Colchicine twice a day for hand osteoarthritis (COLOR): a double-blind, randomised, placebo-controlled trial.
Journal
The Lancet. Rheumatology
ISSN: 2665-9913
Titre abrégé: Lancet Rheumatol
Pays: England
ID NLM: 101765308
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
received:
21
12
2022
revised:
21
02
2023
accepted:
21
02
2023
medline:
22
1
2024
pubmed:
22
1
2024
entrez:
22
1
2024
Statut:
ppublish
Résumé
Colchicine has been suggested for osteoarthritis treatment, but evidence is contradictory. We aimed to investigate colchicine's efficacy and safety compared with placebo in people with hand osteoarthritis. In this single-centre, double-blind, randomised, placebo-controlled trial we recruited adults with symptomatic hand osteoarthritis and finger pain of at least 40 mm on a 100 mm visual analogue scale from an outpatient clinic in Denmark. The hand with the most severe finger pain at inclusion was the target hand. Participants were randomly assigned (1:1) to 0·5 mg colchicine or placebo taken orally twice a day for 12 weeks, stratified by BMI (≥30 kg/m Between Jan 15, 2021, and March 3, 2022, 186 people were screened for eligibility, and 100 were randomly assigned to receive colchicine (n=50) or placebo (n=50). Participants had a mean age of 70·9 (SD 7·5) years, 69 (69%) of 100 were women and 31 (31%) were men. All participants completed the study. The mean change from baseline to week 12 in finger pain were -13·9 mm (SE 2·8) in the colchicine group and -13·5 mm (2·8) in the placebo group, with a between-group difference (colchicine vs placebo) of -0·4 mm (95% CI -7·6 to 6·7; p=0·90). In the colchicine group, there were 76 adverse events in 36 (72%) of 50 participants and one serious adverse advent (migraine attack leading to hospital admission). In the placebo group, there were 42 adverse events in 22 (44%) of 50 participants and two serious adverse events (cholecystitis and elevated alanine aminotransferase concentrations, in the same patient). In people with painful hand osteoarthritis, treatment with 0·5 mg of colchicine twice day for 12 weeks did not effectively relieve pain, and treatment with colchicine was associated with more adverse events. The Oak Foundation, IMK Almene Fond, Minister Erna Hamilton's Scholarship for Science and Art, AP Moller and Wife Chastine McKinney Moller's Foundation for Medical Science Advancement, The Danish Medical Association, the Velux Foundation, Aase and Ejnar Danielsen's Foundation, and Director Emil C Hertz and Wife Inger Hertz's foundation.
Sections du résumé
BACKGROUND
BACKGROUND
Colchicine has been suggested for osteoarthritis treatment, but evidence is contradictory. We aimed to investigate colchicine's efficacy and safety compared with placebo in people with hand osteoarthritis.
METHODS
METHODS
In this single-centre, double-blind, randomised, placebo-controlled trial we recruited adults with symptomatic hand osteoarthritis and finger pain of at least 40 mm on a 100 mm visual analogue scale from an outpatient clinic in Denmark. The hand with the most severe finger pain at inclusion was the target hand. Participants were randomly assigned (1:1) to 0·5 mg colchicine or placebo taken orally twice a day for 12 weeks, stratified by BMI (≥30 kg/m
FINDINGS
RESULTS
Between Jan 15, 2021, and March 3, 2022, 186 people were screened for eligibility, and 100 were randomly assigned to receive colchicine (n=50) or placebo (n=50). Participants had a mean age of 70·9 (SD 7·5) years, 69 (69%) of 100 were women and 31 (31%) were men. All participants completed the study. The mean change from baseline to week 12 in finger pain were -13·9 mm (SE 2·8) in the colchicine group and -13·5 mm (2·8) in the placebo group, with a between-group difference (colchicine vs placebo) of -0·4 mm (95% CI -7·6 to 6·7; p=0·90). In the colchicine group, there were 76 adverse events in 36 (72%) of 50 participants and one serious adverse advent (migraine attack leading to hospital admission). In the placebo group, there were 42 adverse events in 22 (44%) of 50 participants and two serious adverse events (cholecystitis and elevated alanine aminotransferase concentrations, in the same patient).
INTERPRETATION
CONCLUSIONS
In people with painful hand osteoarthritis, treatment with 0·5 mg of colchicine twice day for 12 weeks did not effectively relieve pain, and treatment with colchicine was associated with more adverse events.
FUNDING
BACKGROUND
The Oak Foundation, IMK Almene Fond, Minister Erna Hamilton's Scholarship for Science and Art, AP Moller and Wife Chastine McKinney Moller's Foundation for Medical Science Advancement, The Danish Medical Association, the Velux Foundation, Aase and Ejnar Danielsen's Foundation, and Director Emil C Hertz and Wife Inger Hertz's foundation.
Identifiants
pubmed: 38251589
pii: S2665-9913(23)00065-6
doi: 10.1016/S2665-9913(23)00065-6
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04601883']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e254-e262Informations de copyright
Copyright © 2023 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests The Parker Institute is supported by a core grant from the Oak Foundation (OCAY-18–774-OFIL). AD has received grants to this project from IMK Almene Fond, Erna Hamilton's Foundation (Minister Erna Hamilton's Scholarship for Science and Art), the AP Møller Foundation (AP Møller and wife Chastine McKinney Møller's Foundation for Medical Science Advancement), The Danish Medical Association, the Velux Foundation, Aase and Ejnar Danielsen's Foundation and Director Emil C Hertz and wife Inger Hertz's foundation. FB has received consulting fees from Horizon Therapeutics. FCM has received grants from Innovation Fund Denmark; and payment or honoraria from Varian and Siemens Healthineers. IKH has received grants from Pfizer and Lily; and payment or honoraria from Novartis and GSK. LT has received payment or honoraria from Eli Lilly, Novartis, and Janssen; and is on the advisory board for Bristol Meyers Squibb and Janssen. MH is on the European Advisory Board for Thuasne Group. MK has received grants from the Innovative Medicines Initiative (APPROACH project) and Dutch Arthritis Society; royalties or licenses from Wolters Kluwer and Springer Verlag; consulting fees for Abbvie, Pfizer, Kiniksa, Flexion, Galapagos, Centre for Human Drug Research, Novartis, and UCB; payment or honoraria from Galapagos and Jansen; and is a member of the Osteoarthritis Research Society International board, a member of the European Alliance of Associations for Rheumatology (EULAR) council and President for the Dutch Society for Rheumatology. PGC has received consulting fees from AbbVie, AstraZeneca, Eli Lilly, Galapagos, GlaxoSmithKline, Grunenthal, Janssen, Levicept, Merck, Novartis, Pfizer, Regeneron, Stryker, and UCB; payment or honoraria from AbbVie; and support from AbbVie to congress attendance. LKS has received grants from the Health Reserach Council of New Zealand amd consulting fees from Pharmac. GMM has received support for attending meeting from Janssen; and is president for the Irish Society of Rheumatology. All other authors declare no competing interests.