Contributions
Abstract: EP1720
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: In order to improve treatment decisions in natalizumab-treated relapsing-remitting multiple sclerosis (RRMS) patients at higher risk for progressive multifocal leukoencephalopathy (PML), standardised monitoring procedures may provide a superior basis for individual benefit/risk evaluation. However, management of these patients in the clinical practice in Germany is highly heterogeneous.
Goals: Key goals of the prospective, non-interventional TRUST study are to assess the course of disease over 36 months in patients with sustained natalizumab therapy versus those who discontinue natalizumab treatment and to evaluate the use and effects of an integrated, adaptive patient management approach.
Methods: The ongoing TRUST study enrols up to 1260 RRMS patients treated with natalizumab for ≥12 months. Patients are documented over 3 years irrespective of treatment changes. Endpoints include clinical, subclinical, and patient reported outcomes as well as utilisation of risk-stratification tools and expert advice in the clinical routine. This interim analysis presents baseline data at the end of the recruitment period (cut-off date Jan 17, 2017).
Results: The full analysis set of this interim analysis comprised 1186 patients (71.8% female, mean [±standard deviation, SD] age 39.2±10.1 years) from 154 sites. Mean (±SD) EDSS score at start of natalizumab was 3.1±1.6. The pre-study annualised relapse rate (ARR) before and after starting natalizumab was 2.09 and 0.15, respectively. Patients received 43.0±29.7 (mean±SD) natalizumab infusions before study inclusion. At baseline, 95.5% of patients had John-Cunningham-virus (JCV) antibody tests and 96.9% patients had initial magnetic resonance imaging data available. Until April 20, 2017, 20 cases of suspected PML were reported (8 were confirmed and 12 were ruled out) and expert opinion was requested by 13 sites (46 requests in total), mostly focusing on PML risk assessment. 9.4% of patients discontinued natalizumab after study inclusion.
Conclusion: The TRUST study examines a population of MS patients with high disease activity as seen by their ARR before natalizumab start. Compared to the first interim analysis (n=427), there were slight increases in the number of patients with available JCV antibody tests. As follow-up continues irrespective of natalizumab discontinuation, TRUST will provide insight into individual benefit/risk considerations and decision making in clinical routine practice.
Disclosure: The TRUST study is funded by Biogen GmbH, Ismaning, Germany.
Hans-Peter Hartung has received fees for consulting, speaking and serving on steering committees from Bayer Healthcare, Biogen Idec, CSL Behring, GeNeuro, Genzyme, MedImmune, Merck Serono, Novartis, Opexa, Receptos, Roche, Sanofi and Teva, with approval by the Rector of Heinrich-Heine-University.
Jens Wuerfel is CEO of MIAC AG. He served on advisory boards for Actelion, Biogen, Genzyme, Novartis, Teva, TG Therapeutics and Roche. He received speaker honoraria from Bayer, Biogen, Genzyme, Novartis, and Teva, and expert reading compensation from mediri. JW was supported by the DFG, the EU, the German ministry of education and research (BMBF/KKNMS) and the German ministry of economy (BMWi).
Achum Gass has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Novartis, Biogen Idec, Merck Serono, Genzyme.
Björn Tackenberg received personal speaker honoraria and consultancy fees as a speaker and advisor from Bayer Healthcare, Biogen, CSL Behring, GRIFOLS, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, TEVA und UCB Pharma. His University received unrestricted research grants from Biogen-idec, Novartis, TEVA, Bayer Healthcare, CSL-Behring, GRIFOLS, Octapharma, Sanofi Genzyme und UCB Pharma.
Ralf Linker received compensation for activities with or research support from Allmirall, Bayer Health Care, Biogen, Fresenius, Genzyme, Merck, Novartis Pharma, Roche, TEVA.
Mathias Mäurer has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Almirall, Bayer Healthcare, Boehringer Ingelheim, Biogen, Genzyme/Sanofi Aventis, Merck Serono, Novartis, Roche, Talecris and Teva. Dr Mäurer serves on a steering committee for Biogen and Novartis. Dr Mäurer serves as a consultant for Biogen, Genzyme and Roche.
Martin Stangel has received honoraria for scientific lectures or consultancy from Bayer Healthcare, Biogen, Baxalta/Shire, CSL Behring, Euroimmune, Grifols, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, and Teva. His institution received research support from Bayer Healthcare, Biogen Idec, Genzyme, Merck-Serono, Novartis, and Teva.
Tjalf Ziemssen has served on scientific advisory boards, and has received scientific grants and speaker honoraria from Bayer, Biogen, Genzyme, Merck Serono, Novartis, and TEVA.
Antonios Bayas received personal compensation from Merck, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme and grants for congress trips and participation from Biogen, TEVA, Novartis, Sanofi/Genzyme and Merck.
Volker Limmroth has been an advisory board member for Biogen, Bayer, Genzyme, GSK,
Merck Serono and Novartis. He received travel and research grants or honoraria from Biogen, Bayer, Genzyme, GSK, Merck Serono, Novartis, Pfizer, and TEVA.
Judith Haas received grants from Octapharma, Bayer and Teva; compensation for advisory boards from Sanofi Aventis, Teva, Biogen and Novartis; and speaker's compensation from Biogen, Teva, Bayer, Biotest and Novartis.
Abstract: EP1720
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: In order to improve treatment decisions in natalizumab-treated relapsing-remitting multiple sclerosis (RRMS) patients at higher risk for progressive multifocal leukoencephalopathy (PML), standardised monitoring procedures may provide a superior basis for individual benefit/risk evaluation. However, management of these patients in the clinical practice in Germany is highly heterogeneous.
Goals: Key goals of the prospective, non-interventional TRUST study are to assess the course of disease over 36 months in patients with sustained natalizumab therapy versus those who discontinue natalizumab treatment and to evaluate the use and effects of an integrated, adaptive patient management approach.
Methods: The ongoing TRUST study enrols up to 1260 RRMS patients treated with natalizumab for ≥12 months. Patients are documented over 3 years irrespective of treatment changes. Endpoints include clinical, subclinical, and patient reported outcomes as well as utilisation of risk-stratification tools and expert advice in the clinical routine. This interim analysis presents baseline data at the end of the recruitment period (cut-off date Jan 17, 2017).
Results: The full analysis set of this interim analysis comprised 1186 patients (71.8% female, mean [±standard deviation, SD] age 39.2±10.1 years) from 154 sites. Mean (±SD) EDSS score at start of natalizumab was 3.1±1.6. The pre-study annualised relapse rate (ARR) before and after starting natalizumab was 2.09 and 0.15, respectively. Patients received 43.0±29.7 (mean±SD) natalizumab infusions before study inclusion. At baseline, 95.5% of patients had John-Cunningham-virus (JCV) antibody tests and 96.9% patients had initial magnetic resonance imaging data available. Until April 20, 2017, 20 cases of suspected PML were reported (8 were confirmed and 12 were ruled out) and expert opinion was requested by 13 sites (46 requests in total), mostly focusing on PML risk assessment. 9.4% of patients discontinued natalizumab after study inclusion.
Conclusion: The TRUST study examines a population of MS patients with high disease activity as seen by their ARR before natalizumab start. Compared to the first interim analysis (n=427), there were slight increases in the number of patients with available JCV antibody tests. As follow-up continues irrespective of natalizumab discontinuation, TRUST will provide insight into individual benefit/risk considerations and decision making in clinical routine practice.
Disclosure: The TRUST study is funded by Biogen GmbH, Ismaning, Germany.
Hans-Peter Hartung has received fees for consulting, speaking and serving on steering committees from Bayer Healthcare, Biogen Idec, CSL Behring, GeNeuro, Genzyme, MedImmune, Merck Serono, Novartis, Opexa, Receptos, Roche, Sanofi and Teva, with approval by the Rector of Heinrich-Heine-University.
Jens Wuerfel is CEO of MIAC AG. He served on advisory boards for Actelion, Biogen, Genzyme, Novartis, Teva, TG Therapeutics and Roche. He received speaker honoraria from Bayer, Biogen, Genzyme, Novartis, and Teva, and expert reading compensation from mediri. JW was supported by the DFG, the EU, the German ministry of education and research (BMBF/KKNMS) and the German ministry of economy (BMWi).
Achum Gass has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Novartis, Biogen Idec, Merck Serono, Genzyme.
Björn Tackenberg received personal speaker honoraria and consultancy fees as a speaker and advisor from Bayer Healthcare, Biogen, CSL Behring, GRIFOLS, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, TEVA und UCB Pharma. His University received unrestricted research grants from Biogen-idec, Novartis, TEVA, Bayer Healthcare, CSL-Behring, GRIFOLS, Octapharma, Sanofi Genzyme und UCB Pharma.
Ralf Linker received compensation for activities with or research support from Allmirall, Bayer Health Care, Biogen, Fresenius, Genzyme, Merck, Novartis Pharma, Roche, TEVA.
Mathias Mäurer has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Almirall, Bayer Healthcare, Boehringer Ingelheim, Biogen, Genzyme/Sanofi Aventis, Merck Serono, Novartis, Roche, Talecris and Teva. Dr Mäurer serves on a steering committee for Biogen and Novartis. Dr Mäurer serves as a consultant for Biogen, Genzyme and Roche.
Martin Stangel has received honoraria for scientific lectures or consultancy from Bayer Healthcare, Biogen, Baxalta/Shire, CSL Behring, Euroimmune, Grifols, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, and Teva. His institution received research support from Bayer Healthcare, Biogen Idec, Genzyme, Merck-Serono, Novartis, and Teva.
Tjalf Ziemssen has served on scientific advisory boards, and has received scientific grants and speaker honoraria from Bayer, Biogen, Genzyme, Merck Serono, Novartis, and TEVA.
Antonios Bayas received personal compensation from Merck, Biogen, Bayer Vital, Novartis, TEVA, Roche and Sanofi/Genzyme and grants for congress trips and participation from Biogen, TEVA, Novartis, Sanofi/Genzyme and Merck.
Volker Limmroth has been an advisory board member for Biogen, Bayer, Genzyme, GSK,
Merck Serono and Novartis. He received travel and research grants or honoraria from Biogen, Bayer, Genzyme, GSK, Merck Serono, Novartis, Pfizer, and TEVA.
Judith Haas received grants from Octapharma, Bayer and Teva; compensation for advisory boards from Sanofi Aventis, Teva, Biogen and Novartis; and speaker's compensation from Biogen, Teva, Bayer, Biotest and Novartis.