Pregnancy and natalizumab: results of an observational study in 35 accidental pregnancies during natalizumab treatment

2011 ◽  
Vol 17 (8) ◽  
pp. 958-963 ◽  
Author(s):  
Kerstin Hellwig ◽  
Aiden Haghikia ◽  
Ralf Gold
Keyword(s):  
Post Partum ◽  
Termination Of Pregnancy ◽  
Control Group ◽  
Healthy Children ◽  
Relapsing Remitting ◽  
Planned Pregnancy ◽  
Natalizumab Treatment ◽  
Elective Termination ◽  
Relapsing Remitting Multiple Sclerosis

Background: Natalizumab, a therapeutic monoclonal antibody approved for the treatment of relapsing–remitting multiple sclerosis (RRMS), is recommended to be withdrawn 3 months prior to a planned pregnancy. Our aim was to analyse the safety and impact of natalizumab exposure on course of disease and pregnancy outcome. Objectives: Prospective follow-up of women with MS who became accidentally pregnant during natalizumab treatment in comparison with pregnancies of women with MS not exposed to disease-modifying treatments (DMT). Method: 35 women with MS who became accidentally pregnant while treated with natalizumab, and 23 women with MS who became pregnant devoid of any DMT as a control group, were chosen. Results: All pregnancies except one were followed in a prospective fashion. Of the women exposed to natalizumab during pregnancy, 29 women gave birth to 28 healthy children; one child was born with hexadactyly. Five pregnancies ended in an early miscarriage and one woman decided to undergo an elective termination of pregnancy. MS activity did not rebound during pregnancy or post partum after natalizumab was withdrawn, and no significant differences were observed when compared with the non-DMT-exposed control group. Conclusion: Our data may support the notion that an elective termination of pregnancy due to natalizumab exposure may not be necessary, but rather requires careful monitoring. Women should still be advised to stop natalizumab in the course of planned pregnancy until more data on long-term outcomes are available.

REDUCED MS RELAPSE RATES WITH NATALIZUMAB: TOP UK COHORT

2015 ◽  
Vol 86 (11) ◽  
pp. e4.5-e4
Author(s):  
Richard Nicholas ◽  
Roger Berry
Keyword(s):  
Steroid Treatment ◽  
Long Term Outcomes ◽  
Open Label ◽  
Prior Therapy ◽  
Relapsing Remitting ◽  
Natalizumab Treatment ◽  
Previously Treated ◽  
The Uk ◽  
Relapsing Remitting Multiple Sclerosis

IntroductionThe Tysabri® Observational Program (TOP) is a 10-year, ongoing, global, open-label study of long-term outcomes in natalizumab-treated patients with relapsing-remitting multiple sclerosis.MethodsBaseline characteristics were summarised. On-treatment annualised relapse rate (ARR) was compared with baseline.ResultsAs of 1 May 2014, the UK cohort included 134 patients. Median disease duration was 5.3 years and 84 patients (62.7%) had prior treatment with ≥1 other therapy. ARR decreased from 2.21 at baseline to 0.29 (86.9% reduction; p<0.0001); on-treatment ARR was low with ≥6 months of treatment (0.29; 87.2% reduction; p<0.0001; n=120) and remained low after ≥3.5 years (0.33; 85.7% reduction; p<0.0001; n=20). In patients previously treated with interferon or glatiramer acetate, ARR decreased by 83.5%–87.7% (p≤0.0009). Relapses resulting in hospitalisation or steroid treatment decreased by 93.3% (p<0.0001) and 86.5% (p<0.0001), respectively.ConclusionsUK TOP patients exhibited ≥83.5% reduction in ARR with ≥6 months of natalizumab treatment regardless of prior therapy, a reduction maintained over ≥3.5 years with no waning of effect. Relapses resulting in hospitalisation or steroid treatment were significantly reduced post natalizumab therapy initiation.Sponsored by Biogen Idec Ltd. Disclosures: RN: grant and conference travel support from Biogen Idec Ltd. RB: employee of Biogen Idec Ltd.

scholarly journals Relationship between Expanded Disability Status Scale scores and the presence of temporomandibular disorders in patients with multiple sclerosis

2018 ◽  
Vol 12 (01) ◽  
pp. 144-148 ◽  
Author(s):  
Lucas Senra Correa Carvalho ◽  
Osvaldo José Moreira Nascimento ◽  
Luciane Lacerda Franco Rocha Rodrigues ◽  
Andre Palma Da Cunha Matta
Keyword(s):  
Multiple Sclerosis ◽  
Temporomandibular Disorders ◽  
Control Group ◽  
Expanded Disability Status Scale ◽  
Exact Test ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Scale Scores ◽  
Axis I ◽  
Relapsing Remitting Multiple Sclerosis

ABSTRACTObjectives: The objectives of this study were to assess the prevalence of temporomandibular disorders (TMDs) in patients with relapsing-remitting multiple sclerosis (MS) and to investigate whether an association exists between the presence of TMD symptoms and the degree of MS-related disability. Materials and Methods: In all, 120 individuals were evaluated: 60 patients with a diagnosis of relapsing-remitting MS and 60 age- and sex-matched controls without neurological impairments. A questionnaire recommended by the European Academy of Craniomandibular Disorders for the assessment of TMD symptoms was administered. For those who answered affirmatively to at least one of the questions, the RDC/TMD Axis I instrument was used for a possible classification of TMD subtypes. The Expanded Disability Status Scale (EDSS) was the measure of the degree of MS-related disability. Statistical Analysis Used: Fisher’s exact test was used to analyze the data. ANOVA was used to detect significant differences between means and to assess whether the factors influenced any of the dependent variables by comparing means from the different groups. Results: The prevalence of TMD symptoms in patients with MS was 61.7% versus 18.3% in the control group (CG). A diagnosis of TMD was established for 36.7% in the MS group and 3.3% in the CG (P = 0.0001). There were statistically significant differences between degrees of MS-related disability and the prevalence of TMD (P = 0.0288). Conclusions: The prevalence of both TMD and TMD symptoms was significantly greater in the MS group. EDSS scores and TMD prevalence rates were inversely related.

Case Report: Delayed Alemtuzumab-Induced Concurrent Neutropenia and Thrombocytopenia in Relapsing-Remitting Multiple Sclerosis

2021 ◽  
pp. 089719002110212
Author(s):  
Akaansha Ganju ◽  
James C. Stock ◽  
Kim Jordan
Keyword(s):  
Multiple Sclerosis ◽  
Case Reports ◽  
Severe Neutropenia ◽  
Cell Counts ◽  
Immune Mediated ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Study Participants ◽  
Relapsing Remitting Multiple Sclerosis

Alemtuzumab is an anti-CD52 monoclonal antibody used to treat relapsing-remitting multiple sclerosis following failure of second-line medications. It is administered intravenously in 2 treatment sequences 1 year apart. This drug is frequently associated with mild infusion reactions within days of administration, increased infection risk, and long term adverse events from secondary autoimmunity. Alemtuzumab-induced serious immune-mediated thrombocytopenia (ITP) is well-reported and occurred in 1.0-2.2% of participants in initial phase 2 and 3 trials for multiple sclerosis. Significant neutropenia, however, is rare and was only observed in 0.1% of study participants. Delayed neutropenia and/or ITP is thought to occur from secondary autoimmunity. Few case reports have described severe neutropenia occurring beyond 2 months of last alemtuzumab dose. We present an unusual case of delayed combined neutropenia and thrombocytopenia that occurred 15 months after the second infusion of alemtuzumab. The patient was asymptomatic and presented following discovery of neutropenia and thrombocytopenia during routine laboratory studies. The patient responded to steroids initially and was discharged, although outpatient cell counts subsequently revealed recurrent neutropenia and ITP. The adverse drug reaction probability (Naranjo) scale was completed and showed probable likelihood that the adverse event was alemtuzumab-related. Long term screening for delayed hematologic abnormalities, at least 4 years after initial dose, is necessary when using alemtuzumab. Greater research is needed to understand the mechanism of drug-associated neutropenia.

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