Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate.
Adult
Aged
Antirheumatic Agents
/ administration & dosage
Arthritis, Rheumatoid
/ drug therapy
Azetidines
/ administration & dosage
Disability Evaluation
Disease Progression
Double-Blind Method
Drug Substitution
/ methods
Drug Therapy, Combination
Female
Humans
Male
Methotrexate
/ administration & dosage
Middle Aged
Purines
Pyrazoles
Severity of Illness Index
Sulfonamides
/ administration & dosage
Treatment Outcome
Journal
Arthritis care & research
ISSN: 2151-4658
Titre abrégé: Arthritis Care Res (Hoboken)
Pays: United States
ID NLM: 101518086
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
07
11
2018
accepted:
11
06
2019
pubmed:
25
6
2019
medline:
7
10
2020
entrez:
25
6
2019
Statut:
ppublish
Résumé
To evaluate the long-term efficacy and safety of maintaining baricitinib monotherapy in patients with active rheumatoid arthritis (RA) originally treated with baricitinib monotherapy or switched from methotrexate (MTX) or the combination of baricitinib plus MTX to baricitinib monotherapy. This is a post hoc analysis of patients from the RA-BEGIN study who entered a long-term extension, RA-BEYOND, and were assessed for up to 24 weeks. In RA-BEGIN, MTX-naive patients with early active RA were randomized to MTX monotherapy, baricitinib 4 mg monotherapy, or baricitinib 4 mg plus MTX. At week 52, all patients entering RA-BEYOND received baricitinib 4 mg monotherapy. MTX could be prescribed during RA-BEYOND at the investigator's discretion. Patients in RA-BEYOND who were not rescued in RA-BEGIN (n = 423) were evaluated. Of these, 47% continued baricitinib monotherapy and 53% added MTX, with similar proportions from the 3 original arms. Patients with lower disease activity at the RA-BEYOND baseline generally continued to do well with baricitinib monotherapy as assessed by the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the Health Assessment Questionnaire disability index scores. Patients prescribed MTX had higher disease activity at the RA-BEYOND baseline and had improved disease activity after the addition of MTX. Safety outcomes were similar across treatment groups. Many patients responded well to continued baricitinib monotherapy or to switching to baricitinib monotherapy from MTX monotherapy or baricitinib plus MTX, showing sustained or improved disease control. The groups of patients who had less disease control on their original therapies showed sustained or improved disease control with the addition of MTX to baricitinib.
Substances chimiques
Antirheumatic Agents
0
Azetidines
0
Purines
0
Pyrazoles
0
Sulfonamides
0
baricitinib
ISP4442I3Y
Methotrexate
YL5FZ2Y5U1
Banques de données
ClinicalTrials.gov
['NCT01711359', 'NCT01885078']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1112-1121Informations de copyright
© 2019, American College of Rheumatology.
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