The efficacy and tolerability of
pyritinol and auranofin (AU) were compared in a multicentre double-blind
study. Patients with RA received 600 mg/day
pyritinol or 6 mg/day AU for 1 year. Response was rated by a defined improvement in at least four of the following:
Ritchie index, joint swelling index, rating scales for pain and general
well-being, functional index, morning stiffness, ESR. Of the 139 fully
evaluable
pyritinol patients 61 (44%) dropped out due to adverse events or response
failure compared with 44 (31%) of the 142 AU patients. In patients treated for
1 year efficacy parameters improved more in the
pyritinol than in the AU group, with
significant differences for the general well-being (P = 0.022), ESR (P =
0.029) and haemoglobin (P = 0.0042). The response rate for
pyritinol (61/78 patients,
78%) was significantly superior to AU (58/98 patients, 59% P = 0.009). An
intention-to-treat analysis corroborated this result (P = 0.030). Adverse
events (AE) occurred in 64% of
pyritinol patients and in 58% of AU patients: main AE
were mucocutaneous symptoms (pyritinol 36%, AU 23%) and gastrointestinal complaints
(pyritinol 30% AU 37%). Single cases of proteinuria, hepatic and haematological
abnormalities were noted in both groups