Sajan Shrestha1,2, Jing Zhao2, Changqing Yang3, Jinping Zhang4. 1. Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, 210008, Jiangsu, China. 2. School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, 639 Longmian Avenue, Jiangning, Nanjing, 211198, China. 3. School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, 639 Longmian Avenue, Jiangning, Nanjing, 211198, China. ycq0315@yahoo.com. 4. Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, 210008, Jiangsu, China. zjp16500@163.com.
Abstract
OBJECTIVES: This study aims to compare the efficacy and the safety of the iguratimod with placebo and other disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis. METHODS: Two authors independently searched and selected randomized controlled trials from Cochrane library, Medline (through Pubmed), and Chinese databases, and then assessed the risk of bias (using ROB 2 tool), and graded the certainty of evidence (using the GRADEpro GDT software). We applied the RevMan 5 software for performing meta-analyses of the final consensus data. RESULTS: We identified 12 trials involving 1938 participants. Ten trials had an overall high risk of bias. Although iguratimod had superior efficacy than placebo, the incidence of adverse events was also higher. Inferring to non-inferiority analysis with other DMARD therapy (primarily comprising methotrexate), iguratimod is likely to result in similar treatment response (20% (OR 1.04, 95% CI 0.79 to 1.36), 50% and 70% improvement in American College of Rheumatology criteria) and functional ability at 24 weeks. Although the disease state was slightly better with iguratimod (MD - 0.55, 95% CI - 0.85 to - 0.25), a clinically important improvement was not achieved. Iguratimod may have lower C-reactive protein and erythrocyte sedimentation rate values. Swollen joint count, tender joint count, pain intensity, and patient's and physician's global assessment of disease state may be comparable between the therapies. Both the therapies are likely to have similar odds (OR 0.91, 95% CI 0.67 to 1.26) of adverse events. CONCLUSION: Our evidence suggests that iguratimod may be considered a potential alternative to methotrexate to treat rheumatoid arthritis.Key Points• The Asia Pacific League of Association for Rheumatology (APLAR) has recommended that iguratimod may be used a first-line drug for rheumatoid arthritis in specific cases.• Patients on iguratimod may have similar treatment response, functional ability, disease state, and adverse event profile at 24 weeks compared with those on methotrexate.• Iguratimod may be considered a better alternative to methotrexate in RA patients having high CRP and ESR values.• Future clinical trials in diverse population comparing the efficacy and safety of iguratimod in monotherapy or combination therapy with DMARDs (other than methotrexate) are warranted.
OBJECTIVES: This study aims to compare the efficacy and the safety of the iguratimod with placebo and other disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis. METHODS: Two authors independently searched and selected randomized controlled trials from Cochrane library, Medline (through Pubmed), and Chinese databases, and then assessed the risk of bias (using ROB 2 tool), and graded the certainty of evidence (using the GRADEpro GDT software). We applied the RevMan 5 software for performing meta-analyses of the final consensus data. RESULTS: We identified 12 trials involving 1938 participants. Ten trials had an overall high risk of bias. Although iguratimod had superior efficacy than placebo, the incidence of adverse events was also higher. Inferring to non-inferiority analysis with other DMARD therapy (primarily comprising methotrexate), iguratimod is likely to result in similar treatment response (20% (OR 1.04, 95% CI 0.79 to 1.36), 50% and 70% improvement in American College of Rheumatology criteria) and functional ability at 24 weeks. Although the disease state was slightly better with iguratimod (MD - 0.55, 95% CI - 0.85 to - 0.25), a clinically important improvement was not achieved. Iguratimod may have lower C-reactive protein and erythrocyte sedimentation rate values. Swollen joint count, tender joint count, pain intensity, and patient's and physician's global assessment of disease state may be comparable between the therapies. Both the therapies are likely to have similar odds (OR 0.91, 95% CI 0.67 to 1.26) of adverse events. CONCLUSION: Our evidence suggests that iguratimod may be considered a potential alternative to methotrexate to treat rheumatoid arthritis.Key Points• The Asia Pacific League of Association for Rheumatology (APLAR) has recommended that iguratimod may be used a first-line drug for rheumatoid arthritis in specific cases.• Patients on iguratimod may have similar treatment response, functional ability, disease state, and adverse event profile at 24 weeks compared with those on methotrexate.• Iguratimod may be considered a better alternative to methotrexate in RApatients having high CRP and ESR values.• Future clinical trials in diverse population comparing the efficacy and safety of iguratimod in monotherapy or combination therapy with DMARDs (other than methotrexate) are warranted.
Authors: M Kohno; Y Aikawa; Y Tsubouchi; A Hashiramoto; R Yamada; Y Kawahito; K Inoue; Y Kusaka; M Kondo; H Sano Journal: J Rheumatol Date: 2001-12 Impact factor: 4.666
Authors: Josef S Smolen; Daniel Aletaha; Anne Barton; Gerd R Burmester; Paul Emery; Gary S Firestein; Arthur Kavanaugh; Iain B McInnes; Daniel H Solomon; Vibeke Strand; Kazuhiko Yamamoto Journal: Nat Rev Dis Primers Date: 2018-02-08 Impact factor: 52.329