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Table 2 Summary of Safety Data Through Week 56 From SELECT-PsA 1 (non-bDMARD-IR)

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

EAER, E/100 PYa

(95% CI)

Without Axial Involvement

Investigator Alone

Investigator + PRO-Based

UPA 15 mg QDb

(n = 411; PY = 572.1)

ADA 40 mg EOW

(n = 302; PY = 448.3)

UPA 15 mg QDb

(n = 206; PY = 267.0)

ADA 40 mg EOW

(n = 127; PY = 183.1)

UPA 15 mg QDb

(n = 158; PY = 206.9)

ADA 40 mg EOW

(n = 85;

PY = 122.9)

Any AE

283.7 (270.1, 297.8)

247.2 (232.8, 262.1)

275.7 (256.1, 296.3)

311.9 (286.8, 338.5)

280.3 (258.0, 304.1)

335.2 (303.6, 369.2)

Any serious AE

10.1 (7.7, 13.1)

8.3 (5.8, 11.4)

6.7 (4.0, 10.7)

12.0 (7.5, 18.2)

7.7 (4.4, 12.6)

15.5 (9.3, 24.1)

Any AE leading to discontinuation

of study drug

4.7 (3.1, 6.9)

7.8 (5.4, 10.9)

4.5 (2.3, 7.9)

6.6 (3.4, 11.4)

4.3 (2.0, 8.3)

8.1 (3.9, 15.0)

All deaths (n/100 PY)c

0.3 (0.0, 1.3)

0

0

0.5 (0.0, 3.0)

0

0.8 (0.0, 4.5)

AEs of special interest

 Any infection

100.3 (92.3, 108.9)

70.5 (62.9, 78.7)

83.1 (72.6, 94.8)

72.6 (60.8, 86.1)

80.7 (68.9, 93.9)

73.2 (58.9, 90.0)

 Serious infection

3.1 (1.9, 5.0)

0.9 (0.2, 2.3)

2.2 (0.8, 4.9)

2.2 (0.6, 5.6)

2.4 (0.8, 5.6)

2.4 (0.5, 7.1)

 Opportunistic infectiond

0.3 (0.0, 1.3)

0

0.4 (0.0, 2.1)

0

0.5 (0.0, 2.7)

0

 Herpes zoster

3.7 (2.3, 5.6)

0.7 (0.1, 2.0)

4.5 (2.3, 7.9)

0

4.8 (2.3, 8.9)

0

 Active tuberculosis

0

0

0

0

0

0

   GI perforation (adjudicated)

0.3 (0.0, 1.3)

0

0

0

0

0

 Hepatic disorder

16.6 (13.4, 20.3)

19.0 (15.1, 23.4)

24.3 (18.8, 31.0)

39.3 (30.8, 49.5)

27.5 (20.9, 35.7)

45.6 (34.4, 59.2)

 Anemia

1.9 (1.0, 3.4)

1.3 (0.5, 2.9)

5.2 (2.9, 8.8)

2.2 (0.6, 5.6)

4.3 (2.0, 8.3)

1.6 (0.2, 5.9)

 Neutropenia

2.3 (1.2, 3.9)

3.8 (2.2, 6.1)

2.6 (1.1, 5.4)

5.5 (2.6, 10.0)

2.9 (1.1, 6.3)

4.9 (1.8, 10.6)

 Lymphopenia

2.6 (1.5, 4.3)

0.2 (0.0, 1.2)

4.5 (2.3, 7.9)

0

2.4 (0.8, 5.6)

0

 CPK elevation

12.8 (10.0, 16.0)

5.8 (3.8, 8.5)

10.1 (6.7, 14.7)

10.9 (6.7, 16.9)

10.1 (6.3, 15.5)

11.4 (6.2, 19.1)

 Renal dysfunction

0

0

0.7 (0.1, 2.7)

0

0.5 (0.0, 2.7)

0

 Any malignancy

1.1 (0.4, 2.3)

0.7 (0.1, 2.0)

1.1 (0.2, 3.3)

1.6 (0.3, 4.8)

1.5 (0.3, 4.3)

0.8 (0.0, 4.5)

 Malignancy (excl. NMSC)

0.5 (0.1, 1.5)

0.7 (0.1, 2.0)

0.7 (0.1, 2.7)

0.5 (0.0, 3.0)

1.0 (0.1, 3.5)

0.8 (0.0, 4.5)

 NMSC

0.7 (0.2, 1.8)

0

0.4 (0.0, 2.1)

1.1 (0.1, 4.0)

0.5 (0.0, 2.7)

0

 Lymphoma

0

0

0

0

0

0

 MACE (adjudicated)e

0.5 (0.1, 1.5)

0.2 (0.0, 1.2)

0

1.1 (0.1, 4.0)

0

1.6 (0.2, 5.9)

 VTE (adjudicated)f

0.3 (0.0, 1.3)

0.2 (0.0, 1.2)

0.4 (0.0, 2.1)

0.6 (0.0, 3.1)

0.5 (0.0, 2.7)

0.8 (0.0, 4.6)

  1. ADA Adalimumab, 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
  2. aSafety data presented as events per 100 patient-years (with 95% CIs), unless indicated
  3. 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
  4. cTwo deaths were reported with upadacitinib 15 mg from the sub-group without axial involvement, one death with adalimumab from the investigator alone sub-group, and one death with adalimumab from the investigator judgement and PRO-based sub-group
  5. dOpportunistic infections excluding tuberculosis and herpes zoster
  6. eMajor adverse cardiovascular events defined as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death
  7. fVenous thromboembolism includes deep vein thrombosis (DVT) and pulmonary embolism (PE) (fatal and non-fatal)
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Arthritis Research & Therapy

ISSN: 1478-6362

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