Contributions
Abstract: P1879
Type: Poster
Abstract Category: Late breaking news
Background: Multiple sclerosis (MS) is a chronic immune-mediated neurodegenerative disorder requiring prolonged treatment; evaluation of long-term effect of disease-modifying therapies is important for treatment optimisation in clinical practice. LONGTERMS is an open-label, single-arm, extension study evaluating the long-term safety, tolerability and efficacy of fingolimod in patients who previously participated in Phase 2/3/3b fingolimod studies.
Objective: To present the key safety and efficacy results for up to 10 years of fingolimod treatment in patients with relapsing-remitting MS (RRMS).
Methods: The full analysis set included all patients with the highest assigned dose of fingolimod 0.5 mg. The key efficacy measures included annualised relapse rate (ARR), proportion of patients free of 6-month confirmed disability progression (6m-CDP), annualised rate of new or newly enlarging T2 lesions (ARneT2), and annualised rate of brain atrophy (ARBA). Safety analyses included reporting the frequencies of adverse events (AEs) and serious AEs (SAEs).
Results: Overall, 3168 patients (women, 71.2%; age [mean±SD], 38.0±9.1 years) were included in the analysis. At baseline, the mean (±SD) Expanded Disability Status Scale was 2.4±1.5 and the median (range) duration of MS since diagnosis was 4.7 (0-36.6) years. Median exposure to fingolimod in the study was 528.5 (range, 75-3805) days. ARR decreased gradually with longer exposure from 0.26 in Month (M) 0-12 to 0.20 in M0-60 and 0.19 in M0-120. The majority of patients remained free from 6m-CDP at M60 (79.3%) and M120 (68.1%). Radiological stability was demonstrated by a gradual decrease in ARneT2 from 1.31 in M0-12 to 0.90 in M0-60, and 0.71 in M0-120. Change in brain volume as assessed by ARBA was stable throughout the study (−0.37 at M12, −0.33 at M60 and −0.32 at M120). Long-term exposure to fingolimod did not raise new safety concerns. The most common AEs were viral upper respiratory tract infection (15.4%), headache (11.9%), and hypertension (8.5%). Frequency of Herpes Zoster infections was 2.0%. The most common SAEs were MS relapse (1.0%), basal cell carcinoma (0.6%), pneumonia and urinary tract infection (0.3%). No increase in frequencies of reported AEs or SAEs per year was observed over long-term fingolimod treatment.
Conclusion: Long-term follow-up confirmed the established safety profile of fingolimod. Treatment was associated with a sustained low level of disease activity as expressed by clinical and MRI outcomes.
Disclosure: This study was funded by Novartis Pharma AG, Basel, Switzerland.
Jeffrey Cohen has received personal compensation for serving as a consultant from Novartisand research support through his institution from Genzyme, Novartis, Receptos, Synthon, andTeva.
Nadia Tenenbaum, Alit Bhatt, and Ron Pimentel are employees of Novartis.
Ludwig Kappos has received no personal compensation. Ludwig Kappos' institution (University Hospital Basel) has received in the last 3 years and used exclusively for research support: steering committee, advisory board and consultancy fees from Actelion, Addex, Bayer HealthCare, Biogen Idec, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Receptos, Sanofi, Santhera, Siemens, Teva, UCB and Xenoport; speaker fees from Bayer HealthCare, Biogen Idec, Merck, Novartis, Sanofi and Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi and Teva; license fees for Neurostatus products and grants from Bayer HealthCare, Biogen Idec, European Union, Merck, Novartis, Roche Research Foundation, Swiss MS Society and the Swiss National Research Foundation.
Abstract: P1879
Type: Poster
Abstract Category: Late breaking news
Background: Multiple sclerosis (MS) is a chronic immune-mediated neurodegenerative disorder requiring prolonged treatment; evaluation of long-term effect of disease-modifying therapies is important for treatment optimisation in clinical practice. LONGTERMS is an open-label, single-arm, extension study evaluating the long-term safety, tolerability and efficacy of fingolimod in patients who previously participated in Phase 2/3/3b fingolimod studies.
Objective: To present the key safety and efficacy results for up to 10 years of fingolimod treatment in patients with relapsing-remitting MS (RRMS).
Methods: The full analysis set included all patients with the highest assigned dose of fingolimod 0.5 mg. The key efficacy measures included annualised relapse rate (ARR), proportion of patients free of 6-month confirmed disability progression (6m-CDP), annualised rate of new or newly enlarging T2 lesions (ARneT2), and annualised rate of brain atrophy (ARBA). Safety analyses included reporting the frequencies of adverse events (AEs) and serious AEs (SAEs).
Results: Overall, 3168 patients (women, 71.2%; age [mean±SD], 38.0±9.1 years) were included in the analysis. At baseline, the mean (±SD) Expanded Disability Status Scale was 2.4±1.5 and the median (range) duration of MS since diagnosis was 4.7 (0-36.6) years. Median exposure to fingolimod in the study was 528.5 (range, 75-3805) days. ARR decreased gradually with longer exposure from 0.26 in Month (M) 0-12 to 0.20 in M0-60 and 0.19 in M0-120. The majority of patients remained free from 6m-CDP at M60 (79.3%) and M120 (68.1%). Radiological stability was demonstrated by a gradual decrease in ARneT2 from 1.31 in M0-12 to 0.90 in M0-60, and 0.71 in M0-120. Change in brain volume as assessed by ARBA was stable throughout the study (−0.37 at M12, −0.33 at M60 and −0.32 at M120). Long-term exposure to fingolimod did not raise new safety concerns. The most common AEs were viral upper respiratory tract infection (15.4%), headache (11.9%), and hypertension (8.5%). Frequency of Herpes Zoster infections was 2.0%. The most common SAEs were MS relapse (1.0%), basal cell carcinoma (0.6%), pneumonia and urinary tract infection (0.3%). No increase in frequencies of reported AEs or SAEs per year was observed over long-term fingolimod treatment.
Conclusion: Long-term follow-up confirmed the established safety profile of fingolimod. Treatment was associated with a sustained low level of disease activity as expressed by clinical and MRI outcomes.
Disclosure: This study was funded by Novartis Pharma AG, Basel, Switzerland.
Jeffrey Cohen has received personal compensation for serving as a consultant from Novartisand research support through his institution from Genzyme, Novartis, Receptos, Synthon, andTeva.
Nadia Tenenbaum, Alit Bhatt, and Ron Pimentel are employees of Novartis.
Ludwig Kappos has received no personal compensation. Ludwig Kappos' institution (University Hospital Basel) has received in the last 3 years and used exclusively for research support: steering committee, advisory board and consultancy fees from Actelion, Addex, Bayer HealthCare, Biogen Idec, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Receptos, Sanofi, Santhera, Siemens, Teva, UCB and Xenoport; speaker fees from Bayer HealthCare, Biogen Idec, Merck, Novartis, Sanofi and Teva; support of educational activities from Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi and Teva; license fees for Neurostatus products and grants from Bayer HealthCare, Biogen Idec, European Union, Merck, Novartis, Roche Research Foundation, Swiss MS Society and the Swiss National Research Foundation.