Roche’s Actemra has become the first drug approved by US regulators specifically to treat giant cell arteritis, a form of vasculitis that results in inflammation of blood vessels.
The disease is characterised by inflammation of large and medium sized arteries predominantly in the head and neck, which impedes blood flow, causing symptoms such as severe headache, visual loss, jaw and muscular pain and possibly permanent sight loss if left untreated.
The current approach is to give high-dose steroids to reduce inflammation, but the majority of patients end up experiencing significant side effects such as osteoporosis, cataract, hypertension and type 2 diabetes mellitus because of prolonged use in a cycle of treatment and relapse.
In clinical trials, a greater proportion of patients receiving subcutaneous Actemra (tocilizumab) with standardised prednisone regimens achieved sustained remission from Week 12 through Week 52 as compared to patients receiving placebo with standardised prednisone regimens.
The cumulative prednisone dose was lower in treated patients with Actemra relative to placebo, the US Food and Drug Administration noted.
However, the drug does carry a Boxed Warning for serious infections and, as such, live vaccines should be avoided in patients being treated with it. Also, hypersensitivity reactions, including anaphylaxis and death, have occurred, and laboratory monitoring is recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids and liver function tests, the regulator said.
Subcutaneous Actemra has already picked up a green light to treat moderate to severely active rheumatoid arthritis, while an intravenous formulations of the drug is cleared for moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis.