Published in:
01-10-2019 | Disease Modifying Anti-Rheumatic Drug | Original Article
International multicenter randomized, placebo-controlled phase III clinical trial of β-d-mannuronic acid in rheumatoid arthritis patients
Authors:
Zahra Rezaieyazdi, Abid Farooqi, Hossein Soleymani-Salehabadi, Arman Ahmadzadeh, Mona Aslani, Saiedeh Omidian, Arezoo Sadoughi, Zohreh Vahidi, Mandana Khodashahi, Shazia Zamurrad, Seyed Shahabeddin Mortazavi-Jahromi, Hossein Fallahzadeh, Mostafa Hosseini, Zahra Aghazadeh, Parvin Ekhtiari, Hidenori Matsuo, Bernd H. A. Rehm, Salvatore Cuzzocrea, Antimo D’Aniello, Abbas Mirshafiey
Published in:
Inflammopharmacology
|
Issue 5/2019
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Abstract
Background
The oral administration of drug β-d-mannuronic acid (M2000) showed a potent therapeutic effect in phase I/II study in rheumatoid arthritis (RA) patients. Here, our aim is to assess the efficacy and safety of this new drug in RA patients under a multinational, randomized placebo-controlled phase III clinical trial.
Method
Patients (n = 288) with active disease at baseline and inadequate response to conventional drugs were randomly allocated to three groups; (1) receiving mannuronic acid at a dose of two capsules (500 mg) per day orally for 12 weeks, (2) placebo-controlled, and (3) conventional. The primary endpoints were the America College of Rheumatology 20 response (ACR20), 28-joint disease activity score (DAS28) and Modified Health Assessment Questionnaire-Disability Index (M-HAQ-DI). In addition, the participants were followed-up for safety assessment.
Results
In this phase III trial, after 12 weeks of treatment, there was a significant reduction in ACR20 between mannuronic-treated patients compared to placebo and conventional groups. Moreover, there was a similar significant improvement for DAS28 following mannuronic therapy. The statistical analysis showed a significant reduction in the swollen and tender joint count in mannuronic-treated patients compared with the placebo group. On the other side, mannuronic acid showed no-to-very low adverse events in comparison to placebo.
Conclusion
The results of this multinational, phase III clinical trial provided a potent evidence base for the use of β-d-mannuronic acid as a new highly safe and efficient drug in the treatment of RA.