Stéphanie Ferrero1, Ruth Wittoek2, Edem Allado3, Coralie Cruzel4, Eric Fontas4, Veronique Breuil5, Liana Ziegler5, Joel Kremer6, Damien Loeuille7, Christian H Roux8. 1. Department of Rheumatology, Pasteur Hospital, Nice University Hospital, Cote d'Azur University, Nice F-06000, France. Electronic address: ferrero.s@chu-nice.fr. 2. Department of Rheumatology, Faculty of Medicine and Health Sciences, Ghent University, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. 3. Center of Sports Medicine and Adapted Physical Activity, University, Hospital of Nancy, Nancy F-54000, France. 4. Department of Clinical Research, Cimiez Hospital, Nice University Hospital, Nice F-06000, France. 5. Department of Rheumatology, Pasteur Hospital, Nice University Hospital, Cote d'Azur University, Nice F-06000, France. 6. Department of Rheumatology, Albany Medical Center, Albany, NY, USA. 7. Department of Rheumatology, University Hospital of Nancy, Nancy F-54000, France. 8. Department of Rheumatology, Pasteur Hospital, Nice University Hospital, Cote d'Azur University, Nice F-06000, France; Department of Rheumatology, University of Cote d'Azur, Nice Hospital, Laboratory LAMHESS, EA6312, IBV CNRS IMR 7277 INSERM U1091 UNS, France.
Abstract
OBJECTIVE: To examine the effect of methotrexate (MTX) on pain and structural progression in symptomatic erosive hand osteoarthritis (HOA). METHODS: This 1-year prospective, single-centre, randomised, double-blind, placebo-controlled study (www.ClinicalTrial.gov, NCT01068405) followed up patients with symptomatic erosive HOA. Patients were randomised into two groups based on the drug that was administered: 10 mg methotrexate (MTX) per week or a placebo. The primary endpoint was the change in pain (determined using a visual analogue scale [VAS]) from baseline to 3 months. The secondary endpoints were pain VAS score at 12 months, clinical features (pain VAS score and function), radiographic features (the anatomical radiographic Verbruggen-Veys [VV] score and Gent University Score System), and magnetic resonance imaging (MRI) at 12 months. RESULTS: Sixty-four patients with HOA were randomised into either the placebo or MTX group. At 3 months, there was no significant difference in the mean decrease in the pain VAS score (mm) (MTX: 21.1 [standard deviation, 27.4], placebo: 11.7 [24.3]; p = 0.2). At 12 months, according to the VV score, erosive joints progressed significantly more to a remodelling phase in the MTX group than in the placebo group (27% vs 15%; p = 0.03). Joints with space loss appeared to be eroding less in the MTX group compared to the placebo group (8% vs 29%; p = 0.2). Synovitis on MRI at baseline could be associated with the erosive structural evolution of non-erosive joints (p = 0.02). CONCLUSIONS: Weekly doses of 10-mg MTX showed no superiority over the placebo in terms of pain relief at 3 or 12 months. CLINICAL TRIAL REGISTRATION NUMBER: This study was registered at www.ClinicalTrial.gov (NCT01068405).
OBJECTIVE: To examine the effect of methotrexate (MTX) on pain and structural progression in symptomatic erosive hand osteoarthritis (HOA). METHODS: This 1-year prospective, single-centre, randomised, double-blind, placebo-controlled study (www.ClinicalTrial.gov, NCT01068405) followed up patients with symptomatic erosive HOA. Patients were randomised into two groups based on the drug that was administered: 10 mg methotrexate (MTX) per week or a placebo. The primary endpoint was the change in pain (determined using a visual analogue scale [VAS]) from baseline to 3 months. The secondary endpoints were pain VAS score at 12 months, clinical features (pain VAS score and function), radiographic features (the anatomical radiographic Verbruggen-Veys [VV] score and Gent University Score System), and magnetic resonance imaging (MRI) at 12 months. RESULTS: Sixty-four patients with HOA were randomised into either the placebo or MTX group. At 3 months, there was no significant difference in the mean decrease in the pain VAS score (mm) (MTX: 21.1 [standard deviation, 27.4], placebo: 11.7 [24.3]; p = 0.2). At 12 months, according to the VV score, erosive joints progressed significantly more to a remodelling phase in the MTX group than in the placebo group (27% vs 15%; p = 0.03). Joints with space loss appeared to be eroding less in the MTX group compared to the placebo group (8% vs 29%; p = 0.2). Synovitis on MRI at baseline could be associated with the erosive structural evolution of non-erosive joints (p = 0.02). CONCLUSIONS: Weekly doses of 10-mg MTX showed no superiority over the placebo in terms of pain relief at 3 or 12 months. CLINICAL TRIAL REGISTRATION NUMBER: This study was registered at www.ClinicalTrial.gov (NCT01068405).
Authors: Nicholas Fuggle; Nathalie Bere; Olivier Bruyère; Mario Manuel Rosa; María Concepción Prieto Yerro; Elaine Dennison; Fitnat Dincer; Cem Gabay; Ida K Haugen; Gabriel Herrero-Beaumont; Mickaël Hiligsmann; Marc C Hochberg; Andrea Laslop; Radmila Matijevic; Emmanuel Maheu; Alberto Migliore; Jean-Pierre Pelletier; Régis Pierre Radermecker; François Rannou; Brigitte Uebelhart; Daniel Uebelhart; Nicola Veronese; Mila Vlaskovska; René Rizzoli; Ali Mobasheri; Cyrus Cooper; Jean-Yves Reginster Journal: Aging Clin Exp Res Date: 2022-07-21 Impact factor: 4.481