Pain Reduction With Oral Methotrexate in Knee Osteoarthritis : A Randomized, Placebo-Controlled Clinical Trial.


Journal

Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351

Informations de publication

Date de publication:
30 Jul 2024
Historique:
medline: 29 7 2024
pubmed: 29 7 2024
entrez: 29 7 2024
Statut: aheadofprint

Résumé

Treatments for osteoarthritis (OA) are limited. Previous small studies suggest that the antirheumatic drug methotrexate may be a potential treatment for OA pain. To assess symptomatic benefits of methotrexate in knee OA (KOA). A multicenter, randomized, double-blind, placebo-controlled trial done between 13 June 2014 and 13 October 2017. (ISRCTN77854383; EudraCT: 2013-001689-41). 15 secondary care musculoskeletal clinics in the United Kingdom. A total of 207 participants with symptomatic, radiographic KOA and knee pain (severity ≥4 out of 10) on most days in the past 3 months with inadequate response to current medication were approached for inclusion. Participants were randomly assigned 1:1 to oral methotrexate once weekly (6-week escalation 10 to 25 mg) or matched placebo over 12 months and continued usual analgesia. The primary end point was average knee pain (numerical rating scale [NRS] 0 to 10) at 6 months, with 12-month follow-up to assess longer-term response. Secondary end points included knee stiffness and function outcomes and adverse events (AEs). A total of 155 participants (64% women; mean age, 60.9 years; 50% Kellgren-Lawrence grade 3 to 4) were randomly assigned to methotrexate ( Not permitting oral methotrexate to be changed to subcutaneous delivery for intolerance. Oral methotrexate added to usual medications demonstrated statistically significant reduction in KOA pain, stiffness, and function at 6 months. Versus Arthritis.

Sections du résumé

BACKGROUND UNASSIGNED
Treatments for osteoarthritis (OA) are limited. Previous small studies suggest that the antirheumatic drug methotrexate may be a potential treatment for OA pain.
OBJECTIVE UNASSIGNED
To assess symptomatic benefits of methotrexate in knee OA (KOA).
DESIGN UNASSIGNED
A multicenter, randomized, double-blind, placebo-controlled trial done between 13 June 2014 and 13 October 2017. (ISRCTN77854383; EudraCT: 2013-001689-41).
SETTING UNASSIGNED
15 secondary care musculoskeletal clinics in the United Kingdom.
PARTICIPANTS UNASSIGNED
A total of 207 participants with symptomatic, radiographic KOA and knee pain (severity ≥4 out of 10) on most days in the past 3 months with inadequate response to current medication were approached for inclusion.
INTERVENTION UNASSIGNED
Participants were randomly assigned 1:1 to oral methotrexate once weekly (6-week escalation 10 to 25 mg) or matched placebo over 12 months and continued usual analgesia.
MEASUREMENTS UNASSIGNED
The primary end point was average knee pain (numerical rating scale [NRS] 0 to 10) at 6 months, with 12-month follow-up to assess longer-term response. Secondary end points included knee stiffness and function outcomes and adverse events (AEs).
RESULTS UNASSIGNED
A total of 155 participants (64% women; mean age, 60.9 years; 50% Kellgren-Lawrence grade 3 to 4) were randomly assigned to methotrexate (
LIMITATION UNASSIGNED
Not permitting oral methotrexate to be changed to subcutaneous delivery for intolerance.
CONCLUSION UNASSIGNED
Oral methotrexate added to usual medications demonstrated statistically significant reduction in KOA pain, stiffness, and function at 6 months.
PRIMARY FUNDING SOURCE UNASSIGNED
Versus Arthritis.

Identifiants

pubmed: 39074374
doi: 10.7326/M24-0303
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Auteurs

Sarah R Kingsbury (SR)

Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre, Leeds, United Kingdom (S.R.K., P.G.C.).

Puvan Tharmanathan (P)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Ada Keding (A)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Fiona E Watt (FE)

Centre for Inflammatory Disease, Department of Immunology and Inflammation, Hammersmith Campus, Imperial College London, and Centre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and Department of Rheumatology, Oxford University Hospitals NHS Foundation Trust, and Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, Oxford, United Kingdom (F.E.W.).

David L Scott (DL)

King's College London, London, United Kingdom (D.L.S.).

Edward Roddy (E)

Primary Care Centre Versus Arthritis, Keele University, and Haywood Academic Rheumatology Centre, Midlands Partnership University NHS Foundation Trust, Keele, United Kingdom (E.R.).

Fraser Birrell (F)

Medical Research Council-Versus Arthritis Centre for Integrated Research into Musculoskeletal Ageing, Newcastle University, and Northumbria Healthcare NHS Foundation Trust, Newcastle upon Tyne, United Kingdom (F.B.).

Nigel K Arden (NK)

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, and Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, University of Oxford, Oxford, United Kingdom (N.K.A.).

Mike Bowes (M)

Imorphics, Manchester, United Kingdom (M.B.).

Catherine Arundel (C)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Michelle Watson (M)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Sarah J Ronaldson (SJ)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Catherine Hewitt (C)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Michael Doherty (M)

Academic Rheumatology and Pain Centre Versus Arthritis, University of Nottingham, Nottingham, United Kingdom (M.D.).

Robert J Moots (RJ)

Faculty of Heath Social Care and Medicine, Edge Hill University, Ormskirk, and Department of Rheumatology, Aintree University Hospital, Liverpool, United Kingdom (R.J.M.).

Terence W O'Neill (TW)

Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom (T.W.O.).

Michael Green (M)

Harrogate and District NHS Foundation Trust, Harrogate, and York Teaching Hospital NHS Foundation Trust, York, United Kingdom (M.G.).

Gulam Patel (G)

Rheumatology Department, Ashford and St. Peter's Hospital NHS Trust, Chertsey, United Kingdom (G.P.).

Toby Garrood (T)

Department of Rheumatology, Guy's and St. Thomas' NHS Trust, London, United Kingdom (T.G.).

Christopher J Edwards (CJ)

NIHR Southampton Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom (C.J.E.).

Phil J Walmsley (PJ)

Department of Orthopaedics, Victoria Hospital Kirkcaldy and School of Medicine, St. Andrews University, Fife and Fife NHS Trust, Kirkcaldy, United Kingdom (P.J.W.).

Tom Sheeran (T)

Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, United Kingdom (T.S.).

David J Torgerson (DJ)

York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, Heslington, York, United Kingdom (P.T., A.K., C.A., M.W., S.J.R., C.H., D.J.T.).

Philip G Conaghan (PG)

Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre, Leeds, United Kingdom (S.R.K., P.G.C.).

Classifications MeSH