REPRINTED WITH PERMISSION OF IASP PAIN 164 (2023) 741748: Adjuvanted recombinant zoster vaccine decreases herpeszoster-associated pain and the use of pain medicationacross 3 randomized, placebo-controlled trials

Abstract

Herpes zoster (HZ) and HZ-associated pain greatly affect patients quality of life, particularly in older andimmunocompromised adults, for whom comorbidities and polypharmacy are often reported. Three phase III,randomized, placebo-controlled clinical trials have reported the adjuvanted recombinant zoster vaccine (RZV) ashighly efficacious in preventing HZ and reducing pain severity in healthy adults 50 years old (Zoster Efficacy Study[ZOE]-50 study, NCT01165177) and 70 years old (ZOE-70; NCT01165229) and in immunocompromised adults18 years old undergoing autologous hematopoietic stem cell transplantation (ZOE-HSCT; NCT01610414). Here,we investigated efficacy of RZV in reducing (i) the duration of clinically significant pain (Zoster Brief Pain Inventorypain score 3) and (ii) HZ-associated pain medication use and duration of use in participants with confirmed HZ(breakthrough cases) from the 3 studies. Recombinant zoster vaccine effectively reduced the duration of clinicallysignificant HZ-associated pain during HZ episodes by 38.5% (P-value: 0.010) in the ZOE-HSCT study. Althougha similar trend was observed in the ZOE-50 and ZOE-70 studies, the results were not statistically significant becauseof the high vaccine efficacy (VE) against HZ resulting in rare breakthrough cases.VE in reducing pain medication use(39.6%;P-value: 0.008) and duration of medication use (49.3%, P-value: 0.040) was reported in the ZOE-70 study;corresponding positive VE estimates were observed in the ZOE-50 and ZOE-HSCT studies but were not statisticallysignificant. Data reported here demonstrate efficacy of RZV in reducing HZ-associated pain duration and painmedication use in breakthrough cases, thereby improving quality of life of those with HZ.