If AbbVie is successful with its FDA application submission for JAK inhibitor Rinvoq in adult patients with ankylosing spondylitis (AS), the drug is expected to greatly increase its patient pool – accumulating 2028 sales of $113m in AS across the seven major markets (7MM*) – but may have a tough time to gain ground in the axSpA market due to strong competition both within and outside of its drug class, says GlobalData, a leading data and analytics company.

Antoine Grey, Senior Immunology Analyst at GlobalData, comments: “Although Rinvoq is widely expected to be prescribed as a third-line or fourth-line therapy in the AS treatment algorithm, the fact that AbbVie only recruited biologic-naïve patients in its SELECT Axis 1 study suggests that the company believes its drug has a chance at being prescribed to these patient types before market staples such as anti-TNFs and the anti-IL-17s.

“Rinvoq may struggle in the AS market as recommendations made in the 2019 update of the American College of Rheumatology’s (ACR) axSpA treatment guidelines suggest this will not be the case. For example, Pfizer’s Xeljanz (tofacitinib), another JAK inhibitor seeking approval in AS, is recommended as a treatment option only after a patient experiences primary or secondary nonresponse with an anti-TNF and then an anti-IL-17 drug.”

On top of treatment algorithm placing, Rinvoq will have to face other difficulties when entering the AS market.

Grey continues: “With Xeljanz and Galapagos’s filgotinib both aiming for an AS approval, Rinvoq is looking at fierce competition within its own drug class and will have to contend with cheaper biosimilar options launching at various points in the next few years. Infliximab biosimilars are already available and adalimumab biosimilars launching in the US in 2023.”

AbbVie is already conducting a Phase III study named SELECT Axis 2 that is examining the safety and efficacy of Rinvoq in patients with a milder form of axSpA, called non-radiographic axSpA (nr-axSpA).

Grey adds: “With an approval in nr-axSpA, Rinvoq could substantially increase its patient pool, although it will still see competition in this patient segment from UCBs Cimzia (certolizumab pegol), Novartis’s Cosentyx (secukinumab), and Taltz. Overall, Rinvoq has an uncertain future ahead in the axSpA market.”

* 7MM: The US, France, Germany, Italy, Spain, the UK and Japan

If you would like to know more, please email your questions to Rebecca Panks, PR Executive at GlobalData (pr@globaldata.com)