The Patient and Clinician Assessment of Gastrointestinal (GI) Related Adverse Events Associated with Oral Disease-Modifying Therapies in Multiple Sclerosis: A Qualitative Study.
Cross-Sectional Studies
Crotonates
Dimethyl Fumarate
/ adverse effects
Fingolimod Hydrochloride
/ adverse effects
Humans
Hydroxybutyrates
Immunosuppressive Agents
/ adverse effects
Multiple Sclerosis
/ drug therapy
Multiple Sclerosis, Relapsing-Remitting
/ drug therapy
Nitriles
Qualitative Research
Recurrence
Toluidines
Dimethyl fumarate
Diroximel fumarate
Disease-modifying therapy
Gastrointestinal tolerability
Multiple sclerosis
Patient preference
Patient-reported outcome (PRO)
Tolerability
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
received:
08
04
2022
accepted:
29
06
2022
pubmed:
3
9
2022
medline:
5
10
2022
entrez:
2
9
2022
Statut:
ppublish
Résumé
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 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.
Identifiants
pubmed: 36053450
doi: 10.1007/s12325-022-02250-x
pii: 10.1007/s12325-022-02250-x
pmc: PMC9438375
doi:
Substances chimiques
Crotonates
0
Hydroxybutyrates
0
Immunosuppressive Agents
0
Nitriles
0
Toluidines
0
teriflunomide
1C058IKG3B
Dimethyl Fumarate
FO2303MNI2
Fingolimod Hydrochloride
G926EC510T
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
5072-5086Informations de copyright
© 2022. The Author(s).
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