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Abstract Number: 12L

Assessment of Immunogenicity of Live Zoster Vaccination (Zostavax®) in Rheumatoid Arthritis Patients on Background Methotrexate before and after Initiating Tofacitinib or Placebo

Kevin Winthrop IV1, Ann Wouters2, Ernest H. Choy3, Koshika Soma2, Jennifer Hodge2, Chudy Nduaka2, Pinaki Biswas2, Lisa K. McNeil2, Sherry Passador2, Christopher F. Mojcik2 and William F.C. Rigby4, 1Oregon Health and Sciences University, Portland, OR, 2Pfizer Inc, New York, NY, 3CREATE Center, Institute of Infection and Immunity, Cardiff University School of Medicine, Cardiff, United Kingdom, 4Geisel School of Medicine at Dartmouth, Lebanon, NH

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: October 27, 2015

Keywords: Late-Breaking 2015, Tofacitinib and vaccines

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Session Information

Date: Tuesday, November 10, 2015

Session Title: ACR Late-breaking Abstract Poster Presentations

Session Type: ACR Late-breaking Abstract Session

Session Time: 9:00AM-11:00AM

Background/Purpose: Tofacitinib
is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis
(RA). Clinical guidelines recommend using live zoster vaccine (LZV) to prevent
shingles in RA, but this vaccine has not been previously studied in RA patients
(pts) and the effect of tofacitinib on humoral or cell-mediated live vaccine
responses is unknown.

Methods:
To evaluate the effect of tofacitinib upon the immune response and safety of LZV,
we recruited pts aged ≥50 years with active RA (≥4 tender/painful joints and ≥4 swollen joints) despite
methotrexate (MTX) therapy (≥4
months of treatment with 15–25 mg/week [wk] before screening) (study NCT02147587).
Pts with prior history of zoster vaccination were excluded, as were those
receiving any vaccine in the 6 wks prior to randomization. After screening,
eligible pts were given LZV and then randomized to either tofacitinib 5 mg
BID or placebo (PBO) to start 2–3
wks post-vaccination with continuation of background MTX. We measured both
humoral (varicella-zoster virus [VZV]-specific IgG via gpELISA) and
cell-mediated responses (VZV-specific T cell enumeration via ELISPOT) prior to
vaccination (baseline, day of vaccination), and then at 2, 6, and 14 wks
post-vaccination. The primary endpoint was an assessment of the geometric mean
fold rise (GMFR) in VZV-specific IgG titer at 6 wks post-vaccination. Secondary
endpoints included the proportion of patients achieving a ≥1.5 fold rise
in VZV-specific IgG titer 6 wks post-vaccination. Exploratory endpoints
included the GMFR in VZV-specific T cells (spot-forming cells/106 peripheral blood mononuclear cells [PBMCs])
by ELISPOT between baseline and 6 wks post-vaccination. Pts were followed for
12 wks after randomization for safety.

Results: 112
pts were randomized into PBO (n=57) and tofacitinib arms (n=55). Most PBO (93%)
and tofacitinib (98%) pts were evaluable for immune response endpoints. Pts were
similar with regard to sex, age, baseline disease activity, and baseline VZV
immune measures (i.e. IgG, ELISPOT). The GMFR in VZV-specific IgG titer
at 6 wks was 2.11 for tofacitinib pts and 1.74 for PBO pts. The GMFRs both in
tofacitinib and PBO pts were comparable with the GMFRs in healthy people
≥50 years as indicated in the LZV labels. The proportion of patients
developing a 1.5 fold post-vaccination rise in IgG titer at 6 wks trended
higher for tofacitinib (57.4%) versus PBO (43.4%). For cell-mediated immune responses,
the VZV-specific T cell GMFR at 6 wks increased similarly for tofacitinib pts (1.50)
and PBO pts (1.29). SAEs occurred in 0 (0%) and 3
(5.5%) of PBO and tofacitinib arms respectively. One pt in the study developed
cutaneous dissemination with vaccine-strain VZV (Oka strain virus) that
occurred 2 days after starting tofacitinib (16 days post-vaccination).
Subsequently, this pt was found to lack pre-existing immunity to VZV,
consistent with vaccine-induced disease. This event resolved after tofacitinib
discontinuation and antiviral therapy.

Conclusion:
Pts starting tofacitinib had similar VZV-specific humoral and cell-mediated immune
responses to LZV as compared to PBO-treated pts. Vaccination appeared safe in
all pts but one who lacked pre-existing VZV immunity.

 


Disclosure: K. Winthrop IV, Pfizer and BMS, 2,Pfizer, UCB, AbbVie, Lilly, BMS, Galapagos, and Amgen, 5; A. Wouters, Pfizer Inc, 1,Pfizer Inc, 3; E. H. Choy, Amgen, Boehringer Ingelheim, Chugai Pharma, Ferring Pharmaceuticals, Novimmune, Pfizer, Roche, and UCB, 2,Abbott Laboratories, Amgen, AstraZeneca, Biogen, BMS, Boehringer Ingelheim, Celgene, Chelsea Therapeutics, Chugai Pharma, Daiichi Sankyo, Eli Lilly, Ferring Pharmaceutical, GSK, Hospita, ISIS, Jazz Pharmaceuticals, Jenssen, MedImmune, Merrimack Pharmaceut, 9,Amgen, Boehringer Ingelheim, Chugai Pharma, Eli Lilly, Hospira, MSD, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, and UCB, 8; K. Soma, Pfizer Inc, 1,Pfizer Inc, 3; J. Hodge, Pfizer Inc, 1,Pfizer Inc, 3; C. Nduaka, Pfizer Inc, 1,Pfizer Inc, 3; P. Biswas, Pfizer Inc, 1,Pfizer Inc, 3; L. K. McNeil, Pfizer Inc, 1,Pfizer Inc, 3; S. Passador, Pfizer Inc, 1,Pfizer Inc, 3; C. F. Mojcik, Pfizer Inc, 1,Pfizer Inc, 3; W. F. C. Rigby, Bristol Myers Squibb, Eli Lilly, Pfizer and Roche, 5,Amgen, Pfizer and Roche, 2.

To cite this abstract in AMA style:

Winthrop K IV, Wouters A, Choy EH, Soma K, Hodge J, Nduaka C, Biswas P, McNeil LK, Passador S, Mojcik CF, Rigby WFC. Assessment of Immunogenicity of Live Zoster Vaccination (Zostavax®) in Rheumatoid Arthritis Patients on Background Methotrexate before and after Initiating Tofacitinib or Placebo [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/assessment-of-immunogenicity-of-live-zoster-vaccination-zostavax-in-rheumatoid-arthritis-patients-on-background-methotrexate-before-and-after-initiating-tofacitinib-or-placebo/. Accessed August 12, 2022.
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