Extended reports
Does sulphasalazine cause drug induced systemic lupus
erythematosus? No effect evident in a prospective randomised trial of
200 rheumatoid patients treated with sulphasalazine or auranofin over
five years
a Centre for Rheumatic
Diseases, Glasgow Royal Infirmary, Glasgow, b Department of Rheumatology, Gartnavel
General Hospital, Glasgow
Correspondence to: Corresponence to: Dr M-M Gordon, Centre for Rheumatic Diseases, Glasgow Royal Infirmary, 84 Castle Street, Glasgow G4 0SF.
Accepted for publication 26 February 1999
BACKGROUND
Sulphasalazine
(SSZ) has been reported to cause drug induced systemic lupus
erythematosus (SLE), but diagnosis of this complication in the context
of rheumatoid arthritis (RA) is difficult.
OBJECTIVETo determine
prospectively: (1) if patients become seropositive for antinuclear
antibodies (ANA) during prolonged treatment with SSZ without clinical
evidence of SLE; (2) if ANA positive patients develop more adverse
reactions than ANA negative patients; (3) if drug induced SLE was
identified in this cohort.
METHODS200 patients
enrolled in a randomised prospective trial of SSZ and auranofin (AUR)
were followed up for five years. Baseline and annual ANA results were
collected along with information on drug toxicity and reasons for
discontinuation of treatment.
RESULTSOver five
years 24 patients stopped taking SSZ and 49 AUR because of side
effects. Of the features common to SLE, rash developed in nine SSZ
patients and 11 AUR treated patients and mouth ulcers in three and four
patients respectively. Six SSZ treated patients and three treated with
AUR developed leucopenia, which promptly resolved with drug withdrawal.
No adverse event was ascribed to drug induced SLE. Of the 72 SSZ
treated patients who were ANA negative or weakly positive at outset, 14 (19%) became strongly ANA positive compared with 11 (14%) of 80 AUR
patients. Patients ANA positive at baseline or who became ANA positive
were not more likely to develop drug toxicity or to withdraw from
treatment than those ANA negative throughout.
CONCLUSIONANA
positivity is common in patients with RA, but the presence or
development of ANA did not increase the likelihood of withdrawing from
treatment. No case of drug induced SLE was seen over five years in this study.
© 1999 by Annals of the Rheumatic Diseases
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