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Good results got phase 2 rheumatoid arthritis treatment.From announcement:Analyses were performed for the whole study population and for the pre-specified exploratory subgroups based on whether the subjects had previously received 1-2 biologic agents or more than 2 biologic agents.Key findings:• Infusions were well-tolerated and there were no treatment-related serious adverse events reported during the 52-week period, with the safety profile over 52 weeks comparable among the placebo and two MPC treatment groups.• A single intravenous MPC infusion in biologic refractory RA patients resulted in dose-related improvements in clinical symptoms, function, disease activity and patient-reported outcomes. Efficacy signals were observed for each of ACR 20/50/70, ACR-N, HAQ-DI, SF-36 and DAS-28 disease activity score.• The 2 million MPC/kg dose showed the greatest overall treatment responses. Onset of treatment responses occurred as early as 4 weeks, peaked at 12 weeks, were maintained through 39 weeks, and waned by 52 weeks.• Greatest benefits over 52 weeks were seen in patients who had failed less than 3 biologics (1-2 biologic sub-group) prior to MPC treatment, identifying this as a potentially optimal target population.• The following statistically significant outcomes were observed over the 52-week study period:
Good results got phase 2 rheumatoid arthritis treatment.
From announcement:
Analyses were performed for the whole study population and for the pre-specified exploratory subgroups based on whether the subjects had previously received 1-2 biologic agents or more than 2 biologic agents.
Key findings:
• Infusions were well-tolerated and there were no treatment-related serious adverse events reported during the 52-week period, with the safety profile over 52 weeks comparable among the placebo and two MPC treatment groups.
• A single intravenous MPC infusion in biologic refractory RA patients resulted in dose-related improvements in clinical symptoms, function, disease activity and patient-reported outcomes. Efficacy signals were observed for each of ACR 20/50/70, ACR-N, HAQ-DI, SF-36 and DAS-28 disease activity score.
• The 2 million MPC/kg dose showed the greatest overall treatment responses. Onset of treatment responses occurred as early as 4 weeks, peaked at 12 weeks, were maintained through 39 weeks, and waned by 52 weeks.
• Greatest benefits over 52 weeks were seen in patients who had failed less than 3 biologics (1-
2 biologic sub-group) prior to MPC treatment, identifying this as a potentially optimal target population.
• The following statistically significant outcomes were observed over the 52-week study period:
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