Rheumatoid Arthritis Researchers Limber Up

Tuesday 25 February 2014, Amsterdam

Upcoming therapeutics and an emerging biosimilars industry will improve the lives of Rheumatoid Arthritis (RA) sufferers around the world, claims a new report by healthcare experts.

The new report states that the chronic autoimmune disease, which causes inflammation and deformity of the joints, forces nearly 50% of patients to give up work during the first decade following diagnosis due to the physical, emotional, and financial burdens of the condition. The estimated direct and indirect cost of RA therapy in the US in 2011 alone reached close to $19 billion. The disease therefore represents a huge personal and social burden, making its treatment of paramount importance.

Abbott has been a dominant player in the RA market due to the success of Humira (adalimumab), but the drug is faced with a looming patent expiry, which will see Abbott’s sales start to slip. Humira does have a loyal following and looks likely to maintain the lion’s share of the market in 2022, but Abbott’s lack of RA pipeline products suggests that the company’s RA fortunes will fade.  

Many RA drugs such as Humira already offer patients good safety and efficacy profiles, and current R&D efforts therefore aim to offer something new to the market – oral administration, more convenient dosing frequencies, novel mechanisms of action (MOA), or improved drug availability based on formulations.  

Upcoming pipeline products include Pfizer’s first-in-class JAK3 inhibitor tofacitinib, which offers a novel MOA and oral formulation, Eli Lilly’s first-in-class anti-BAFF (B-cell activating factor) compound tabalumab, and Rigel Pharmaceuticals/AstraZeneca spleen tyrosine kinase (SYK) inhibitor (AZ) oral treatment, fostamatinib. These compounds will challenge current biologics, and attempt to dislodge the market dominance of TNF inhibitors, if their safety and efficacy profiles are proven.  

The emergence of biosimilars will also provide alternatives to current biologics, and hopefully at a lower cost. The impending arrival of biosimilars is predicted for many markets, including the US, who are anticipated to finalize a biosimilar approval pathway in time for the patent expiration of Remicade and Actemra in 2015. However, emerging markets present a challenge for companies producing RA biologics. While these countries represent a potential source of massive sales growth, there is increasing pressure in these markets to provide cost-effective drug access, and both India and China have been manufacturing and selling biosimilars for top-selling RA therapies despite the protests of Big Pharma against patent infringement.

Future developments in the RA market would ideally see predictive biomarker tools allowing the increased identification of early-stage RA patients, increased understanding of disease pathogenesis, and corresponding new drug targets. So far, no definitive cause of the disease has been found, but research has suggested several hypotheses involving genetics, environment, and infectious agents.  Insights into disease progression may help meet the need of a curative therapy, as current therapies can only act to alleviate RA symptoms.

Analysts estimate RA drug sales in 2012 will reach over $15.5 billion across the US, the UK, France, Germany, Italy, Spain, Japan, China, India and Australia, reaching over $21 billion by 2022.