Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis

J 2025

Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis

NEWSOME, Scott D; Ewa KRZYSTANEK; Krzysztof W SELMAJ; Michal DUFEK; Lawrence GOLDSTICK et. al.

Základní údaje

Originální název

Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis

Autoři

NEWSOME, Scott D; Ewa KRZYSTANEK; Krzysztof W SELMAJ; Michal DUFEK (203 Česká republika, domácí); Lawrence GOLDSTICK; Carlo POZZILLI; Catarina FIGUEIREDO; Ben TOWNSEND; Heidemarie KLETZL; Oscar BORTOLAMI; Dusanka ZECEVIC; Caroline GIACOBINO; Susanne CLINCH; Yun-An SHEN; Gurpreet Deol BHULLAR; Hans-Martin SCHNEBLE a Diego CENTONZE

Vydání

Neurology, Philadelphia, LIPPINCOTT WILLIAMS & WILKINS, 2025, 0028-3878

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 8.500 v roce 2024

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1212/WNL.0000000000213574

UT WoS

001472065700001

EID Scopus

2-s2.0-105002677815

Klíčová slova anglicky

Multiple Sclerosis; Subcutaneous Ocrelizumab

Štítky

14110127, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 5. 5. 2025 13:46, Mgr. Tereza Miškechová

Anotace

V originále

Background and ObjectivesIV-administered ocrelizumab (OCR) is approved for the treatment of relapsing and primary progressive multiple sclerosis (RMS/PPMS). OCARINA II (NCT05232825) was designed to demonstrate noninferiority in drug exposure of OCR subcutaneous (SC) vs IV administration.MethodsThis phase 3, randomized, open-label study enrolled OCR-naive patients aged 18-65 years with RMS/PPMS and an Expanded Disability Status Scale score of 0-6.5. Patients received OCR IV 600 mg or OCR SC 920 mg (controlled period), followed by OCR SC 920 mg every 24 weeks, up to week 96 (OCR IV/SC and OCR SC/SC). The primary end point was OCR area under the serum concentration-time curve from day 1 to week 12 (AUCW1-12); other end points included clinical, biomarker, and pharmacodynamic outcomes and safety data.ResultsBaseline demographics were balanced across OCR IV/SC and OCR SC/SC arms (N = 118/118, 40.0 +/- 11.9/39.9 +/- 11.4 years, 59.3%/65.3% female, 89.0%/89.0% with RMS). The study demonstrated noninferiority of OCR SC 920 mg to OCR IV 600 mg for the primary end point AUCW1-12 and also over the dosing interval for AUCW1-24 (geometric mean ratios [90% CI] 1.29 [1.23-1.35] and 1.27 [1.21-1.34], respectively). At week 48, 111 of 118 (OCR IV/SC) and 114 of 118 (OCR SC/SC) had received OCR SC. A near-complete suppression of MRI activity was reported in OCR IV/SC and OCR SC/SC: 0 of 113 and 0 of 113 patients had T1 lesions while 1 of 114 and 1 of 113 had 2 and 1 new/enlarging T2 lesions, respectively. Two patients (1.9%) in each arm had 1 relapse, and 1 patient (0.9%; OCR SC/SC) had 2 relapses. In both arms, rapid and sustained B-cell depletion was observed and serum neurofilament light chain reduction was comparable. Patients receiving at least 1 dose of OCR SC 920 mg in the OCR IV/SC and OCR SC/SC arms reported adverse events (AEs): 75.4% and 86.4%, and serious AEs: 5.9% and 2.5%. The most frequently reported AEs were injection reactions (IRs, 51.5%); local and systemic IRs were experienced by 117 of 233 patients (50.2%) and 27 of 233 patients (11.6%), respectively. All IRs were mild/moderate; intensity and duration decreased with subsequent injections.DiscussionThe OCR SC formulation demonstrated noninferiority to OCR IV formulation regarding drug exposure, providing comparable efficacy and safety and an additional treatment option for patients with multiple sclerosis.Classification of EvidenceThis study provides Class II evidence that a single SC injection of 920 mg of OCR achieves a noninferior 12-week area under serum concentration-time curve to that of 2 IV infusions of 300-mg OCR administered 2 weeks apart.

Citovat

NEWSOME, Scott D; Ewa KRZYSTANEK; Krzysztof W SELMAJ; Michal DUFEK; Lawrence GOLDSTICK; Carlo POZZILLI; Catarina FIGUEIREDO; Ben TOWNSEND; Heidemarie KLETZL; Oscar BORTOLAMI; Dusanka ZECEVIC; Caroline GIACOBINO; Susanne CLINCH; Yun-An SHEN; Gurpreet Deol BHULLAR; Hans-Martin SCHNEBLE a Diego CENTONZE. Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis. Neurology. Philadelphia: LIPPINCOTT WILLIAMS & WILKINS, 2025, roč. 104, č. 9, s. 1-13. ISSN 0028-3878. Dostupné z: https://doi.org/10.1212/WNL.0000000000213574.

@article{2494919,
   author = {Newsome, Scott D and Krzystanek, Ewa and Selmaj, Krzysztof W and Dufek, Michal and Goldstick, Lawrence and Pozzilli, Carlo and Figueiredo, Catarina and Townsend, Ben and Kletzl, Heidemarie and Bortolami, Oscar and Zecevic, Dusanka and Giacobino, Caroline and Clinch, Susanne and Shen, YunandAn and Bhullar, Gurpreet Deol and Schneble, HansandMartin and Centonze, Diego},
   article_location = {Philadelphia},
   article_number = {9},
   doi = {https://doi.org/10.1212/WNL.0000000000213574},
   keywords = {Multiple Sclerosis; Subcutaneous Ocrelizumab},
   language = {eng},
   issn = {0028-3878},
   journal = {Neurology},
   title = {Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis},
   url = {https://pmc.ncbi.nlm.nih.gov/articles/PMC12006663/pdf/WNL-2024-104165.pdf},
   volume = {104},
   year = {2025}
}

TY  - JOUR
ID  - 2494919
AU  - Newsome, Scott D - Krzystanek, Ewa - Selmaj, Krzysztof W - Dufek, Michal - Goldstick, Lawrence - Pozzilli, Carlo - Figueiredo, Catarina - Townsend, Ben - Kletzl, Heidemarie - Bortolami, Oscar - Zecevic, Dusanka - Giacobino, Caroline - Clinch, Susanne - Shen, Yun-An - Bhullar, Gurpreet Deol - Schneble, Hans-Martin - Centonze, Diego
PY  - 2025
TI  - Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis
JF  - Neurology
VL  - 104
IS  - 9
SP  - 1-13
EP  - 1-13
PB  - LIPPINCOTT WILLIAMS & WILKINS
SN  - 00283878
KW  - Multiple Sclerosis
KW  - Subcutaneous Ocrelizumab
UR  - https://pmc.ncbi.nlm.nih.gov/articles/PMC12006663/pdf/WNL-2024-104165.pdf
N2  - Background and ObjectivesIV-administered ocrelizumab (OCR) is approved for the treatment of relapsing and primary progressive multiple sclerosis (RMS/PPMS). OCARINA II (NCT05232825) was designed to demonstrate noninferiority in drug exposure of OCR subcutaneous (SC) vs IV administration.MethodsThis phase 3, randomized, open-label study enrolled OCR-naive patients aged 18-65 years with RMS/PPMS and an Expanded Disability Status Scale score of 0-6.5. Patients received OCR IV 600 mg or OCR SC 920 mg (controlled period), followed by OCR SC 920 mg every 24 weeks, up to week 96 (OCR IV/SC and OCR SC/SC). The primary end point was OCR area under the serum concentration-time curve from day 1 to week 12 (AUCW1-12); other end points included clinical, biomarker, and pharmacodynamic outcomes and safety data.ResultsBaseline demographics were balanced across OCR IV/SC and OCR SC/SC arms (N = 118/118, 40.0 +/- 11.9/39.9 +/- 11.4 years, 59.3%/65.3% female, 89.0%/89.0% with RMS). The study demonstrated noninferiority of OCR SC 920 mg to OCR IV 600 mg for the primary end point AUCW1-12 and also over the dosing interval for AUCW1-24 (geometric mean ratios [90% CI] 1.29 [1.23-1.35] and 1.27 [1.21-1.34], respectively). At week 48, 111 of 118 (OCR IV/SC) and 114 of 118 (OCR SC/SC) had received OCR SC. A near-complete suppression of MRI activity was reported in OCR IV/SC and OCR SC/SC: 0 of 113 and 0 of 113 patients had T1 lesions while 1 of 114 and 1 of 113 had 2 and 1 new/enlarging T2 lesions, respectively. Two patients (1.9%) in each arm had 1 relapse, and 1 patient (0.9%; OCR SC/SC) had 2 relapses. In both arms, rapid and sustained B-cell depletion was observed and serum neurofilament light chain reduction was comparable. Patients receiving at least 1 dose of OCR SC 920 mg in the OCR IV/SC and OCR SC/SC arms reported adverse events (AEs): 75.4% and 86.4%, and serious AEs: 5.9% and 2.5%. The most frequently reported AEs were injection reactions (IRs, 51.5%); local and systemic IRs were experienced by 117 of 233 patients (50.2%) and 27 of 233 patients (11.6%), respectively. All IRs were mild/moderate; intensity and duration decreased with subsequent injections.DiscussionThe OCR SC formulation demonstrated noninferiority to OCR IV formulation regarding drug exposure, providing comparable efficacy and safety and an additional treatment option for patients with multiple sclerosis.Classification of EvidenceThis study provides Class II evidence that a single SC injection of 920 mg of OCR achieves a noninferior 12-week area under serum concentration-time curve to that of 2 IV infusions of 300-mg OCR administered 2 weeks apart.
ER  -

NEWSOME, Scott D; Ewa KRZYSTANEK; Krzysztof W SELMAJ; Michal DUFEK; Lawrence GOLDSTICK; Carlo POZZILLI; Catarina FIGUEIREDO; Ben TOWNSEND; Heidemarie KLETZL; Oscar BORTOLAMI; Dusanka ZECEVIC; Caroline GIACOBINO; Susanne CLINCH; Yun-An SHEN; Gurpreet Deol BHULLAR; Hans-Martin SCHNEBLE a Diego CENTONZE. Subcutaneous Ocrelizumab in Patients With Multiple Sclerosis. \textit{Neurology}. Philadelphia: LIPPINCOTT WILLIAMS \&{} WILKINS, 2025, roč.~104, č.~9, s.~1-13. ISSN~0028-3878. Dostupné z: https://doi.org/10.1212/WNL.0000000000213574.

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