Spherix Global Insights

August 16, 2022

New IBD Mechanisms of Action Are Poised to Gain EU5 Patient Switches as Anti-TNF Therapy Efficacy Fades in Ulcerative Colitis and Crohn’s Disease, According to Spherix Global Insights

AbbVie’s Rinvoq is primed for breakout switching opportunities in the EU5 UC market with its approval by the EMA

EXTON, Pa., August 12, 2022 /PRNewswire/ — According to the latest report published as part of Spherix’s RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (EU) service, EU gastroenterologists (n=285) have accelerated their switching of ulcerative colitis (UC) and Crohn’s disease (CD) patients from anti-TNF therapies to treatments that include new pathways such as IL12/IL23 inhibition, α4β7 integrin binding, JAK inhibition, and S1P modulation. The Spherix study  includes 1,280 unique IBD patient records from the EU5 (France, Germany, Italy, Spain, and the UK) that encapsulate patient-level data.

All patients were recently switched from one advanced therapy to another, and the study examines several aspects of the process of switching, such as the criteria for assessing a potential switch patient, the clinical attribute drivers in the decision to switch, and the consideration set for switched therapies.

The report also identifies a significant level of opportunity that still exists for new pathways and agents in IBD. Similar to previous years, more than one-quarter of UC and CD patients are switched to another advanced therapy every year due to efficacy of a therapy waning or patients being unable to get to full clinical remission. More specifically, 27% of UC patients and 30% of CD patients who have recently switched did so because of secondary efficacy failure.

The biosimilar therapies (infliximab and adalimumab) are the two treatment options most likely to trigger an efficacy-based switch. In UC, half of the patients who switched due to secondary efficacy failure were previously on a biosimilar; in CD, that estimate rises to 55%. In fact, when combining biosimilars and brands, TNF therapy represents the switch-from agent for a majority of all UC and CD patients.

While EU5 gastroenterologists may be switching to another TNF therapy in some cases, alternative mechanism of action therapies (AMOAs) represent more than half of all the “switched to” therapies in UC and CD treatment areas. While Galapagos/Gilead’s Jyseleca and BMS’ Zeposia are recently AMOA switch options since their approval late last year, Janssen’s Stelara is still the most commonly switched to AMOA therapy, capturing nearly one-fifth of all UC switches and close to one-third of all CD switches.

Along with a deep profile of each patient record in terms of time since diagnosis, comorbidities, lab results, and treatment history – the report profiles each available UC and CD brand, along with the infliximab biosimilars and adalimumab biosimilars as a separate class (across several different metrics), including:

  • Time on the previous agent before switching
  • Primary and secondary reasons for switching with follow-up probes if efficacy, cost, safety or tolerability is the reason for the switch
  • Primary and secondary reasons for new choice/switched to agent with follow-up probes if efficacy, MOA, patient request, is the reason for the selection
  • What other agents were also considered at the switch and analysis of why the selection was/was not made

The audit also includes a future perspective as it asks about the potential switch opportunities for several UC and CD pipeline therapies if they were approved and available. Most notably, this analysis revealed a significant potential for future switching to AbbVie’s Rinvoq (upadacitinib) in UC, given its approval by the EMA.

About RealWorld Dynamix™
RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (EU) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,200 patients. The report uncovers the “why” behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.