Efficacy, immunogenicity and safety of live-attenuated herpes zoster vaccination in patients with AIIRD
| First author +ref. | Year | Study design | No. cases | Efficacy | Immunogenicity | Safety | Influence IS on eff./imm. | LoE | ||
| Eff. | Imm. | Saf. | ||||||||
| Winthrop170 | 2017 | RCT | 55 RA MTX+TFC* 57 RA MTX+PCB* | – | Similar CMI response. Trend towards higher humoral response MTX+TFC | 3 SAE in MTX-TFC group versus 0 in MTX+PCB: one cholangitis, one bronchitis and one disseminated primary varicella in seronegative patient. Mild AE no difference. | See column immunogenicity. | – | 2b | 4 |
| Russell173 | 2015 | RCT | 206 GC vacc. (25% PMR) 100 GC PCB-vacc (31% PMR) Mostly no AIIRD. >10–20 mg: n=39 | – | Higher postvacc. humoral response in vacc. | More injection-site AE and headache in vacc. Other systemic and serious AE: no difference. | No influence of limited daily GC dose | – | 2b | 4 |
| Koh169 | 2018 | Cohort | 41 RA 28 OA | – | Lower CMI response in RA. Similar humoral response. | No SAE. Mild systemic AE in 11.6% of all participants. 6 RA flares during 12 weeks postvacc. Median Disease Activity Index unchanged. | – | – | 2b | 4 |
| Zhang167
and Yun168 | 2012 2017 | Cohort (retrospective database) | Total: 463 541 Vacc: 18 683 (4.0%) Vacc on biologics: 633 7780 vaccinated patients in analysis | Lower incidence of HZ in vacc. patients. Rapid decline difference incidence rate vacc. and unvacc. 6 years postvacc: no longer significant. | – | <42 of vacc: HZ incidence decreased, no cases of hospitalised meningitis or encephalitis, no HZ in patients using biologics | Lower HZ incidence in vacc. patients using biologics, DMARDs or GC alone | 2b | – | 4 |
| Guthridge171 | 2013 | Cohort | 10 SLE 10 HC | – | Similar proportion of subjects with 50% increase in CMI measures postvacc. | No difference. No flares. | – | – | 2b | 4 |
*Tofacitinib or placebo was started 2–3 weeks postvaccination.
†Patients with rheumatoid arthritis (n=292 169), psoriasis (n=89 565), psoriatic arthritis (n=11 030), ankylosing spondylitis (n=4026) and/or inflammatory bowel disease (n=66 751).
AIIRD, auto-immune inflammatory rheumatic disease; CMI, cell-mediated immunity; DMARD, disease-modifying antirheumatic drug; eff., efficacy; GC, glucocorticoids; HC, healthy controls; HZ, herpes zoster; imm., immunogenicity; IS, immunosuppressives; LoE, Level of evidence; MTX, methotrexate; No., number; OA, osteoarthritis; PCB, placebo; PMR, polymyalgiarheumatica; RA, rheumatoid arthritis; RCT, randomised controlled trial; ref., reference; (S)AE, serious adverse event(s); Saf., safety; SLE, systemic lupus erythematosus; TFC, tofacitinib; vacc., vaccinated.