ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 824

Results from a Randomized Controlled Trial of the Safety of the Live Varicella Vaccine in TNF-Treated Patients

Jeffrey Curtis1, S Louis Bridges 2, Stacey S Cofield 2, John Bassler 1, Theresa Ford 3, Stephen Lindsey 4, Alan Kivitz 5, Ilhem Messaoudi 6, Kaleb Michaud 7, Joseph Huffstutter 8, Ted Mikuls 9, David Ridley 10, William Shergy 11, Sarah Siegel 12 and Kevin Winthrop 13, 1University of Alabama at Birmingham, Birmingham, AL, 2University of Alabama at Birmingham, Birmingham, 3North Georgia Rheumatology Group, PC, Lawrenceville, GA, 4Ochsner Clinic Foundation, Baton Rouge, LA, 5Altoona Center for Clinical Research, Duncansville, PA, 6University of California Irvine, Irvine, CA, 7University of Nebraska Medical Center, Omaha, NE, 8Arthritis Associates, Hixon, TN, 9VA Nebraska-Western IA Health Care System & University of Nebraska Medical Center, Omaha, NE, 10St. Paul Rheumatology, Eagan, MN, 11Rheumatology Associates of North Alabama, Huntsville, AL, 12Oregon Health Science University, Portland, OR, 13Oregon Health and Science University, Portland, OR

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Sunday, November 10, 2019

Session Title: 3S074: Epidemiology & Public Health I: Risk Factors & Outcomes for Rheumatic Diseases (821–826)

Session Type: ACR Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: There has been minimal evaluation of the safety of live virus vaccines in patients receiving biologic therapies who may be immunocompromised. The Varicella Zoster Vaccine (VERVE) study is a blinded, 1:1 randomized placebo-controlled trial of the live attenuated zoster vaccine (ZV) in patients receiving TNF inhibitors (TNFi) to evaluate safety and immunogenicity.

Methods: Eligible participants: at least 50 years of age, current users of TNFi for any indication, and no prior ZV. Safety follow-up occurred over 6 weeks (the FDA-specified risk window for vaccine-related infection, were it to occur). Suspected cases of varicella infection or shingles had clinical assessment, PCR collection (with subtyping to differentiate wild-type vs. vaccine [Oka]-related infection), and digital photographs. Review was conducted under oversight of an NIH-appointed Data Safety Monitoring Board. Serum and PBMCs were collected at baseline and week 6 to assess ZV-related immunity, with safety follow-up through 6 months, at which time participants were unmasked to treatment arm.

Results: Recruitment closed in December 2018, with 617 randomized participants recruited at 33 centers: mean (SD) age 62.4 (7.5) years, 66.9% female, 87.2% white, 8.8% AA, 4.4% Hispanic. Most common TNFi indications: rheumatoid arthritis (59.6%), psoriatic arthritis (24.5%); TNFi medication at baseline: adalimumab (32.7%), infliximab (31.3%), etanercept (21.2%), golimumab (9.1%), certolizumab (5.7%). Concomitant therapies included background methotrexate (48.0%), and oral glucocorticoids (10.5%). Through week 6, there were zero cases of confirmed disseminated or local varicella infection, either wild type or vaccine strain, yielding an upper bound of the 95% confidence interval for vaccine-related varicella infection of < 1%. A total of 8 rashes were swabbed for varicella PCR; none were positive, and no clinically adjudicated varicella or shingles reactivation cases were observed through week 6. VERVE will close to blinded follow up in Summer 2019 and immunologic effectiveness of ZV will be reported in the full cohort in November 2019.

Conclusion: The randomized VERVE trial comprised of more than 600 patients receiving TNFi for multiple indications observed no cases of vaccine-related varicella infection or reactivation in the 6-week risk period following live zoster vaccination. This trial informs safety concerns of use of live virus vaccines in this population.

Disclosure: J. Curtis, AbbVie, 2, 5, Abbvie, 2, 5, AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, and UCB, 2, 5, Amgen, 2, 5, Amgen Inc., 2, 5, BMS, 2, 5, Bristol-Myers Squibb, 2, 5, Corrona, 2, 5, Crescendo, 2, 5, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, Genentech, 2, 5, Janseen, 5, Janssen, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Myriad, 2, 5, Patient Centered Outcomes Research Insitute (PCORI), 2, Pfizer, 2, 5, Radius Health, Inc., 9, Regeneron, 2, 5, Roche, 2, 3, 5, Roche/Genentech, 5, UCB, 2, 5; S. Bridges, None; S. Cofield, None; J. Bassler, None; T. Ford, None; S. Lindsey, Pfizer, 5, 8, Novartis, 8; A. Kivitz, None; I. Messaoudi, None; K. Michaud, FORWARD, The National Databank for Rheumatic Diseases, 3, Pfizer, 2, Pfizer & Rheumatology Research Foundation, 2, Rheumatology Research Foundation, 2, University of Nebraska Medical Center, 3; J. Huffstutter, Janssen, 8, UCB, 8; T. Mikuls, BMS, 2, Horizon, 2; D. Ridley, None; W. Shergy, None; S. Siegel, None; K. Winthrop, AbbVie, 5, Abbvie, 5, Bristol-Myers Squibb, 2, 5, Eli Lilly, 5, Galapagos, 5, Galapagos NV, 5, Gilead, 5, Gilead Sciences, Inc., 5, GSK, 5, Lilly, 5, Pfizer, 2, 5, Roche, 5, UCB, 5, UCB Pharma, 5, UCB Pharma, Pfizer, Bristol-Myers Squibb, Eli Lilly, AbbVie, and Roche., 2, 5.

To cite this abstract in AMA style:

Curtis J, Bridges S, Cofield S, Bassler J, Ford T, Lindsey S, Kivitz A, Messaoudi I, Michaud K, Huffstutter J, Mikuls T, Ridley D, Shergy W, Siegel S, Winthrop K. Results from a Randomized Controlled Trial of the Safety of the Live Varicella Vaccine in TNF-Treated Patients [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/results-from-a-randomized-controlled-trial-of-the-safety-of-the-live-varicella-vaccine-in-tnf-treated-patients/. Accessed May 31, 2020.

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