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Table 1 ADRs of glucocorticoids and synthetic DMARDs in patients with JIA, JSLE and JDM

From: Adverse drug reactions associated with treatment in patients with chronic rheumatic diseases in childhood: a retrospective real life review of a single center cohort

Medications
  GCs MTX LEF HCQ/CQ CSA MMF AZA CPA TOTAL
Patients on MED 339 398 86 271 92 29 115 75 1405
Patients on MED with ADR 151 252 18 30 31 5 17 34 538
Patients on MED with ADR(%) (44.5) (63.3) (20.9) (11.1) (33.7) (17.2) (14.8) (45.3) (38,3)
Infections 9 20 – 2 3 2 5 2 43
Blood and lymphatic system disorders:
 - Persistent anemia – 1 – – – – – – 1
 - Leukopenia/Lymphopenia – – – – – – 6 4 10
 - Pancytopenia/Neutropenia – – – – – – 1 – 1
Immune system disorders:
 - MAS – – 1 – – – – – 1
Endocrine disorders:
 - Cushing syndrome 122 – – – – – – – 122
 - Obesity 3 – – – – – – – 3
Metabolism and nutrition disorders:
 -Osteoporosis*/ Low bone mineral density 51 9 – – – – – – 60
Nervous system disorders:
 - Chronic headache/dizziness/discomfort 8 32 0 1 – 2 – 4 47
 - Pseudotumor cerebri 2 – – – – – – – 2
 -↓ convulsive threshold – – 1 – – – – – 1
Eye disorders:
 - Glaucoma 2 – – – – – – – 2
 - Cataract 19 – – – – – – – 19
 - Maculopathy – – – 16 – – – – 16
 - Blurred vision – 1 – – –   – – 1
Cardiovascular disorders:
 - Arterial hypertension 42 – – – 3 – – – 45
 - Arrhythmia – – – 1 – – 1 – 2
 - Edema 4 – – – – – – – 4
Gastrointestinal disorders:
 - Nausea/vomiting 10 199 4 6 17 – 2 28 266
 - Epigastric/abdominal pain 7 73 2 2 6 – 2 1 93
 - Diarrhea – 8 – 1 – 2 – – 11
 - Hyporexia – 7 – – 1 – – – 8
 - Constipation – 1 – – – – – 1 2
Hepatobiliary disorders:
 - ↑ liver enzymes 2 68 7 1 1 – 5 1 85
 - Hepatic steatosis 1 – – – – – – – 1
 - Jaundice – – 1 1 – – – – 2
Oral disorders:          
 - Mouth ulcers – 3 1 – – – – – 4
 - Mucositis – 3 – – – – – – 3
 - Gingival hyperplasia – – – – 2 – – – 2
Skin and subcutaneous tissue disorders:
 - Striae 3 – – – – – – – 3
 - Atopic dermatitis – – – 1 – – – – 1
 - Alopecia – 5 4 – – – 1 10 20
 - Hypertrichosis – – – – 7 – – – 7
 - Urticaria 4 5 1 2 2 – – – 14
Musculoskeletal and connective tissue disorders:
 -↑ muscle enzymes – – – 1 – – – – 1
 - Myositis – – – 1 – – – – 1
 - Myalgia 3 – – – – – – – 3
Renal and urinary disorders:
 -↑ urea – – – – 1 – – – 1
General disorders and administration site conditions:
 - Infusion reactions and pain 3 4 – – – – – – 7
Total number of ADRs 295 439 22 36 43 6 23 51 915
  1. ADR - adverse drug reaction, DMARDs - disease modifying antirheumatic drugs, JIA - juvenile idiopathic arthritis, JSLE - juvenile systemic lupus erythematosus, JDM - juvenile dermatomyositis, MED - Medication. Patients on MED- number of patients who used the medication. Patients on MED with ADR- number of patients who used the medication and experienced at least one adverse drug reaction. Patients on MED with ADR(%)- percentage of patients who used the medication and experienced at least one adverse drug reaction = N. P with ADR X 100/N.P on MED. ↑ liver enzymes - elevated liver enzymes. MAS - macrophagic activation syndrome. ↑ muscle enzymes - elevated muscle enzymes. ↓ convulsive threshold - reduction of the convulsive threshold. ↑ urea - elevated urea. MTX - methotrexate (median dose - 0.65 mg/kg/week and median length of treatment - 35.5 months). GCs - glucocorticoids (median dose - 0.64 mg/kg/day and median length of treatment - 28 months). CSA - cyclosporine (median dose - 4.2 mg/kg/day and median length of treatment - 35.3 months). LEF -leflunomide (median dose of 0.6 mg/kg/day and median length of treatment - 13.5 months). MMF - Mycophenolate mofetil (median dose - 32.2 mg/kg/day and median length of treatment - 19.8 months). HCQ-hydroxychloroquine (median dose - 5.5 mg/kg/day and median length of treatment - 30.7 months). CQ-diphosphate chloroquine (median dose - 4.7 mg/kg/day and median length of treatment - 28.3 months). CPA - cyclophosphamide (median dose of 734 mg/dose and median length of treatment - 5.9 months). AZA - azathioprine (median dose - 1.3 mg/kg/day and median length of treatment - 28.1 months). * one fracture
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Advances in Rheumatology

ISSN: 2523-3106

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