Session Information
Date: Tuesday, November 7, 2017
Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects Poster III: Juvenile Arthritis
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in childhood. The treatment of JIA has been revolutionized by the use of biologic agents. Since studies on biologic therapy in young adults include relatively low numbers of patients and short trial durations, more evidence regarding safety issues is needed. Our aim is to evaluate the safety of biological therapy in JIA.
Methods: Multicenter prospective study. Information was obtained from BIOBADASER, a study based on routine clinical practice All patients diagnosed before age 16 in our database between 2000 and 2015 were included in the analysis. JIA is classified into 7 subgroups: systemic, persistent or extended oligoarthritis, RF positive polyarthritis, RF negative polyarthritis, enthesitis-related arthritis, psoriatic arthritis, and undifferentiated arthritis. Due to the design of the registry, it was not possible to identify each of the JIA subgroups; thus, we classified them into systemic/oligo/polyarticular JIA, JIA related to enthesitis, and psoriatic JIA. Adverse event were coded using version 13.0 MedDRA (Medical Dictionary for Regulatory Activities).
Proportions, means and standard deviations (SD) were used to describe our population. Incidence rates and 95% confidence intervals were calculated to assess adverse events.
Results: A total of 469 patients were classified as systemic/oligo/polyarticular JIA (70.6%), JIA related to enthesitis (25%) and psoriatic JIA (4.5%). 46.1% of patients were women. Age at diagnosis was 9.4 (SD = 5.3) and years of disease evolution 24.1 (SD = 14.1). The age at biological treatment initiation was 23.9 years (SD= 13.9). Biologicals were used as monotherapy in the 42.4% of the treatments, while methotrexate was used in combination in 44.0% of the treatments. Table 1 shows incidence rates for adverse events. Serious adverse events had an incidence of 41.4 (35.2-48.7). Only in one case was a fatal adverse event (mycoplasma pneumonia during treatment with anakinra) recorded.
Conclusion: The most common incident adverse events were: infections, gastrointestinal disorders, skin and subcutaneous tissue disorders. There seemed to be little difference between the results for patients with JIA and those diagnosed with rheumatoid arthritis in BIOBADASER. Although this project allowed us to examine long-term drug safety in JIA, large registries that focus on such patients are needed to better understand rare adverse events.
Table 1. Incidence of adverse events recorded in patients with JIA by line of treatment.
|
Incidence (CI95%) x 1,000 persons/year |
First-line biologic |
Second-line Biologic |
Total |
|
Total adverse events |
367.2 (342.8-393.3) |
383.2 (351.3-417.9) |
373.2 (353.6-393.8) |
|
Severe adverse events |
36.6 (29.4-45.5) |
49.5 (38.9-63.0) |
41.4 (35.2-48.7) |
|
Fatal adverse events |
– |
0.7 (0.1-5.3) |
0.3 (0.0-2.0) |
|
By system / organ class |
|||
|
Infections and infestations |
171.2 (154.8-189.3) |
151.5 (131.9-173.9) |
163.8 (151-177.6) |
|
Gastrointestinal disorders |
19 (14-25.7) |
24.7 (17.6-34.8) |
21.1 (16.9-26.5) |
|
Skin and subcutaneous tissue disorders |
17.2 (12.5-23.6) |
25.5 (18.2-35.7) |
20.3 (16.1-25.6) |
|
General disorders and administration site conditions |
19.9 (14.8-26.7) |
21 (14.5-30.4) |
20.3 (16.1-25.6) |
|
Eye disorders |
13.5 (9.5-19.4) |
19.5 (13.3-28.6) |
15.8 (12.1-20.5) |
|
Complementary explorations |
15.4 (11-21.5) |
15.7 (10.3-24.1) |
15.5 (11.9-20.2) |
|
Musculoskeletal and connective tissue disorders |
10.8 (7.3-16.2) |
13.5 (8.5-21.4) |
11.8 (8.7-16) |
|
Surgical and medical procedures |
9.5 (6.2-14.5) |
14.2 (9.1-22.3) |
11.3 (8.3-15.4) |
|
Nervous system disorders |
11.3 (7.6-16.7) |
11.2 (6.8-18.7) |
11.3 (8.3-15.4) |
|
Blood and lymphatic system disorders |
8.6 (5.5-13.5) |
10.5 (6.2-17.7) |
9.3 (6.6-13.1) |
|
Renal and urinary disorders |
9.9 (6.5-15.1) |
8.2 (4.6-14.9) |
9.3 (6.6-13.1) |
|
Reproductive system and breast disorders |
8.1 (5.1-12.9) |
9 (5.1-15.8) |
8.5 (5.9-12.1) |
|
Injury, poisoning and procedural complications |
9 (5.8-14) |
6.7 (3.5-13) |
8.2 (5.7-11.8) |
|
Respiratory, thoracic and mediastinal disorders |
8.1 (5.1-12.9) |
6 (3-12) |
7.3 (5-10.8) |
|
Neoplasms: benign, malignant and unspecified (including cysts and polyps) |
6.3 (3.7-10.7) |
3.7 (1.6-9) |
5.4 (3.4-8.4) |
|
Hepatobiliary disorders |
5 (2.8-9) |
5.2 (2.5-11) |
5.1 (3.2-8.1) |
|
Metabolism and nutrition disorders |
4.5 (2.4-8.4) |
5.2 (2.5-11) |
4.8 (3-7.7) |
|
Pregnancy, puerperium and perinatal conditions |
1.4 (0.4-4.2) |
9 (5.1-15.8) |
4.2 (2.5-7) |
|
Vascular disorders |
3.6 (1.8-7.2) |
4.5 (2-10) |
3.9 (2.3-6.7) |
|
Psychiatric disorders |
3.6 (1.8-7.2) |
4.5 (2-10) |
3.9 (2.3-6.7) |
|
Ear and labyrinth disorders |
1.8 (0.7-4.8) |
4.5 (2-10) |
2.8 (1.5-5.2) |
|
Immune system disorders |
1.4 (0.4-4.2) |
4.5 (2-10) |
2.5 (1.3-4.9) |
|
Cardiac disorders |
2.7 (1.2-6) |
1.5 (0.4-6) |
2.3 (1.1-4.5) |
|
Endocrine disorders |
1.8 (0.7-4.8) |
1.5 (0.4-6) |
1.7 (0.8-3.8) |
|
Social circumstances |
1.4 (0.4-4.2) |
1.5 (0.4-6) |
1.4 (0.6-3.4) |
|
Congenital, familial and genetic disorders |
2.3 (0.9-5.4) |
0 (-) |
1.4 (0.6-3.4) |
To cite this abstract in AMA style:
Bethencourt Baute JJ, Sánchez-Piedra C, Expósito Pérez L, Hernández MV, Manero J, Rosello R, Sánchez-Alonso F, Ruiz-Montesinos D, Perez Pampín E, Rodriguez-Lozano C, Campos Fernandez C, Fernández-Carballido C, Martín-Domenech R, Del Pino-Montes J, Freire M, Díaz-González F, Gomez-Reino JJ, Bustabad S. Safety of Biologic Therapies for the Treatment of Juvenile Idiopathic Arthritis: Results from the Spanish Registry of Adverse Events with Biologic Therapies (BIOBADASER) [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/safety-of-biologic-therapies-for-the-treatment-of-juvenile-idiopathic-arthritis-results-from-the-spanish-registry-of-adverse-events-with-biologic-therapies-biobadaser/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-biologic-therapies-for-the-treatment-of-juvenile-idiopathic-arthritis-results-from-the-spanish-registry-of-adverse-events-with-biologic-therapies-biobadaser/