Contributions
Abstract: P596
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: The TYSABRI Observational Program (TOP) is an ongoing, global, open-label study in patients with relapsing-remitting multiple sclerosis (RRMS) treated with natalizumab in the real world. Country-specific data from TOP can provide information on the effectiveness of natalizumab in local clinical practice. The German cohort is the largest country-specific population in TOP.
Objectives: To evaluate the effectiveness of natalizumab in patients with RRMS in the German cohort in TOP.
Methods: Data from study initiation in July 2007 to November 2017 were included in this analysis. Annualized relapse rates (ARRs) before and on natalizumab were compared using a repeated Poisson model. The cumulative probabilities of 24-week-confirmed Expanded Disability Status Scale (EDSS) worsening (increase of ≥1.5 from a score of 0.0, ≥1.0 from a score of 1.0-5.5, or ≥0.5 from a score ≥6.0) and 24-week-confirmed EDSS improvement (decrease of ≥1.0 from a score ≥2.0) were estimated using the Kaplan-Meier method.
Results: As of November 2017, 6149 patients were enrolled in TOP globally; 1707 TOP patients (27.8%) were German. At baseline, German TOP patients had a median (range) disease duration of 6.7 (0-37.2) years and mean (standard deviation) EDSS scores of 3.2 (1.65). Most patients (92.1%) had used a disease-modifying therapy prior to natalizumab initiation. On study, German patients received a median (range) of 35 (1-135) doses of natalizumab. ARR decreased from 2.21 pre-natalizumab to 0.25 on treatment (an 88.7% decrease; P< 0.0001). At 10 years, the cumulative probability of confirmed EDSS worsening was 37.5%, and the cumulative probability of confirmed EDSS improvement was 37.7%.
Conclusions: Over 10 years of treatment with natalizumab, ARRs remained low in German patients with RRMS. The probabilities of EDSS worsening and improvement were similar. Overall, these results are consistent with outcomes observed in the global TOP population and support the long-term effectiveness of natalizumab in real-world settings.
Disclosure: Supported by Biogen.
SGM: honoraria for lecturing, travel expenses for attending meetings, and financial research support from Almirall, Amicus Therapeutics Germany, Bayer Health Care, Biogen, Celgene, Diamed, Genzyme, MedDay, Merck Serono, Novartis, Novo Nordisk, ONO Pharma, Roche, Sanofi-Aventis, Chugai Pharma, QuintilesIMS and Teva.
LK: compensation for serving on scientific advisory boards for Genzyme, Novartis, and Roche; speaker honoraria and travel support from Genzyme, CSL Behring, Merck Serono, Novartis; and research support from Biogen, Novartis.
SS: speaking honoraria, travel compensation, and fees for serving on advisory boards from Bayer Vital, Biogen, Merck Serono, Novartis, Teva.
FH: institutional research grants and personal honoraria as speaker from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva.
HS-F: nothing to disclose.
KR, SL: employees of and/or hold stock and/or stock options in Biogen.
HW: honoraria from AbbVie, Actelion, Alexion, Biogen, Cognomed, Evgen, F. Hoffmann-La Roche, MedDay, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva; research support from Biogen, GlaxoSmithKline GmbH, Roche, Sanofi-Genzyme.
Abstract: P596
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: The TYSABRI Observational Program (TOP) is an ongoing, global, open-label study in patients with relapsing-remitting multiple sclerosis (RRMS) treated with natalizumab in the real world. Country-specific data from TOP can provide information on the effectiveness of natalizumab in local clinical practice. The German cohort is the largest country-specific population in TOP.
Objectives: To evaluate the effectiveness of natalizumab in patients with RRMS in the German cohort in TOP.
Methods: Data from study initiation in July 2007 to November 2017 were included in this analysis. Annualized relapse rates (ARRs) before and on natalizumab were compared using a repeated Poisson model. The cumulative probabilities of 24-week-confirmed Expanded Disability Status Scale (EDSS) worsening (increase of ≥1.5 from a score of 0.0, ≥1.0 from a score of 1.0-5.5, or ≥0.5 from a score ≥6.0) and 24-week-confirmed EDSS improvement (decrease of ≥1.0 from a score ≥2.0) were estimated using the Kaplan-Meier method.
Results: As of November 2017, 6149 patients were enrolled in TOP globally; 1707 TOP patients (27.8%) were German. At baseline, German TOP patients had a median (range) disease duration of 6.7 (0-37.2) years and mean (standard deviation) EDSS scores of 3.2 (1.65). Most patients (92.1%) had used a disease-modifying therapy prior to natalizumab initiation. On study, German patients received a median (range) of 35 (1-135) doses of natalizumab. ARR decreased from 2.21 pre-natalizumab to 0.25 on treatment (an 88.7% decrease; P< 0.0001). At 10 years, the cumulative probability of confirmed EDSS worsening was 37.5%, and the cumulative probability of confirmed EDSS improvement was 37.7%.
Conclusions: Over 10 years of treatment with natalizumab, ARRs remained low in German patients with RRMS. The probabilities of EDSS worsening and improvement were similar. Overall, these results are consistent with outcomes observed in the global TOP population and support the long-term effectiveness of natalizumab in real-world settings.
Disclosure: Supported by Biogen.
SGM: honoraria for lecturing, travel expenses for attending meetings, and financial research support from Almirall, Amicus Therapeutics Germany, Bayer Health Care, Biogen, Celgene, Diamed, Genzyme, MedDay, Merck Serono, Novartis, Novo Nordisk, ONO Pharma, Roche, Sanofi-Aventis, Chugai Pharma, QuintilesIMS and Teva.
LK: compensation for serving on scientific advisory boards for Genzyme, Novartis, and Roche; speaker honoraria and travel support from Genzyme, CSL Behring, Merck Serono, Novartis; and research support from Biogen, Novartis.
SS: speaking honoraria, travel compensation, and fees for serving on advisory boards from Bayer Vital, Biogen, Merck Serono, Novartis, Teva.
FH: institutional research grants and personal honoraria as speaker from Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche, Teva.
HS-F: nothing to disclose.
KR, SL: employees of and/or hold stock and/or stock options in Biogen.
HW: honoraria from AbbVie, Actelion, Alexion, Biogen, Cognomed, Evgen, F. Hoffmann-La Roche, MedDay, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva; research support from Biogen, GlaxoSmithKline GmbH, Roche, Sanofi-Genzyme.