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EFFICACY AND SAFETY OF NATALIZUMAB TREATMENT FOR RELAPSING–REMITTING MULTIPLE SCLEROSIS: INTERIM RESULTS OF THE TYSABRI® OBSERVATIONAL PROGRAMME IN THE UK
  1. Jerome Hanna,
  2. Jan Paul Rosen,
  3. Caroline Smethurst
  1. Biogen Idec Ltd

    Abstract

    Introduction The natalizumab (TYSABRI®) Observational Program (TOP) is an ongoing, open–label, 10–year prospective study of relapsing–remitting Multiple Sclerosis (RRMS) patients in European, Australian, and Canadian clinical settings. Patients must be naïve to natalizumab when deciding to enrol but may have received other disease–modifying therapies (DMTs) pre–natalizumab. The objective of this analysis was to evaluate interim efficacy and safety data in the subset of patients in the United Kingdom (UK).

    Methods Baseline characteristics were summarised. Annualised relapse rate (ARR) was analysed for overall pre–and postbaseline differences as well as by treatment and relapse histories at baseline. Expanded Disability Status Scale (EDSS) scores were evaluated at baseline and years 1 and 2. The incidence of serious adverse events (SAEs) was evaluated.

    Results As of June 1, 2012, 117 patients were enroled in the UK. Most (80.3%) were female; mean age was 39.1 years. The median duration of RRMS was 5.6 (range 0.4–25.3) years. The median number of relapses in the year prior to natalizumab treatment was 2.0 (range 1.0–6.0); 24.8% of patients had 1 relapse and 75.2% had >1 relapse in the prior year. At baseline, 35.0% of patients were treatment naïve, 49.6% were treated with 1 DMT, and 15.4% were treated with >1 DMT prior to natalizumab. Approximately half (51.3%) had a history of interferon use, 25.6% had a history of glatiramer acetate use, and 1.7% had a history of immunosuppressant use. Most patients (60.7%, n=71) have been followed for at least 12 months; 39.3% (n=46) have been followed for at least 18 months. Patients received a median of 15 (range 1–27) natalizumab infusions. ARR overall decreased from 2.26 at baseline to 0.38 on treatment (n=117; P<0.0001). ARR decreased significantly from baseline regardless of baseline treatment history (treatment naïve [n=41]: 2.54 at baseline vs 0.48 on treatment, P<0.0001; 1 prior DMT [n=58]: 2.14 at baseline vs 0.36 on treatment, P<0.0001; >1 prior DMT [n=18]: 2.00 at baseline vs 0.26 on treatment, P=0.0003) or relapse history (1 relapse in prior year [n=29]: 1.00 at baseline vs 0.27 on treatment, P<0.0001); >1 relapse [n=88]: 2.67 at baseline vs 0.43 on treatment, P<0.0001). EDSS scores were stable with a mean of 4.2 at baseline (n=115), 4.0 at month 6 (n=33), 4.4 at year 1 (n=19), and 4.3 at year 2 (n=9). No cases of progressive multifocal leukoencephalopathy, malignancy, or opportunistic infections were reported.

    Conclusions In this interim analysis of UK TOP results, patients treated with natalizumab had significantly improved ARRs, regardless of baseline treatment or relapse history. EDSS scores remained stable over time. Safety data were consistent with natalizumab's known safety profile. Analyses of UK TOP data over longer periods of time will further characterise the effect of natalizumab on disability, as well as on other long–term efficacy and safety parameters in a real–world setting.

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