Table 3 Adverse effects, changes in DEXA scores, withdrawals and concomitant steroid therapy
Methotrexate (n = 117)Added ciclosporin (n = 119)Added prednisolone (n = 115)Triple therapy (n = 116)
Serious adverse events
Total21181923
Deaths1112
Malignancies5201
Myocardial infarctions, angina, strokes1224
Upper gastrointestinal1201
Infections7342
Common adverse events (>5% cases)
Respiratory track infection54514955
Nausea or vomiting15312010
Headache6171015
Mouth ulcer516414
Elevated blood pressure111817
Dizziness41465
Diarrhoea510103
Paraesthesia35811
Cough75114
Abdominal pain7397
Transient creatine elevation523435
Changes in DEXA scores
Median spine T score (IQR)−0.8 (−3.7, 1.2)−0.1 (−3.4, 2.8)−1.1 (−4.0, 2.2)0.1 (−4.5, 3.2)
Median hip T score (IQR)−0.5 (−4.3, 1.5)−1.2 (−3.1, 2.6)−1.9 (−4.7, 0.9)−1.6 (−4.4, 0.8)
Withdrawals
All49625455
Exclusively for toxicity891423
Toxicity implicated12212233
Exclusively for lack of effect138107
Lack of effect implicated19171315
  • IQR, interquartile range.