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Table 1 (Abstract A60). Overview of CAN dosing, disease activity and safety in the RELIANCE study across all study indications (N=268 patients)

From: Abstracts of the 35th Meeting of the German Society for Pediatric and Adolescents Rheumatology (Gesellschaft für Kinder- und Jugendrheumatology (GKJR)

 

Baseline (n=265)*

Month 30 (n=120)*

Month 60 (n=17)*

CAN dose category1

< SD

SD

> SD

< SD

SD

> SD

< SD

SD

> SD

n (% of patients)

8

(3.3)

152

(63.1)

81

(33.6)

19

(18.3)

28

(26.9)

57

(54.8)

2

(13.3)

1

(6.7)

12

(80.0)

Investigator’s assessment of disease activity (PGA), n (% of patients)

 Absent

29 (59.2)

9 (25.7)

28 (37.8)

13 (76.5)

4 (66.7)

22 (62.9)

n.a.

n.a.

n.a.

 Mild/moderate

15 (30.6)

25 (71.4)

40 (54.1)

4 (23.5)

2 (33.3)

13 (37.1)

   

 Severe

3 (6.1)

0 (0.0)

4 (5.4)

0 (0.0)

0 (0.0)

0 (0.0)

   

 Not done

2 (4.1)

1 (2.9)

2 (2.7)

0 (0.0)

0 (0.0)

0 (0.0)

   

 Missing

20

38

21

12

22

23

   

Patient’s assessment of disease activity

(VAS score 0-10), median

2.0

2.0

3.0

1.0

2.0

1.0

2.0

n.a.

1.0

(min.; max.), n

(0.0;10.0, n=66

(0.0; 10.0), n=71

(0.0; 10.0), n=93

(0.0; 9.0), n=27

(0.0; 6.0), n=26

0.0; 8.0), n=49

(0.0; 5.0), n=3

 

(0.0; 4.0), n=12

 

Safety (interim analysis cut-off date December 2023), all patients (N=268)

 

< SD

(n=69)

SD

(n=73)

> SD

(n=95)

Dose missing

(n=31)

Patients with nsADR, n (%)

17 (24.6)

15 (20.5)

42 (44.2)

8 (25.8)

Patients with SADR, n (%)

5 (7.2)#

0 (0.0)

8 (8.4)#

1 (3.2)

  1. *Patients with baseline, month 30 and 60 visits yet documented. 1Body weight > 40kg: Standard dose is 150 mg per 8 weeks for CAPS and 150 mg per 4 weeks for FMF, TRAPS and HIDS/MKD. Body weight ≤40 kg: Standard dose is 2 mg per kg per 8 weeks (CAPS) or per 4 weeks (FMF, TRAPS and HIDS/MKD). Less than SD (<SD) defined as <87.5% of SD and greater than SD (>SD) defined as >112.5% of SD
  2. #Comparison of SADR rates between <SD and >SD groups showed no statistically significant difference (p=0.783; chi-square test). n.a.: not annotated (data not yet available); nsADR: non-serious adverse drug reactions; PGA: physician global assessment; SADR: serious adverse drug reactions; SD: recommded starting dose; VAS: visual analogue scale (range 1-10)