Table 2

 All reported and/or observed adverse events in the 15 patients treated with leflunomide, indicated per individual patient

Patients
Adverse event123456789101112131415Total n (%)
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.
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+ 15 (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)