Recent milestones include Pfizer’s Xeljanz approval for PsA in December, the pending review of Xeljanz in UC expected in mid-2018, and this week’s announcement by AbbVie that its JAK1 has been granted Breakthrough Therapy Designation by the FDA for atopic dermatitis.
EXTON, Pa., January 10, 2017 /PRNewswire/ — On-going, independent research conducted by Spherix Global Insights over the past several years highlights expanding use of Pfizer’s JAK inhibitor Xeljanz (tofacitinib) in rheumatoid arthritis (RA), with momentum anticipated to continue. Over the past year, the Xeljanz user-base and rheumatologist reported satisfaction with the agent in RA has consistently increased. Additionally, over half of all rheumatologists surveyed in Q4 (n=103), note that they would place Xeljanz in their top three RA-treatments, if limited to just three, while many also report that it has recently been easier to secure insurance approvals for Pfizer’s JAK. Finally, over half of the collaborating rheumatologists anticipate increasing their use of Xeljanz for RA in 2018 and projected six month share reveals significant future gains for the brand. However, positive projections for Xeljanz in RA are just the beginning of what is shaping up to be a JAK-explosion that will cut across many autoimmune conditions.
To be certain, Pfizer benefitted from Eli Lilly’s stumble with what would have been the second-to-market JAK inhibitor, Olumiant (baricitinib). Approval delays for Olumiant pushed back the re-filing date to later this month, giving Pfizer at least another six months of free reign as the only RA JAK in play. Given this delay, it looks as though 2018 will be the year for Pfizer to solidify Xeljanz’s position and inject major growth into the brand with a potential trifecta in hand: expanding use in RA (by far the largest population), its newly minted indication in psoriatic arthritis (PsA), and a highly anticipated entry into the gastroenterology space with a possible new indication for ulcerative colitis (UC).
According to Spherix’s latest research in PsA, conducted in December just prior to the approval, the majority of rheumatologists plan immediate incorporation of Xeljanz into the PsA treatment paradigm. In fact, a sizeable percent reported off-label experience with the agent prior to approval. Additionally, data from large scale patient audits in PsA conducted in 2016 and 2017 reveals the patient preference for an oral agent in PsA is exceptionally high, which historically has fueled use of Celgene’s Otezla. However, rheumatologists report less than half of the Otezla-treated PsA patients are well-managed, presenting immediate switch opportunities for Xeljanz. The studies also indicate that Xeljanz will largely compete for first-line non-TNF use in PsA, taking on the IL-17 inhibitors (Novartis’ Cosentyx and Lilly’s Taltz, also recently approved in PsA) and Janssen’s Stelara. While the lack of an indication in psoriasis could potentially be a barrier for Xeljanz, the patient audit found that the majority of switches in PsA were related to joint efficacy issues rather than skin efficacy.
In the gastroenterology space, the availability of an efficacious, oral treatment is highly anticipated, and an oral formulation was one of the top attributes desired in new biologics or small molecule agents amongst surveyed gastroenterologists. Patient audit data for patients with UC and Crohn’s disease illustrates that TNF cycling has been losing favor as alternative MOA agents, in the form of Takeda’s Entyvio and Stelara, are capturing a solid second-line position. This is likely where Xeljanz will compete in UC, due to market access practices that largely favor a “TNF first” algorithm and the oral formulation which will provide a substantial advantage over Entyvio’s IV option.
A little further down the pipeline other JAKs are percolating, including AbbVie’s upadacitinib, Gilead/Galapagos’ filgotinib, and Lilly’s Olumiant. Upadacitinib just received Breakthrough Therapy Designation in atopic dermatitis, a condition that recently saw the first biologic entry in 2017 with Sanofi-Regeneron’s Dupixent (dupilumab). As evidenced by the crowded pipeline, opportunity in atopic dermatitis is massive with patients and dermatologists being, at best, moderately satisfied with topical agents and resistance by some to move to an injectable agent, again opening the door for a potent oral option. Upadacitinib is also being developed for RA, PsA, UC and Crohn’s and, all clinical data aside, the market should not underestimate the heritage of AbbVie in all of these areas. According to on-going quarterly tracking in RealTime Dynamix, AbbVie (with blockbuster Humira) outperforms competitors with regard to company perceptions about support for healthcare providers and patients among rheumatologists, dermatologists, and gastroenterologists.
Despite the JAK-infusion across immunology, not everything is rosy for the oral mechanism. Recent data suggests that use of JAK inhibitors may be associated with an increased risk of thromboembolic adverse events. Though Xeljanz does not presently carry an associated safety label for such issues, recent data from Spherix suggests a potential “class effect” association could be in the works. Indeed, when rheumatologists were prompted about the potential safety issues associated with JAKs and VTE’s, the respondents were divided with regard to how their perceptions of Xeljanz’s safety are impacted, with half noting it has no effect on their views of Xeljanz, and the other half reporting that they believe a “class effect” could be at play, and will proceed to prescribe Xeljanz with increased caution.
Safety issues aside, the big question in 2018 is how will specialists compartmentalize all of these new agents entering the market and to what extent can products sharing the same MOA truly differentiate from each other? Pipeline JAKs are counting on Pfizer to expand JAK use in 2018 – from there on it becomes a question of whether the class can grow the markets or whether cannibalization will become the norm as new JAKs are approved.
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About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.
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