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AB0609 Are hydroxychloroquine (HCQ) and leflunomide (LEF) effective in DMARD naive patients with early rheumatoid arthritis (RA)?
  1. S. Stoica1,
  2. G. Zugravu2
  1. 1Rheumatology, Emergency Hospital Elena Beldiman, Barlad
  2. 2Rheumatology, Rehabilitation Hospital, Iasi, Romania


Background Both HCQ and LEF are members of disease-modifying antirheumatic drugs (DMARDs)drugs (DMARDs)used to slow down RA progression. They have documented efficacy in reducing signs and symptoms in RA and are widely used as first-line DMARD therapies across Europe.

Objectives To compare early RA patients starting HCQ and LEF, in terms of demographics, baseline characteristics, clinical responses and drug survival.

Methods We investigated 56 DMARD naive RA pacients with disease duration <6 months starting HCQ or LEF. 23 pacients treated with HCQ (400mg/day) and 33 pacients treated with LEF (20 mg/day) met the inclusion criteria. There were significant differences in baseline characteristics between HCQ/LEF pacients: mean age 47.9/53.9 years, DAS28 4.1/5.2, SDAI 22.0/27.2, MHAQ 0.48/0.57, 56%/68% rheumatoid factor positive (p=0.006), 65% vs 74% female (p=0.11). No corticotherapy association was admitted. Baseline characteristics were compared by appropriate statistic tests, drug survival compared by Kaplan-Meier analysis. Pacients were evaluated at baseline, 3 months and 6 months.

Results The results were inferior for HCQ vs LEF (log rank p<0.001), with estimated drug survival rates of 58%/84% and 65%/96% at 3, 6 months. Mean 6-month improvements for HCQ(n=23)/LEF(n=33) were as follows (unadjusted p-values/propensity score quartile-adjusted p-values): DAS28 -1.1/-1.6 (p=0.003/p=0.29), SDAI -6.3/-12.8 (p<0.001/p=0.02), MHAQ -0.12/-0.25 (p=0.002/p=0.03), ESR -5.7/-10.9 (p=0.006/p=0.29), CRP (mg/L) -7.5/-11.9 (p=0.12/p=0.61), physician global -10.8/-18.9 (p<0.001/p=0.004), patient global -7.5/-11.7 (p=0.10/p=0.56). ACR20/50/70 response rates at 3 months and ACR20 at 6 months was in favour of LEF, but no difference for EULAR good responses. ACR20, ACR50 and ACR70 response rates for HCQ/LEF were: 23%/35%, 21%/42%, 15%/24% at 6 months. showed larger improvement for MHAQ, CRP and physician global and higher ACR response rates for LEF vs HCQ.

Conclusions Drug survival was far superior for LEF, and there was a tendency towards superior effectiveness of LEF vs HCQ also when taking the differences in baseline characteristics into account.

  1. Emery P. Therapeutic approaches for early rheumatoid arthritis. How early? How aggressive? Br J Rheum 1995;34(suppl.2):87-90.

  2. van Zeben D, Breedveld FC. Prognostic factors in rheumatoid arthritis. J Rheum 1996;23(suppl.44):31-3.

  3. Fries JF. Effectiveness and toxicity considerations in outcome directed therapy in rheumatoid arthritis. J Rheum 1996;23(suppl.44):102-6.

  4. Boers M, Tugwell P, Felson DT, et al. World Health Organization and international league of associations for rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheum 1994;21(suppl.41):86-9.

  5. Porter DR, Capell HA. The “natural” history of active rheumatoid arthritis over 3-6 months - an analysis of patients enrolled into trials of potential disease-modifying anti-rheumatic drugs, and treated with placebo. Brit J Rheum 1993;32:463-6.

Disclosure of Interest None Declared

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