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Table 1 Overview of adverse events through 5 years

From: Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial

Events (E/100 PY)a

MTX mono

(N = 314; PY = 860.2)

UPA 15 mg QD mono

(N = 317; PY = 1062.6)

UPA 30 mg QD monob

(N = 314; PY = 741.5)

UPA 15 mg QD mono switched from UPA 30 mg QD mono

(N = 181; PY = 292.5)

Any AE

1767 (205.4)

2396 (225.5)

2077 (280.1)

451 (154.2)

Serious AEs

78 (9.1)

111 (10.4)

118 (15.9)

44 (15.0)

Any AE leading to discontinuation of study drug

50 (5.8)

58 (5.5)

57 (7.7)

10 (3.4)

COVID-19

23 (2.7)

34 (3.2)

6 (0.8)

39 (13.3)

All deathsc, d

8 (0.9)

6 (0.6)

9 (1.2)

5 (1.7)

Deaths ≤ 30 days after last dose

1 (0.1)

3 (0.3)

8 (1.1)

3 (1.0)

Deaths > 30 days after last dose

7 (0.8)

3 (0.3)

1 (0.1)

2 (0.7)

  1. DMARD, disease-modifying antirheumatic drug; E, event; mono, monotherapy; MTX, methotrexate; PY, patient-years; QD, once daily; TEAE, treatment-emergent adverse event; UPA, upadacitinib
  2. aExcept mortality, data are presented as treatment-emergent adverse events, which is defined as any adverse event with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. Data include patients receiving UPA or MTX monotherapy, censored at either time of rescue to UPA + MTX or with addition of background conventional synthetic DMARD
  3. bUPA 30 mg exposure was censored at time of dose switch to the approved 15 mg dose. Safety outcomes following the switch from UPA 30 mg to UPA 15 mg are reported separately (last column)
  4. cIncludes treatment-emergent and non-treatment-emergent deaths. Seven deaths were COVID-19-related: 2 on UPA 30 mg mono and 3 on UPA 15 mg mono switched from UPA 30 mg mono. Two COVID-19-related deaths also occurred in patients on MTX who switched from UPA 30 mg to UPA 15 mg (not shown in the table)
  5. dIn addition to the presented treatment groups, 1 death occurred in a patient receiving UPA 30 mg plus MTX
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Arthritis Research & Therapy

ISSN: 1478-6362

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