Spherix Global Insights

September 06, 2018

Ankylosing Spondylitis Market Largely Dominated by TNF-Inhibitors, Though Novartis’ Cosentyx Enjoyed Significant Year Over Year Gains and a Growing Percent of Rheumatologists Report Off-Label Use of Pfizer’s Xeljanz

With no current FDA approved biologics for the treatment of non-radiographic axial spondyloarthropathy, overall penetration of biologics/JAKs is significantly lower than for ankylosing spondylitis; however, when these agents are prescribed, brand usage closely mirrors the ankylosing spondylitis indication, according to a new publication by Spherix Global Insights

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EXTON, Pa., September 6, 2018 (Newswire.com) – Spherix Global Insights has just released the results of an independent report based on a survey of 104 US rheumatologists which highlights differences in the management of patients with active ankylosing spondylitis (AS) and those with non-radiographic axial spondyloarthropathy (nr-axSpA). The report is the second wave of an annual study that monitors treatment patterns in these markets.

The report found that the majority of patients come under rheumatologists’ care from primary care physician referrals after an estimated three years of misdiagnosis and unsuccessful treatment. Radiographic imaging is paramount to correctly diagnosing and treating the disease, but nearly two-thirds of rheumatologists believe primary care physicians are not properly educated on identifying AS and nr-axSpA symptomology, indicating a significant number of patients must live with important quality of life limitations.

While the majority of AS patients are currently treated with a biologic/JAK regimen, significantly fewer patients with nr-axSpA are treated with these agents, despite the majority of these patients being considered biologic-eligible. Lower rates of treatment in the nr-axSpA population potentially point to the difficulties in the approval process, given there currently are not any FDA approved agents for the treatment of nr-axSpA. AbbVie’s Humira and Amgen’s Enbrel continue to be the most preferred biologics for both conditions, accounting for the lion’s share of biologic use. Furthermore, patients with AS and nr-axSpA are significantly more likely to respond to their first-line biologic treatment, resulting in higher TNF share compared to analogue markets, such as rheumatoid arthritis and psoriatic arthritis, and indicating a tough road ahead for new agents who are aiming to compete in this market.

Despite TNF inhibitor dominance, Novartis’ Cosentyx continues to show potential as a viable alternate treatment option. Almost two years post-launch, Cosentyx is being used by more than half of surveyed rheumatologists for AS, a significant increase over 2017 reports, and Cosentyx’s market share now eclipses that of more established options like UCB’s Cimzia and Janssen’s Simponi. Additionally, rheumatologists report that Novartis sales representative were more likely than other representatives to focus their messaging around the AS indication (as opposed to other rheumatology-treated indications) during their recent visits. While still lagging AbbVie, Novartis has made significant gains in being recognized as an industry partner for their collaboration to help improve the management of AS and nr-axSpA. Partially attributable to Novartis’ focus and dedication to the spondyloarthropathy space, use of the IL-17 inhibitor is expected to increase significantly over the next six months, with the AS user base projected to surpass 90%. While the same positive trends with Cosentyx are observed for nr-axSpA, Humira will continue to hold on as market leader, maintaining its position as the preferred agent for both types of axial disease.

Other year-over-year changes highlight an increased willingness among rheumatologists to prescribe Xeljanz off-label for AS. Satisfaction with the brand for both AS and nr-axSpA has increased significantly over the prior year, largely driven by its convenient oral formulation. With over five years of post-marketing experience in rheumatoid arthritis and a newly minted psoriatic arthritis indication, it is not surprising that rheumatologists are increasingly experimenting with off-label use in AS and nr-axSpA. Indeed, future projections for use of Xeljanz in AS continue to be bullish.

Reaction to Janssen’s newly approved Simponi Aria for AS has been more reserved, with rheumatologists still unsure of the value proposition provided by less frequent dosing and faster infusion times. As a result, they are less likely to believe that Simponi Aria fulfills any unmet needs, as Janssen’s own Remicade is already well-entrenched as the go-to option for patients suitable for infusion.

Regarding the AS and nr-axSpA pipeline, rheumatologists highly desire an oral formulation, agents with an alternative mechanism of action, an agent that is efficacious for TNF failures, as well as the availability of a predictive test for identifying appropriate patients. Rheumatologists report the greatest familiarity with agents already approved in other indications, Xeljanz (or other JAK inhibitors in general) and Eli Lilly’s ixekizumab (Taltz). Less top of mind for rheumatologists is Sun Dermatology’s tildrakizumab (Ilumya), however, that may be influenced by the recent negative trial readout for AbbVie’s risankizumab in AS, which shares a similar mechanism of action (IL-23 inhibition). Though at present, the treatment patterns for nr-axSpA are very similar to those in AS, rheumatologists are quick to agree that an official nr-axSpA indication would bolster the use of any agent able to secure the FDA stamp for nr-axSpA use.

RealTime Dynamix: Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthropathy is an independent report series published annually. The series tracks the evolution of the AS and nr-axSpA market, provides a deep dive on launch effectiveness, and highlights opportunities for pipeline agents.

About Spherix Global Insights
Spherix Global Insights is a business intelligence and market research company specializing in renal, autoimmune, neurologic and rare disease markets. We provide clients with strategic insights leveraged from our independent studies conducted with healthcare providers and other stakeholders.

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