PMID- 36053450
OWN - NLM
STAT- MEDLINE
DCOM- 20221004
LR  - 20230622
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 39
IP  - 11
DP  - 2022 Nov
TI  - The Patient and Clinician Assessment of Gastrointestinal (GI) Related Adverse 
      Events Associated with Oral Disease-Modifying Therapies in Multiple Sclerosis: A 
      Qualitative Study.
PG  - 5072-5086
LID - 10.1007/s12325-022-02250-x [doi]
AB  - INTRODUCTION: 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((R))), fingolimod (Gilenya((R))), and teriflunomide 
      (Aubagio((R))). 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. METHODS: 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. RESULTS: 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. 
      CONCLUSION: 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.
CI  - (c) 2022. The Author(s).
FAU - Jivraj, Farah
AU  - Jivraj F
AD  - Biogen, 3250 Bloor St West, Suite #1200, Toronto, ON, Canada.
FAU - Kang, Sha
AU  - Kang S
AD  - Biogen, 3250 Bloor St West, Suite #1200, Toronto, ON, Canada. 
      sha.kang@biogen.com.
FAU - Reedie, Scott
AU  - Reedie S
AD  - Biogen, 3250 Bloor St West, Suite #1200, Toronto, ON, Canada.
FAU - Kapadia, Shivani
AU  - Kapadia S
AD  - Biogen, Cambridge, MA, USA.
FAU - Strzok, Sara
AU  - Strzok S
AD  - Modus Outcomes, a Division of THREAD, Cambridge, MA, USA.
FAU - Elliott, Emma
AU  - Elliott E
AD  - Modus Outcomes, a Division of THREAD, Cambridge, MA, USA.
FAU - Cano, Stefan
AU  - Cano S
AD  - Modus Outcomes, a Division of THREAD, Cambridge, MA, USA.
FAU - Rock, Marvin
AU  - Rock M
AD  - Biogen, Cambridge, MA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220902
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Crotonates)
RN  - 0 (Hydroxybutyrates)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Nitriles)
RN  - 0 (Toluidines)
RN  - 1C058IKG3B (teriflunomide)
RN  - FO2303MNI2 (Dimethyl Fumarate)
RN  - G926EC510T (Fingolimod Hydrochloride)
MH  - Cross-Sectional Studies
MH  - Crotonates
MH  - Dimethyl Fumarate/adverse effects
MH  - Fingolimod Hydrochloride/adverse effects
MH  - Humans
MH  - Hydroxybutyrates
MH  - Immunosuppressive Agents/adverse effects
MH  - *Multiple Sclerosis/drug therapy
MH  - *Multiple Sclerosis, Relapsing-Remitting/drug therapy
MH  - Nitriles
MH  - Qualitative Research
MH  - Recurrence
MH  - Toluidines
PMC - PMC9438375
OTO - NOTNLM
OT  - Dimethyl fumarate
OT  - Diroximel fumarate
OT  - Disease-modifying therapy
OT  - Gastrointestinal tolerability
OT  - Multiple sclerosis
OT  - Patient preference
OT  - Patient-reported outcome (PRO)
OT  - Tolerability
EDAT- 2022/09/03 06:00
MHDA- 2022/10/05 06:00
PMCR- 2022/09/02
CRDT- 2022/09/02 11:20
PHST- 2022/04/08 00:00 [received]
PHST- 2022/06/29 00:00 [accepted]
PHST- 2022/09/03 06:00 [pubmed]
PHST- 2022/10/05 06:00 [medline]
PHST- 2022/09/02 11:20 [entrez]
PHST- 2022/09/02 00:00 [pmc-release]
AID - 10.1007/s12325-022-02250-x [pii]
AID - 2250 [pii]
AID - 10.1007/s12325-022-02250-x [doi]
PST - ppublish
SO  - Adv Ther. 2022 Nov;39(11):5072-5086. doi: 10.1007/s12325-022-02250-x. Epub 2022 
      Sep 2.