Clinical impact of hydroxychloroquine dose adjustment according to the American Academy of Ophthalmology guidelines in systemic lupus erythematosus

Abstract

ObjectiveThe American Academy of Ophthalmology recommends a maximum hydroxychloroquine (HCQ) dose of ≤5.0 mg/kg/day to reduce the risk of HCQ-induced retinopathy. To determine if this dose adjustment would have an impact on the clinical course of SLE, we compared outcome measures in a cohort of patients with SLE before and after adjusting HCQ dose.MethodsSixty Puerto Ricans with SLE (per 1997 American College of Rheumatology criteria) treated with HCQ who were changed to HCQ ≤5.0 mg/kg/day were studied. Visits were ascertained every 6 months for 2 years before and 2 years after HCQ dose adjustment (baseline visit). Disease activity (per Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)), SLE exacerbations, emergency room visits, hospitalisations, disease damage (per Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index), corticosteroids exposure, prednisone dose and immunosuppressive drugs exposure were determined before and after HCQ dose change.ResultsAt baseline visit, the mean age was 43.8±15.1 years. All patients were women. The mean disease duration was 13.8±9.1 years. After HCQ dose adjustment, patients required a lower prednisone dose when compared with visits before HCQ dose reduction. No significant differences were observed for mean SLEDAI scores, lupus exacerbations, emergency room visits, hospitalisations, disease damage and exposure to immunosuppressive drugs before and after HCQ dose adjustment.ConclusionsThis study suggests that adjustment of daily HCQ dose to ≤5.0 mg/kg/day of actual body weight does not have a significant impact on the short-term and mid-term outcomes in this group of patients with SLE.

Hydroxychloroquine Screening Guidelines: Best Evidence, Controversies, and Future Areas of Research

“…They showed no significant differences in disease activity scores, exacerbations, emergency room visits, hospitalizations, and diseaserelated damage from before and 2 years after the change. 41 Of note, this study was limited by its small sample size, limited diversity, and short follow-up. Another case-crossover study looked at 342 patients with SLE from Massachusetts General Hospital in the 5-year period following the 2016 HCQ dosing recommendations and found that HCQ dosing of 5 mg/kg per day or less, in accordance with current guidelines, was associated with a higher risk of lupus flares.…”

How toxic is an old friend? A review of the safety of hydroxychloroquine in clinical practice

“…Current dosing recommendations of 5 mg/kg/day were developed to mitigate the risk of retinal toxicity rather than to maximise efficacy 59 . The European League Against Rheumatism recommends dose‐reducing patients with long‐standing stable disease 59 with some data suggesting no increased risk of flare when reducing from 6.5 to 5 mg/kg/day 60 . However, recent data raise the question of whether body weight dosing is the ideal method of HCQ dosing.…”

The place of hydroxychloroquine in modern dermatology

“…It is important to emphasize that the studies confirming the effectiveness of HCQ were carried out at the dose of 6.5 mg/kg [38]. Recently, results have been published according to which the use of doses of ≤ 5 mg/kg does not affect the effectiveness of therapy [73]. Taking the currently recommended dose, a person weighing 40 kg, 60 kg, or 80 kg should receive 200 mg, 300 mg, or 400 mg, respectively, of the drug per day.…”

“…Należy podkreślić, że badania potwierdzające skuteczność HCQ były przeprowadzane przy stosowaniu dawki 6,5 mg/kg [38]. Ostatnio opublikowano jednak wyniki, według których stosowanie dawek ≤ 5 mg/kg nie wpływa na skuteczność terapii [73]. Przyjmując aktualnie rekomendowaną dawkę, w uproszczeniu: osoba ważąca 40 kg powinna otrzymywać 200 mg leku na dobę, osoba ważąca 60 kg -300 mg, a osoba ważąca 80 kg -400 mg. Z uwagi na długi okres półtrwania leku i uwzględniając dostępną gramaturę tabletek zawierających HCQ, w przypadku podawania 300 mg/dobę, sugeruje się schemat naprzemiennego stosowania 400 mg i 200 mg w kolejne dni [3,10].…”