Worawit Louthrenoo1, Surasak Nilganuwong2, Ratanavadee Nanagara3, Boonjing Siripaitoon4, Sabine Collaud Basset5. 1. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand. worawit.louthrenoo@cmu.ac.th. 2. Division of Rheumatology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. 3. Division of Allergy Immunology and Rheumatology, Department of Medicine, Faculty of Medicine, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand. 4. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand. 5. TRB Chemedica International SA, Geneva, Switzerland.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of diacerein in patients with rheumatoid arthritis (RA) who are methotrexate inadequate responders (MTX-IR). METHOD: In this pilot, multicenter, double-blind, placebo-controlled trial, MTX-IR RA patients were randomized to either diacerein or matching placebo as add-on treatment to MTX for 24 weeks. Efficacy and safety were evaluated every 4 weeks until week 28. Primary and secondary efficacy endpoints were the percentage of patients achieving the ACR20 criteria and a moderate EULAR response at week 24, respectively. RESULTS: Forty patients were equally randomized to both study treatments; 16 and 19 participants completed the study in the diacerein and the placebo arms, respectively. Baseline characteristics were similar in both groups, except that tender joint count, DAS28-ESR score, and non-steroidal anti-inflammatory drug consumption were higher in the placebo arm. The ACR20 response at week 24 was similar in the diacerein and placebo groups (65% vs 45%, P = .20). However, treatment response according to the EULAR criteria was better in patients taking diacerein (75% vs 25% of moderate response, P = .002). In the 35 patients with assessments through week 28, diacerein was superior to placebo in ACR20 at weeks 24 and 28 (both 81% vs 47%, P = .04). Incidence of adverse events was comparable in both arms, with only chromaturia being more common with diacerein than placebo (40% vs 10%, P = .03). CONCLUSIONS: These preliminary results show the potential benefits of diacerein on pain, joint function, and disease activity in MTX-IR RA patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01264211 Key Points • Diacerein has shown positive effects on rheumatoid arthritis symptoms. • A good safety profile of diacerein has been observed when it was administered as add-on therapy to methotrexate in patients with rheumatoid arthritis.
OBJECTIVE: To evaluate the efficacy and safety of diacerein in patients with rheumatoid arthritis (RA) who are methotrexate inadequate responders (MTX-IR). METHOD: In this pilot, multicenter, double-blind, placebo-controlled trial, MTX-IR RA patients were randomized to either diacerein or matching placebo as add-on treatment to MTX for 24 weeks. Efficacy and safety were evaluated every 4 weeks until week 28. Primary and secondary efficacy endpoints were the percentage of patients achieving the ACR20 criteria and a moderate EULAR response at week 24, respectively. RESULTS: Forty patients were equally randomized to both study treatments; 16 and 19 participants completed the study in the diacerein and the placebo arms, respectively. Baseline characteristics were similar in both groups, except that tender joint count, DAS28-ESR score, and non-steroidal anti-inflammatory drug consumption were higher in the placebo arm. The ACR20 response at week 24 was similar in the diacerein and placebo groups (65% vs 45%, P = .20). However, treatment response according to the EULAR criteria was better in patients taking diacerein (75% vs 25% of moderate response, P = .002). In the 35 patients with assessments through week 28, diacerein was superior to placebo in ACR20 at weeks 24 and 28 (both 81% vs 47%, P = .04). Incidence of adverse events was comparable in both arms, with only chromaturia being more common with diacerein than placebo (40% vs 10%, P = .03). CONCLUSIONS: These preliminary results show the potential benefits of diacerein on pain, joint function, and disease activity in MTX-IR RA patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01264211 Key Points • Diacerein has shown positive effects on rheumatoid arthritis symptoms. • A good safety profile of diacerein has been observed when it was administered as add-on therapy to methotrexate in patients with rheumatoid arthritis.
Authors: F Tubach; P Ravaud; E Martin-Mola; H Awada; N Bellamy; C Bombardier; D T Felson; N Hajjaj-Hassouni; M Hochberg; I Logeart; M Matucci-Cerinic; M van de Laar; D van der Heijde; M Dougados Journal: Arthritis Care Res (Hoboken) Date: 2012-11 Impact factor: 4.794
Authors: M A Alvarez-Soria; G Herrero-Beaumont; O Sánchez-Pernaute; M Bellido; R Largo Journal: Rheumatology (Oxford) Date: 2008-03-27 Impact factor: 7.580
Authors: W Louthrenoo; S Nilganuwong; S Aksaranugraha; P Asavatanabodee; S Saengnipanthkul Journal: Osteoarthritis Cartilage Date: 2007-04-19 Impact factor: 6.576
Authors: Shahinaze A Fouad; Fady A Malaak; Mohamed A El-Nabarawi; Khalid Abu Zeid; Amira M Ghoneim Journal: PLoS One Date: 2021-01-20 Impact factor: 3.240