PMID- 38090266
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231213
IS  - 1664-2295 (Print)
IS  - 1664-2295 (Electronic)
IS  - 1664-2295 (Linking)
VI  - 14
DP  - 2023
TI  - Adherence to subcutaneous interferon beta-1a treatment among patients with 
      relapsing multiple sclerosis: the MAIN-MS study.
PG  - 1257455
LID - 10.3389/fneur.2023.1257455 [doi]
LID - 1257455
AB  - INTRODUCTION AND BACKGROUND: Adherence is a critical factor for optimal clinical 
      outcomes in multiple sclerosis (MS) treatment. This study investigated the 
      adherence and clinical outcomes of MS patients treated with subcutaneous (sc) 
      interferon (IFN) (beta)-1a, an established immunomodulatory treatment for relapsing 
      MS. The benefits of a patient support programme (PSP) were also studied. METHODS: 
      This phase-IV prospective, observational multicentre study enrolled patients with 
      relapsing MS who were treated with sc IFN beta-1a for 24 months was conducted at 53 
      centres across 17 countries. The primary endpoint was adherence to sc IFN beta-1a 
      treatment, as assessed using Morisky Green Levine Medication Adherence Scale 
      (MGLS) scores at 24 months. The MGLS is a self-reported diagnostic tool to 
      address medication non-adherence, with a score ranging from 0 to 4, with 0 
      representing high adherence, 1-2 representing medium adherence, and 3-4 
      representing low adherence. Other endpoints included time to study and treatment 
      discontinuation over 24 months, the proportion of relapse-free patients, and 
      Expanded Disability Status Scale (EDSS) progression (defined as >/=1.0 point 
      increase sustained for 3 months) at 24 months. A subgroup analysis was performed 
      for endpoints based on patients assigned to PSP (yes/no-PSP versus non-PSP 
      subgroup). RESULTS: Of the 577 patients enrolled, 408 had evaluable MGLS scores 
      at 24 months. A total of 336 (58.2%; 95% confidence interval [CI]: 54.1-62.3%) 
      patients reported high adherence, 57 (9.9%; 95% CIs: 7.6-12.7%) reported medium 
      adherence, and 15 (2.6%; 95% CI: 1.5-4.3%) reported low adherence at 24 months. 
      The PSP subgroup reported higher adherence (n = 206; 65.8%) than the non-PSP 
      subgroup (n = 130; 56.5%). By 24 months, 52.2% of the patients were relapse-free 
      and 17.2% patients experienced >/=1 relapse. Expanded Disability Status Scale 
      progression was observed in 12.3% of patients. Over the 24-month period, 30.8% of 
      the patients discontinued treatment, and the most common reasons for treatment 
      discontinuation were adverse events (AEs, 10.4%), being lost to followup (7.1%), 
      and a lack of efficacy (5.5%). Overall, 39.6% patients experienced >/=1 AE, which 
      ranged from mild to moderate. CONCLUSION: The study demonstrated high adherence 
      to sc IFN beta-1a treatment with an added benefit of PSP participation. More than 
      half of the patients remained relapse-free over a 24-month period. No new safety 
      concerns to sc IFN beta-1a treatment were observed. CLINICAL TRIAL REGISTRATION: 
      https://clinicaltrials.gov/study/NCT02921035, NCT02921035.
CI  - Copyright (c) 2023 Al-Roughani, Zakaria, Cupler and Taha.
FAU - Al-Roughani, Raed
AU  - Al-Roughani R
AD  - Division of Neurology, Amiri Hospital, Sharq, Kuwait.
FAU - Zakaria, Magd
AU  - Zakaria M
AD  - Department of Neurology, Ain Shams University, Cairo, Egypt.
FAU - Cupler, Edward J
AU  - Cupler EJ
AD  - Division of Neurology, Department of Neurosciences, King Faisal Specialist 
      Hospital and Research Centre, Riyadh, Saudi Arabia.
FAU - Taha, Karim
AU  - Taha K
AD  - Neurology and Immunology Medical Affairs, EMEA Region, Merck Serono Middle East 
      FZ-Ltd., Dubai, United Arab Emirates.
LA  - eng
SI  - ClinicalTrials.gov/NCT02921035
PT  - Journal Article
DEP - 20231128
PL  - Switzerland
TA  - Front Neurol
JT  - Frontiers in neurology
JID - 101546899
PMC - PMC10713779
OTO - NOTNLM
OT  - Rebif
OT  - adherence
OT  - patient support programme
OT  - relapsing multiple sclerosis
OT  - subcutaneous interferon beta-1a
COIS- RA-R reports receiving personal compensation for serving on speaker/advisory 
      boards for Bayer, Biogen, Merck, Novartis, Roche, and Sanofi, and receiving 
      research support from Biogen, Merck, Novartis, and Roche for the establishment of 
      regional multiple sclerosis registries and the conduct of clinical trials. MZ has 
      received fees for advisory boards and lectures from Merck, Biogen, Roche, Sanofi, 
      Bayer and Novartis. EC has received speaker honoraria from Novartis, Biogen, 
      Sanofi, and Merck and travel support from Novartis, Biogen, Sanofi, and Merck. KT 
      is an employee of Merck Serono Middle East FZ-Ltd., Dubai, UAE, an affiliate of 
      Merck KGaA.
EDAT- 2023/12/13 18:42
MHDA- 2023/12/13 18:43
PMCR- 2023/11/28
CRDT- 2023/12/13 13:06
PHST- 2023/07/12 00:00 [received]
PHST- 2023/10/17 00:00 [accepted]
PHST- 2023/12/13 18:43 [medline]
PHST- 2023/12/13 18:42 [pubmed]
PHST- 2023/12/13 13:06 [entrez]
PHST- 2023/11/28 00:00 [pmc-release]
AID - 10.3389/fneur.2023.1257455 [doi]
PST - epublish
SO  - Front Neurol. 2023 Nov 28;14:1257455. doi: 10.3389/fneur.2023.1257455. 
      eCollection 2023.