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Table 2 Adverse events: overview of adverse events in the DB and OL phases

From: Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population

 

DB phase week 0 – week 12

OL phase week 12 – week 28

(Safety set)

(OL set)

 

Placebo

CZP

Placebo → CZPa

CZP → CZPa

(n = 209)

(n = 846)

(n = 184)

(n = 770)

Any AE, incidence/100 pt-yrs (n, %)

483.2 (129, 61.7)

522.1 (571, 67.5)

328.9 (142, 77.2)

239.1 (521, 67.7)

Patients discontinuing due to AE, n (%)

8 (3.8)

40 (4.7)

3 (1.6)

26 (3.4)

Injection and infusion site reactions, incidence/100 pt-yrs (n, %)

4.2 (2, 1.0)

25.3 (49, 5.8)

8.8 (9, 4.9)

3.2 (14, 1.8)

Serious AEs, incidence/100 pt-yrs (n, %)

25.8 (12, 5.7)

26.7 (52, 6.1)

20.6 (21, 11.4)

13.0 (56, 7.3)

Serious infections, incidence/100 pt-yrs (n, %)

8.3 (4, 1.9)

11.1 (22, 2.6)

5.7 (6, 3.3)

4.1 (18, 2.3)

Deaths, n (%)

0

2 (0.2)

1 (0.5)

1 (0.1)

  1. DB double-blind, OL open-label, CZP certolizumab pegol, AE adverse event, Pt-yrs patient-years, n number of patients reporting AE
  2. aPatients who completed 12 weeks of treatment with either CZP 200 mg every other week (Q2W) or placebo during the double-blind phase entered the OL phase and subsequently received active treatment (CZP 200 mg Q2W) for ≥16 weeks