Karen H. Costenbader, MD, MPH: Clinical Rheumatology Year in Review

Rheumatology interviewed Karen H. Costenbader, MD, MPH, to discuss her ACR Convergence presentation, “Year in Review: Clinical Rheumatology.” Costenbader is a rheumatologist at Brigham and Women’s Hospital. She discusses the key takeaways of her presentation, including challenges, the biggest successes in the world of rheumatology in 2021, and her predictions for 2022.

Rheumatology Network: What are the key takeaway points of your presentation?

Karen H. Costenbader, MD, MPH: The rheumatology clinical research community produces a very high volume of excellent research annually! There were so many studies this year that it was very challenging to pick and choose and hope I did rheumatology clinical investigators justice. I organized the talk into 5 themes of this year: testing new medications for rheumatic diseases, assessing JAK inhibitors: the evolving story, improving clinical care, examining disparities, and combating COVID-19.

RN: What are some of the challenges rheumatologists have faced this year?

KC: Obviously the ongoing pandemic and rapidly evolving data and guidance have been a huge challenge for us all, and especially for clinical rheumatologists and their patients. Huge kudos to all the rheumatology clinical and basic scientists who have been right in the thick of collecting and analyzing these data, leading to new and targeted recommendations for immunosuppressed patients. We now know that individuals at higher risk of severe COVID-19, inadequate vaccination responses, breakthrough infections, and death include those taking glucocorticoids, immunosuppressive and B cell depleting therapies, and those with high disease activity. This has led to evolving ACR, CDC, and FDA guidance and new recommendations for repeat vaccine doses for immunosuppressed, elderly, and high-risk people (healthcare workers).

Another challenge has been the evolving story concerning JAK inhibitor safety, leading to a new black box warning about increased risk of cardiovascular events, cancers, blood clots, and death for all classes of JAK inhibitors and for all diseases. We are still awaiting the full peer-reviewed publication of the results of the 4-year Pfizer long-term safety study, but we know it did not meet the non-inferiority margin and prove that tofacitinib was not worse in these regards than anti-TNF drugs (among 4,362 patients with rheumatoid arthritis), and now patients and their physicians are rightly concerned.

RN: What are some of the successes you’ve seen in clinical rheumatology in 2021?

KC: Successful trials of new oral agents as add-on therapies, and hopefully steroid-sparing therapies, for both ANCA-associated vasculitis and lupus nephritis. Avacopan, an oral C5a inhibitor, was just FDA-approved in October as add-on therapy for severe ANA-associated vasculitis, and voclosporin, an oral calcineurin inhibitor without need for intensive monitoring, was approved by the FDA in January 2021. Perhaps a new day is dawning in both of these difficult to treat diseases!

The clinical rheumatology community is really pulling together and organizing and contributing to large observational cohorts, such as the ACR’s Rheumatology Informatics System for Effectiveness (RISE) registry and the Global Rheumatology Alliance (GRA) registry. These have led to high impact studies and new insights about our diseases.

RN: Do you have any predictions for rheumatology in 2022?

KC: I hope we will see more high-quality and positive trials for new therapies for rheumatic diseases. I am particularly excited about new oral medications that can be steroid-sparing for difficult to treat diseases with large unmet need. Additionally, maybe even before 2022, we should have the publication of the Pfizer ORAL Surveillance phase 3b/4 tofacitinib vs. anti-TNF safety trial that was mandated by the FDA. I‘m sure there will be a lot of interest in pouring over those results in detail! Lastly, we are learning more about how to COVID vaccinate our immunosuppressed patients effectively and multiple ongoing studies, including a large multicenter NIH-sponsored trial, will hopefully provide more answers about holding versus continuing medications and for how long, and whether we should re-test anti-COVID antibody levels and how often, etc.

RN: What are you most looking forward to in the upcoming ACR Convergence?

KC: I am most looking forward to connecting with my peers and colleagues from all over the world. I’ll be in the virtual Lupus Community Hub for 4 hours a day for 4 days and hope as many people come to visit as possible so that we can hash out all the talks and abstracts and breaking news together.

RN: Is there anything else you’d like our audience to know?

KC: Despite the challenges of not being together, this ACR Convergence promises to be a great conference. The ability to go back and review lectures and abstract presentations at a later time was key to my learning last year, as you can’t possibly capture it all in real time. In that respect, it is better than the in-person meeting.