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.

Long-term (up to 22 years), open-label, compassionate-use study of glatiramer acetate in relapsing—remitting multiple sclerosis

2008 ◽  
Vol 14 (4) ◽  
pp. 494-499 ◽  
Author(s):  
Aaron Miller ◽  
Vincent Spada ◽  
Dorothy Beerkircher ◽  
Rivka Riven Kreitman
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Glatiramer Acetate ◽  
Open Label ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Pretreatment Score

To evaluate the safety and efficacy of long-term glatiramer acetate (GA) therapy, 46 patients with relapsing—remitting multiple sclerosis (RRMS) were treated for up to 22 years in an ongoing, open-label study. Kurtzke expanded disability status scale (EDSS) was measured every six months, relapses were reported at occurrence and patients self-reported adverse events (AEs). At GA initiation, disease durations ranged from 0—20 years (median 6.0 years) and at data cut-off (October 2004), GA therapy duration ranged from 1—22 years (median 12.0 years). Mean EDSS score increased 0.9 ± 1.9 from the pretreatment score (3.0 ± 1.8; P = 0.076). Only 10/28 (36%) patients with baseline EDSS <4.0 had a last observed value ≥ 4.0 and 8/34 (24%) with entry EDSS < 6.0 reached EDSS ≥ 6.0. A majority (57%) maintained improved or unchanged EDSS scores. Annualized relapse rate decreased to 0.1 ± 0.2 from 2.9 ± 1.4 prestudy ( P < 0.0001). Of the 18 remaining patients in October 2004 (average disease duration 23 years), 17% with baseline EDSS scores < 4.0 reached EDSS ≥ 4.0 and 28% with baseline scores < 6.0 reached EDSS ≥ 6.0. Adverse events were similar to those reported in short-term clinical trials. This study shows a low rate of relapses and EDSS progression in RRMS patients on GA for up to 22 years. Multiple Sclerosis 2008; 14: 494—499. http://msj.sagepub.com

LONG-TERM SAFETY OF ALEMTUZUMAB IN RELAPSING-REMITTING MULTIPLE SCLEROSIS: PREGNANCY AND INFECTION DATA FROM A COHORT OF PATIENTS ON OPEN LABEL STUDIES IN CAMBRIDGE

2015 ◽  
Vol 86 (11) ◽  
pp. e4.15-e4
Author(s):  
Claire McCarthy ◽  
Orla Tuohy ◽  
Laura Azzopardi ◽  
Onajite Kousin-Ezewu ◽  
Joanne Jones ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Varicella Zoster Virus ◽  
Open Label ◽  
Varicella Zoster ◽  
Serious Infections ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

BackgroundAlemtuzumab is recently licensed for use in active relapsing-remitting multiple sclerosis (RRMS) in Europe and the USA. This observational cohort study investigated the long term safety of alemtuzumab in RRMS.MethodsClinical data was collected from a cohort of 87 patients who participated in open label studies of alemtuzumab in Cambridge, UK from 1999 to 2012. Pregnancy outcomes and the occurrence of moderate to severe infections were recorded.ResultsOver a median 7-year follow-up (range 33–144 months), no serious infections occurred that required hospitalisation. There were 11 cases of varicella zoster virus reactivation and one case of primary varicella zoster virus infection. In this cohort 15 babies were born to 12 women treated with alemtuzumab. The median interval from their most recent alemtuzumab treatment to birth was 26 months (range 13–86 months). All of the babies were healthy and delivered without complications. One woman had experienced a miscarriage at 8 weeks gestation but went on to have two successful pregnancies.ConclusionsDuring prolonged follow-up of this cohort of patients treated with alemtuzumab no serious infections occurred. No increased risk of miscarriage or foetal abnormality was seen in the small number of pregnancies studied.

scholarly journals Long-term safety and efficacy of daclizumab beta in relapsing–remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study

2020 ◽  
Vol 267 (10) ◽  
pp. 2851-2864 ◽  
Author(s):  
Ralf Gold ◽  
Ernst-Wilhelm Radue ◽  
Gavin Giovannoni ◽  
Krzysztof Selmaj ◽  
Eva Kubala Havrdova ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Event ◽  
Extension Study ◽  
Open Label ◽  
Immune Mediated ◽  
Relapsing Remitting ◽  
Open Label Extension ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Beta Dose

Abstract Objective SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED. Methods Eligible participants who completed 1–2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION. Results Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0–24 was 0.21 (0.16–0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time. Conclusions The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED. Trial registration Clinicaltrials.gov NCT01051349; first registered on January 15, 2010.

THUR 171 Natalizumab effectiveness and safety in top uk patients

2018 ◽  
Vol 89 (10) ◽  
pp. A22.1-A22
Author(s):  
Nicholas Richard ◽  
Rosales Karen ◽  
Licata Stephanie ◽  
Syed Farooq Syed Feisal ◽  
Smethurst Caroline
Keyword(s):  
Open Label ◽  
Serious Adverse Event ◽  
Open Label Study ◽  
Specific Data ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Edss Score ◽  
The Uk ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

IntroductionThe TYSABRI® Observational Program (TOP) is an ongoing, global open-label study enrolling natalizumab-treated relapsing-remitting multiple sclerosis patients in real-world settings. Country-specific data can provide information on natalizumab’s benefit-risk in local clinical practice.MethodsClinical outcomes in UK and rest of world (ROW) TOP patients were compared.ResultsAs of May 2016, 134 UK and 5793 ROW patients were enrolled in TOP. Mean baseline Expanded Disability Status Scale (EDSS) score was 4.27 in the UK and 3.45 in ROW. Mean years on natalizumab was 3.52 in the UK and 3.04 in ROW. Annualized relapse rate (ARR) decreased by 89.7% (from 2.21 pre-natalizumab to 0.23 post natalizumab initiation; p<0.0001) in the UK and by 89.0% (from 1.99 to 0.22; p<0.0001) in ROW. In both cohorts, ARR decrease by baseline EDSS score was 91.0%–93.2% for <3.0 and 87.3%–88.9% for ≥3.0; mean EDSS score change from baseline over 6 years was <1.0. Overall, 9 of 134 UK patients (6.7%) experienced ≥1 serious adverse event.ConclusionsNatalizumab demonstrated similar effectiveness in the UK and ROW cohorts. Safety in the UK cohort was consistent with natalizumab’s established safety profile.SupportBiogenDisclosuresRN: grant/travel support from Biogen; KR, SL, SFSF, CS: Biogen employees.

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.

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