The quality of evidence is downgraded by inconsistency (unexplained variability in results), and by imprecise results (few patients and wide confidence intervals).
A randomized double-blind study 1 including 120 patients with primary Sjögren syndrome (SS) compared hydroxychloroquine (400 mg/d) to placebo until week 24. Between weeks 24 and 48, all patients were prescribed hydroxychloroquine. The primary end point was the proportion of patients with a 30% or greater reduction between weeks 0 and 24 in scores on 2 of 3 numeric analog scales (from 0 = best to 10 = worst) evaluating dryness, pain, and fatigue. Proportion of patients meeting the primary end point are shown in table T1, and mean numeric analog scale scores and mean erythrocyte sedimentation rate are shown in table T2. During the first 24 weeks, there were 2 serious adverse events in the hydroxychloroquine group and 3 in the placebo group; in the last 24 weeks, there were 3 serious adverse events in the hydroxychloroquine group and 4 in the placebo group.
| Placebo | Hydroxychloroquine | OR (95% CI) | |
|---|---|---|---|
| Week 24 | 17.2 % | 17.9% | 1.01 (0.37 to 2.78) |
| Week 48 | 18.8 % | 30.4 % | 2.06 (0.66 to 6.43) |
| Outcome | Placebo, week 0 | Placebo, week 24 | Hydroxychloroquine, week 0 | Hydroxychloroquine, week 24 | P value |
|---|---|---|---|---|---|
| Dryness | 6.38 (2.14) | 5.85 (2.57) | 6.53 (1.97) | 6.22 (1.87) | 0.55 |
| Pain | 4.92 (2.94) | 5.08 (2.48) | 5.09 (3.06) | 4.59 (2.90) | 0.06 |
| Fatigue | 6.26 (2.27) | 5.72 (2.38) | 6.00 (2.52) | 5.94 (2.40) | 0.54 |
| ESR, mm | 21.0 (14.1) | 24.7 (16.6) | 21.5 (23.4) | 17.5 (21.0) | <0.001 |
| ESR = erythrocyte sedimentation rate | |||||
| Another placebo controlled, 2 year double blind crossover study 2 included 19 patients. Use of hydroxychloroquine in a dose of 400 mg daily taken over a 12 month period did not have a clinical beneficial effect in patients with primary Sjögren's syndrome in spite of an improvement of hyperglobulinaemia and slight changes in the ESR and IgM.
In a retrospective study 3 of 50 patients with primary SS sustained improvement of local symptoms (painful eyes, painful mouth) and improvement of systemic manifestations (arthralgias and myalgias) after treatment with hydroxychloroquine 6-7 mg/kg/day over mean three-year follow-up were found; laboratory analysis showed a significant improvement in their ESR and their quantitative IgG levels. Fourteen SS patients treated with hydroxychloroquine 200 mg/day for 12 months were investigated in an open prospective study 4, and only a partial clinical effect could be noted. A significant reduction of some salivary inflammatory markers was seen at the end of 12 months. Hydroxychloroquine 200 mg per day for 12 months was evaluated in 10 patients with SS 5. For comparison, 10 patients matched according to age and sex, who did not receive hydroxychloroquine were studied. Hydroxychloroquine treatment decreased total IgG and IgA levels with little change in IgM levels, decreased IgA-rheumatoid factor with a smaller decrease in IgM-rheumatoid factor, decreased IgG anti-Sjögren's syndrome-associated antigen B autoantibody, and erythrocyte sedimentation rate, and increased hemoglobin level suggesting that hydroxychloroquine modulates lymphoproliferation in patients with Sjögren's syndrome and may prevent progression to extraglandular sites of neoplastic transformation. A case report 6 described one SS patient who had a flare of vasculitis shortly after being tapered off hydroxychloroquine. Clinical commentsNoteDate of latest search: References
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