COMBINATION THERAPY WITH GOLD AND HYDROXYCHLOROQUINE IN RHEUMATOID ARTHRITIS: A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED STUDY

We studied combination therapy with two slow-acting antirheumaticdrugs given concurrently in active rheumatoid arthritis (RA).A 12-month prospective randomized controlled trial comparedgold and hydroxychloroquine in 52 patients to gold and placeboin 49. The patients continued to receive non-steroidal anti-inflammatorydrugs and analgesics. They were selected from three rheumatologycentres in the West Midlands. Combination therapy led to a greaternumber of withdrawals due to adverse reactions (18 cases comparedto 10 receiving gold/placebo). Patients completing 12 months'therapy (27 taking gold/ hydroxychloroquine and 32 on gold/placebo)were compared using five clinical, seven laboratory, and oneradiological measure. All 13 variables favoured gold/hydroxychloroquinewith an overall advantage of 20–25% for the combination.This only reached statistical significance (at the 1% level)for C-reactive protein. An overall disease activity index wasbetter at 12 months (at the 5% level) and showed a more rapidresponse with gold/hydroxychloroquine. This is the first randomizedprospective placebo-controlled trial to show a significant advantagefrom a combination of two slow-acting drugs. There are manydifferent ways of giving such combinations and we consider theseshould be explored to maximize the effectiveness of treatmentfor RA. KEY WORDS: Rheumatoid arthritis, Treatment, Antimalarials, Sodium aurothiomalate