罗氏皮下注射剂型Actemra获加拿大批准

关键词:罗氏,Actemra,单抗,皮下注射剂型,类风湿性关节炎,tocilizumab

2014年5月9日讯 /生物谷BIOON/ --罗氏(Roche)5月8日宣布,皮下注射(SC)剂型Actemra(通用名:tocilizumab)获加拿大卫生部批准,用于对一种或多种疾病修饰抗风湿药物(DMARDs)和/或肿瘤坏死因子(TNF)拮抗剂响应不足的中度至重度活动性类风湿性关节炎(RA)成人患者的治疗。

与静脉注射(IV)剂型Actemra,Actemra SC可用作单药疗法,也可与甲氨蝶呤(MTX)或其他非生物类DMARDs联合用药。罗氏计划于6月将Actemra SC推向市场。

Actemra是首个也是唯一一个获加拿大批准可同时用于静脉注射给药(IV)和皮下注射给药(SC)的人源化白细胞介素6受体拮抗剂单克隆抗体。临床试验中,Actemra SC和Actemra IV具有同等的疗效和安全性。

Actemra SC的获批,是基于III期临床试验SUMMACTA和BREVACTA研究的数据。

SUMMACTA是一项随机、双盲、活性药物对照、平行组、多中心III期临床研究,在1262例中度至重度活动性RA患者中开展。研究结果表明,皮下注射剂型(subcutaneous,SC)Actemra(162mg/周),达到了与静脉注射剂型(intravenous,IV)Actemra(8mg/kg/4周)相媲美的疗效,各组在24周时达到ACR20反应的患者比例相似(Actemra SC vs Actemra IV :69% vs 73% )。 24周时的安全性分析表明,除SC组注射部位反应外,SC组和IV组不良事件相当。

Brevacta是一项随机、双盲、平行组III期研究,调查了皮下注射剂型Actemra联合DMARDs用于治疗中度至重度活动性类风湿性关节炎患者时相对于安慰剂和DMARDs的疗效和安全性。研究结果表明,与安慰剂+DMARDs治疗组相比,Actemra SC+DMARDs治疗组有更多的患者达到ACR20反应(61% vs 32%)。该项研究中,除注射位点反应外,未发现临床意义的新安全信号。(生物谷Bioon.com)

英文原文:Health Canada Approves ACTEMRA? (tocilizumab) Subcutaneous For Use In Adult Patients Living With Moderately To Severely Active Rheumatoid Arthritis

MISSISSAUGA, ON, May 8, 2014 /CNW/ - Roche today announced that Health Canada has approved a subcutaneous (SC) formulation of ACTEMRA (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF) antagonists.1 Like the intravenous (IV) formulation, the SC formulation can be used both as a single-agent therapy, or monotherapy, and in combination with methotrexate or other non-biologic DMARDs.2 The ACTEMRA pre-filled syringe (PFS) injection formulation will be available in Canada in June.

ACTEMRA SC is the first and only humanized interleukin-6 receptor-antagonist monoclonal antibody approved by Health Canada for both subcutaneous and intravenous administration in rheumatoid arthritis. The subcutaneous formulation has comparable efficacy and safety to the IV formulation.3,4 Under guidance of a healthcare practitioner and after appropriate training, adult patients or the patient's caregiver will be able to administer ACTEMRA SC via a pre-filled syringe at home.1

"ACTEMRA SC is an option for RA patients who are better suited to a subcutaneous injection or for those who don't respond well to methotrexate, as it can be administered as a monotherapy," says Dr. Boulos Haraoui, Rheumatologist at Centre hospitalier de l'Université de Montréal (CHUM Montreal). "In the studies, patients responded well to ACTEMRA SC – it reduced inflammation while having a good safety profile."

"This announcement is exciting for RA patients throughout Canada," says Terri Lupton, Registered Nurse Clinician specializing in Rheumatology. "Patients who are currently prescribed a subcutaneous formulation appreciate the ease of self-injection at home, and ACTEMRA SC provides another great option for these patients."

The approval is based on data from the Phase III clinical trials SUMMACTA and BREVACTA. The recommended starting dose of ACTEMRA SC for adult patients who have had an inadequate response to one or more DMARDs and/or TNF antagonists is 162 mg given every other week followed by an increase to once every week based on clinical response as a subcutaneous injection.1

About SUMMACTA

SUMMACTA is a randomized, double-blind, active-controlled, parallel-group, multicenter study with a double-blind period of 24 weeks in 1,262 patients with moderately to severely active RA. SUMMACTA demonstrated comparable efficacy (non-inferiority) of the SC formulation of ACTEMRA 162 mg given weekly plus DMARDs compared to 8 mg/kg of ACTEMRA given intravenously every four weeks plus DMARDs in patients with moderately to severely active RA in the DMARD-IR population (20 percent of whom had inadequate response to anti-tumor necrosis factor [anti-TNF] therapy). A similar proportion of RA patients in each group experienced at least a 20 percent improvement in tender and swollen joints (American College of Rheumatology [ACR] 20 response) at Week 24 (69 percent with ACTEMRA SC formulation vs. 73 percent with ACTEMRA IV). Analysis of safety at Week 24 showed that the adverse event profile of the SC and IV groups were comparable, except for SC injection site reactions.

About BREVACTA

BREVACTA is a randomized, double-blind, parallel-group study of ACTEMRA SC versus placebo SC in combination with traditional DMARDs in patients with moderately to severely active RA who had an inadequate response to DMARD therapy. In the study, 656 patients were randomly assigned in a 2:1 ratio to two treatment groups receiving ACTEMRA SC every two weeks administered with a PFS and placebo SC every two weeks with a PFS. All patients continued their background DMARD therapy.

Results from BREVACTA showed RA patients who received the SC formulation of ACTEMRA every two weeks plus DMARDs were significantly more likely to have achieved ACR20 response than those given placebo SC plus DMARDs at 24 weeks (61 percent vs. 32 percent, respectively). At Week 24, significantly less structural joint damage progression was observed in patients receiving ACTEMRA SC plus DMARDs compared to placebo plus DMARDs as assessed radiographically and expressed as a change from baseline in the van der Heijde modified total Sharp score (mTSS) (mean change from baseline in mTSS of 0.62 vs. 1.23, respectively, with an adjusted mean difference of -0.60 [-1.1, -0.1]). No new clinically meaningful safety signals for ACTEMRA, except SC injection site reactions, were observed in this study.

About ACR20

ACR20 score represents a 20 per cent reduction in tender and swollen joint counts in addition to a corresponding improvement in three of the following five parameters:

Acute phase reactant (such as erythrocyte sedimentation rate)

Patients Global Assessment of Disease Activity

Physicians Global Assessment of Disease Activity

Pain scale

Health Assessment Questionnaire (HAQ)

About Rheumatoid Arthritis (RA)

RA is thought to affect about one per cent of the population worldwide5, and has both an emotional and physical impact on a person's quality of life. Physically, RA causes individuals to experience morning stiffness, lack of flexibility, tiredness, pain, and joint swelling, while emotionally, it leaves a large number of patients feeling isolated and alone. In Canada, RA affects about 300,000 individuals, or one in every 100.6

RA is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anemia, and osteoporosis, and may contribute to shortening life expectancy by affecting major organ systems. Furthermore, musculoskeletal conditions, including arthritis, are the second most costly category of diseases in Canada at $16.4 billion.7

About ACTEMRA Subcutaneous

ACTEMRA (tocilizumab) subcutaneous is a formulation of ACTEMRA designed to be administered via injection under the skin. It complements the intravenous (IV) formulation that is infused into a vein over a one-hour period in a hospital setting. The subcutaneous formulation of ACTEMRA, along with the IV formulation, allows physicians more flexibility to tailor the treatment to different RA patient's needs.

The ACTEMRA subcutaneous formulation comes in a pre-filled syringe and has comparable efficacy and safety to the established IV formulation.2,8 Subcutaneous administration via the pre-filled syringe takes approximately 15 seconds. Under the guidance of a healthcare practitioner and after appropriate training, adult patients or the patient's caregiver will be able to administer ACTEMRA via pre-filled syringe at home.

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