Roche’s RoActemra beats Humira in arthritis study
pharmafile | March 5, 2012 | News story | Research and Development, Sales and Marketing | Humira, RA, RoActemra, Roche, arthritis
Roche’s rheumatoid arthritis drug RoActemra has beaten Abbott’s Humira in a head-to-head study.
The Phase IV trial showed that RoActemra (tocilizumab) achieved a significantly greater reduction in disease activity after six months, when compared to patients taking Humira (adalimumab).
The ADACTA trial is the first study of its kind to determine superiority between two approved rheumatoid arthritis (RA) drugs in this setting.
The trial was studying the drugs in RA patients who had an intolerance or inadequate response to methotrexate (MTX).
MTX is widely prescribed for people with the disease, but around one in three patients on a biologic medicine do not take MTX, as they are intolerant to the drug
Hal Barron, head of global product development at Roche, said: “These data add to the growing body of evidence supporting the benefit of RoActemra alone when methotrexate is not appropriate.
“Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients.”
Humira gained FDA approval for RA in 2003 for moderately to severely active RA on its own or in combination with MTX, or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Since then it has added Crohn’s disease, psoriatic arthritis, and ankylosing spondylitis to its list of approved indications.
The drug will soon face generic erosion across all markets, but will become the world’s biggest selling drug before it loses exclusivity.
The Humira brand made $7.9 billion in sales in 2011 and is now expected to replace Lipitor as the biggest selling by global revenue drug this year, according to analysts at EvaluatePharma.
RoActemra, which is co-developed by Roche and Chugai, was approved for arthritis in Europe in 2009 and the US a year later, and is hoping to gain significant market share as Humira’s patent expiry bites.
Its US license is to treat patients with moderate to severe RA who have not adequately responded to or cannot tolerate other approved drugs for the disease.
But the RA marketplace is a crowded one, with J&J’s Remicade and Pfizer’s Enbrel all competing for their share.
The market is set to become even more crowded with Pfizer’s JAK inhibitor tofacitinib waiting in the wings, which could be more attractive to patients due to its tablet form, whereas the others are all injectables.
Remicade, Enbrel and Humira also have a number of other licences, including indications for Crohn’s disease, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis.
RoActemra also has licences for systemic juvenile idiopathic arthritis and Castleman’s disease, and made Roche CHF618 ($676 million) million last year.
Ben Adams
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