Upadacitinib Use Does Not Affect Pneumococcal Vaccine Response in Patients With RA

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Researchers studied the response to pneumococcal vaccination among patients with rheumatoid arthritis receiving upadacitinib and methotrexate.

Patients with rheumatoid arthritis (RA) had a satisfactory humoral response to the pneumococcal 13-valent conjugate vaccine (PCV-13), despite use of immunosuppressive agents such as upadacitinib, methotrexate (MTX), and corticosteroids, according to a results of a study published in RMD Open.

Multiple studies have evaluated pneumococcal vaccine response in patients with RA receiving disease-modifying antirheumatic drugs (DMARDs), including Janus kinase (JAK) inhibitors; however, limited information is available on stopping JAK inhibitor or MTX treatment prior to vaccination.

To evaluate the humoral response of PCV-13 in patients with RA receiving concomitant upadacitinib and MTX, researchers used data from a phase 2 open-label extension study (BALANCE-EXTEND; ClinicalTrials.gov Identifier: NCT02049138).

Participants from the BALANCE-EXTEND trial who received upadacitinib 15 mg or 30 mg once-daily and MTX for at least 4 weeks prior to and after PCV-13 vaccination were included in the current analysis. Patients receiving corticosteroids continued to receive a stable dose of less than 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after vaccination.

Primary endpoint was satisfactory humoral response, which was defined as a 2-fold increase or more in at least 6 of 12 pneumococcal antigens at 4 weeks after vaccination.

A total of 111 patients (upadacitinib 15 mg, n=87; upadacitinib 30 mg, n=24) were included in analysis. A total of 97.3% and 44.1% of patients received treatment with concomitant MTX and oral corticosteroids, respectively.

A total of 67.5% and 56.5% of patients who received upadacitinib 15 mg and upadacitinib 30 mg, respectively, mounted a satisfactory humoral response to PCV-13 at 4 weeks after vaccination. Similar results were seen at week 12 (64.6% and 54.5%, respectively).  

Overall, PCV-13 vaccination was well tolerated, with adverse effects reported among 18 patients (16.2%) 30 days after vaccination; however, no serious adverse events or death occurred.

Study limitations included the small sample sizes, the lack of a control group, and the fact that the results may not be generalizable to patients with RA receiving other vaccinations.  

“Future studies should assess whether temporary discontinuation of either upadacitinib or MTX (or both) would further enhance the immune response to PCV-13, particularly in older adults who are more likely to have a less robust response,” the researchers added.

Disclosure: This research was supported by AbbVie Inc. Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of authors’ disclosures.


Winthrop K, Varga JI, Drescher E, et al. Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study. RMD Open 2022;8:e002110. doi:10.1136/rmdopen-2021-002110