Firstly, the meeting was a great success. Finally, over 3500 in-person attendees gathered, many for the first time since the beginning of the pandemic. What great relief and joy, once again, to meet, socialize, learn, mentor, and collaborate in the ACG community. In addition, approximately the same number attended virtually; emphasizing how medical education and the development and distribution of best practices, guidelines, training, and research continue to morph in this evolving digital age. While the final cards (think Las Vegas) are not in yet, in-person attendees valued the resurgence of camaraderie and human contacts.
As the current pandemic wanes amidst expanding vaccinations, I remain proud of our international IBD consortia that as early as February 2020 began communicating, studying, and documenting the impact of the SARS-CoV2 virus on our patient population and the potential impact of differing immune modifying medications on risks of COVID course and complications. In particular, the SECURE registry and subsequent institutional experiences from New York provided near “real time”, reassuring data reflecting minimal impacts on COVID outcomes from aminosalicylates, thiopurines, methotrexate, anti-cytokines (TNF, IL12/23), anti-adhesion molecules, and JAK inhibitors often confirmed by rheumatologic and dermatologic societies. At ACG 2021 reassuring data was presented by Kimberly Weaver from UNC representing the “PREVENT-COVID'' cohort (abstract #3 from the Presidential Plenary session), an offshoot from the SECURE registry consortia that documented comparable humoral serologic responses to COVID-19 vaccines despite therapeutic classes…except with steroids. Also consistent with the SECURE registry data, steroids were the only therapeutic class implicated to have negative impacts on disease course and vaccine response!
Hence, the steroid-blight continues to impact both the course and complications of IBD despite consistent messaging regarding long-term harm steroids impose on our patients, including the perpetually demonstrated risks of serious infections, morbidities and deaths that supersede any other drug class.
How can we circumvent the steroid-blight? I consider delayed access to effective steroid-avoidance therapies are the primary reason. Therapy for moderate-severe IBD historically and contemporaneously begins with steroids. Steroids are inexpensive, prescribed without restrictions or authorizations, and can be initiated within minutes to hours of a patient encounter. In contrast, “advanced effective steroid-sparing therapies”, perhaps better utilized as “effective steroid-avoidance therapies” require pre-authorizations, specialty pharmacy consultations, infusion center reservations, specialty nursing education as well as appropriate health maintenance prevention strategies (TB and hepatitis B testing, age-appropriate and opportunistic infection vaccines) after an extensive shared-decision making consultation.
Furthermore, once treated with steroids, steroid-dependence becomes the norm, despite the advent of thiopurines, methotrexate, anti-TNFs, anti-integrins, anti-IL12/23, tofactinib, and ozanimod. Numerous therapy reviews during the conference provided data that far less than 50% of patients receiving steroids in clinical trials are in a steroid-free remission after 1-year.
I believe an important priority in achieving steroid-free treatment of IBD is to accelerate access to steroid-avoidance (vs steroid-sparing) practices. In the absence of prospectively defined comparative effectiveness studies for moderate-severe disease such as Varsity (vedolizumab vs adalimumab in UC) and Seavue (ustekinumab vs adalimumab in Crohn’s disease) informing a prioritization of effective therapies, the current availability of two oral therapies (tofacitinib and ozanimod for UC) affords potential for immediate administration of rapidly acting treatments approved by the FDA (although tofacitinib is currently recommended by the FDA after TNFinibitors). Think office or specialty pharmacy availability for patients who meet “access criteria.” Both manufacturers of the newer oral therapies provide rapid access to patients with commercial insurance. In office infusions or specialty pharmacy distribution of biologics (often on-site at many institutions) could also accelerate access obviate the need to initiate steroids. However it will be necessary to avoid the (imposed) authorization delays that prevent the rapid reduction in symptoms and eventual mucosal and histologic healing for these sick patients burdened by substantial abdominal pain, diarrhea, bleeding, etc.
It's time we relegate steroids to “rescue therapy” rather than first-line symptom palliation that impedes the long-term course of chronic IBD.
Dr. Hanauer is involved in consulting and lectures for Abbvie, Janssen, Takeda, Pfizer, and BMS.
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