Contributions
Abstract: P648
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Teriflunomide, a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS, has demonstrated consistent efficacy on disability worsening and relapse outcomes in 2 large, phase 3 studies in patients with relapsing forms of MS (RMS), and has a well-characterized, long-term safety profile. The phase 4 Teri-PRO study (NCT01895335) investigated the efficacy, safety, tolerability, and satisfaction with teriflunomide treatment in routine clinical practice using patient-reported outcomes.
Objective: To report the safety outcomes with teriflunomide up to Week 48 in patients enrolled in the Teri-PRO study.
Methods: In this prospective, single-arm, open-label study, 1000 patients with RMS received once-daily teriflunomide 7 mg (US patients only) or 14 mg for 48 weeks, administered according to local labelling in the United States, Canada, Europe, and Chile. The occurrence of adverse events (AEs) was reported at each study visit.
Results: Treatment-emergent AEs were reported in 823 (82.3%) patients. The most commonly reported (≥5% of patients) AEs were alopecia (23.0%, n=230), diarrhoea (17.3%, n=173), nausea (8.2%, n=82), headache (6.9%, n=69), urinary tract infection (6.7%, n=67), alanine aminotransferase (ALT) increase (6.3%, n=63), nasopharyngitis (5.4%, n=54), and fatigue (5.2%, n=52), and were mostly mild or moderate in severity. Serious AEs were reported in 127 (12.7%) patients; MS relapse (n=21), hypertension (n=6), ALT increase (n=6), urinary tract infection (n=5), pneumonia (n=4), syncope (n=4), chest pain (n=3), and non-cardiac chest pain (n=3) were reported in >2 patients. AEs resulted in treatment discontinuation in 109 (10.9%) patients, with diarrhoea (n=17), MS relapse (n=12), alopecia (n=9), ALT increase (n=6), fatigue (n=4), nausea (n=4), headache (n=3), influenza-like illness (n=3), pain (n=3), and vomiting (n=3), reported in >2 patients. Four deaths were reported during the study due to pneumonia, non-small cell lung cancer stage IV, MS relapse, and myocardial infarction; none of these were considered related to study treatment.
Conclusions: In the Teri-PRO study, the real-world safety profile of teriflunomide was consistent with that previously observed in the clinical development programme, with no unexpected AEs reported, and a low rate of discontinuation due to AEs.
Disclosure: Study supported by Sanofi Genzyme.
PKC: Consulting fees (AbbVie, Accordant, Acorda, Bayer, Biogen Idec, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, Teva); research support (Actelion, Genentech/Roche, Novartis, NINDS, Opexa).
BK: Consulting fees (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva); speakers bureaus (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva).
KRE: Consulting fees (Biogen, Genzyme); speakers bureaus (Biogen, Genzyme, Novartis); research support (Actelion, Biogen, Eisai, Eli Lilly, Forum Pharmaceuticals, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, Merz Pharmaceuticals, Novartis, Pfizer, Vaccinex).
JML: Consulting fees (Almirall, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva).
SC: Employee of Sanofi Genzyme, with ownership interest.
PR: Employee of Sanofi Genzyme.
MB: Employee of Sanofi Genzyme
SB: Employee of Lincoln, mandated by Sanofi.
RG: Consulting fees (Bayer Schering, Biogen, Elan, Genzyme, Roche, Teva); grant/research support (Bayer Schering, Biogen, Genzyme, Teva).
Abstract: P648
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Teriflunomide, a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS, has demonstrated consistent efficacy on disability worsening and relapse outcomes in 2 large, phase 3 studies in patients with relapsing forms of MS (RMS), and has a well-characterized, long-term safety profile. The phase 4 Teri-PRO study (NCT01895335) investigated the efficacy, safety, tolerability, and satisfaction with teriflunomide treatment in routine clinical practice using patient-reported outcomes.
Objective: To report the safety outcomes with teriflunomide up to Week 48 in patients enrolled in the Teri-PRO study.
Methods: In this prospective, single-arm, open-label study, 1000 patients with RMS received once-daily teriflunomide 7 mg (US patients only) or 14 mg for 48 weeks, administered according to local labelling in the United States, Canada, Europe, and Chile. The occurrence of adverse events (AEs) was reported at each study visit.
Results: Treatment-emergent AEs were reported in 823 (82.3%) patients. The most commonly reported (≥5% of patients) AEs were alopecia (23.0%, n=230), diarrhoea (17.3%, n=173), nausea (8.2%, n=82), headache (6.9%, n=69), urinary tract infection (6.7%, n=67), alanine aminotransferase (ALT) increase (6.3%, n=63), nasopharyngitis (5.4%, n=54), and fatigue (5.2%, n=52), and were mostly mild or moderate in severity. Serious AEs were reported in 127 (12.7%) patients; MS relapse (n=21), hypertension (n=6), ALT increase (n=6), urinary tract infection (n=5), pneumonia (n=4), syncope (n=4), chest pain (n=3), and non-cardiac chest pain (n=3) were reported in >2 patients. AEs resulted in treatment discontinuation in 109 (10.9%) patients, with diarrhoea (n=17), MS relapse (n=12), alopecia (n=9), ALT increase (n=6), fatigue (n=4), nausea (n=4), headache (n=3), influenza-like illness (n=3), pain (n=3), and vomiting (n=3), reported in >2 patients. Four deaths were reported during the study due to pneumonia, non-small cell lung cancer stage IV, MS relapse, and myocardial infarction; none of these were considered related to study treatment.
Conclusions: In the Teri-PRO study, the real-world safety profile of teriflunomide was consistent with that previously observed in the clinical development programme, with no unexpected AEs reported, and a low rate of discontinuation due to AEs.
Disclosure: Study supported by Sanofi Genzyme.
PKC: Consulting fees (AbbVie, Accordant, Acorda, Bayer, Biogen Idec, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, Teva); research support (Actelion, Genentech/Roche, Novartis, NINDS, Opexa).
BK: Consulting fees (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva); speakers bureaus (Bayer, Biogen Idec, Genzyme, Novartis, Pfizer, Questcor, Serono, Terumo, Teva).
KRE: Consulting fees (Biogen, Genzyme); speakers bureaus (Biogen, Genzyme, Novartis); research support (Actelion, Biogen, Eisai, Eli Lilly, Forum Pharmaceuticals, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, Merz Pharmaceuticals, Novartis, Pfizer, Vaccinex).
JML: Consulting fees (Almirall, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva).
SC: Employee of Sanofi Genzyme, with ownership interest.
PR: Employee of Sanofi Genzyme.
MB: Employee of Sanofi Genzyme
SB: Employee of Lincoln, mandated by Sanofi.
RG: Consulting fees (Bayer Schering, Biogen, Elan, Genzyme, Roche, Teva); grant/research support (Bayer Schering, Biogen, Genzyme, Teva).