Ana Pons1, José Rosas1, José Miguel Senabre2, JC Cortés-Quiroz1, Carmen Raya-Santos2, Gregorio Santos-Soler2, Lara Pons2, Marisa Lorente2, José Antonio Bernal3, Xavier Barber4 and José Alberto Garciía-Gómez4, 1Rheumatology Department, Hospital Marina Baixa, Villajoyosa, Spain, 2Hospital Marina Baixa, Villajoyosa, Spain, 3Hospital Marina Baixa (Villajoyosa), Alicante, Spain, 4CIO Miguel Hernández University Elche, Alicante, Spain
Background/Purpose: Patients receiving treatment with JAK inhibitor drugs (JAKi) have an increased risk of developing herpes zoster (HZ). A new recombinant vaccine effective against HZ (Shingrix-RV) is current available , with an indication for patients treated with JAKi
Methods: Retrospective study of the safety in the first 2 weeks after receiving the first dose of the HZ-RV in patients with RA treated with JAKi, followed up in the Rheumatology Clinic of our center.
The following variables were collected: general information of the patients, type of JAKi and time in treatment; use and dosage of DMARDcs drugs and/or corticosteroids; number of vaccines against COVID-19 received and side effects. Regarding HZ: infection prior to HZ-RV and time elapsed; occurence and type of side effects during the two weeks after vaccination
Results: Of 107 patients on treatment with JAKi, 99 (93%) patients were finally analyzed, and 8 (7%) were removed from the analysis: 5 patients refused vaccination and 3 had had HZ less than 1 year, before vaccination, being a mean of 36 months in treatment with JAKi. Twenty-one (20%) patients have had HZ more than a year before vaccination. Twenty-six (26%) had previously suffered from COVID19. Ninety-four (95%) patients received the first vaccine against COVID19, 91 (92%) the second and 84 (85%) patients the third.
Eighty-nine (89%) are female, with a mean age: 61 (SD: 12) years, on JAKi treatment a mean of: 2.2 (SD: 2.6) years. 76 (71%) patients were treated with baricitinib (2 mg/day dose: 26 [34%] patients; 4 mg/day: 50 [66%] patients), upadacitinib: 28 (26%) and 3 (3%) patients with tofacitinib. Seventy-five (65%) patients were receiving DMARDcs: methotrexate: 46 (70%) with a mean weekly dose: 13 mg, leflunomide: 15 (21%), hydroxychloroquine: 7 (10%), sulfasalazine: 2 (3%). Forty-three (41%) patients received prednisone: mean daily dose: 4.5 mg (SD: 3.2).
Sixty-five (66%) patients had any side effects: local pain: 61 (94%) patients, fatigue: 16 (25%), arthralgia-myalgia: 9 (14%), fever-low-grade fever: 8 (12%), headache: 7 (11%), local itching: 3 (5%), gastrointestinal symptoms: 2 (3%) and others in 4 (6%) patients (urinary tract infection, oral ulcer, dizziness, injection site erythema).
Lymphadenopathy, hospital admission or serious secondary effects were not detected in any patient. A flare of RA, early after vaccination was not detected.
Conclusion: In patients with RA treated with JAKi, evaluated two weeks after receiving the first dose of HZ-RV: 1. Vaccination is safe. 2. Although 66% of patients have experienced any side effect, these are mild. 3. No flare of RA has been detected in this early period. 4. No relationship was detected between patients who presented side effects with the COVID19 vaccine and with HZ-RV.
Disclosures: A. Pons, None; J. Rosas, None; J. Senabre, None; J. Cortés-Quiroz, None; C. Raya-Santos, None; G. Santos-Soler, None; L. Pons, None; M. Lorente, None; J. Bernal, None; X. Barber, None; J. Garciía-Gómez, None.