Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study

Table 1 Treatment-emergent AEs

Exposure-adjusted event rates, E (E/100 PY)	Any upadacitinib 15 mg QD^a (n = 414; PY = 534.4)
Any AE	877 (164.1)
Serious AE	53 (9.9)
AE leading to discontinuation of study drug	16 (3.0)
Any COVID-19-related AE	81 (15.2)
Any death^b	1 (0.2)
Infection	301 (56.3)
Serious infection	24 (4.5)
Opportunistic infection^c	0
Herpes zoster^d	19 (3.6)
Active tuberculosis	0
Malignancy other than NMSC^e	1 (0.2)
NMSC	2 (0.4)
Adjudicated MACE^f	1 (0.2)
Adjudicated VTE^g	2 (0.4)
Adjudicated gastrointestinal perforation	0
Renal dysfunction^h	1 (0.2)
Anemia	11 (2.1)
Lymphopenia	3 (0.6)
Neutropenia	19 (3.6)
Hepatic disorder	47 (8.8)
Uveitisⁱ	7 (1.3)
Inflammatory bowel disease^j	1 (0.2)
Psoriasis	2 (0.4)

^aAll patients who received ≥ 1 dose of upadacitinib 15 mg QD.
^bOne patient died due to polytrauma.
^cExcluding tuberculosis and herpes zoster.
^dOne serious AE of herpes zoster.
^eOne severe AE of colon neoplasm with liver metastases.
^fMACE defined as cardiovascular death (includes acute myocardial infarction, sudden cardiac death, heart failure, cardiovascular procedure-related death, death due to cardiovascular hemorrhage, fatal stroke, pulmonary embolism, and other cardiovascular causes), non-fatal myocardial infarction, and non-fatal stroke. One AE of basal ganglia hemorrhage.
^gVTE included fatal and non-fatal deep vein thrombosis and pulmonary embolism. One serious AE of pulmonary embolism. One non-serious AE of deep vein thrombosis; study drug was discontinued.
^hOne serious AE of acute kidney injury; study drug dose remained unchanged.
ⁱOne serious event of recurrent uveitis and one serious event of iridocyclitis in a patient with a history of uveitis. One new serious AE of uveitis. One new serious AE of iridocyclitis.
^jOne grade 2 event of Crohn’s disease.
AE adverse event, E events, MACE major adverse cardiovascular event, NMSC non-melanoma skin cancer, PY patient-years, QD once daily, VTE venous thromboembolic event

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