Therapy Areas: Autoimmune
Janssen's Stelara and Pfizer's Xeljanz Battle Takeda's Entyvio to Claim the Preferred Alternate Mechanism of Action Position in Inflammatory Bowel Disease Patients Who Are Being Switched from Their Current Treatment, According to Spher
15 January 2019 - - US-based business intelligence and market research company Spherix Global Insights has published the third annual edition of RealWorld Dynamix: Biologic/JAK Switching in IBD, a large-scale audit examining the charts of 1,006 inflammatory bowel disease patients recently switched from one biologic/JAK inhibitor to another brand, the company said.

The 2018 study found that TNF inhibitors were largely preferred for first-line treatment in both Crohn's disease and ulcerative colitis, though close to half of surveyed gastroenterologists (n=191) chose an alternate mechanism of action in CD and in UC as their preferred agent for second-line treatment.

Likewise, the majority of respondents agree that they typically move to an alternate MOA agent after an initial first-line TNF failure when treating IBD.

Indeed, analysis of the patient level data substantiated gastroenterologists' self-reported preference for second- or later-line treatment options.

While TNF cycling has remained the most common switching pattern, the rate of consecutive TNF use has decreased dramatically over the past two years.

As such, the alternate advanced therapy segment of the market has increased in both CD and UC, at the expense of the established TNF inhibitors, namely AbbVie's Humira and Janssen's Remicade.

Takeda's Entyvio, a monoclonal antibody which shares the "alternate MOA" tag with Janssen's IL-12/23 inhibitor, Stelara, and Pfizer's JAK inhibitor, Xeljanz, is competing for their piece of that second-line share in both CD and UC.

In Crohn's disease, Entyvio and Stelara are neck and neck in the battle for switches from TNFs, though the former is preferred by slightly more gastroenterologists in the second line.

Conversely, in UC, while Entyvio captured significantly more switches than newcomer Xeljanz, the latter is shaping up to be a major threat. Indeed, had Xeljanz not been on the market, respondents indicated that Entyvio could have gained an additional 5% of the recent UC switches, but these patients were ultimately prescribed Pfizer's oral JAK inhibitor instead.

Findings from the patient chart audit correspond with data from the latest quarterly update of Spherix's RealTime Dynamix: Inflammatory Bowel Disease report series.

US gastroenterologists (n=101) report that TNF inhibitors continue to dominate brand share in both CD and UC; however, TNF inhibitor share has steadily declined over the past two years, while alternate MOA share has done just the opposite, with the continued uptake of Entyvio playing a key role.

Of note, according to the Q4 2018 report, Entyvio had significantly higher share in UC (competing against Xeljanz) than it did in CD, where it has faced head-on competition from key competitor Stelara.

Interestingly, over half of surveyed gastroenterologists perceive Entyvio as performing significantly better in UC than in CD, which may explain the distinction in share between each indication but begs the question as to why CD share of Stelara has not matched or exceeded that of Entyvio's and future share projections indicate the IL-12/23 inhibitor will continue to lag Entyvio into 2019.

On the other hand, more gastroenterologists anticipate increasing their current use of Xeljanz compared to Entyvio in UC over the next three months.

While the battle continues for these brands to claim the position as the preferred alternate MOA agent, it cannot go unsaid that this group has yet to break the "TNF first" prescribing habits of gastroenterologists, as seen in the continued dominance of TNF cycling in the patient chart audit and TNF brand share in the quarterly report.

While Xeljanz's oral formulation bodes well for the drug to successfully penetrate the first-line patient segment, other factors including market access issues and product labeling could be preventing earlier uptake.

Indeed, over one-third of respondents agree that they would use Xeljanz as their first-line choice in UC if payer approval was equivalent to that of established TNFs. Experience and time on the market may just be what is holding the alternate advanced therapies back from overtaking the established TNFs in this increasingly dynamic market.

RealWorld Dynamix: Biologic/JAK Switching in IBD (n=191 physicians, n=1,006 patients), fielded in September 2018, will help you to understand the drivers of treatment switches in this volatile market.

The study continues the annual audit series, trending data from 2016 and 2017 studies and blends physician attitudes ("what they say") with patient record data ("what they do") to understand which products are positioned by the doctor in which patient.

A parallel audit, RealWorld Dynamix: Biologic/JAK Switching in IBD (n=283 physicians, n=1,261 patients), fielded in September-October 2018, examines IBD patients in the EU5 (France, Italy, Germany, Spain, and the UK) who were switched from on from one biologic/JAK to another brand.

RealTime Dynamix: Inflammatory Bowel Disease is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development.

The next wave of the study will field in March 2019 and will continue to track emerging trends, with a focus on the Xeljanz launch in UC. A companion report series, RealTime Dynamix: Inflammatory Bowel Disease, tracks the evolution of the IBD market in the EU5 countries on a bi-annual basis and will field next in 2Q19.

Spherix Global Insights is an independent business intelligence and market research company, specialising in renal, autoimmune, neurologic and rare disease markets.
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