Contributions
Abstract: EP1641
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Glatiramer acetate 40 mg 3 times a weeks (GA40) has been approved as an alternative treatment schedule to glatiramer acetate 20 mg daily (GA20). Albeit similar on a weekly basis, a GA40 dose and concentration are twice as high as a GA20 one, and systemic reactions (SR) following each injection might differ.
Aim: To investigate unexpected SR (USR) following GA40.
Methods: Prospective, observational study performed at 2 tertiary Multiple Sclerosis (MS) Centers between February and May 2017. Consecutive MS patients treated with GA40 for at least 3 months were administered a semi-structured, face to face questionnaire on frequency and characteristics of USR, defined as SR other than chest pain, palpitations, dyspnoea and constriction of the throat following injections. Treating neurologists evaluated USR as mild, moderate or severe. Descriptive statistics were used to describe patients' characteristics and logistic regression was used to evaluate predictors of USR under GA40.
Results: 162 patients were included [n=119 (73.4%) females; median (interquartile range, IQR) age 41.5 (35.4-49.3) years; median disease duration 3.4 (1.4-8.9) years; median treatment duration 9(5-12) months; patients previously on GA20 n=96 (59.6%)].Thirty-seven patients on GA40 (22.8%) had ≥1 USR: of these, 22 (13.5%) had ≥1 gastrointestinal symptoms (diarrhea, abdominal cramps, nausea/vomiting), 26 (16.0%) fever and/or shivering, and 11 (6.8%) both. A single patient reported abdominal cramps also during previous GA20 exposure. USR were severe in 7(4.3%) patients, and 12(7.4%) patients discontinued GA40 because of SR. Age, gender and previous exposure to GA20 were not related to different risk of USR under GA40.
Conclusion: Gastrointestinal symptoms and fever are unexpected SR following GA40 injections and were reported by approximately one quarter of patients. Preliminary data do not support a protective role of previous treatment with GA20.
Disclosure: Chiara Zecca, Giulio Disanto, Claudio Gobbi: The Department of Neurology, Regional Hospital Lugano, Switzerland, receives financial support from TEVA, Merck Serono, Roche, Biogen Idec, Genzyme, and Novartis. None of these agreement was related to the present work.
Rossi S acted as an Advisory Board member of Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for consultancy, speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva, Novartis and Roche.
Mantegazza R acted as an Advisory Board member of Biomarin, received Funding for Travel or Speaker Honoraria from Sanofi-Aventis, Biomarin, Grifols, Teva, Bayer, Alexion, Argenx; he is is involved as principal investigator in clinical trials for Alexion, Merck Serono, Hoffman-La Roche, Teva, Besta-Azienda Ospedaliera San Gerardo, Biogen, Biomarin, Almirall, Novartis, Genzyme Corporation, Catalyst.
Brambilla L received honoraria for speaking from Novartis.
Antozzi C received funding for travel and congress attendance from Biogen, Merck Serono and Teva
Pareja-Gutierrez L, Camera G, Bellavia G, Bernardini L, Perugini J, Gerardi C have nothing to disclosure
Confalonieri P acted as Board member for Biogen-idec and Roche, received support for conference travel from Sanofi-Aventis, Biogen Dompé AG, Merk Serono anf Novarrtis; received support for scientific projects from Merk Serono and Novarstis
Torri Clerici V acted as an Advisory Board member of Merck and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen, Merck and Almirall. She received support for research project by Almirall.
Abstract: EP1641
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Glatiramer acetate 40 mg 3 times a weeks (GA40) has been approved as an alternative treatment schedule to glatiramer acetate 20 mg daily (GA20). Albeit similar on a weekly basis, a GA40 dose and concentration are twice as high as a GA20 one, and systemic reactions (SR) following each injection might differ.
Aim: To investigate unexpected SR (USR) following GA40.
Methods: Prospective, observational study performed at 2 tertiary Multiple Sclerosis (MS) Centers between February and May 2017. Consecutive MS patients treated with GA40 for at least 3 months were administered a semi-structured, face to face questionnaire on frequency and characteristics of USR, defined as SR other than chest pain, palpitations, dyspnoea and constriction of the throat following injections. Treating neurologists evaluated USR as mild, moderate or severe. Descriptive statistics were used to describe patients' characteristics and logistic regression was used to evaluate predictors of USR under GA40.
Results: 162 patients were included [n=119 (73.4%) females; median (interquartile range, IQR) age 41.5 (35.4-49.3) years; median disease duration 3.4 (1.4-8.9) years; median treatment duration 9(5-12) months; patients previously on GA20 n=96 (59.6%)].Thirty-seven patients on GA40 (22.8%) had ≥1 USR: of these, 22 (13.5%) had ≥1 gastrointestinal symptoms (diarrhea, abdominal cramps, nausea/vomiting), 26 (16.0%) fever and/or shivering, and 11 (6.8%) both. A single patient reported abdominal cramps also during previous GA20 exposure. USR were severe in 7(4.3%) patients, and 12(7.4%) patients discontinued GA40 because of SR. Age, gender and previous exposure to GA20 were not related to different risk of USR under GA40.
Conclusion: Gastrointestinal symptoms and fever are unexpected SR following GA40 injections and were reported by approximately one quarter of patients. Preliminary data do not support a protective role of previous treatment with GA20.
Disclosure: Chiara Zecca, Giulio Disanto, Claudio Gobbi: The Department of Neurology, Regional Hospital Lugano, Switzerland, receives financial support from TEVA, Merck Serono, Roche, Biogen Idec, Genzyme, and Novartis. None of these agreement was related to the present work.
Rossi S acted as an Advisory Board member of Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Genzyme, and received funding for traveling and honoraria for consultancy, speaking or writing from Biogen Idec, Merck Serono, Teva, Novartis, Bayer Schering, Genzyme, Almirall. She received support for research project by Teva, Merck Serono and Bayer Schering and is involved as principal investigator in clinical trials for Teva, Novartis and Roche.
Mantegazza R acted as an Advisory Board member of Biomarin, received Funding for Travel or Speaker Honoraria from Sanofi-Aventis, Biomarin, Grifols, Teva, Bayer, Alexion, Argenx; he is is involved as principal investigator in clinical trials for Alexion, Merck Serono, Hoffman-La Roche, Teva, Besta-Azienda Ospedaliera San Gerardo, Biogen, Biomarin, Almirall, Novartis, Genzyme Corporation, Catalyst.
Brambilla L received honoraria for speaking from Novartis.
Antozzi C received funding for travel and congress attendance from Biogen, Merck Serono and Teva
Pareja-Gutierrez L, Camera G, Bellavia G, Bernardini L, Perugini J, Gerardi C have nothing to disclosure
Confalonieri P acted as Board member for Biogen-idec and Roche, received support for conference travel from Sanofi-Aventis, Biogen Dompé AG, Merk Serono anf Novarrtis; received support for scientific projects from Merk Serono and Novarstis
Torri Clerici V acted as an Advisory Board member of Merck and Genzyme, and received funding for traveling and honoraria for speaking or writing from Biogen, Merck and Almirall. She received support for research project by Almirall.