Kulasekararaj AG, Brodsky RA, Nishimura JI, et al. The importance of terminal complement inhibition in paroxysmal nocturnal hemoglobinuria. Ther Adv Hematol. 2022;13:20406207221091050.
Article CAS PubMed PubMed Central Google Scholar
Oliver M, Patriquin CJ. Paroxysmal nocturnal hemoglobinuria: current management, unmet needs, and recommendations. J Blood Med. 2023;14:613–28.
Article CAS PubMed PubMed Central Google Scholar
Panse J. Paroxysmal nocturnal hemoglobinuria: where we stand. Am J Hematol. 2023;98(Suppl 4):S20–32.
National Medical Products Administration. NMPA approval notice. 2024. https://www.nmpa.gov.cn/zhuanti/zt2023/ypgzhlfzh/shypqxgg/ggjzcx/20240207173310135.html. Accessed 29 Feb 2024.
Roche. Crovalimab: Chinese prescribing information. 2024. https://assets.roche.com/f/249469/x/dc4cbe0f74/kefalidankangzhusheye_20240206.pdf. Accessed 27 Feb 2024.
Chugai Pharmaceutical. Chugai obtains regulatory approval for “Piasky 340mg” for paroxysmal nocturnal hemoglobinuria in Japan [media release]. 26 Mar 2024. https://www.chugai-pharm.co.jp/english/news/.
Fukuzawa T, Sampei Z, Haraya K, et al. Long lasting neutralization of C5 by SKY59, a novel recycling antibody, is a potential therapy for complement-mediated diseases. Sci Rep. 2017;7(1):1080.
Article PubMed PubMed Central Google Scholar
Sampei Z, Haraya K, Tachibana T, et al. Antibody engineering to generate SKY59, a long-acting anti-C5 recycling antibody. PLoS ONE. 2018;13(12): e0209509.
Article PubMed PubMed Central Google Scholar
Zelek WM, Stott M, Walters D, et al. Characterizing a pH-switch anti-C5 antibody as a tool for human and mouse complement C5 purification and cross-species inhibition of classical and reactive lysis. Immunology. 2018;155(3):396–403.
Article CAS PubMed PubMed Central Google Scholar
Brocchieri C, Beveridge L, Buri M, et al. Rapid complement inhibition with the C5 inhibitor crovalimab: a timing analysis using animal model and COMPOSER trial data [abstract no. 4033 plus poster presentation]. Nephrol Dialy Transplant. 2023;38(Suppl 1):I223–4.
Buatois S, Benkali K, Henrich A, et al. Pharmacokinetic characterization and exposure-response relationship of crovalimab in the COMPOSER and COMMODORE 3 trials of patients with paroxysmal nocturnal hemoglobinuria (PNH) [abstract] [abstract no. Blood. 2022;140(Suppl 1):2918–20.
Röth A, Nishimura JI, Nagy Z, et al. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020;135(12):912–20.
Article PubMed PubMed Central Google Scholar
Nishimura JI, Usuki K, Ramos J, et al. Crovalimab for treatment of patients with paroxysmal nocturnal haemoglobinuria and complement C5 polymorphism: subanalysis of the phase 1/2 COMPOSER study. Br J Haematol. 2022;198(3):e46–50.
Article CAS PubMed Google Scholar
Roth A, Rong FU, He G, et al. Safety of crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH): pooled esults from the phase III COMMODORE 1, COMMODORE 2, and COMMODORE 3 studies [abstract plus poster presentation]. Blood. 2023;142(Suppl 1):575.
Liu H, Xia L, Weng J, et al. Efficacy and safety of the C5 inhibitor crovalimab in complement inhibitor-naive patients with PNH (COMMODORE 3): a multicenter, phase 3, single-arm study. Am J Hematol. 2023;98(9):1407–14.
Article CAS PubMed Google Scholar
Liu H, Xia L, Weng J, et al. Six-month crovalimab extension in the phase 3 commodore 3 study: updated efficacy and safety results in complement inhibitor-naive patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) [abstract no. P785 plus poster]. HemaSphere. 2023;7(Suppl 3): e1287903.
Article PubMed Central Google Scholar
Röth A, He G, Brodsky A, et al. The phase III, randomized COMMODORE 2 trial: results from a multicenter study of crovalimab vs eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) patients naive to complement inhibitors [abstract no. S181 plus oral presentation]. HemaSphere. 2023;7(Suppl 3):187–8.
Panse J, Cermak J, Kyselova O, et al. Patient-reported utcomes (PROs) in patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with crovalimab and eculizumab: results from the phase III randomized COMMODORE 2 and COMMODORE 1 trials [abstract and poster presentation]. Blood. 2023;142(Suppl 1):4090.
Kulasekararaj A, Fernandez FAG, Scheinberg P, et al. Patient preferences and treatment satisfaction in patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with crovalimab and approved C5 inhibitors in the phase III randomized COMMODORE 1 and COMMODORE 2 trials [abstact]. Blood. 2023;142(Suppl 1):5628.
Lundberg P, de la Iglesia S, Kelly RJ, et al. Biomarker analyses in patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with crovalimab and eculizumab: results from the phase III randomized COMMODORE 2 trial [abstract]. Blood. 2023;142(Suppl 1):4088.
Scheinberg P, Cle D, Edwards J, et al. Phase III randomized, multicenter, open-label COMMODORE 1 trial: comparison of crovalimab vs eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria (PNH) [abstract no. S183 plus oral presentation]. HemaSphere. 2023;7(Suppl 3):191–2.
Röth A, Ichikawa S, Ito Y, et al. Crovalimab treatment in patients with paroxysmal nocturnal haemoglobinuria: long-term results from the phase I/II COMPOSER trial. Eur J Haematol. 2023;111(2):300–10.
Peffault de Latour R, Sica S, Ramos J, et al. COMPOSER part 4: an optimized dosing strategy for crovalimab in the treatment of complement inhibitor-naïve or -experienced patients with paroxysmal nocturnal hemoglobinuria [abstract]. Blood. 2020;136(Supplement 1):6–7.
Nishimura JI, Soubret A, Arase N, et al. Mitigating drug-target-drug complexes in patients with paroxysmal nocturnal hemoglobinuria who switch C5 inhibitors. Clin Pharmacol Ther. 2023;113(4):904–15.
Article CAS PubMed Google Scholar
Sreckovic S, Brocchieri C, Leon PG, et al. Phase 3 COMMODORE Trials of crovalimab in paroxysmal nocturnal hemoglobinuria (PNH): impact on Kidney Function [abstract no. SA-PO280 plus poster]. J Am Soc Nephrol. 2023;34:800.
Sheerin N, Greenbaum LA, Ito S, et al. Two phase 3 trials evaluating crovalimab in patients with atypical haemolytic uremic syndrome (aHUS): COMMUTE-a and COMMUTE-p [abstract no. INFO19 plus poster]. In: Kidney Week 2022 Annual Meeting of The American Society of Nephrology. 2022.
Callaghan M, Ataga KI, De Franceschi L, et al. Trial in progress: the randomized, double-blind, placebo-controlled phase 2a crosswalk-c trial evaluating the efficacy of crovalimab as adjunct treatment in the prevention of vasoocclusive episodes (VOEs) in patients (pts) with sickle cell disease (SCD) [abstract no. 5612539]. Hemasphere. 2023;7(Suppl 1):26.
Article PubMed Central Google Scholar
Bartolucci P, Ataga KI, Callaghan M, et al. Trial in progress: The randomized, doubleblind, placebo-controlled phase 1b crosswalk-a trial evaluating the safety of crovalimab for the management of acute uncomplicated vaso-occlusive episodes (VOES) in patients (pts) with sickle cell disease (SCD) [abstract no. 5610823]. Hemasphere. 2023;7(Suppl 1):22.
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