Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies

Table 3 Summary of Safety Data Through Week 56 From SELECT-PsA 2 (bDMARD-IR)

EAER, E/100 PY^a (95% CI)	Without Axial Involvement	Investigator Alone	Investigator + PRO-Based
EAER, E/100 PY^a (95% CI)	UPA 15 mg QD^b (n = 184; PY = 272.5)	UPA 15 mg QD^b (n = 106; PY = 146.9)	UPA 15 mg QD^b (n = 81; PY = 113.4)
Any AE	259.8 (241.0, 279.7)	262.1 (236.6, 289.6)	254.0 (225.5, 285.1)
Any serious AE	12.5 (8.6, 17.4)	17.7 (11.6, 25.9)	18.5 (11.5, 28.3)
Any AE leading to discontinuation of study drug	11.0 (7.4, 15.7)	8.2 (4.2, 14.3)	7.9 (3.6, 15.1)
All deaths (n/100 PY)	0	0	0
AEs of special interest
Any infection	91.0 (80.0, 103.1)	87.1 (72.7, 103.6)	82.0 (66.2, 100.5)
Serious infection	2.9 (1.3, 5.8)	2.0 (0.4, 6.0)	1.8 (0.2, 6.4)
Opportunistic infection^c	0.4 (0.0, 2.0)	1.4 (0.2, 4.9)	1.8 (0.2, 6.4)
Herpes zoster	4.0 (2.0, 7.2)	3.4 (1.1, 7.9)	3.5 (1.0, 9.0)
Active tuberculosis	0	0	0
GI perforation (adjudicated)	0	0	0
Hepatic disorder	5.9 (3.4, 9.5)	2.7 (0.7, 7.0)	2.6 (0.5, 7.7)
Anemia	2.6 (1.0, 5.3)	1.4 (0.2, 4.9)	1.8 (0.2, 6.4)
Neutropenia	1.5 (0.4, 3.8)	0	0
Lymphopenia	1.1 (0.2, 3.2)	0	0
CPK elevation	4.4 (2.3, 7.7)	6.8 (3.3, 12.5)	7.9 (3.6, 15.1)
Renal dysfunction	0.7 (0.1, 2.7)	0	0
Any malignancy	1.5 (0.4, 3.8)	4.2 (1.5, 9.1)	5.4 (2.0, 11.8)
Malignancy (excl. NMSC)	0.4 (0.0, 2.0)	2.7 (0.7, 7.0)	3.5 (1.0, 9.0)
NMSC	1.1 (0.2, 3.2)	1.4 (0.2, 5.0)	1.8 (0.2, 6.5)
Lymphoma	0.7 (0.1, 2.7)	0	0
MACE (adjudicated)^d	0	0.7 (0.0, 3.8)	0.9 (0.0, 5.0)
VTE (adjudicated)^e	0.4 (0.0, 2.0)	0	0

AE Adverse event, bDMARD Biologic disease-modifying antirheumatic drug, CI Confidence interval, CPK Creatine phosphokinase, E Event, EAER Exposure-adjusted event rate, EOW Every other week, IR Inadequate response, MACE Major adverse cardiovascular event, NMSC Non-melanoma skin cancer, PsA Psoriatic arthritis, PY Patient-years, QD Once daily, UPA Upadacitinib, VTE Venous thromboembolism
^aSafety data presented as events per 100 patient-years (with 95% CIs), unless indicated
^bPatients in the UPA 15 mg QD group include those who were assigned to UPA 15 mg QD at baseline, as well as those switched from placebo to UPA 15 mg QD at week 24
^cOpportunistic infections excluding tuberculosis and herpes zoster
^dMajor adverse cardiovascular events defined as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death
^eVenous thromboembolism includes deep vein thrombosis (DVT) and pulmonary embolism (PE) (fatal and non-fatal)

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