Patients Taking Anti-Inflammatory Drugs Respond Less Well to COVID-19 Vaccine

One-quarter of people who take the drug methotrexate for common immune system disorders — from rheumatoid arthritis to multiple sclerosis — mount a weaker immune response to a COVID-19 vaccine, a new study shows.

Published recently in Annals of the Rheumatic Diseases, the study addressed disorders that result when the immune system, meant to fight disease and drive healing, is triggered abnormally. This in turn causes inflammation, the pain and swelling that come as immune cells rush into damaged or infected tissue, but often in the wrong amount or context. Called immune-mediated inflammatory disorders, they are typically treated with drugs that reduce inflammation, including methotrexate.

Led by researchers at NYU Grossman School of Medicine, the new study looked specifically at patients’ responses to the Pfizer-BioNTech mRNA COVID-19 vaccine, which they measured by looking at the antibodies produced in each patient by the vaccine. Once injected into the body, vaccine ingredients are meant to trigger the production of antibodies, immune proteins that specifically glom onto this viral target protein, disabling it and tagging it for removal from the body.

The lower antibody response in patients who take methotrexate does not necessarily mean that these patients are not protected against COVID-19, cautions co-first study author Rebecca Haberman, MD, clinical instructor in the Department of Medicine at NYU Langone Health.

“It is most important to state that patients should not be concerned about our study findings as the majority of patients with immune system disorders are responding well to the mRNA vaccines,” Dr. Haberman says. “It is also possible that methotrexate is delaying, rather than preventing, an adequate immune response against COVID-19.”

Researchers have known that rheumatoid arthritis patients who take methotrexate have a reduced response to seasonal flu vaccines. Because mRNA vaccines use a new mechanism of action that patients with these common immune disorders have not seen before, the researchers wanted to determine how well these patients are protected.

The research was conducted at NYU Langone and at Friedrich-Alexander University Erlangen Nuremberg in Germany and enrolled healthy people and patients treated for common immune-mediated disorders, including rheumatoid arthritis, psoriatic arthritis and psoriasis. Study participants received two doses of Pfizer-BioNTech mRNA COVID-19 vaccine. The researchers analyzed blood samples to determine the amount of antibodies patients produced after receiving the vaccine and measured the activation of key immune system cells, including CD8 killer T cells, which are generated as part of the body’s immune response.

The researchers found that over 90 percent of healthy subjects and patients taking drugs other than methotrexate to control inflammation in both the New York and German study groups mounted strong antibody responses. Patients with immune-mediated inflammatory disorders who were taking methotrexate achieved an adequate response in only 62 percent of cases. Similarly, while healthy patients and those with common immune disorders who were taking anti-inflammatory drugs other than methotrexate produced CD8 T cells, patients taking methotrexate did not show an increase in CD8 T cell activation after vaccination.

“More research is needed to understand why such a significant proportion  of people with common immune disorders who take methotrexate have deficiencies in mounting an antibody and cellular response,” says study co-senior author Jose U. Scher, MD, an associate professor in the Department of Medicine at NYU Langone. “This may not necessarily mean that the vaccine is not efficacious, but that alternate vaccine strategies need to be investigated.”

These alternate vaccine strategies include potentially discontinuing methotrexate during the time these patients receive the vaccine, changing the dosage of methotrexate or possibly administering a booster shot to the vaccine, says Dr. Scher, who is also director of the Psoriatic Arthritis Center at NYU Langone. The research team is currently leading studies to determine the best course of action for these patients.

This work was supported by National Institutes of Health grants R01 AR074500, T32 AR069515, and UM1 AI148574; a Rheumatology Research Foundation Scientist Development Award; the Bloomberg Philanthropies COVID-19 Initiative; the Pfizer COVID-19 Competitive Grant Program; The Beatrice Snyder Foundation; and The Riley Family Foundation.

Dr. Scher has served as a consultant for Janssen, Novartis, Pfizer, Bristol Myers Squibb, Sanofi and UCB, and Abbvie, and he has received funding for investigator-initiated studies from Novartis, Sanofi, Pfizer and Janssen. Dr. Haberman has received consulting fees from Janssen. Study co-investigators Peter M. Izmirly, MD, has received consulting fees from GSK and Momenta/Janssen; and Steven B. Abramson, MD, has received grants from Johnson and Johnson. Study co-corresponding author Mark J. Mulligan, MD, has received grants from Eli Lilly, Pfizer, and Sanofi and personal fees from Meissa Vaccines. All of these relationships are being managed in accordance with the policies and procedures of NYU Langone.

In addition to Drs. Scher, Haberman, Izmirly, Abramson, and Mulligan, other NYU Langone investigators are co-first authors Ramin Herati, MD, and Marie Samanovic-Golden, MD; and study co-investigators Rebecca B. Blank, MD, PhD; Michael Tuen, PhD; Sergei B. Koralov, PhD; Joseph R. Allen; Rochelle L. Castillo, MD; Amber R. Cornelius; Paula Rackoff, MD; Gary E. Solomon, MD; Samrachana Adhikari, PhD; Natalie E. Azar, MD; Pamela Rosenthal, MD; Jonathan Samuels, MD; Brian D. Golden, MD; and Soumya M. Reddy, MD. Other researchers involved in the study are co-corresponding author Georg Schett, MD, PhD; co-first author David Simon, MD; and study co-investigators Raja Atreya, MD; Koray Tascilar, MD; and Markus Neurath, MD, at Friedrich-Alexander University Erlangen Nuremberg.

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”