Safety evaluation of shorter infusion for ocrelizumab in a substudy of the Phase IIIb CHORDS trial

被引：4

作者：

Bermel, Robert A. ^{[1
]}

Waubant, Emmanuelle ^{[2
]}

Pardo, Gabriel ^{[3
]}

Bass, Ann ^{[4
]}

Repovic, Pavle ^{[5
]}

Newsome, Scott ^{[6
]}

Lindsey, John W. ^{[7
]}

Kile, Deidre ^{[8
]}

Pradhan, Ashish ^{[8
]}

Musch, Bruno ^{[8
]}

Zabeti, Aram ^{[9
]}

机构：

[1] Cleveland Clin, Neurol Inst, Mellen Ctr Multiple Sclerosis, Cleveland, OH 44106 USA

[2] Univ Calif San Francisco, Weill Inst Neurosci, San Francisco, CA 94143 USA

[3] Oklahoma Med Res Fdn, Multiple Sclerosis Ctr Excellence, 825 NE 13th St, Oklahoma City, OK 73104 USA

[4] Neurol Ctr San Antonio, San Antonio, TX USA

[5] Swedish Neurosci Inst, Seattle, WA USA

[6] Johns Hopkins Univ Hosp, Div Neuroimmunol & Neuroinfect Dis, Baltimore, MD USA

[7] Univ Texas Hlth Sci Ctr Houston, Dept Neurol, Houston, TX 77030 USA

[8] Genentech Inc, San Francisco, CA 94080 USA

[9] UC Waddell Ctr Multiple Sclerosis, Cincinnati, OH USA

来源：

ANNALS OF CLINICAL AND TRANSLATIONAL NEUROLOGY | 2021年 / 8卷 / 03期

关键词：

D O I：

10.1002/acn3.51310

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing-remitting multiple sclerosis who had a suboptimal response to previous disease-modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing four doses of OCR per initial US prescribing recommendations in the main study, participants in the substudy (N = 129) received a fifth dose over a 2-h duration (vs. 3.5 h). Infusion-related reactions occurred in 12.4% of patients. None were severe, life-threatening or led to treatment discontinuation. Shorter infusion time did not change the safety profile of OCR. Clinicaltrials.gov (NCT0237856).

引用

页码：711 / 715

页数：5

共 13 条

[1]

[Anonymous], 2020, PRESCRIBING INFORM

[2]

[Anonymous], 2017, Prescribing Information

[3]

[Anonymous], 2020, Summary of Product Characteristics

[4] Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS [J].

Hartung, Hans-Peter .

NEUROLOGY-NEUROIMMUNOLOGY & NEUROINFLAMMATION, 2020, 7 (05)

[5] Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis [J].

Hauser, S. L. ;

Bar-Or, A. ;

Comi, G. ;

Giovannoni, G. ;

Hartung, H. -P. ;

Hemmer, B. ;

Lublin, F. ;

Montalban, X. ;

Rammohan, K. W. ;

Selmaj, K. ;

Traboulsee, A. ;

Wolinsky, J. S. ;

Arnold, D. L. ;

Klingelschmitt, G. ;

Masterman, D. ;

Fontoura, P. ;

Belachew, S. ;

Chin, P. ;

Mairon, N. ;

Garren, H. ;

Kappos, L. .

NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (03) :221-234

[6]

Kolaczkowski, 2017, MULTIPLE SCLEROSIS N

[7] Ocrelizumab infusion experience in patients with relapsing and primary progressive multiple sclerosis: Results from the phase 3 randomized OPERA I, OPERA II, and ORATORIO studies [J].

Mayer, Lori ;

Kappos, Ludwig ;

Racke, Michael K. ;

Rammohan, Kottil ;

Traboulsee, Anthony ;

Hauser, Stephen L. ;

Julian, Laura ;

Kondgen, Harold ;

Li, Carrie ;

Napieralski, Julie ;

Zheng, Hanzhe ;

Wolinsky, Jerry S. .

MULTIPLE SCLEROSIS AND RELATED DISORDERS, 2019, 30 :236-243

[8] Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis [J].

Montalban, X. ;

Hauser, S. L. ;

Kappos, L. ;

Arnold, D. L. ;

Bar-Or, A. ;

Comi, G. ;

de Seze, J. ;

Giovannoni, G. ;

Hartung, H. -P. ;

Hemmer, B. ;

Lublin, F. ;

Rammohan, K. W. ;

Selmaj, K. ;

Traboulsee, A. ;

Sauter, A. ;

Masterman, D. ;

Fontoura, P. ;

Belachew, S. ;

Garren, H. ;

Mairon, N. ;

Chin, P. ;

Wolinsky, J. S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (03) :209-220

[9]

Multiple Sclerosis Society of Canada, 2020, FAC PAG

[10] Safety of infusing rituximab at a more rapid rate in patients with rheumatoid arthritis: results from the RATE-RA study [J].

Pritchard, Charles H. ;

Greenwald, Maria W. ;

Kremer, Joel M. ;

Gaylis, Norman B. ;

Rigby, William ;

Zlotnick, Steve ;

Chung, Carol ;

Jaber, Birgit ;

Reiss, William .

BMC MUSCULOSKELETAL DISORDERS, 2014, 15

← 1 2 →