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dc.contributor.authorWinthrop, K
dc.contributor.authorNash, P
dc.contributor.authorYamaoka, K
dc.contributor.authorMysler, E
dc.contributor.authorCalabrese, L
dc.contributor.authorKhan, N
dc.contributor.authorEnejosa, JJ
dc.contributor.authorSong, Y
dc.contributor.authorSuboticki, J
dc.contributor.authorCurtis, JR
dc.description.abstractBackground: Upadacitinib (UPA) is an oral JAK inhibitor approved for the treatment of rheumatoid arthritis (RA). The background rate of herpes zoster (HZ) in patients (pts) with RA is around 0.98/100 person years (PY)1. Pts with RA receiving JAK inhibitors have been reported to have an increased risk of HZ. Objectives: To evaluate the incidence and risk factors for HZ in pts with RA receiving UPA relative to active comparators in the Phase 3 clinical trial program. Methods: The incidence rate of HZ was determined in pts receiving UPA (as monotherapy [mono] or combination therapy) in five randomized Phase 3 trials (SELECT-EARLY, SELECT-MONOTHERAPY, SELECT-NEXT, SELECT-COMPARE, and SELECT-BEYOND), of which 4 evaluated both the UPA 15 and 30 mg once-daily (QD) doses and 1 trial (SELECT-COMPARE) evaluated only the 15 mg QD dose. Incidence of HZ was also determined in pts receiving adalimumab (ADA) + methotrexate (MTX) in SELECT-COMPARE and MTX mono in SELECT-EARLY. Risk factors for HZ were assessed using univariate and multivariate Cox regression models. Data cut-off was 30 June 2019. Results: Overall, 2629 pts who received UPA 15 mg QD (4565.8 patient-years [PY]), 1204 pts who received UPA 30 mg QD (2309.7 PY), 579 pts who received ADA + MTX (768.6 PY), and 314 pts who received MTX mono (456.0 PY) were analyzed. Fewer than 5% of pts across the treatment groups reported prior HZ vaccination. HZ (n/100 PY [95% CI]) occurred in 142 pts (3.1 [2.6–3.7]) with UPA 15 mg, 126 pts (5.5 [4.5–6.5]) with UPA 30 mg, 8 pts (1.0 [0.4–2.1]) with ADA + MTX, and 5 pts (1.1 [0.4–2.6]) with MTX mono. Most of the HZ cases (~71%) with UPA (Table) and all cases with ADA + MTX and MTX mono involved a single dermatome. Ophthalmic involvement was seen in 6 (4.2%) and 3 (2.4%) cases in the UPA 15 and 30 mg groups, respectively, and unilateral involvement with multiple dermatomes was seen in 26 (18.3%) and 23 (18.3%) cases. There was a single case of HZ meningitis reported in a Japanese pt on UPA 30 mg. In multivariate analyses, prior history of HZ and Asian region were associated with an increased risk of HZ in both the UPA groups (p≤0.01; Figure). In addition, pts ≥65 years old had increased risk of HZ in the 15 mg group. Conclusion: HZ events in pts with RA receiving UPA were more common in the 30 mg vs 15 mg group, and in both UPA groups compared with the ADA + MTX and MTX groups.
dc.publisherBMJ Publishing Group
dc.relation.ispartofconferencenameAnnual European Congress of Rheumatology (EULAR)
dc.relation.ispartofconferencetitleAnnals of the Rheumatic Diseases
dc.relation.ispartofissueSuppl 1
dc.subject.fieldofresearchClinical sciences
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.titleIncidence and risk factors for herpes zoster in rheumatoid arthritis patients receiving upadacitinib
dc.typeConference output
dc.type.descriptionE3 - Conferences (Extract Paper)
dcterms.bibliographicCitationWinthrop, K; Nash, P; Yamaoka, K; Mysler, E; Calabrese, L; Khan, N; Enejosa, JJ; Song, Y; Suboticki, J; Curtis, JR, Incidence and risk factors for herpes zoster in rheumatoid arthritis patients receiving upadacitinib, Annals of the Rheumatic Diseases, 2020, 79, pp. 331-332
gro.hasfulltextNo Full Text
gro.griffith.authorNash, Peter

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