Actemra (tocilizumab; Roche/Chugai), known as RoActemra in Europe, is a first-in-class humanized interleukin-6 receptor monoclonal antibody. Intravenous Actemra was first approved for rheumatoid arthritis (RA) in Japan in April 2008. This was followed by EU and US approvals in January 2009 and January 2010, respectively. In October 2013, a new subcutaneous (SC) formulation of Actemra received US Food and Drug Administration approval for use in RA. In the EU and Japan, the SC formulation was approved in April 2014 and March 2013, respectively. In September 2014, Actemra received EU approval for use in patients with early RA.
Actemra (tocilizumab; Roche/Chugai) has not been able to penetrate the first-line biologic setting in rheumatoid arthritis (RA), even though it is approved for use in inadequate responders to one or more disease-modifying antirheumatic drugs (DMARDs). Rheumatologists indicate that they typically use a non-anti-tumor necrosis factor (TNF) biologic after the failure of two anti-TNFs. While the approval of Actemra’s subcutaneous (SC) formulation has led to an overall higher use of the brand, Datamonitor Healthcare expects Actemra to continue being used in late lines of therapy due to the extensive experience rheumatologists have with anti-TNFs and the trust they place in well-established brands such as Enbrel (etanercept; Amgen/Pfizer/Takeda/GlaxoSmithKline) and Humira (adalimumab; AbbVie/Eisai).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Actemra : Rheumatoid arthritis
LIST OF FIGURES
12 Figure 1: Phase III SUMMACTA trial design in rheumatoid arthritis
13 Figure 2: Phase III SUMMACTA 24-week trial results
14 Figure 3: Phase III BREVACTA 24-week trial results
18 Figure 4: Actemra’s SWOT analysis in rheumatoid arthritis
20 Figure 5: Datamonitor Healthcare’s drug assessment summary of Actemra in rheumatoid
20 Figure 6: Datamonitor Healthcare’s drug assessment summary of Actemra in rheumatoid
LIST OF TABLES
4 Table 1: Actemra’s drug profile in rheumatoid arthritis
7 Table 2: Overview of pivotal trial data for Actemra in rheumatoid arthritis
11 Table 3: Trial results for the open-label period (49 weeks) of the SUMMACTA trial in
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