Table IV.
Reported adverse events and laboratory abnormalities in 47 patients with atopic dermatitis during 16 weeks’ upadacitinib treatment
| Adverse events | n (%) |
|---|---|
| Number of patients with AE | 36 (76.6) |
| Total number of AEs | 57 |
| Severity of AEs | |
| Mild | 44 (77.2) |
| Moderate | 8 (14.0) |
| Severe | 5 (8.8) |
| Number of patients with AE leading to treatment discontinuation | 7 (14.9) |
| Dyspnoea | 1 (2.1) |
| Nausea | 1 (2.1) |
| Recurrent herpes simplex | 1 (2.1) |
| Reactive lymphoid infiltrate | 1 (2.1) |
| Elevated liver enzymes † | 1 (2.1) |
| Combination of headache and acne | 1 (2.1) |
| Combination of headache, nausea, acne | 1 (2.1) |
| Infections | 14 (29.8) |
| Herpes simplex | 6 (12.8) |
| Upper airway infection | 4 (8.5) |
| Herpes zoster* † | 2 (4.3) |
| Impetiginization | 1 (2.1) |
| Folliculitis | 1 (2.1) |
| Non-infectious skin-related | 14 (29.8) |
| Acneiform eruptions | 10 (21.3) |
| Hair growth** | 1 (2.1) |
| Psoriasis pustulosa | 1 (2.1) |
| Reactive lymphoid infiltrate | 1 (2.1) |
| Hair loss | 1 (2.1) |
| General | 8 (17.0) |
| Weight gain | 3 (6.4) |
| Headache | 3 (6.4) |
| Fever | 1 (2.1) |
| Malaise | 1 (2.1) |
| Gastrointestinal | 4 (8.5) |
| Nausea | 4 (8.5) |
| Other | 4 (8.5) |
| Dry eyes | 1 (2.1) |
| Paraesthesia | 1 (2.1) |
| Renal calculi | 1 (2.1) |
| Dyspnoea | 1 (2.1) |
| Laboratory abnormalities | 14 (29.8) |
| Hypertriglyceridaemiaa | 4 (8.5) |
| Increase of CPKb † | 4 (8.5) |
| Hypercholesterolaemiac | 3 (6.4) |
| Increase of ALATb † | 2 (4.3) |
| Increase of creatinined † | 1 (2.1) |
Upadacitinib treatment was temporarily discontinued.
Referring to a patient with alopecia areata.
Adverse events of special interest according clinical trials with upadacitinib treatment (10).
Triglycerides > 2.0 mmol/l.
Increase > 3 times upper limit of normal (ULN).
Hypercholesterolaemia > 8.0 mmol/L.
Creatinine increase of > 130%.
Other reference categories; anaemia: haemoglobin < 8.5 mmol/l (men) or < 7.5 mmol/l (women) and if clinically relevant by physician’s decision, leukocytes < 2.0× 109/l, thrombocytosis >600× 109/l, neutropaenia < 1.0× 109/l, lymphocytopaenia < 0.5× 109/l. AE: adverse event; ALAT: alanine aminotransferase; CPK: creatinine phosphokinase.