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Posted: Tue Oct 28, 2008 8:38 am Post subject: Poster presentation 22
I found this on the ECTRIMS website:
An open-label study of high dose cyclophosphamide for moderate to severe refractory multiple sclerosis
D. Callegaro1; S. L. Apóstolos-Pereira1; M. Scaff1; P. E. Marchiori1
1. Clinics Hospital, São Paulo, Brazil.
Treatment-refractory clinically active multiple sclerosis (MS) can quickly lead to irreversible neurological disability. High dose cyclophosphamide (CTX) could benefit the most severely affected patients, resistant to traditional treatment. This effect appears to be durable. In Brazil, the monoclonal antibodies were not approved and treating patients with devastating MS can be a frustrating challenge to the clinician.
To evaluate the therapeutic response to High Doses Immunosupression (HDI): CTX and Methylprednisolone (MP) for Moderate Severe refractory MS patients.
Assessment prospectively, consecutive patients fulfilled the inclusion criteria: diagnosis of relapsing–remitting MS (RRMS) (McDonald criteria), Expanded Disability Score Status (EDSS) >3.5, new severe or >2 relapses within the previous year, despite use of standard therapies, active lesions measured by gadolinium enhancement (Gd+) on Magnetic Resonance Imaging (MRI). Patients received HDI: MP 1g/day for 8 days plus CTX 50–200mg/Kd/day for 4 days. The exclusion criteria were: active infection, contraindication for use of MP or CF. The response was measured by EDSS and free time of relapse (FTR).
Eleven patients: 10 female, aged 18–51 years, 6 months to 7 years after MS diagnosis. The median EDSS pre-treatment was 6.5 (4.0–8.0). MRI discloses active Gd+ lesions and three showed pseudo tumor hemispheric lesions (Marburg Variant). All patients received complete schedule treatment. Moderate clinical improvement occurred in seven, discrete in three and no improvement in one. The median EDSS final was 3.5 (1.5–6.5). The most common complications: leukopenia (10), infection (4), alopecia (6). Nine patients reach a clear stabilization in 6–36 months follow-up, and median FTR reach was 12.
HDI (MP and CTX) was beneficial and safe for all patients in this series. HDI showed a clear stabilization in refractory patients, who had a more aggressive course from the onset. High dose CTX has not been described in South America.
Posted: Tue Oct 28, 2008 8:39 am Post subject: Poster Presentation 522
...and this one:
Immunoablation with high-dose cyclophosphamide for refractory multiple sclerosis
S. Tilwalli1; R. Balabanov1; D. Stefoski1; G. Katsamakis1; M. Ko1; J. Shammo1; S. Gregory1
1. Neurology, Rush University Medical Center, Chicago, IL, USA.
High-dose cyclophosphamide (HD-CTX) has demonstrated efficacy in arresting multiple sclerosis (MS) and other autoimmune diseases. The aldehyde dehydrogenase mediated resistance of CD34+ cells to CTX allows for immune reconstitution without hematopoietic stem cell rescue.
To assess safety and efficacy of HD-CTX for patients with refractory MS, defined as having failed standard therapies.
We evaluated patients with recurring relapses, worsening disabilities, and increasing magnetic resonance imaging (MRI) lesions over 12 months for immunoablation with HD-CTX (200 mg/kg over 4 days), followed by filgrastim for reconstitution. Clinical, laboratory and MRI monitoring was scheduled at 3-6 month intervals over 24 months.
Six patients were treated since 2005 without lasting complications and monitored over 24 to 36 months. All adverse events resolved using standard therapies within 2 weeks of HD-CTX, and included neutropenic fevers (5 patients), diarrhea (3), hematuria (2), acute dystonia from prochlorperazine (1), urinary tract infection (1), fungal rash (1), and anemia and thrombocytopenia (4). Full hematologic recoveries occurred within 4 weeks of HD-CTX. All 6 patients demonstrated clinical and MRI evidence of improvement with effects ranging from stabilization to dramatic attenuations of disabilities, up to 4.5 Expanded Disability Status Scale points in 5 patients, and 1 to 14 SDs on Multiple Sclerosis Functional Composite in 3 patients. After 20 months of stability 2 patients had a milder than pre-HD-CTX relapse; one by MRI only, and the other clinically and by MRI. The latter patient received intravenous corticosteroids.
Immunoablation with HD-CTX in our patients with intractable MS had realistic safety and tolerability, and resulted in significant improvements ranging from amelioration to stabilization of the disease course, and reduction of disabilities.
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