Efficacy and Safety of WOBENZYM® as Disease Modifying Drug in Rheumatoid Arthritis as Compared with an Oral Gold Therapy

Efficacy and Safety of WOBENZYM^® as Disease Modifying Drug in Rheumatoid Arthritis as Compared with an Oral Gold Therapy

Randomised Open Clinical Trial
Biometric Final Report

Investigator: Prof. Gert Klein, M.D.

Ludwig-Boltzmann-Institute for Rehabilitation of Internal Diseases, Rehabilitationszentrum Saalfelden, Thorerstrasse 26, A-5760 Saalfelden, Austria

Evaluation by: MUCOS Pharma GmbH & Co, Dept. Clinical Research, Alpenstrasse 29, D-8192 Geretsried 1, F.R.G.

SUMMARY

In an open randomised clinical trial the efficacy and safety of WOBENZYM^â as basic treatment in patients with rheumatoid arthritis was compared with oral gold (Auranofin) as a proven standard therapy.

51 patients (26 WOBENZYM^â , 25 gold) could be evaluated. The duration of therapy was normally six months. 69% of the WOBENZYM^â -patients and 76% of the gold patients terminated the treatment according to the protocol.

Despite of randomisation, statistically significantly elder patients with statistically significantly more severe diseases were taken into the WOBENZYM^â -group.

All checked symptoms (pain at rest, pain at motion, pain by pressure, joint swelling, joint motility, circumference of the index joint, grip strength, morning stiffness and walking time) improved during WOBENZYM^â -therapy significantly. All symptoms but grip strength also improved markedly during gold therapy.

By means of the analysis of covariance the differences in the intensities of the symptoms at baseline were adjusted for calculation. Thus, the both groups could be made comparable for statistical analysis.

There was not found a statistically significant difference for any symptom between the WOBENZYM^â - and the gold-therapy.

In this study, the course of the circulating immune complexes (CIC) showed no correlation with the course of the disease. In both groups the CIC increased significantly until the third treatment month, with a more distinct increase in the WOBENZYM^â -group. In the WOBENZYM^â -group the values continued to increase until the sixth month, whereas they decreased slightly in the gold group from the third month. In both groups the values at the end of the therapy were higher than the baseline values. Possibly this is due to a mobilisation of tissue-bound immune complexes and to a break of big CIC to smaller ones.

All laboratory parameters measured showed no or only an inconsiderable change of the values during the therapy in both groups. However, during gold therapy the number of patients with pathologically elevated SGPT values increased from 4% to 22.7%.