The first prescription of satrilizumab landed in my country, filling the gap in domestic NMOSD treatment!

*Only for medical professionals to read and refer to the first prescription of China's first NMOSD treatment drug, which marks the availability of medicines for NMOSD patients in China
.

On April 30, 2021, satrilizumab was officially approved by the China National Medical Products Administration for the treatment of aquaporin-4 immunoglobulin G antibody (AQP4-IgG)-positive neuromyelitis optica spectrum in patients over 12 years of age disease (NMOSD) patients, becoming the first drug approved for NMOSD treatment indications in China
.

Since its commercial launch at the end of November 2021, patients in Guangdong and Sichuan have started to use satrilizumab injection, marking the first drug approved for the treatment of NMOSD in China to officially benefit patients
.

 High recurrence and high disability, traditional treatment is overstretched.
NMOSD is a group of autoimmune-mediated central nervous system (CNS) inflammatory demyelinating diseases that mainly involve the optic nerve and spinal cord.
NMOSD is a high recurrence and high disability disease.
, More than 90% of patients have multiphase disease course, of which 40%-60% of patients relapse within 1 year, and about 90% relapse within 3 years
.

In the natural history, about 50% of patients have severe visual or motor dysfunction within 5-10 years [1]
.

The first survey of NMOSD patients in China in 2019 showed that more than 60% of patients could not take care of themselves completely[2]
.

NMOSD patients accumulate disability due to frequent and severe disease recurrence [3], so prevention of recurrence is the top priority of NMOSD treatment.
However, most of the existing drugs for prevention of recurrence in China are empirical use of targeted B cells and T cells.
of immunosuppressive drugs, including azathioprine, glucocorticoids, methotrexate, and mitoxantrone, all of which are used off-label, lack high-level evidence, and have unsatisfactory efficacy [4,5], and Existing drugs have many safety problems such as infection and liver function damage, which cannot be ignored [1,6]
.

 AQP4-IgG positive patients are more prone to recurrence than negative patients, and the recurrence symptoms are more severe, so AQP4-IgG is a specific disease marker for NMOSD[7,8]
.

Interleukin-6 (IL-6) specifically increases AQP4-IgG secretion and participates in many aspects of NMOSD disease mechanisms, including specifically promoting plasmablast survival, increasing AQP4-IgG antibody secretion, and promoting inflammatory Th17 cells Differentiation, increase the permeability of the blood-brain barrier, allow AQP4-IgG antibodies and pro-inflammatory cells to enter the center, combine to activate the complement cascade, damage astrocytes, and lead to demyelination [9-11]
.

 Figure 1: IL-6 specifically increases the secretion of AQP4-IgG and is involved in many aspects of the NMOSD disease mechanism.
The approved satrilizumab just targets the IL-6 receptor, binds to the membrane and binds IL-6R and soluble IL-6R.
IL-6R binds, blocks IL-6 signal transduction, and regulates multiple aspects of NMOSD disease, including inhibiting the production of NMOSD-specific antibody AQP4-IgG and alleviating IL-6-related CNS inflammatory responses [12,13]
.

Compared with traditional IgG1 antibodies, satrilizumab uses recirculating antibody technology, that is, it can be dissociated from the receptor under acidic conditions and re-released back into the plasma, where it binds to the antigen multiple times, thereby prolonging the plasma half-life of the drug [14]
.

 Figure 2: Mechanism of action of satrilizumab significantly reduces the risk of relapse, especially in patients with AQP4-IgG(+) Blind, placebo-controlled phase III clinical studies - SAkuraSky [15] and SAkuraStar [16]
.

 SAkuraSky [15] and SAkuraStar [16] aimed to evaluate the efficacy and safety of satrilizumab with or without immunosuppressive agents (IST) in the treatment of patients with NMOSD
.

Baseline data showed that the proportion of AQP4-IgG-positive patients in the SAkuraSky and SAkuraStar studies were 66% and 65%, respectively [15,16]
.

The results showed that at 96 weeks, the proportion of patients without recurrence in the total population of the combination therapy group was 78%, and the 96-week recurrence-free rate of patients with AQP4-IgG positive was as high as 92%, compared with 59% in the placebo group [15]; Satrilizumab also resulted in a relapse-free rate of 72% in the total population, with a 96-week relapse-free rate of 77% in the AQP4-IgG-positive subgroup and 51% in the placebo group [16]
.

 Figure 3: At 96 weeks, SAkuraSky (left) and SAkuraStar (right) study results At 192 weeks (3.
7 years), AQP4-IgG positive patients in the combination therapy group were 71% relapse-free and 91% severe relapse-free %, and 90% of patients without Extended Disability Scale (EDSS) scores; saterilizumab alone also resulted in 73% of AQP4-IgG-positive patients relapse-free and 90% of patients without severe relapse %, and the proportion of patients without continuous deterioration of EDSS was 86% [17]
.

 Figure 4: Pooled analysis of SAkuraSky (left) and SAkuraStar (right) results at 192 weeks The results of SAkuraSky and SAkuraStar found [18] that satrilizumab significantly reduced severe PDR by 79% (meaning research protocol-defined relapse) risk (P=0.
002), in addition, a combined double-blind and open-label extension-phase analysis [19] showed that satrilizumab significantly reduced investigator-reported PDR risk by 51% of the total population (P=0.
002) , significantly reduced the risk of PDR reported by 66% of the AQP4-IgG positive population (P < 0.
001), and patients can continue to benefit from long-term use
.

 In terms of safety, in the double-blind (DB) phase and open extension phase of the two studies, the incidence of infection and serious infection in the satrilizumab group was comparable to the placebo group, and there were no serious allergic reactions and deaths [20, 21]
.

Moreover, its safety profile was comparable between the DB phase and the overall saterilizumab treatment (OST) phase of both studies, with adverse events in the saterilizumab and placebo groups during the OST phase ( AEs) and serious AEs occurred at rates comparable to those in DB, overall and serious infection rates during OST were similar to DB, and no allergies related to study treatment were reported during DB or OST in either study Reactions, all injection-related reactions were not serious and did not lead to treatment interruption or discontinuation [22]
.

Table 1: Summary of Adverse Events During DB and OST in 2 Studies For patients, satrilizumab is convenient to use because it is administered subcutaneously and can be self-administered by patients or caregivers at home with appropriate training Injections can be used at home, and patients can avoid multiple visits to the hospital due to injections [23]
.

It is reported that in the early stage of the commercial launch of satelizumab, in order to ensure that NMOSD patients can receive satrilizumab injection in a timely manner, satrilizumab injection can be purchased online and offline pharmacies with prescriptions in the following ways: 1.
You can call the national designated drug purchase service hotline 010-64019487 for details; 2.
Offline drug purchase address: China Resources Suzhou Li'an Pharmaceutical Chain Store Co.
, Ltd.
Pharmaceutical Building
.

As the first drug approved for NMOSD treatment indications in China, the approval of satrilizumab fills the gap of NMOSD treatment drugs in the Chinese market, and also symbolizes the arrival of a new treatment era for NMOSD, which is an epoch-making milestone.
The issuance of the first prescription marks that this drug has officially benefited NMOSD patients in China
.

Satrilizumab will benefit more patients and their families with its significantly reduced recurrence, good safety profile and convenience
.

 It is reported that satrilizumab injection has recently been commercially launched in China, and relevant information or information can be inquired through the following email address: wenxun@yxj.
org.
cn
.

References: [1] Guidelines for the diagnosis and treatment of neuromyelitis optica spectrum disorders in China (2021 edition) [J].
Chinese Journal of Neuroimmunology and Neurology, 2021, 28(06): 423-436.
[2] 2019 Chinese Optic Nerve Comprehensive social survey of patients with myelitis spectrum diseases Volume 23 Issue 3 [5] Ciron.
J Rev Neurol (Paris) .
2018 Apr;174(4):255-264[6]Tahara M, et al.
Lancet Neurol 2020;19:298–306.
[7] Guidelines for the diagnosis and treatment of neuromyelitis optica spectrum disorders in China[J].
Chinese Journal of Neuroimmunology and Neurology,2016,23(03):155-166.
[8]Jan-Patrick Stellmann, et al.
J Neurol Neurosurg Psychiatry.
2017 Aug;88(8):639-647.
[9]Araki M, et al.
Neurochem Int.
2019 Nov;130104315.
Epub 2018 Oct 17.
[10]Chihara N, et al.
Proc Natl Acad Sci US A.
2011 Mar 1;108(9)3701-6.
[11]Wang, et al.
Brain Disord Ther 2015, 43 1000e119.
[12]Schett G.
Rheumatology 2018;57:ii43-ii50[13]Kim GW et al.
Arch Pharm Res 2015;38:575-84.
[14]https:// Accessed May 2020.
[15]Yamamura T et al.
N Engl J Med.
2019 Nov 28;381(22):2114-2124[16]Traboulsee A, et al.
Lancet Neurol.
2020 May;19(5):402-412.
[ 17] Ingo Kleiter, et al.
ACTRIMS/ECTRIMS 2021: Long-term efficacy of satralizumab in AQP4-IgG-seropositive NMOSD Results from the open-label extension periods of SAkuraSky and SAkuraStar[18]J.
Palace, et al.
ACTRIMS/ ECTRIMS 2020: Relapse Severity in SAkuraSky and SAkuraStar[19]B.
Greenberg, et al.
ACTRIMS/ECTRIMS 2020: SAkuraSky/SAkuraStar Pooled Efficacy OLE[20]Benjamin M.
Greenbergd, et al.
ACTRIMS/ECTRIMS 2020: Safety of satralizumab based on pooled data from phase 3 studies in patients with neuromyelitis optica spectrum disorder[21]Brian G.
Weinshenker, et al.
ACTRIMS/ECTRIMS 2020: Infections in SAkuraSky and SAkuraStar[22]Benjamin M.
Greenbergd, et al.
ACTRIMS/ECTRIMS 2021Long-term safety of satralizumab in neuromyelitis optica spectrum disorder Results from the open-label extension periods of SAkuraSky and SAkuraStar: [23]Satrilizumab China Instructions *This article is for healthcare professionals only Scientific information, does not represent the platform's views