Table 2 All reported and/or observed adverse events in the 15 patients treated with leflunomide, indicated per individual patient.
Patients | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse event | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | Total n (%) |
Diarrhoea | + | + | + | + | + | + | + | 7 (47) | ||||||||
GI discomfort | + | + | + | + | + | + | 6 (40) | |||||||||
Anorexia | + | + | 2 (13) | |||||||||||||
Oral ulcers | + | + | 2 (13) | |||||||||||||
Hair loss | + | + | + | + | + | + | + | 7 (47) | ||||||||
Headache | + | + | + | + | + | 5 (33) | ||||||||||
Fatigue/lethargy | + | + | + | 3 (20) | ||||||||||||
Dysaesthesia | + | + | 2 (13) | |||||||||||||
Dizziness | + | + | + | + | 4 (26) | |||||||||||
Alcohol intolerance | + | 1 (6) | ||||||||||||||
Weight loss >2 kg | + | + | + | + | + | 5 (33) | ||||||||||
Dyspnoea | + | 1 (6) | ||||||||||||||
↑Transpiration | + | 1 (6) | ||||||||||||||
↑Conjunctivitis | + | + | 2 (13) | |||||||||||||
Pharyngitis | + | + | 2 (13) | |||||||||||||
↓Libido | + | 1 (6) | ||||||||||||||
Mood changes | + | 1 (6) | ||||||||||||||
↓Taste | + | 1 (6) | ||||||||||||||
ALAT 1–2* ULN | + | + | 2 (13) | |||||||||||||
ALAT >2* ULN | +* | +† | 2 (13) | |||||||||||||
↑Pre‐existing ↑RR | + | + | 2 (13) | |||||||||||||
LE skin lesions | +‡§ | +¶** | +1,2 | +1,2 | + 1 | 5 (33) | ||||||||||
Other skin lesions | + | +†† | +‡‡ | + | 3 (20) | |||||||||||
Leucopenia 3–4×109/l | + | + | + | + | 4 (26) | |||||||||||
Leucopenia <3×109/l | + | + | 2 (13) | |||||||||||||
Anaemia <7.4 mmol/l | + | + | + | + | + | 5 (33) |
ALAT, alanine aminotransferase; GI, gastrointestinal; LE, lupus erythematosus; ULN, upper limit of normal; ↑RR, hypertension; ↓, decrease; +, present.
*Requiring temporary stop of leflunomide (LEF) treatment. After normalisation of ALAT, LEF was restarted at a dose of 10 mg OD.
†Requiring temporary stop of LEF treatment twice. After first normalisation of ALAT, LEF was restarted at a dose of 10 mg. After second normalisation, LEF 10 mg OD was restarted without subsequent increase of ALAT again.
‡Causing permanent withdrawal at 17 weeks.
§Biopsy proven.
¶Not biopsy proven.
**Reactivation of lesions that had been occurring before LEF treatment.
††Itching maculopapular rash.
‡‡Oral lesions, self‐reported, not confirmed.