]Conradsson D Changes in disability in people with multiple sclerosis: a 10-year prospective study J Neurol 2018 265 1 119 126 10.1007/s00415-017-8676-8 29159465 PMC5760611 · DOI
  2. [2]Filippi M Multiple sclerosis Nat Rev Dis Primers 2018 4 1 43 10.1038/s41572-018-0041-4 30410033 · DOI · Paper page
  3. [3]Rae-Grant A Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology Neurology 2018 90 17 777 788 10.1212/WNL.0000000000005347 29686116 · DOI
  4. [4]Montalban X ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis Mult Scler J 2018 24 2 96 120 10.1177/1352458517751049 29353550 · DOI
  5. [5]Freedman MS Treatment optimization in multiple sclerosis Can J Neurol Sci 2004 31 2 157 168 10.1017/S0317167100053804 15198439 · DOI
  6. [6]Metz LM Clinically isolated syndrome and early relapsing multiple sclerosis Continuum 2019 25 3 670 688 31162311
  7. [7]Amato MP Disease-modifying drugs can reduce disability progression in relapsing multiple sclerosis Brain 2020 143 10 3013 3024 10.1093/brain/awaa251 32935843 · DOI
  8. [8]Claflin SB Broadley S Taylor BV The effect of disease modifying therapies on disability progression in multiple sclerosis: a systematic overview of meta-analyses Front Neurol 2019 9 1150 10.3389/fneur.2018.01150 30687214 PMC6335290 · DOI
  9. [9]Tsivgoulis G The effect of disease modifying therapies on disease progression in patients with relapsing-remitting multiple sclerosis: a systematic review and meta-analysis PLoS ONE 2015 10 12 e0144538 10.1371/journal.pone.0144538 26642051 PMC4671570 · DOI
  10. [10]Cohan SL Clinical outcomes in patients with relapsing-remitting multiple sclerosis who switch from natalizumab to delayed-release dimethyl fumarate: A multicenter retrospective observational study (STRATEGY) Mult Scler Relat Disord 2018 22 27 34 10.1016/j.msard.2018.02.028 29524759 · DOI
  11. [11]Kresa-Reahl K Effectiveness of delayed-release dimethyl fumarate on clinical and patient-reported outcomes in patients with relapsing multiple sclerosis switching from glatiramer acetate: RESPOND, a Prospective Observational Study Clin Ther 2018 40 12 2077 2087 10.1016/j.clinthera.2018.10.011 30470580 · DOI
  12. [12]Zadeh AR Mechanism and adverse effects of multiple sclerosis drugs: a review article. Part 2 Int J Physiol Pathophysiol Pharmacol 2019 11 4 105 31523358 PMC6737425
  13. [13]Wundes A Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study Ther Adv Neurol Disord 2021 14 1756286421993999 10.1177/1756286421993999 33796143 PMC7985943 · DOI
  14. [15]Naismith RT Diroximel fumarate demonstrates an improved gastrointestinal tolerability profile compared with dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: results from the randomized, double-blind, phase III EVOLVE-MS-2 study CNS Drugs 2020 34 2 185 196 10.1007/s40263-020-00700-0 31953790 PMC7018784 · DOI
  15. [22]Harris PA Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support J Biomed Inf 2009 42 2 377 381 10.1016/j.jbi.2008.08.010 PMC2700030 18929686 · DOI · Paper page
  16. [24]Bowling A Research methods in health: investigating health and health services 2009 3 Maidenhead Open University Press
  17. [25]Bryman A Burgess B Analyzing qualitative data 2002 New York Routledge
  18. [26]Thomas DR A general inductive approach for analyzing qualitative evaluation data Am J Eval 2006 27 2 237 246 10.1177/1098214005283748 · DOI · Paper page
  19. [29]Meyrick J What is good qualitative research? A first step towards a comprehensive approach to judging rigour/quality J Health Psychol 2006 11 5 799 808 10.1177/1359105306066643 16908474 · DOI · Paper page
  20. [30]Hohol MJ Orav EJ Weiner HL Disease steps in multiple sclerosis: a simple approach to evaluate disease progression Neurology 1995 45 2 251 255 10.1212/WNL.45.2.251 7854521 · DOI
  21. [33]Nicholas JA Real-world adherence to, and persistence with, once-and twice-daily oral disease-modifying drugs in patients with multiple sclerosis: a systematic review and meta-analysis BMC Neurol 2020 20 1 1 15 10.1186/s12883-020-01830-0 32664928 PMC7371467 · DOI
  22. [34]Sippel A Patients experiences with multiple sclerosis disease-modifying therapies in daily life - a qualitative interview study BMC Health Serv Res 2021 21 1 1141 10.1186/s12913-021-07012-z 34686166 PMC8539738 · DOI
  23. [35]Manzano A Patient perspective on decisions to switch disease-modifying treatments in relapsing-remitting multiple sclerosis Mult Scler Relat Disord 2020 46 102507 10.1016/j.msard.2020.102507 32979733 · DOI
  24. [36]Lee Mortensen G Rasmussen PV The impact of quality of life on treatment preferences in multiple sclerosis patients Patient Prefer Adherence 2011 11 1789 1796 10.2147/PPA.S142373 PMC5656344 29089746 · DOI
  25. [37]Lynd LD Quantitative analysis of multiple sclerosis patients' preferences for drug treatment: a best-worst scaling study Ther Adv Neurol Disord 2016 9 4 287 296 10.1177/1756285616648060 27366235 PMC4916526 · DOI
  26. [38]Van Reenen E Fear, fight, familiarize: the experiences of people living with relapsing-remitting multiple sclerosis and taking oral medication Int J Qual Stud Health Well-Being 2019 14 1 1648946 10.1080/17482631.2019.1648946 31390951 PMC6713094 · DOI
  27. [39]Kremer IEH Comparison of preferences of healthcare professionals and MS patients for attributes of disease-modifying drugs: a best-worst scaling Health Expect 2018 21 1 171 180 10.1111/hex.12599 28734004 PMC5750752 · DOI
  28. [40]Jonker MF Summarizing patient preferences for the competitive landscape of multiple sclerosis treatment options Med Decis Making 2020 40 2 198 211 10.1177/0272989X19897944 32065023 · DOI
  29. [41]Bansback N Development and usability testing of a patient decision aid for newly diagnosed relapsing multiple sclerosis patients BMC Neurol 2019 19 1 173 10.1186/s12883-019-1382-7 31325961 PMC6642472 · DOI

Cited by

Sorted by citations

Authors
Jivraj, F., Kang, S., Reedie, S., Kapadia, S., Strzok, S., Elliott, E., Cano, S., & Rock, M.
Affiliations
Biogen (United States) (US)
Corresponding author
Kang, Sha
ORCID
Venue
Advances in Therapy
Publisher
Springer Science and Business Media LLC
Published
2022-09-02
Volume
39
Issue
11
Pages
5072-5086
ISSN
  • 0741-238X (ISSN-L)
  • 1865-8652
DOI
10.1007/s12325-022-02250-x
PMC
PMC9438375
OpenAlex
W4294238099
Cited by
3
References
2
Citations by year
2024: 1 · 2023: 2
FWCI
0.51
Type
journal article
Language
en
Open access
Licence
Locations
  • Advances in Therapy (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Research Explorer (The University of Manchester) (publishedVersion, other-oa)
Funders
Biogen
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
Keywords
relapsing-remitting multiple sclerosis, oral disease-modifying therapy, gastrointestinal adverse effects, dimethyl fumarate, fingolimod, teriflunomide, patient experience, clinician experience, patient-reported outcome measures, content validity, diarrhea, nausea, dose titration, treatment acceptability
MeSH terms
Fingolimod Hydrochloride, Dimethyl Fumarate, Cross-Sectional Studies, Crotonates, Humans, Hydroxybutyrates, Immunosuppressive Agents, Multiple Sclerosis, Nitriles, Recurrence, Toluidines, Multiple Sclerosis, Relapsing-Remitting, Qualitative Research

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