P789: EFFICACY AND SAFETY OF SWITCHING TO IPTACOPAN (IPTA) MONOTHERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) TREATED WITH THE ANTI-C5 MONOCLONAL ANTIBODY (MAB) TESIDOLUMAB (TESI)

Autor: Kiyoshi Ando, Laimonas Griškevičius, Takayuki Ikezoe, Yoshikazu Ito, Masayoshi Masuko, Yasutaka Ueda, Morten Bagger, Rambabu Danekula, Izabela Rozenberg, Guido Junge, Jiri Mayer

Publikováno v: HemaSphere, Vol 7, p e17022e8 (2023)

Externí odkaz: https://doaj.org/article/3baea057a4f5492bb9c388708b1331fd

Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years

Autor: Stephen L Hauser, Anne H Cross, Kevin Winthrop, Heinz Wiendl, Jacqueline Nicholas, Sven G Meuth, Paul S Giacomini, Francesco Saccà, Linda Mancione, Ronald Zielman, Morten Bagger, Ayan Das Gupta, Dieter A Häring, Valentine Jehl, Bernd C Kieseier, Ratnakar Pingili, Dee Stoneman, Wendy Su, Roman Willi, Ludwig Kappos

Publikováno v: Multiple sclerosis (Houndmills, Basingstoke, England), vol 28, iss 10

Background: Ofatumumab is approved for the treatment of relapsing multiple sclerosis (RMS). Ongoing safety reporting is crucial to understand its long-term benefit–risk profile. Objective: Report the safety and tolerability of ofatumumab in RMS aft

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7139988437461a0ac31674b667d1c754
https://doi.org/10.1177/13524585221079731

Population Pharmacokinetic–B Cell Modeling for Ofatumumab in Patients with Relapsing Multiple Sclerosis

Autor: Huixin Yu, Gordon Graham, Olivier J. David, Joseph M. Kahn, Marina Savelieva, Etienne Pigeolet, Ayan Das Gupta, Ratnakar Pingili, Roman Willi, Krishnan Ramanathan, Bernd C. Kieseier, Dieter A. Häring, Morten Bagger, Per Soelberg Sørensen

Publikováno v: Yu, H, Graham, G, David, O J, Kahn, J M, Savelieva, M, Pigeolet, E, Das Gupta, A, Pingili, R, Willi, R, Ramanathan, K, Kieseier, B C, Häring, D A, Bagger, M & Soelberg Sørensen, P 2022, ' Population Pharmacokinetic–B Cell Modeling for Ofatumumab in Patients with Relapsing Multiple Sclerosis ', CNS Drugs, vol. 36, no. 3, pp. 283-300 . https://doi.org/10.1007/s40263-021-00895-w

Background: Ofatumumab, a fully human anti-CD20 monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (RMS), binds to a unique conformational epitope, thereby depleting B cells very efficiently and allowing subcutan

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4cd1a7371f9906632e07d074109cda96
https://curis.ku.dk/portal/da/publications/population-pharmacokineticbcell-modeling-for-ofatumumab-in-patients-with-relapsing-multiple-sclerosis(d6bf6e3c-651f-4327-b794-143666f97dcf).html

Effect of ofatumumab on pregnancy, parturition, and lactation in cynomolgus monkeys

Autor: Muriel Bellot, C. Marc Luetjens, Morten Bagger, Courtney Horvath, Esther Sutter, Anthony DeLise, Dominique Brees, José M. Carballido, Ratnakar Pingili, Krishnan Ramanathan, Bernd C. Kieseier, Kerstin Hellwig

Publikováno v: Reproductive toxicology (Elmsford, N.Y.). 108

Knowledge of the impacts of the anti-CD20 monoclonal antibody ofatumumab on the developing immune system is limited. This study examined the effects of intravenous ofatumumab on pregnancy, parturition, and lactation, and on pre- and postnatal surviva

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::60a189381fa70939c38c8505d9df9734
https://pubmed.ncbi.nlm.nih.gov/34942355

Intranasal bioavailability of buprenorphine in rabbit correlated to sheep and man

Autor: Karsten Lindhardt, Kasper Huus Andreasen, Erik Bechgaard, Morten Bagger

Publikováno v: International Journal of Pharmaceutics. 217:121-126

The purpose of the present study of buprenorphine is to add information about the correlation between various animal models and nasal bioavailabilities in man. PEG 300 was added to one formulation to study whether the addition of the co-solvent resul

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dd47cc7ef6407776ee0014f34828b52d
https://doi.org/10.1016/s0378-5173(01)00591-9