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EULAR 2013: Hydroxychloroquine is often prescribed for primary Sjögren’s. But a randomized trial shows no evidence of short-term efficacy other than some biomarker changes.
While hydroxychloroquine (HQ) is often prescribed to patients with primary Sjgren’s syndrome (pSS), a randomized, placebo-controlled trial shows no evidence of its short-term efficacy, even though some disease activity markers decreased slightly, according to French researchers.
In the controlled phase of the crossover trial, 120 pSS patients, half of whom had systemic involvement, were randomly assigned to HQ (400 mg/j) or placebo for 24 weeks; during the open extension phase (24 to 48 weeks), all patients were prescribed HQ.
At six months, similar numbers of patients treated with HQ or placebo (19.6% and 19.8% respectively) showed an overall favorable response, defined as >30% improvement in two of three visual analog scale values for measuring dryness, pain, and fatigue. Researchers reported these results at the 2013 annual meeting of the European League Against Rheumatism (EULAR) in Madrid.
They saw no significant difference in secondary outcomes (change in the ESSDAI, ESSPRI, or Schirmer’s test,unstimulated salivary flow, serum gammaglobulin levels, SF-36, HAD, PROFAD, or SSI.)
There was also no significant difference among patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement.
However at 12 months, 18.8% of patients treated with placebo for 6 months followed by HQ and 32.1% of those who took H! for the full year were considered responders, a significant finding. The drug proved comparably tolerable to placebo.
As for disease activity markers, in patients treated with HQ showed a significant decrease in IgM, but only a trend towards decreased serum IgG.
Among the 45 patients whose serum was assessed at baseline, HQ induced a decrease in the serum interferon-regulated chemokines CXCL10 and CCL19, but not in CCL2. There was also a reduction in two IFN-induced chemokines. Other than that, the researchers found no response associated with HQ in any patient subgroup.