PMID- 36459119
OWN - NLM
STAT- MEDLINE
DCOM- 20221223
LR  - 20230927
IS  - 1536-7355 (Electronic)
IS  - 1076-1608 (Print)
IS  - 1076-1608 (Linking)
VI  - 29
IP  - 1
DP  - 2023 Jan 1
TI  - Effects of Disease-Worsening Following Withdrawal of Etanercept or Methotrexate 
      on Patient-Reported Outcomes in Patients With Rheumatoid Arthritis: Results From 
      the SEAM-RA Trial.
PG  - 16-22
LID - 10.1097/RHU.0000000000001893 [doi]
AB  - BACKGROUND/OBJECTIVE: The effect of treatment withdrawal on patient-reported 
      outcomes (PROs) in patients with rheumatoid arthritis (RA) whose disease is in 
      sustained remission has not been well described. This analysis aimed to compare 
      PRO changes in patients with RA following medication withdrawal and disease 
      worsening. METHODS: SEAM-RA (Study of Etanercept and Methotrexate in Combination 
      or as Monotherapy in Subjects With Rheumatoid Arthritis) was a phase 3, 
      multicenter, randomized withdrawal, double-blind controlled study in patients 
      with RA taking methotrexate plus etanercept and in remission (Simple Disease 
      Activity Index </=3.3). Patient's Global Assessment of Disease Activity, Patient's 
      Assessment of Joint Pain, Health Assessment Questionnaire-Disability Index, and 
      36-Item Short-Form Health Survey were evaluated for 48 weeks following 
      methotrexate or etanercept withdrawal. Treatment differences for patients with 
      versus without disease worsening were evaluated using a 2-sample t test for 
      continuous end points and log-rank test for time-to-event end points. RESULTS: Of 
      253 patients, 121 experienced disease worsening and 132 did not. All PRO scores 
      were similar to those of a general population at baseline and deteriorated over 
      time across the study population. The PtGA and Patient's Assessment of Joint Pain 
      values deteriorated less in those on etanercept monotherapy compared with 
      methotrexate monotherapy. More patients with versus without disease worsening 
      experienced deterioration that was greater than the minimal clinically important 
      difference (MCID) for all PROs tested. In patients with disease worsening, PtGA 
      deterioration more than the MCID preceded Simple Disease Activity Index disease 
      worsening. CONCLUSIONS: Etanercept monotherapy showed benefit over methotrexate 
      in maintaining PRO scores. Patients with disease worsening experienced a more 
      rapid worsening of PtGA beyond the MCID versus patients without disease 
      worsening.Categories: autoinflammatory disease, biological therapy, DMARDs, 
      rheumatoid arthritis.
CI  - Copyright (c) 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Curtis, Jeffrey R
AU  - Curtis JR
AD  - From the Division of Clinical Immunology and Rheumatology, University of Alabama 
      at Birmingham, Birmingham, AL.
FAU - Stolshek, Bradley
AU  - Stolshek B
AD  - Amgen Inc., Thousand Oaks, CA.
FAU - Emery, Paul
AU  - Emery P
AD  - Leeds Institute of Rheumatic and Musculoskeletal Medicine, NIHR Leeds Biomedical 
      Research Centre, Leeds Teaching Hospitals NHS Trust, University of Leeds, Leeds, 
      United Kingdom.
FAU - Haraoui, Boulos
AU  - Haraoui B
AD  - Centre Hospitalier de I'Universite de Montreal, Montreal, Quebec, Canada.
FAU - Karis, Elaine
AU  - Karis E
AD  - Amgen Inc., Thousand Oaks, CA.
FAU - Kricorian, Greg
AU  - Kricorian G
AD  - Amgen Inc., Thousand Oaks, CA.
FAU - Collier, David H
AU  - Collier DH
AD  - Amgen Inc., Thousand Oaks, CA.
FAU - Yen, Priscilla K
AU  - Yen PK
AD  - Amgen Inc., Thousand Oaks, CA.
FAU - Bykerk, Vivian P
AU  - Bykerk VP
AD  - Hospital for Special Surgery, New York, NY.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20221022
PL  - United States
TA  - J Clin Rheumatol
JT  - Journal of clinical rheumatology : practical reports on rheumatic & 
      musculoskeletal diseases
JID - 9518034
RN  - YL5FZ2Y5U1 (Methotrexate)
RN  - OP401G7OJC (Etanercept)
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Humans
MH  - Methotrexate/adverse effects
MH  - Etanercept/adverse effects
MH  - Treatment Outcome
MH  - Drug Therapy, Combination
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - *Antirheumatic Agents/adverse effects
MH  - Patient Reported Outcome Measures
MH  - Arthralgia/drug therapy
MH  - Double-Blind Method
PMC - PMC9803379
EDAT- 2022/12/03 06:00
MHDA- 2022/12/24 06:00
PMCR- 2022/12/30
CRDT- 2022/12/02 11:13
PHST- 2022/12/03 06:00 [pubmed]
PHST- 2022/12/24 06:00 [medline]
PHST- 2022/12/02 11:13 [entrez]
PHST- 2022/12/30 00:00 [pmc-release]
AID - 00124743-202301000-00003 [pii]
AID - JCR_220189 [pii]
AID - 10.1097/RHU.0000000000001893 [doi]
PST - ppublish
SO  - J Clin Rheumatol. 2023 Jan 1;29(1):16-22. doi: 10.1097/RHU.0000000000001893. Epub 
      2022 Oct 22.