Notes from the field: irAE consortium ‘organizing’ providers across specialties
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Indications for the use of checkpoint inhibitors are ever expanding. However, even as these drugs have helped patients with cancer live longer, the emergence of various immune related adverse events limits their full potential in many.
There is a pressing need for collaboration between various subspecialists, advanced practice providers and, above all, patients to facilitate the understanding of disease mechanisms, diagnosis and the best ways to manage these immune related adverse events (irAEs). To achieve this goal, the inaugural irAE Consortium was held at the Cleveland Clinic on March 7-8, where an array of medical subspecialists, nurses, nurse practitioners, medical trainees and patient partners participated.
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More than 140 participants from 20 institutions convened for both in-person and virtual discussions, including oncologists, pulmonologists, rheumatologists, gastroenterologists, dermatologists, endocrinologists, cardiologists, nephrologists and pharmacists, as well as providers from the fields of palliative care, physical medicine and rehabilitation. Patient advocates kicked off the meeting by sharing their personal experiences with irAEs.
One patient advocate lost her husband due to the development of various irAEs early on when the understanding of these effects was in its infancy. She stressed the need to better understand ways to minimize toxicities from these agents. Another patient advocate highlighted how there is a gap between what physicians know about irAEs and what their patients might need to understand.
Given the limitations of retrospective, single-center studies, multicenter clinical trials are now underway to determine the best management and prophylaxis strategies for irAEs. Two important clinical trials that were discussed included the Nivolumab in Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) trial, and the ATRIUM trial, both of which are currently enrolling patients. The objective of the phase 1b AIM-NIVO trial is to examine the safety of nivolumab (Opdivo, Bristol-Myers Squibb) among patients with various autoimmune diseases.
ATRIUM, meanwhile, is a multi-center phase 3 clinical trial aimed at assessing the efficacy of abatacept (Orencia, Bristol Myers Squibb) vs. placebo for checkpoint inhibitor-related myocarditis. Representing the Alliance for Clinical Trials in Oncology, David Kozono, MD, PhD, of the Dana-Farber/Harvard Cancer Center, presented details regarding a multicenter biobanking registry, which will enable more mechanistic evaluation of checkpoint toxicities.
The irAE Consortium also focused on optimizing interdisciplinary care, including improving patient access to specialists. To minimize patient burden, there exist models where cancer patients see radiation oncologists, surgical oncologists and their primary oncologists on the same day. The key to this model is the fact that these are all oncology specialized practices. We need to expand this model to patients with irAEs, where the patient sees their oncologist and the indicated subspecialists on the same day to enable real time collaboration and care coordination. However, there are barriers intrinsic to our current health care system that prohibit integrated patient-centered care across subspecialties.
One barrier is that oncology has a higher insurance reimbursement rate compared with other specialties. As such, oncology services generally have more support staff, space and time to provide team-based integrated care compared with other, less reimbursed subspecialties — including rheumatology. Another barrier is that developing a niche clinic takes time to build, and comes with a lower volume at first. As medicine is volume based, most health systems operate in 90-day budget cycles that would not readily support such subspecialty clinics. Although oncologists and subspecialties want to collaborate and create a system that provides optimal patient care, the business considerations of medical practice continue to get in the way.
Although the field of irAE diagnosis and treatment is evolving quickly, there remain many knowledge gaps. Treatment of irAEs with immunosuppression carries the risk for dampening anti-tumor immunity. Hence, there is a need for rigorous multicenter trials that will inform treatment guidelines, which, to date, have been largely based upon expert opinion rather than evidence. An important remit of the irAE Consortium will be organizing this group of oncologists and subspecialists from multiple centers to create the structure for collaborative research that can have the most impact.
- For more information:
- Tamiko Katsumoto, MD, is a clinical associate professor in the division of immunology and rheumatology at Stanford University.
- Alexa Meara, MD, is an associate professor in the division of oncology and the division of rheumatology and immunology at the Ohio State University Wexner Medical Center.
- Namrata Singh, MD, MSCI, is an adjunct assistant professor in the department of epidemiology and an assistant professor in the department of rheumatology at the University of Washington School of Public Health.
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