TY - JOUR
T1 - Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib
T2 - a pooled analysis of six phase III clinical trials
AU - Winthrop, Kevin L.
AU - Nash, Peter
AU - Yamaoka, Kunihiro
AU - Mysler, Eduardo
AU - Khan, Nasser
AU - Camp, Heidi S.
AU - Song, Yanna
AU - Suboticki, Jessica L.
AU - Curtis, Jeffrey R.
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2022.
PY - 2022/2
Y1 - 2022/2
N2 - Background Upadacitinib (UPA) is an oral Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis (RA). JAK inhibitors have been associated with an increased risk of herpes zoster (HZ) in patients with RA. Objectives To evaluate the incidence and risk factors for HZ in UPA-treated patients with RA from the UPA phase III clinical trial programme. Methods Exposure-adjusted incidence/event rates for HZ were determined in patients receiving UPA (monotherapy or combination therapy) in six randomised phase III trials (data cut-off on 30 June 2020). HZ incidence and event rates were also determined in patients receiving methotrexate (MTX) monotherapy or adalimumab (ADA) + MTX. Multivariable Cox regression analysis was used to identify HZ risk factors in UPA-treated patients. Results A total of 5306 patients were included in this analysis. The incidence rate of HZ/100 patient-years (95% CI) was 0.8 (0.3 to 1.9), 1.1 (0.5 to 1.9), 3.0 (2.6 to 3.5) and 5.3 (4.5 to 6.2), in the MTX monotherapy, ADA + MTX, UPA 15 mg and UPA 30 mg groups, respectively. The majority of HZ cases with UPA (71%) involved a single dermatome. Prior history of HZ and Asian region were HZ risk factors in UPA-treated patients. Conclusion In the UPA phase III RA clinical programme, HZ incidence and event rates were higher with UPA versus ADA + MTX or MTX monotherapy, and higher with the 30 mg versus 15 mg dose. Patients from Asia and those with a history of HZ may be at increased risk of HZ while receiving UPA.
AB - Background Upadacitinib (UPA) is an oral Janus kinase (JAK) inhibitor approved for the treatment of rheumatoid arthritis (RA). JAK inhibitors have been associated with an increased risk of herpes zoster (HZ) in patients with RA. Objectives To evaluate the incidence and risk factors for HZ in UPA-treated patients with RA from the UPA phase III clinical trial programme. Methods Exposure-adjusted incidence/event rates for HZ were determined in patients receiving UPA (monotherapy or combination therapy) in six randomised phase III trials (data cut-off on 30 June 2020). HZ incidence and event rates were also determined in patients receiving methotrexate (MTX) monotherapy or adalimumab (ADA) + MTX. Multivariable Cox regression analysis was used to identify HZ risk factors in UPA-treated patients. Results A total of 5306 patients were included in this analysis. The incidence rate of HZ/100 patient-years (95% CI) was 0.8 (0.3 to 1.9), 1.1 (0.5 to 1.9), 3.0 (2.6 to 3.5) and 5.3 (4.5 to 6.2), in the MTX monotherapy, ADA + MTX, UPA 15 mg and UPA 30 mg groups, respectively. The majority of HZ cases with UPA (71%) involved a single dermatome. Prior history of HZ and Asian region were HZ risk factors in UPA-treated patients. Conclusion In the UPA phase III RA clinical programme, HZ incidence and event rates were higher with UPA versus ADA + MTX or MTX monotherapy, and higher with the 30 mg versus 15 mg dose. Patients from Asia and those with a history of HZ may be at increased risk of HZ while receiving UPA.
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U2 - 10.1136/annrheumdis-2021-220822
DO - 10.1136/annrheumdis-2021-220822
M3 - Article
C2 - 34615638
AN - SCOPUS:85123650516
SN - 0003-4967
VL - 81
SP - 206
EP - 213
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 2
ER -