PT  - JOURNAL ARTICLE
AU  - Winthrop, Kevin
AU  - Vargas, Juan Ignacio
AU  - Drescher, Edit
AU  - Garcia, Conrado
AU  - Friedman, Alan
AU  - Hendrickson, Barbara
AU  - Li, Yihan
AU  - Klaff, Justin
AU  - Kivitz, Alan
TI  - 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
AID  - 10.1136/rmdopen-2021-002110
DP  - 2022 Mar 01
TA  - RMD Open
PG  - e002110
VI  - 8
IP  - 1
4099  - http://rmdopen.bmj.com/content/8/1/e002110.short
4100  - http://rmdopen.bmj.com/content/8/1/e002110.full
SO  - RMD Open2022 Mar 01; 8
AB  - Objective To assess the immunogenicity of pneumococcal 13-valent conjugate vaccination (PCV-13) in patients with rheumatoid arthritis receiving upadacitinib and background methotrexate (MTX).Methods Eligible patients from the phase 2 open-label extension trial BALANCE-EXTEND (NCT02049138) receiving stable dosing of upadacitinib 15 mg or 30 mg once daily plus background MTX were given PCV-13. Antibody titres were collected prevaccination and 4 and 12 weeks postvaccination. The primary endpoint was the proportion of patients with satisfactory humoral response to PCV-13, defined as a ≥2-fold increase in ≥6 of 12 pneumococcal antigens at 4 weeks postvaccination.Results Of 111 patients (upadacitinib 15 mg, N=87; 30 mg, N=24), 85.6% were women, 97.3% used concomitant MTX and 44.1% used oral corticosteroids. At 4 weeks, 67.5% (95% CI 57.4 to 77.5) of patients receiving upadacitinib 15 mg and 56.5% (36.3 to 76.8) receiving 30 mg had a satisfactory PCV-13 response. Responses were similar in patients who used or did not use concomitant corticosteroids. No deaths or serious adverse events were reported.Conclusions Approximately two-thirds of patients receiving upadacitinib 15 mg once daily achieved a satisfactory humoral response to PCV-13 despite receiving concomitant MTX. Concomitant corticosteroid use did not negatively affect PCV-13 response.