PMID- 35158459
OWN - NLM
STAT- MEDLINE
DCOM- 20220216
LR  - 20220216
IS  - 2211-0356 (Electronic)
IS  - 2211-0348 (Linking)
VI  - 57
DP  - 2022 Jan
TI  - Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple 
      sclerosis in the real-world setting: Interim results from the Plegridy 
      Observational Program.
PG  - 103350
LID - S2211-0348(21)00617-9 [pii]
LID - 10.1016/j.msard.2021.103350 [doi]
AB  - BACKGROUND: The Plegridy Observational Program (POP) is an ongoing, 5-year, phase 
      4 real-world study of the safety and effectiveness of subcutaneous peginterferon 
      beta-1a in patients with relapsing multiple sclerosis (RMS). METHODS: This 
      interim analysis from POP assessed the safety and effectiveness of peginterferon 
      beta-1a, including subgroup analyses of patients aged < 50 and >/= 50 years, newly 
      diagnosed and non-newly diagnosed patients, and new and experienced peginterferon 
      beta-1a users. RESULTS: A total of 1208 patients enrolled in POP. Mean (standard 
      deviation) peginterferon treatment duration in the overall population was 757.0 
      (529.5) days. The overall incidence of treatment-emergent adverse events (AEs) 
      was 65.5%, and the incidence was higher in new than experienced peginterferon 
      beta-1a users (78.1 vs 52.4%). The overall incidence of treatment-emergent 
      serious AEs was 7.6%, and the incidence was lower in younger than older patients 
      (5.8 vs 11.1%). No new or unexpected safety signals were reported. Overall 
      treatment discontinuation due to AEs occurred in 20.7% of patients, with a higher 
      proportion of new than experienced peginterferon beta-1a users (27.0 vs 14.2%) 
      discontinuing treatment due to AEs. Flu-like symptoms and injection site 
      reactions were significant predictors of time to treatment discontinuation. The 
      adjusted annualized relapse rate (ARR) was 0.12 (95% confidence interval 
      0.11-0.13) in the overall population and was similar across all subgroups. In the 
      overall population at 4 years, 79.1% of patients were relapse free, the estimated 
      cumulative proportion of patients with confirmed disability worsening was 1.8%, 
      and > 67% of patients achieved clinical no evidence of disease activity (NEDA). 
      CONCLUSIONS: Safety data of patients enrolled in POP are consistent with the 
      established clinical safety profile of peginterferon beta-1a. In addition, the 
      low ARR and high proportion of patients achieving clinical NEDA at 4 years across 
      all subgroups indicates the effectiveness of peginterferon beta-1a in treating 
      RMS in real-world clinical settings.
CI  - Copyright (c) 2021. Published by Elsevier B.V.
FAU - Salvetti, Marco
AU  - Salvetti M
AD  - Sapienza University, S. Andrea Hospital, Rome, Italy; IRCCS Neuromed, Pozzilli, 
      Italy.
FAU - Wray, Sibyl
AU  - Wray S
AD  - Hope Neurology MS Center, Knoxville, TN, United States.
FAU - Nelles, Gereon
AU  - Nelles G
AD  - NeuroMed Campus Hohenlind, Cologne, Germany.
FAU - Altincatal, Arman
AU  - Altincatal A
AD  - Biogen, Cambridge, MA, United States, at the time of this analysis.
FAU - Kumar, Achint
AU  - Kumar A
AD  - Biogen, 225 Binney Street, Cambridge, MA 02142, United States.
FAU - Koster, Thijs
AU  - Koster T
AD  - Biogen, 225 Binney Street, Cambridge, MA 02142, United States. Electronic 
      address: thijs.koster@biogen.com.
FAU - Naylor, Maria L
AU  - Naylor ML
AD  - Biogen, Cambridge, MA, United States, at the time of this analysis.
CN  - Plegridy Observational Program investigators
LA  - eng
PT  - Journal Article
DEP - 20211029
PL  - Netherlands
TA  - Mult Scler Relat Disord
JT  - Multiple sclerosis and related disorders
JID - 101580247
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 77238-31-4 (Interferon-beta)
RN  - I8309403R0 (peginterferon beta-1a)
RN  - XRO4566Q4R (Interferon beta-1a)
SB  - IM
MH  - Humans
MH  - Interferon beta-1a
MH  - Interferon-beta
MH  - Middle Aged
MH  - *Multiple Sclerosis
MH  - *Multiple Sclerosis, Relapsing-Remitting/drug therapy/epidemiology
MH  - Polyethylene Glycols
MH  - Recurrence
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Effectiveness
OT  - Multiple sclerosis
OT  - Peginterferon beta-1a
OT  - Real-world data
OT  - Safety
EDAT- 2022/02/16 06:00
MHDA- 2022/02/17 06:00
CRDT- 2022/02/15 01:01
PHST- 2021/07/07 00:00 [received]
PHST- 2021/10/15 00:00 [revised]
PHST- 2021/10/24 00:00 [accepted]
PHST- 2022/02/15 01:01 [entrez]
PHST- 2022/02/16 06:00 [pubmed]
PHST- 2022/02/17 06:00 [medline]
AID - S2211-0348(21)00617-9 [pii]
AID - 10.1016/j.msard.2021.103350 [doi]
PST - ppublish
SO  - Mult Scler Relat Disord. 2022 Jan;57:103350. doi: 10.1016/j.msard.2021.103350. 
      Epub 2021 Oct 29.