Contributions
Abstract: P1616
Type: LB Poster
Abstract Category: Late Breaking News
Introduction: One of the most relevant clinical hallmarks that affects patients with progressive MS is the progression of disability. IB-MS is a labdane dipertene isolated from a medicinal plant that has been proposed effective in the treatment of autoimmune diseases. In support of this, recently, we reported in a placebo controlled study, that a standardized extract of the medicinal plant was able to reduce significantly fatigue in patients with RRMS with interferon after 12 months treatment.
Methods: In order to assess the clinical efficacy of IB-MS in progressive MS, we designed a controlled, randomized, double-blinded human clinical trial, using IB-MS 140 mg orally administered twice per day. The principle outcome of the study is to determine efficacy, safety and tolerability of IB-MS in retarding the progression of brain atrophy at 24 months. Secondary end-points included: delay in disability progression through the Expanded Disability Status Scale (EDSS) at 3, 6, 9, 12 and 24 months compared to the baseline. Additionally, safety and tolerability of treatment, through the record of adverse effects were measured. This study was approved by Ethical Committee from Ministry of Health Chile and registered at clinicaltrials.gov. NCT02273635.
Results: We included 46 patients, 54% secondary and 46% primary progressive, mean age 56.2 years, 61.5% women, mean disease duration 15.5 years, median EDSS 6.0. After one year of treatment an interim statistical analysis was performed. At 12 months of treatment, IB-MS reduced significantly the EDSS score (median EDSS reduction from 6.0 to 5.0), as compared to the placebo group (median EDSS increase from 6.0 to 6.5, p< 0.01). In general, IB-MS treatment was well tolerated by the patients, except for mild adverse events reported consistent of mild skin rash and dysgeusia.
Conclusions: We conclude that IB-MS is a potential new drug for the progressive form of multiple sclerosis. Completion of the two years of treatment and analysis of brain atrophy and other disability measures is still pending.
Disclosure: Funding: INNOVA CORFO 14PIE-26946, INNOBIOSCIENCE SpA. Claudia Carcamo: nothing to disclose; Ethel Ciampi: nothing to disclose; Rafael A. Burgos: nothing to disclose; Juan L. Hancke is consultant of InnoBioscience SpA
Abstract: P1616
Type: LB Poster
Abstract Category: Late Breaking News
Introduction: One of the most relevant clinical hallmarks that affects patients with progressive MS is the progression of disability. IB-MS is a labdane dipertene isolated from a medicinal plant that has been proposed effective in the treatment of autoimmune diseases. In support of this, recently, we reported in a placebo controlled study, that a standardized extract of the medicinal plant was able to reduce significantly fatigue in patients with RRMS with interferon after 12 months treatment.
Methods: In order to assess the clinical efficacy of IB-MS in progressive MS, we designed a controlled, randomized, double-blinded human clinical trial, using IB-MS 140 mg orally administered twice per day. The principle outcome of the study is to determine efficacy, safety and tolerability of IB-MS in retarding the progression of brain atrophy at 24 months. Secondary end-points included: delay in disability progression through the Expanded Disability Status Scale (EDSS) at 3, 6, 9, 12 and 24 months compared to the baseline. Additionally, safety and tolerability of treatment, through the record of adverse effects were measured. This study was approved by Ethical Committee from Ministry of Health Chile and registered at clinicaltrials.gov. NCT02273635.
Results: We included 46 patients, 54% secondary and 46% primary progressive, mean age 56.2 years, 61.5% women, mean disease duration 15.5 years, median EDSS 6.0. After one year of treatment an interim statistical analysis was performed. At 12 months of treatment, IB-MS reduced significantly the EDSS score (median EDSS reduction from 6.0 to 5.0), as compared to the placebo group (median EDSS increase from 6.0 to 6.5, p< 0.01). In general, IB-MS treatment was well tolerated by the patients, except for mild adverse events reported consistent of mild skin rash and dysgeusia.
Conclusions: We conclude that IB-MS is a potential new drug for the progressive form of multiple sclerosis. Completion of the two years of treatment and analysis of brain atrophy and other disability measures is still pending.
Disclosure: Funding: INNOVA CORFO 14PIE-26946, INNOBIOSCIENCE SpA. Claudia Carcamo: nothing to disclose; Ethel Ciampi: nothing to disclose; Rafael A. Burgos: nothing to disclose; Juan L. Hancke is consultant of InnoBioscience SpA