ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 396

Performance of Disease Activity Measures in Juvenile Spondyloarthritis in a Placebo Controlled Trial with Infliximab

Sofia Ramiro1, Julio Casasola2, Désirée van der Heijde3, RBM Landewé4 and Rubén Burgos-Vargas5, 1Leiden University Medical Center, Leiden, Netherlands, 2Rheumatology, Hospital General de Mexico, Mexico, Mexico, 3Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 4Department of Rheumatology, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 5Rheumatology, Hospital General de Mexico, Mexico city, Mexico

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Sunday, November 13, 2016

Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects - Poster I: Juvenile Idiopathic Arthritis, Uveitis

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Several outcome measures in trials with juvenile-onset spondyloarthritis (Jo-SpA) have been borrowed from trials in juvenile idiopathic arthritis and from adult spondyloarthritis, but a proper psychometric analysis has never been conducted in patients with Jo-SpA. We aimed at assessing discriminatory aspects of several disease activity outcome measures and response criteria for Jo-SpA.

Methods: Data from a previously reported 12-week RCT comparing infliximab (IFX) and placebo (PBO) in patients <18 years with Jo-SpA and onset <16 years of age were analyzed. The primary endpoint of the trial was the number of active joints (both swollen and tender). Several other disease activity measures and response criteria were also tested (Table). Statistics to determine how well disease activity measures could discriminate between IFX and PBO included ‘standardized mean difference’ (SMD) and ‘Guyatt’s effect size. Both statistics are standardized measures to compare change from baseline per group. For categorical response criteria, the chi-square test (χ2) was used. Higher numbers indicate better discriminatory capacity.

Results: Patients were randomised to IFX (n=12) and PBO (n=14). Of the continuous measures, the ASDAS showed the best and very good discrimination between IFX and PBO (SMD:1.98; Guyatt: 4.28) (Table). The physician’s global, CRP, JADAS and JSpADA also discriminated well. The BASDAI (or its separate items), BASFI and spinal mobility measures performed worse. Of the response criteria ASAS40 and ACR Pedi 90 discriminated best between IFX and PBO (Table). ASDAS response criteria and ACR Pedi 30-70 also performed well. Table: Discrimination between patients on infliximab and placebo at week 12

0.005

CONTINUOUS OUTCOME MEASURES

Infliximab

mean change (SD)

PBO

mean change (SD)

Guyatt’s effect size

SMD

ASDAS

2.4 (1.3)

0.5 (0.6)

4.28

1.98

Physician’s global assessment, 0-10 mm VAS

5.2 (2.4)

1.6 (2.2)

2.34

1.56

JADAS27 (0-57)

12.7 (5.9)

4.3 (5.7)

2.22

1.46

JSpADA (0-8)

2.8 (1.2)

0.5 (1.4)

1.98

1.73

CRP (mg/L)

21.1 (8.4)

2.3 (10.9)

1.93

1.90

Total enthesitis (0-51)

8.5 (10.6)

1.6 (5.0)

1.71

0.85

Patient’s global assessment, 0-10 mm VAS

4.3 (3.8)

0.8 (2.8)

1.55

1.08

BASDAI total (0-10)

3.3 (3.1)

0.9 (2.3)

1.41

0.90

Pain, 0-10mm VAS

3.3 (2.1)

-1.7 (3.2)

1.03

1.80

Active joint count (0-72)

4.4 (1.7)

2.6 (4.6)

0.96

0.51

Infliximab

mean change (SD)

PBO

mean change (SD)

Chi-square

p-value

ACR Ped 90

8 (67%)

1 (7%)

10.12

0.001

ASAS40

6 (55%)

0 (0%)

10.05

0.002

ACR Ped 70

9 (75%)

2 (14%)

9.76

0.002

BASDAI50

8 (73%)

2 (14%)

8.77

0.003

ASDAS-MI

5 (63%)

0 (0%)

8.65

0.003

ACR Ped 50

11 (92%)

5 (36%)

8.55

0.003

ASDAS-CII

7 (88%)

2 (20%)

8.10

0.004

ASDAS-ID

7 (64%)

1 (8%)

7.74

ACR Ped 30

11 (92%)

6 (43%)

6.80

0.009

JADAS27 MDA (≤2)

6 (50%)

1 (7%)

6.03

0.014

JADAS27 inactive disease/remission (≤1)

3 (25%)

0 (0%)

3.96

0.047

ASAS20

7 (64%)

4 (29%)

3.07

0.080

Conclusion: Of all continuous measures tested in adult axial SpA the ASDAS discriminates best between active treatment and PBO in patients with Jo-SpA. But the child specific JSpADA also performs well. Of all response criteria tested the child-specific ACR Pedi 30 to 90, as well as the adult ASAS40 and ASDAS response criteria work well. One of these measures should be used as primary endpoint in trials with Jo-SpA.

Disclosure: S. Ramiro, None; J. Casasola, None; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boeringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5,Director: Imaging Rheumatology bv, 9; R. Landewé, Abbott, Amgen, Centocor, Novartis, Pfizer, Rhoche, Schering-Plough, UCB, Wyeth., 2,Robert Landewé is director of Rheumatology Consultancy BV, which is a registered company under Dutch law., 4,Abbott/AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Celgene, Janssen (formerly Centocor), Galapagos, Glaxo-Smith-Kline, Novartis, Novo-Nordisk, Merck, Pfizer, Rhoche, Schering-Plough, TiGenix, UCB, Wyeth., 5,Abbott/AbbVie, Amgen, Bristol Myers Squibb, Janssen (formerly Centocor), Merck, Pfizer, Rhoche, Schering-Plough, UCB, Wyeth., 9; R. Burgos-Vargas, Abbvie, Janssen, Pfizer, and UCB, 8.

To cite this abstract in AMA style:

Ramiro S, Casasola J, van der Heijde D, Landewé R, Burgos-Vargas R. Performance of Disease Activity Measures in Juvenile Spondyloarthritis in a Placebo Controlled Trial with Infliximab [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/performance-of-disease-activity-measures-in-juvenile-spondyloarthritis-in-a-placebo-controlled-trial-with-infliximab/. Accessed .

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