TOPLINE:

Patients with rheumatoid arthritis (RA) using abatacept who received the recombinant zoster vaccine (RZV) showed poor immune responses — both humoral and cellular — 4 weeks after the second dose. The vaccine appeared safe and well tolerated, with no increase in RA flares compared with placebo; however, injection-site reactions were common, occurring in 80% of vaccinated participants.

METHODOLOGY:

• Researchers conducted a randomized controlled trial at rheumatology sites in the US to evaluate the immunogenicity and safety of RZV in patients with RA using abatacept.
• They included adults with RA on stable intravenous or subcutaneous abatacept for 30 days or more; concomitant methotrexate ≤ 25 mg/wk and prednisone ≤ 10 mg/d were permitted.
• Patients were randomly assigned in a 4:1 ratio to receive the RZV (n = 56) or placebo (saline; n = 14), administered in two doses 8 weeks apart, with blood collected at weeks 12 and 60.
• The primary immunologic endpoint was assessed at week 12 (4 weeks post-second dose), measuring the proportion of participants with a fourfold or greater increase in anti-glycoprotein E (anti-gE) immunoglobulin G (IgG) antibodies (humoral responders) and a twofold or greater increase in interferon gamma (IFN gamma) or interleukin-2 (IL-2) gE-specific spot-forming cells (cellular responders).
• Safety assessments solicited adverse events post-dose, captured serious adverse events through week 60, and evaluated RA flares using the Disease Activity Score in 28 joints with the erythrocyte sedimentation rate, the Clinical Disease Activity Index, and Outcome Measures in Rheumatology RA flare questionnaire.

TAKEAWAY:

• Among participants receiving RZV, only 42.3% were humoral responders, achieving a fourfold or greater increase in anti-gE IgG concentration at week 12 (geometric mean fold rise, 4.55; 95% CI, 3.16-6.47), whereas no participants in the placebo group were humoral responders.
• Cell-mediated immune responses were limited, with 18.4% of RZV recipients vs 7.1% of placebo recipients achieving a twofold or greater increase in IFN gamma or IL-2 gE-specific spot-forming cells at week 12 and 13.0% of RZV recipients vs 15.4% of placebo recipients achieving this response at week 60.
• The route of abatacept administration affected the responses in the vaccine group : Subcutaneous vs intravenous administration showed a higher humoral response at week 60 (50% vs 12%; P = .02) and a higher cell-mediated response at week 12 (42% vs 6%; P = .01).
• Injection site reactions occurred in 80% of RZV participants, most of which were nonserious. Six serious adverse events were reported (five in the RZV group), all judged unrelated to vaccination; three of these events in the RZV group resulted in death. RA flare rates did not differ between the treatment groups.

IN PRACTICE:

“Our findings suggest that [patients using abatacept ] mount attenuated responses to RZV and may lack clinical protection after vaccination,” the authors of the study wrote. “Alternative strategies to administering this vaccine to those using abatacept should be sought,” they added.

SOURCE:

The study was led by Jeremy A. Hawkins, MPH, Oregon Health & Science University, School of Public Health in Portland, Oregon. It was published online on February 10, 2026, in Annals of the Rheumatic Diseases.

LIMITATIONS:

The study had a relatively small sample and lacked an RA comparator group not using abatacept. The study was underpowered to fully evaluate the influence of concomitant methotrexate use.

DISCLOSURES:

The study was supported through an investigator-initiated research grant from Bristol Myers Squibb. The project was supported by the National Center for Advancing Translational Sciences and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors disclosed serving in consulting or advisory roles and receiving grants from multiple companies, including AstraZeneca, AbbVie, Amgen, Novartis, and others. Additionally, some authors reported receiving speaking and lecture fees, along with travel reimbursement from companies including UCB Pharma, Seqirus, and Swedish Orphan Biovitrum (Sobi). One author reported receiving financial support from the National Institute of Allergy and Infectious Diseases.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.