The U.S. Food and Drug administration has approved the use of Roche’s Actemra/RoActemra (tocilizumab) subcutaneous injection for giant cell arteritis(GCA), a severe autoimmune disease which affects nearly 280,000 people in U.S. every year.
What is Giant cell arteritis?
Giant cell arteritis is a severe autoimmune condition which mostly affect people above 50 years of age. Women have more chances of developing this disease than men. It is a type of vasculitis involving inflammation of arteries of scalp and head. The most common symptoms include headaches, jaw pain, facial pain and difficulties with vision. Symptoms when left untreated might lead to loss of vision,aortic aneurysm or stroke.
How is GCA treated?
Treatment for GCA has been limited to high dose corticosteroid therapy which can effectively reduce inflammation and prevent serious complications but fails to manage the disease in long term. Corticosteroid therapy when continued for long term can give rise to diabetes mellitus, steroid myopathy, vertebral compression fractures, steroid psychosis, and immunosuppression-related infections.
Actemra is an interleukin-6 receptor inhibiting humanised monoclonal antibody available in subcutaneous and intravenous formulations.The drug has been previously approved for treating moderate to severely active rheumatoid arthritis, juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis. With this new indication, Actemra has become the first FDA approved medication for treating GCA specifically.
About GiACTA Study
The approval is based on a double-blind, placebo controlled Phase III GiACTA study (NCT01791153) which included 251 patients with GCA. Actemra when initially combined with a six month steroid regimen, was more effective in sustaining remission for one year (56 percent in the Actemra/RoActemra weekly group and 53.1 percent in the Actemra/RoActemra bi-weekly group) compared to placebo combined with a 26-week steroid taper (14 percent) and placebo combined with a 52-week steroid taper (17.6 percent).
Competitors of Actemra
Some possible competitors of Actemra are under various stages of clinical development. These include GlaxoSmithKline’s sirukumab (IL-6 inhibitor under Phase III trial), Incyte corporation and Eli Lilly’s baricitinib (reversible inhibitor of JAK1 and JAK2 under Phase II trial) and Janssen Biotech’s ustekinumab (IL-12/23 inhibitor under Phase 1 trial). Study evaluating the safety and efficacy of Janssen Biotech’s Remicade (infliximab) was terminated as the drug did not reduce number of first relapses in GCA. AbbVie’s Humira (adalimumab) was not successful in increasing the remission in patients with GCA.
Since there have been no new therapies for this disease in last 50 years and the universally accepted treatment using corticosteroids has its own limitations, approval for Actemra will give new hopes to people suffering from GCA.