Adverse events in patients with chronic hypersensitivity pneumonitis receiving immunosuppression
| Treatment# | Events | Exposure months | Incidence | Unadjusted | Adjusted¶ | ||
| IRR (95% CI) | p-value+ | IRR (95% CI) | p-value+ | ||||
| TEAEs§ | |||||||
| PRED (n=41) | 104 | 525.37 | 0.198 | Ref. | Ref. | Ref. | Ref. |
| MMF (n=32) | 30 | 401.83 | 0.075 | 0.30 (0.15–0.58) | <0.001 | 0.34 (0.17–0.67) | 0.002 |
| AZA (n=20) | 45 | 505.83 | 0.089 | 0.48 (0.23–0.97) | 0.040 | 0.46 (0.21–0.98) | 0.044 |
| SAEsƒ | |||||||
| PRED (n=41) | 8 | 525.37 | 0.015 | Ref. | Ref. | Ref. | Ref. |
| MMF (n=32) | 8 | 401.83 | 0.020 | 1.19 (0.38–3.78) | 0.767 | 1.22 (0.35–4.33) | 0.755 |
| AZA (n=20) | 8 | 505.83 | 0.016 | 1.40 (0.27–7.33) | 0.689 | 0.84 (0.18–3.97) | 0.829 |
IRR: incidence rate ratio; TEAE: treatment-emergent adverse event; PRED: prednisone; MMF: mycophenolate mofetil; AZA: azathioprine; SAE: serious adverse event. #: patients receiving MMF or AZA also had concurrent therapy with low-dose PRED. ¶: for age, sex, race, forced vital capacity (% predicted), diffusing capacity of the lung for carbon monoxide (% predicted) and identified antigen. +: versus PRED. §: MMF TEAEs were constipation, nausea, vomiting, headache, dizziness, blurry vision, diarrhoea, stomach upset/pain, flatulence/bloating/dyspepsia, oedema, hypertension, fever, tremors, insomnia, petechiae/bruising, cellulitis, recurrent urinary tract infections and lower respiratory tract infections; PRED TEAEs were appetite changes, nausea, vomiting, hypokalaemia, headache, dizziness, blurry vision, glucose intolerance, stomach upset/pain, flatulence/dyspepsia, oedema, sodium retention, hypertension, fever, diaphoresis, tremors, insomnia, petechiae/bruising, cellulitis, skin atrophy, impaired wound healing, facial erythema, skin pigmentation, hair loss, acne, rash, urticaria, emotional lability, anxiety, depression, raised intraocular pressure, Cushing's syndrome/moon facies, hirsutism, menstrual irregularities, muscle atrophy/deconditioning/proximal myopathy, osteopenia/osteoporosis, cataracts, glaucoma, thrush, recurrent urinary tract infections and lower respiratory tract infections. ƒ: death, lung transplant or respiratory hospitalisation.