Contributions
Abstract: P597
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Relapsing-remitting multiple sclerosis (RRMS) patients who experience relapses may require hospitalisation and/or treatment with steroids; such relapses contribute to both disability accumulation and overall disease management costs. Natalizumab (NTZ) has reduced relapse rates and severity in the clinical trial setting; published data have confirmed this in the real world. In the phase 3 AFFIRM trial, annualised relapse rates (ARRs) for relapses resulting in hospitalisations or steroid use were 0.04 and 0.15, respectively. Here, we evaluate relapses resulting in hospitalisations or steroid use in the TYSABRI Observational Program (TOP), an ongoing, global, open-label study of NTZ-treated RRMS patients in clinical practice.
Objectives: Examine the impact of NTZ on relapses resulting in hospitalisations or steroid use in RRMS patients in TOP.
Methods: In TOP, data on relapses (overall, requiring hospitalisation, or requiring steroid use) were collected at enrolment (for the previous year) and at clinical visits. ARRs for the year prior to starting NTZ and on NTZ were compared using a repeated Poisson model.
Results: As of November 2017, 6149 patients were enrolled in TOP. Median exposure was 38 (range, 1-135) doses; 3210 patients (52.2%) discontinued NTZ and 2118 patients (34.4%) withdrew from the study. Overall ARR was reduced by 89.4% (from 1.99 pre-NTZ to 0.21 post NTZ initiation; P< .0001). ARR was reduced by 91.1% (from 0.56 to 0.05; P< .0001) and by 89.2% (from 1.67 to 0.18; P< .0001) for relapses resulting in hospitalisations or steroid use, respectively. During NTZ treatment, the proportion of patients with any relapse-related hospitalisation or steroid use decreased from baseline (36.6% [2221 of 6073] to 11.1% [681 of 6149] and 89.1% [5438 of 6104] to 33.0% [2031 of 6149], respectively), despite longer follow-up in the on-NTZ than the pre-NTZ period (22,103 vs 6073 person-years). Overall, 88.9% and 67.0% of NTZ-treated patients remained free of relapses resulting in hospitalisation and steroid use, respectively, after NTZ initiation.
Conclusions: In TOP, NTZ initiation was associated with a significant decrease in relapses resulting in hospitalisation or steroid treatment, and ARRs for both are consistent with those observed in AFFIRM. These results support the long-term, real-world effectiveness of NTZ and may reflect reductions in healthcare resource utilisation associated with NTZ treatment.
Disclosure: Supported by Biogen.
MT: Compensation for consulting from Biogen, Merck Serono, Novartis; speaker honoraria from Biogen, Merck Serono, Novartis, Sanofi, Teva; research grants from Biogen, Merck Serono, Novartis.
TS: Honoraria for consultancy and funding for travel from Biogen, Novartis.
HB: Compensation for steering committee, advisory board and consultancy fees from Biogen, Merck, Roche, Novartis, Teva, Oxford Pharamgenesis; research support from Novartis, Biogen, Merck, NHMRC Australia, MS Research Australia, UK MS Trust.
LK: Ludwig Kappos' Institution (University Hospital Basel) received in the last 3 years and used exclusively for research support at the Department: steering committee, advisory board and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, Excemed, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, sanofi-aventis, Santhera, Teva, Vianex and royalties for Neurostatus-UHB products. The Research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union and Roche Research Foundations.
HW: Honoraria from AbbVie, Actelion, Alexion, Biogen, Cognomed, Evgen, F. Hoffmann-La Roche Ltd, MedDay, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, Teva; research support from Biogen, GlaxoSmithKline GmbH, Roche Pharma AG, Sanofi-Genzyme.
IC, SN, P-RH, SL: employees of and may hold stock and/or stock options in Biogen.
Abstract: P597
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Relapsing-remitting multiple sclerosis (RRMS) patients who experience relapses may require hospitalisation and/or treatment with steroids; such relapses contribute to both disability accumulation and overall disease management costs. Natalizumab (NTZ) has reduced relapse rates and severity in the clinical trial setting; published data have confirmed this in the real world. In the phase 3 AFFIRM trial, annualised relapse rates (ARRs) for relapses resulting in hospitalisations or steroid use were 0.04 and 0.15, respectively. Here, we evaluate relapses resulting in hospitalisations or steroid use in the TYSABRI Observational Program (TOP), an ongoing, global, open-label study of NTZ-treated RRMS patients in clinical practice.
Objectives: Examine the impact of NTZ on relapses resulting in hospitalisations or steroid use in RRMS patients in TOP.
Methods: In TOP, data on relapses (overall, requiring hospitalisation, or requiring steroid use) were collected at enrolment (for the previous year) and at clinical visits. ARRs for the year prior to starting NTZ and on NTZ were compared using a repeated Poisson model.
Results: As of November 2017, 6149 patients were enrolled in TOP. Median exposure was 38 (range, 1-135) doses; 3210 patients (52.2%) discontinued NTZ and 2118 patients (34.4%) withdrew from the study. Overall ARR was reduced by 89.4% (from 1.99 pre-NTZ to 0.21 post NTZ initiation; P< .0001). ARR was reduced by 91.1% (from 0.56 to 0.05; P< .0001) and by 89.2% (from 1.67 to 0.18; P< .0001) for relapses resulting in hospitalisations or steroid use, respectively. During NTZ treatment, the proportion of patients with any relapse-related hospitalisation or steroid use decreased from baseline (36.6% [2221 of 6073] to 11.1% [681 of 6149] and 89.1% [5438 of 6104] to 33.0% [2031 of 6149], respectively), despite longer follow-up in the on-NTZ than the pre-NTZ period (22,103 vs 6073 person-years). Overall, 88.9% and 67.0% of NTZ-treated patients remained free of relapses resulting in hospitalisation and steroid use, respectively, after NTZ initiation.
Conclusions: In TOP, NTZ initiation was associated with a significant decrease in relapses resulting in hospitalisation or steroid treatment, and ARRs for both are consistent with those observed in AFFIRM. These results support the long-term, real-world effectiveness of NTZ and may reflect reductions in healthcare resource utilisation associated with NTZ treatment.
Disclosure: Supported by Biogen.
MT: Compensation for consulting from Biogen, Merck Serono, Novartis; speaker honoraria from Biogen, Merck Serono, Novartis, Sanofi, Teva; research grants from Biogen, Merck Serono, Novartis.
TS: Honoraria for consultancy and funding for travel from Biogen, Novartis.
HB: Compensation for steering committee, advisory board and consultancy fees from Biogen, Merck, Roche, Novartis, Teva, Oxford Pharamgenesis; research support from Novartis, Biogen, Merck, NHMRC Australia, MS Research Australia, UK MS Trust.
LK: Ludwig Kappos' Institution (University Hospital Basel) received in the last 3 years and used exclusively for research support at the Department: steering committee, advisory board and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, Excemed, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, sanofi-aventis, Santhera, Teva, Vianex and royalties for Neurostatus-UHB products. The Research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union and Roche Research Foundations.
HW: Honoraria from AbbVie, Actelion, Alexion, Biogen, Cognomed, Evgen, F. Hoffmann-La Roche Ltd, MedDay, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Genzyme, Teva; research support from Biogen, GlaxoSmithKline GmbH, Roche Pharma AG, Sanofi-Genzyme.
IC, SN, P-RH, SL: employees of and may hold stock and/or stock options in Biogen.