SIMILAR EFFECT ON X-RAY PROGRESSION IN PATIENTS WITH EARLY RA TREATED WITH REUMACON (CPH 82) OR METHOTREXATE (MTX)

Björn Svensson(1), Holger Pettersson(2) and Thomas Lerndal(3), (1) Spenshult´s Hospital, Oskarström, (2) Dept of Radiology, University Hospital, Lund, (3) Dept. of Rheumatology, Karolinska Hospital, Stockholm, Sweden.

(E-mail: bjoern.svensson@swipnet.se)

Objectives
CPH 82 is a DMARD, which has shown anti-rheumatic effect in placebo and comparative drug trials. The primary objective was to compare X-ray progression in patients with RA during treatment with CPH 82 and MTX, a DMARD with X-ray retarding ability. The secondary objective was to evaluate the clinical efficacy, the tolerance and safety profiles of the two drugs.

Methods
The study is a 98-week multi-centre of 100 patients with active RA, disease duration less than two years at start of treatment which was either CPH 82 150-450 mg/day or MTX 5-20 mg/week. During the first 32 weeks, the study was a double-blind, randomised study and later continued as an open, randomised study with parallel groups. Radiographs showing joint destruction were evaluated by Larsen scores and erosion counts. The clinical effect variables were: number of swollen joints, Ritchie's articular index, pain score (VAS), patients´ global assessment (VAS), HAQ, CRP and ESR.

Results
The mean levels for the Larsen score and the number of erosions increased significantly in both groups. No significant differences were found between the groups at endpoint.
All clinical effect variables improved significantly in both groups. ESR, CRP and pain VAS decreased significantly more in the MTX-group.(See below note)
In the CPH 82-group 20 patients dropped out, 2 due to adverse events, 10 due to inefficacy and 8 other reasons. In the MTX-group 26 patients dropped out, 18 due to adverse events, 3 due to inefficacy and 5 other reasons. The gastrointestinal side effects were the most common, similar in frequency, type and severity for both drugs.

Conclusion
Radiological progression with CPH 82 was similar to that with MTX, a DMARD with documented ability to slow radiographic deterioration. The clinical effects of treatment with CPH 82 appear almost equal to those with MTX in this 98-week trial while the safety profile of CPH 82 was more favourable.

Note: After reviewing the data, it is only CRP which decreased significantly more in the MTX-group. No statistical significant difference between CPH 82 and MTX regarding ESR and pain VAS at the end-point.