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ACR 2017 | Daily Highlights
The Occurrence of Shingles and the Effect of Zoster Vaccination with the Use of Methotrexate in Rheumatoid Arthritis Patients
Authors: Antony Lin1, Qiaowu Li2, Jiaxiao Shi2, Serena Lin3, Danielle Wang4, Jenny Wan5, Kevin Lee3, Hung-Fu Tseng2 and TC Cheetham6, 1Southern California Permanente Medical Group, Pasadena, CA, 2Department of Research and Evaluation, Kaiser Permanente, Pasadena, CA, 3Stanford University, Stanford, CA, 4UCI Medical Center, Irvine, CA, 5Kaiser Permanente Drug Information Services - California Regions, Downey, CA, 6Western University of Health Sciences, Pomona, CA
To investigate the efficacy and safety of zoster vaccines administered in rheumatoid arthritis(RA) patients taking methotrexate(MTX).
By reviewing data through the Kaiser Permanente electronic medical record (EMR) retrospectively, we identified 893 adult RA patients who received zoster vaccination between January 1, 2007 and December 31, 2012 and had at least 2 RA diagnoses documented within one year prior to the vaccination date. Patients treated with any biologic DMARDs within 6 months prior to the index dates were excluded. The cohort was followed until the occurrence of zoster infection, disenrollment, death or the end of study, whichever came first. The primary outcome, vaccination safety, was measured by time to occurrence of zoster infections within 42 days after zoster vaccines administered. The secondary outcome, vaccine efficacy, measured by time to occurrence of zoster infections (after day 42) until the end of follow-up period, was studied among those who maintain the treatment during follow-up period (n=762). Dosage effect was also analyzed among those taking MTX (n=342) by comparing patients taking >=25mg/week and those taking 22.5mg/week or less. Cox proportional model was used to analyze hazard ratios between groups.
Among 893 RA patients who were given zoster vaccines, 366 patients were taking MTX within 6 months prior to the zoster vaccination and 527 patients were not taking MTX. At baseline, 707(79%) patients were female with a mean age of 70.1 (SD: .5) and disease duration of 6.6 (3.9) years. The analysis showed that the rate of zoster infection was 0.13 per 1000-person day in the MTX group and the rate was 0.23 per 1000-person day in the non-MTX group. We found no significant statistical difference in the rate of zoster infections within the first 42 days of vaccination with adjusted hazard ratio of .50(95% CI 0.09-2.69, p-value=0.42). During the subsequent follow-up period, 742 patients continued their baseline treatment. The rate of zoster infection was 15.9 per 1000-person year in the MTX group and the rate was 18.6 per 1000-person year in the non-MTX group with the adjusted hazard ratio 0.79(95% CI 0.47-1.33, p-value=0.37). Among the 334 patients taking MTX, 292 patients were taking a dose of 22.5 mg or under while 42 were taking the dose of 25mg or more. The final analysis from the model showed no significant difference in dosage effect, the adjusted hazard ratio was 0.34(95% CI 0.04-2.54, p-value=0.29).
Zoster vaccination is safe to be given to RA patients taking MTX regardless of the dosage. The vaccination is equally effective in RA patients taking MTX and not taking MTX.
A. Lin, None; Q. Li, None; J. Shi, None; S. Lin, None; D. Wang, None; J. Wan, None; K. Lee, None; H. F. Tseng, None; T. Cheetham, Bristol-Myers Squibb, 2.
Patients under biologic DMARDs were excluded from this trial of safety and efficacy of Zoster vaccination in patients with RA. There were 366 patients under methotrexate within 6 months before the vaccination and 527 not taking methotrexate. The rate of zoster infections was 0.13 per 1000-person day in the MTX group and 0.23 per 1000-person day in the non-MTX group within the first 42 days of vaccination with adjusted hazard ratio of 0.50 (95% CI 0.09-2.69, p value=0.42). During the subsequent follow-up period, 742 patients continued their baseline treatment. The rate of zoster infection was 15.9 per 1000-person years in the MTX group and 18.6 in the non-MTX group with an adjusted hazard ratio of 0.79(95% CI 0.47-1.33, p-value=0.37). There was no dosage effect of methotrexate on safety or effectiveness.
Thus, there were no safety concerns with the vaccine under methotrexate und no diminished vaccine responses due to methotrexate. Similarly, abstract 1440 showed good safety of the live Zoster vaccine under methotrexate.
Prof. Dr. Paul Hasler