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PubMed1998

A long-term study of hydroxychloroquine withdrawal on exacerbations in systemic lupus erythematosus. The Canadian Hydroxychloroquine Study Group.

The ability of antimalarials to moderate severe disease activity in systemic lupus erythematosus (SLE) is plausible but undemonstrated. We evaluated the long-term effectiveness of maintaining treatment with hydroxychloroquine sulphate (HCQ) to prevent major flares in quiescent SLE. Forty-seven patients with quiescent SLE who had been randomized to take HCQ (n = 25) or placebo (n = 22) as part of a 24-week withdrawal trial were evaluated for an additional 3 years. The primary outcome was time to a major flare of SLE which resulted in either the institution of or an increase in the current dosage of prednisone of 10 mg/day or more, or institution of therapy with immunosuppressive agents. Secondary outcomes included the specific subtype of these major flares (glomerulonephritis, vasculitis or other) and hospitalization for an exacerbation of SLE. An intent-to-treat analysis was conducted. Over the 42 months of study, 11 of 22 (50%) patients randomized initially to placebo, and seven of 25 (28%) patients randomized to continue treatment experienced a major flare. The relative risk of major flare for those randomized to continue HCQ compared with controls was 0.43 (95% CI: 0.17, 1.12). The relative risks for subtypes of flares were 0.26 (95% CI: 0.03, 2.54) for nephritis, 0.51 (95% CI: 0.09, 3.08) for vasculitis and 0.65 (95% CI: 0.17, 2.41) for flares characterized by other symptoms. The relative risk of hospitalization for major flare for patients randomized to continue hydroxychloroquine was 0.58 (95% CI: 0.13, 2.60). While the results are not statistically significant, they are compatible with the clinical belief that HCQ has a long-term protective effect against major disease flares in SLE and suggest that on average, HCQ use reduces major flares by 57% (95% CI: 83% reduction to 12% increase).

Adult↗

PubMed1993

Enantioselective determination of hydroxychloroquine and its major metabolites in urine and the observation of a reversal in the (+)/(-)-hydroxychloroquine ratio.

A sequential achiral-chiral high-performance liquid chromatographic system has been developed for the quantitation in urine of the enantiomers of hydroxychloroquine (HCQ), and of its 3 major metabolites, desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bisdesethylchloroquine (BDCQ). HCQ and its metabolites were separated and quantified on a cyano-bonded phase, and the enantiomeric ratios were determined using a Chiral-AGP chiral stationary phase. The assay validation and application of this method to a preliminary study in a human volunteer are presented. In this subject, the initial 0-4 h urine contained the 2 HCQ enantiomers in a ratio of (+)-HCQ:(-)-HCQ of 3:2; by the 2,064 h of the study, this ratio had reversed to (+)-HCQ:(-)-HCQ of 3:7.

Chloroquine↗

PubMed1994

Distribution of the enantiomers of hydroxychloroquine and its metabolites in ocular tissues of the rabbit after oral administration of racemic-hydroxychloroquine.

The disposition of the enantiomers of hydroxychloroquine (HCQ) and its major metabolites in ocular tissues of rabbits has been studied. Both albino, New Zealand White (NZW), and pigmented animals were administered daily oral doses of rac-HCQ, (S)-HCQ or (R)-HCQ (20 mg/kg) over 1, 6, or 8 day periods or for 8 days followed by a 7-day washout period. At the end of the study periods, plasma and whole blood samples were collected and the rabbits were sacrificed. The eyes were collected, the aqueous humor removed with a syringe, and the eyes separated into the cornea, lens, vitreous body, iris, choroid-retina, sclera, and conjunctiva. The concentrations of (R)-HCQ, (S)-HCQ, and their respective metabolites were determined using a validated enantioselective liquid chromatographic assay. The data from these studies indicate that HCQ accumulated in both pigmented and nonpigmented ocular tissues. In the pigmented tissues, HCQ and its metabolites were bound to melanin and the binding was not enantiospecific. In the nonpigmented tissues and in the iris and retina-choroid of the NZW rabbits, the accumulation appeared to be the result of a reversible and enantioselective binding of HCQ and its metabolites to an unidentified biopolymer present in these ocular tissues.

Administration, Oral↗

PubMed1993

Determination of the stereoisomers of hydroxychloroquine and its major metabolites in plasma and urine following a single oral administration of racemic hydroxychloroquine.

Plaquenil (hydroxychloroquine, HCQ; Sanofi Winthrop Pharmaceuticals, New York, NY) is a stereoisomeric drug administered as a racemic (50: 50) mixture of two isomeric forms--(+) and (-) HCQ. To correlate clinical efficiency accurately with dose, it is necessary to determine the fate of both isomers. This will allow for the optimization of clinical dosing. A method has been developed for the quantitation of (+) and (-) HCQ and its major metabolites, desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bisdesethylchloroquine (BDCQ), in plasma and in urine. Application of this method in a preliminary study in four human volunteers is reported. After a single oral dose of 200 mg of Plaquenil, the average enantiomeric ratio of (+) to (-) HCQ was approximately 1 over an 8-hour period. However, the average cumulative 48-hour excretion of HCQ, DHCQ, and DCQ showed stereoselective excretion.

Chloroquine↗

PubMed1997

Safety and efficacy of hydroxychloroquine as maintenance therapy for rheumatoid arthritis after combination therapy with methotrexate and hydroxychloroquine.

OBJECTIVE: To evaluate the ability of hydroxychloroquine sulfate (HCQ) to extend the response to combination therapy with HCQ and methotrexate (MTX) and the safety of longterm HCQ maintenance therapy in patients with active rheumatoid arthritis (RA). METHODS: Two-part study consisting of an open label segment evaluating combination HCQ/MTX therapy followed by a double blind segment evaluating maintenance therapy for a total of 60 weeks. First, all patients were treated with HCQ 400 mg/day and MTX 7.5 to 15 mg/week for 24 weeks. Then, responders were randomized into 3 groups: (1) HCQ with MTX as needed for disease flare (n = 40), (2) HCQ 400 mg/day (n = 41), or (3) placebo with MTX as needed for disease flare (n = 40), each for 36 weeks. RESULTS: Clinical disease and laboratory variables improved significantly during initial combination therapy with HCQ and MTX. After MTX withdrawal, HCQ-containing maintenance regimens delayed the onset of disease flare (p = 0.023). There were no unexpected adverse events at any time or between-group differences in the distribution of adverse events during the double blind segment. CONCLUSION: Combination of HCQ and MTX appeared to be effective and well tolerated for 24 weeks. After withdrawal of MTX, HCQ extended the response seen with combination therapy and was well tolerated for 36 weeks. Initial therapy with HCQ and MTX, followed by maintenance HCQ, may be a useful alternative for the treatment of RA.

Aged↗

PubMed2005

Multifocal electroretinographic changes in patients receiving hydroxychloroquine therapy.

PURPOSE: To evaluate the longitudinal changes in multifocal electroretinography (mfERG) in patients receiving hydroxychloroquine and to assess the effects of cumulative hydroxychloroquine dose on mfERG. DESIGN: Prospective cohort study. METHODS: Twenty-four eyes in 12 patients receiving hydroxychloroquine underwent mfERG recordings at baseline and 1 to 2 years later. The first negative (N1) and first positive (P1) response amplitudes and peak latencies were compared with normal controls. Serial changes in the pattern of mfERG abnormalities and in response amplitudes and peak latencies were also compared between eyes in which hydroxychloroquine therapy was continued or stopped. Correlation analyses were performed to assess the effects of a cumulative dose of hydroxychloroquine on mfERG. RESULTS: At baseline, reductions in N1 and P1 response amplitudes were observed in patients receiving hydroxychloroquine compared with controls. At follow-up, in addition to the reductions in N1 and P1 response amplitudes, increases in P1 peak latencies compared with controls were observed. In patients who stopped hydroxychloroquine therapy, there were significant increases in N1 and P1 response amplitudes at follow-up mfERG. CONCLUSIONS: Patients receiving hydroxychloroquine showed a longitudinal decline in retinal function; patients who stopped hydroxychloroquine therapy showed improvement. Although these data are insufficient to demonstrate the sensitivity of mfERG for evaluating early hydroxychloroquine toxicity, the results suggest that serial mfERG assessment may help detect early retinal changes associated with hydroxychloroquine therapy. Further studies with long-term results will be useful in clarifying the value of mfERG in evaluating early retinal toxicity due to hydroxychloroquine.

Adult↗

PubMed1993

Plasma protein binding of the enantiomers of hydroxychloroquine and metabolites.

The in vitro binding of the enantiomers of hydroxychloroquine and its three major metabolites in pooled plasma obtained from four healthy volunteers and the binding of the enantiomers of hydroxychloroquine to purified plasma proteins has been investigated. The plasma protein binding of hydroxychloroquine was found to be stereoselective. The (S)-enantiomer of hydroxychloroquine was 64% bound in plasma, while (R)-hydroxychloroquine was 37% bound. Fifty% of (S)-hydroxychloroquine was bound to a 40 g.l-1 solution of human serum albumin, while only 29% of the (R)-enantiomer was bound. The enantioselectivity of hydroxychloroquine binding was reversed in a 0.7 g.l-1 solution of alpha 1-acid glycoprotein with (R)-hydroxychloroquine being bound to a greater extent than its optical antipode (41% versus 29%). The enantiomers of the metabolites of hydroxychloroquine were bound to a similar extent to plasma and purified plasma proteins. Binding of hydroxychloroquine to plasma and purified proteins was found to be linear over the racemic concentration range of 50 to 1000 ng.ml-1 and hydroxychloroquine metabolite binding to plasma was linear over the range 25 to 500 ng.ml-1.

Blood Proteins↗

PubMed2006

Visual field and multifocal electroretinography and their correlations in patients on hydroxychloroquine therapy.

PURPOSE: To evaluate the effects of hydroxychloroquine on visual field and multifocal electroretinography (mfERG) and their correlations in patients taking hydroxychloroquine. METHODS: This was a cross-sectional study in which patients on hydroxychloroquine therapy underwent automated 10-2 threshold static visual field examination and mfERG recordings. Non-parametric unadjusted and age-adjusted Spearman correlation coefficients rho were calculated between the cumulative dose of hydroxychloroquine and the visual field mean deviation (MD) and pattern standard deviation (PSD) values; and the mfERG response amplitudes and peak latencies. Correlation analysis was also performed between the visual field MD and PSD values and the mfERG response amplitudes and peak latencies. RESULTS: A total of 26 eyes in 13 patients were analyzed. The mean duration of hydroxychloroquine therapy was 4.9 years and the mean cumulative dose was 574 g. No significant correlation was found between the cumulative dose of hydroxychloroquine and the visual field MD and PSD values. There were significant correlations between the cumulative dose of hydroxychloroquine and mfERG N1 and P1 response amplitudes for the central rings (ring 1-3). The correlations between the dose of hydroxychloroquine and mfERG N1 and P1 response amplitudes were strongest for the paracentral ring 2 (rho =-0.63 and rho =-0.62, respectively, P = 0.001). Significant correlations were also found between the visual field MD values and mfERG response amplitudes of various ring eccentricities. CONCLUSIONS: In patients on hydroxychloroquine, mfERG response amplitude correlated with both the 10-2 visual field MD values and with the cumulative dose of hydroxychloroquine used. The use of mfERG can provide objective measurement of retinal function in patients on hydroxychloroquine and may provide supplementary quantitative information to visual field findings.

Adult↗

PubMed2001

Progression of hydroxychloroquine retinopathy after discontinuation of therapy: case report.

Chloroquine and its derivative, hydroxychloroquine sulfate, have been used in treating malaria, dermatitides of systemic lupus erythematosus and rheumatoid arthritis. Hydroxychloroquine retinopathy is uncommon in Taiwan. Here we report a patient with hydroxychloroquine retinopathy which progressed even after discontinuation of hydroxychloroquine. A 42-year-old woman had systemic lupus erythematosus for twenty years. She had been treated with 200 to 400 mg of hydroxychloroquine per day (4 to 8 mg/kg of body weight/day) with a cumulative dose of 657 g. After bull's-eye maculopathy was found, hydroxychloroquine was discontinued. Her medical history revealed no chloroquine administration and no other systemic disease. Five years after cessation of the therapy, her visual acuity and visual fields continued to deteriorate. Ophthalmoscopic examination revealed the hydroxychloroquine retinopathy had advanced. To the best of our knowledge, the progression of hydroxychloroquine retinopathy after discontinuation of medications is a rare phenomenon. Regular ophthalmologic examinations should be performed for patients on hydroxychloroquine regimens because there is no satisfactory treatment for hydroxychloroquine retinal toxicity. Ophthalmologists, dermatologists and rheumatologists should monitor for ocular toxicity of hydroxychloroquine carefully.

Adult↗

PubMed1993

Disposition of the enantiomers of hydroxychloroquine in patients with rheumatoid arthritis following multiple doses of the racemate.

In eight patients with rheumatoid arthritis receiving racemic hydroxychloroquine, blood and urine concentrations of the enantiomers of hydroxychloroquine and its major metabolites were measured each month over the first 6 months of therapy. Plasma concentrations of hydroxychloroquine enantiomers were measured in five of these patients. In all patients, the blood concentration of (R)-hydroxychloroquine exceeded that of the (S)-enantiomer, the mean (R)/(S) ratio being 2.2 (range 1.6-2.9). A similar excess of (R)-hydroxychloroquine was found in the plasma, the mean (R)/(S) ratio being 1.6 (range 1.2-1.9). The mean enantiomer blood concentration ratio (R)/(S) for the metabolite desethylhydroxychloroquine was 0.45 (range 0.34-0.58) and for desethylchloroquine it was 0.56 (range 0.35-0.86) suggesting stereoselective metabolism of hydroxychloroquine. (S)-hydroxychloroquine had a mean (+/- s.d.) renal clearance from blood of 41 +/- 11 ml min-1, approximately twice that of (R)-hydroxychloroquine. The predicted unbound renal clearance was also higher for (S)-hydroxychloroquine. The clinical implications of enantioselective disposition of hydroxychloroquine are currently not known.

Adult↗

PubMedDate not supplied

[Photodermatosis induced by hydroxychloroquine: 4 cases].

BACKGROUND: Hydroxychloroquine is an antimalarial drug often used in dermatology for its photo-protective effects. Four cases of photodermatosis induced by hydroxychloroquine are reported. CASE REPORTS: Four patients, aged from 21 to 68 years, developed a photolocalized eruption from 6 days to 10 weeks after starting hydroxychloroquine. The minimal erythemal dose was decreased in the total spectra and UVA at the onset of the eruption and became normal after stopping hydroxychloroquine in the 2 patients that were controlled. In 3 cases, hydroxychloroquine was the only single drug imputable; chronological imputability was plausible. In the last case, both hydroxychloroquine, carbamazepine and fluvoxamine had a common imputability which was plausible. In the 4 cases, a favourable outcome was observed after stopping hydroxychloroquine, and no recurrence occurred with a mean follow-up of 3.8 years (1-4 years). In one case, a photodistributed eruption occurred during treatment with a related molecule: chloroquine. DISCUSSION: Photodermatosis with hydroxychloroquine have rarely been described in the literature, while quinine from which hydroxychloroquine is derived, is well known for its risk of photosensibilization. The main differential diagnosis of these drug eruptions is an eruption caused by the photodermatosis that initially required treatment with hydroxychloroquine.

Adult↗

PubMed2004

Multifocal electroretinographic evaluation of long-term hydroxychloroquine users.

OBJECTIVES: To observe the long-term effects of hydroxychloroquine sulfate on retinal electrical activity by multifocal electroretinography (mfERG) and to evaluate the regional variation of retinal dysfunction in subjects with hydroxychloroquine retinopathy. METHODS: Multifocal ERG with 103-hexagon stimulation was performed on 19 patients (36 eyes) treated with hydroxychloroquine for systemic lupus erythematosus, rheumatoid arthritis, or localized atypical scleroderma. Visual acuity testing, Amsler grid testing, and Ishihara color vision testing were also performed. In 2 of the patients, hydroxychloroquine was discontinued due to concerns about toxicity. Both of these patients had additional mfERG performed after discontinuation of medication. RESULTS: Twelve patients (19 eyes) had a normal response density in one or both eyes, including 6 patients (12 eyes) with a low lifetime dose (< or =438 g) of hydroxychloroquine who had normal response densities in both eyes. Eleven patients (17 eyes) had abnormal response densities in one or both eyes, and 2 of these patients (4 eyes) had significant attenuation of response densities in almost the whole tested field; 4 patients had a normal mfERG result for one eye but had a slight decrease of response densities for the other eye. There were 4 patterns of abnormal mfERG amplitude change observed: (1) paracentral loss, (2) foveal loss, (3) peripheral loss, and (4) generalized loss. Implicit times were abnormal for pericentral responses in 3 patients. The results of color vision and Amsler grid testing were normal, except for one patient with a generalized loss pattern. In 2 subjects in whom hydroxychloroquine toxicity was suspected, response densities improved after termination of hydroxychloroquine. CONCLUSIONS: Long-term hydroxychloroquine use may be associated with mfERG abnormalities. The mfERG appears to detect retinal physiological change earlier than visual acuity testing, color vision testing, or Amsler grid testing can. The greatest value of the mfERG is in differentiating a retinal cause and, hence, providing important evidence for hydroxychloroquine toxicity, for whatever visual field loss is apparent on perimetry.

Adult↗

PubMed1995

A randomized trial of hydroxychloroquine in early rheumatoid arthritis: the HERA Study.

PURPOSE: Studies of the efficacy of hydroxychloroquine in rheumatoid arthritis have had methodological flaws and have failed to produce definitive results. The benefits and toxicity of hydroxychloroquine sulfate in 120 patients with rheumatoid arthritis of less than 2 years duration are assessed. PATIENTS AND METHODS: A 36-week randomized double-blind, placebo-controlled trial was conducted at two university centers and four community rheumatology private practices. Patients had to have had their disease for less than 2 years and to have never received a second-line drug. Patients were randomly assigned to receive hydroxychloroquine or an equivalent number of placebo tablets in a dose of up to 7 mg/kg per day (maximum 400 mg/day). The initial dose was half the maximum dose and, if after 2 weeks of treatment there had been no side effects, the full dose was prescribed. There were four a priori primary outcomes: (1) a joint index composed of the tender joint count, the swollen joint count, the grip strength, and the duration of morning stiffness; (2) a pain index composed of the pain dimension of the Arthritis Impact Measurement Scales (AIMS) and the visual analog pain scale of the Health Assessment Questionnaire (HAQ); (3) a physical function index composed of the HAQ, the physical disability dimension of the AIMS, and the McMaster-Toronto Arthritis Patient Performance Disability Questionnaire; (4) the psychological function subscale of the AIMS. Secondary outcomes included adverse events, patient and physician global assessments, hematocrit, erythrocyte sedimentation rate (ESR) and corticosteroid usage. An intent-to-treat analysis assessed improvement at 36 weeks by Student's t-test and average improvement over the course of the study by analysis of variance for repeated measures. RESULTS: Of 148 eligible patients, 120 were randomized. The characteristics of those randomized to hydroxychloroquine compared to placebo were similar at the study onset. At 36 weeks and over the course of the study there was statistically significant improvement in the joint index (P = 0.004, P = 0.034, respectively), the pain index (P = 0.007, P = 0.001, respectively), and the physical function index (P = 0.020, P = 0.011, respectively) in the group receiving hydroxychloroquine compared to the placebo group. There was no improvement in psychological function for hydroxychloroquine compared to placebo (P = 0.837 at 36 weeks, P = 0.89 over the course of the study). Among the secondary outcomes there was significant improvement only in the patient's (P = 0.01) and the outcome assessor's (P = 0.03) assessment of change and a trend towards a fewer number of intra-articular corticosteroid injections (P = 0.05) in the hydroxychloroquine-treated group. There were no important differences in the side effects between hydroxychloroquine or placebo. CONCLUSION: Over 36 weeks, hydroxychloroquine had a significant benefit on synovitis, pain, and physical disability of recent-onset rheumatoid arthritis, but did not benefit psychological function.

Adult↗

PubMed2002

Adverse cutaneous reactions to hydroxychloroquine are more common in patients with dermatomyositis than in patients with cutaneous lupus erythematosus.

BACKGROUND: Hydroxychloroquine sulfate and other antimalarial drugs have been used successfully as adjunctive therapy for patients with cutaneous lesions of dermatomyositis over the past 20 years. An increased incidence of cutaneous reactions to hydroxychloroquine has been postulated to occur in patients with dermatomyositis. OBJECTIVE: To determine if adverse cutaneous eruptions due to hydroxychloroquine are more common in patients with dermatomyositis than in those with cutaneous lupus erythematosus. DESIGN: Retrospective, age-, sex-, and race-matched case-control study. SETTING: University-affiliated practice. PATIENTS: The study comprised 42 patients with dermatomyositis (39 adults) and 39 age-, sex-, and race-matched adult patients with lupus erythematosus. MAIN OUTCOME MEASURES: Presence or absence of documented drug eruption due to hydroxychloroquine exposure. RESULTS: Of 39 patients, 12 (31%) with dermatomyositis developed a cutaneous reaction to hydroxychloroquine. Among age-, sex-, and race-matched patients with cutaneous lupus erythematosus, only 1 developed a cutaneous reaction to hydroxychloroquine. None of the reactions observed in our patients resulted in serious morbidity or mortality. Additionally, 4 patients with dermatomyositis who reacted to hydroxychloroquine were treated with oral chloroquine phosphate, 2 of whom also reacted to chloroquine phosphate. CONCLUSIONS: When contemplating antimalarial therapy for dermatomyositis, both the physician and the patient should recognize that non-life-threatening cutaneous reactions may occur in approximately one third of patients and that perhaps one half of those who react to hydroxychloroquine will also react to chloroquine.

Adolescent↗

PubMed1994

Disposition and absorption of hydroxychloroquine enantiomers following a single dose of the racemate.

The disposition of hydroxychloroquine enantiomers has been investigated in nine patients with rheumatoid arthritis following administration of a single dose of the racemate. Blood concentrations of (-)-(R)-hydroxychloroquine exceed those of (+)-(S)-hydroxychloroquine following both an oral and intravenous dose of the racemate. Maximum blood concentrations of (-)-(R)-hydroxychloroquine were higher than (+)-(S)-hydroxychloroquine after oral dosing (121 +/- 56 and 99 +/- 42 ng/ml, respectively, P = 0.009). The time to maximum concentration and the absorption half-life, calculated using deconvolution techniques, were similar for both enantiomers. The fractions of the dose of each enantiomer absorbed were similar, 0.74 and 0.77 for (-)-(R)- and (+)-(S)-hydroxychloroquine, respectively (P = 0.77). The data suggest that absorption of hydroxychloroquine is not enantioselective. The stereoselective disposition of hydroxychloroquine appears to be due to enantioselective metabolism and renal clearance, rather than stereoselectivity in absorption and distribution.

Absorption↗

PubMed1992

Continuation of long term treatment with hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis.

BACKGROUND: Hydroxychloroquine is used for the treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Long term studies have shown a high rate of termination of hydroxychloroquine treatment in patients with RA. Although it has been shown that discontinuation of treatment with hydroxychloroquine is associated with exacerbation of SLE, long term maintenance rates of treatment with hydroxychloroquine in patients with SLE have not been investigated. METHODS: Hydroxychloroquine use in patients with RA and SLE in a group of patients in a single community rheumatology practice was studied. Information was drawn from a computer drug use database containing details of the beginning and end of treatment. Data were analysed using life table methods. RESULTS: Four hundred and three treatment episodes (366 patients with RA, 37 patients with SLE) were observed over eight years. In patients with RA, the cumulative probability of discontinuing treatment was 37% at 12 months and 54% at 24 months. In contrast, hydroxychloroquine treatment of patients with SLE continued over significantly longer periods of time (p < 0.001); the discontinuation probabilities at 12 and 24 months were 8 and 24% respectively. Treatment terminations were predominantly for inefficacy; terminations for toxicity were limited to the first 19 months of treatment. No ocular toxicity was observed. CONCLUSIONS: Treatment of patients with RA in a community rheumatology practice with hydroxychloroquine has a low probability of long term continuation, mostly because of inadequate control of disease manifestations rather than toxicity. In patients with SLE, treatment with hydroxychloroquine has a significantly higher probability of long term continuation.

Adult↗

PubMed1996

Retinal toxicity in long term hydroxychloroquine treatment.

OBJECTIVE: To report clinical experience from patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) who were receiving recommended doses of hydroxychloroquine for more than six years, and were monitored for evidence of hydroxychloroquine related retinopathy every six months. METHODS: A prospective (and continuing) evaluation was made of the potential retinal toxicity of hydroxychloroquine in a cohort of 360 Greek patients followed for RA and SLE, 58 of whom have received long term treatment ( > six years). Fundoscopy, colour vision tests, dark adaptation tests, visual field testing, automated perimetry, and electroretinogram were performed every six months. RESULTS: Among 58 patients receiving hydroxychloroquine for more than six years, two relatively young women (3.5%), one treated for RA and the other treated for SLE, developed characteristic hydroxychloroquine related toxic retinal lesions after cumulative doses of 700 g (6.5 years) and 730 g (8 years) of hydroxychloroquine, respectively. Bilateral visual acuity was 6/6 and 6/7.5, respectively; both patients had normal colour perception. Despite an early diagnosis and cessation of treatment, permanent visual field paracentral scotomata in both patients, and persisting lesions in fluorescein angiography in the patient with SLE, were observed at 4.5 and 3 years of follow up, respectively. No other specific cases of hydroxychloroquine related retinopathy have to date been identified in the remaining 302 patients. CONCLUSION: Cases of irreversible, hydroxychloroquine related retinopathy in patients who did not receive overdoses have not been reported previously. The present observations in two relatively young patients should raise our concern regarding the long term usage of an increasingly popular medication in rheumatology practice.

Adult↗

PubMed2006

Ocular toxicity of hydroxychloroquine.

OBJECTIVES: To review the types, incidence, pathogenesis, risk factors, and clinical characteristics of hydroxychloroquine ocular toxicity and current views about its screening and management. DATA SOURCES: Literature search of Medline up to May 2005. STUDY SELECTION: Key words for the literature search were 'hydroxychloroquine', 'chloroquine', 'ocular', 'toxicity', 'retinopathy', and 'screening'. DATA EXTRACTION: Original articles and review papers were examined. DATA SYNTHESIS: Hydroxychloroquine ocular toxicity includes keratopathy, ciliary body involvement, lens opacities, and retinopathy. Retinopathy is the major concern: others are more common but benign. The incidence of true hydroxychloroquine retinopathy is exceedingly low; less than 50 cases have been reported. Although its pathogenesis is unclear, risk factors include: daily dosage of hydroxychloroquine, cumulative dosage, duration of treatment, coexisting renal or liver disease, patient age, and concomitant retinal disease. Patients usually complain of difficulty in reading, decreased vision, missing central vision, glare, blurred vision, light flashes, and metamorphopsia. They can also be asymptomatic. Most patients have a bull's eye fundoscopic appearance. All patients have field defects including paracentral, pericentral, central, and peripheral field loss. Colour vision is usually undisturbed in early retinopathy, but is impaired in the advanced stage. Most patients have visual loss. Some patients with advanced retinopathy may experience deteriorating visual acuity even after cessation of treatment. There is no consensus on the definition of retinopathy, most-effective ophthalmological assessment, or frequency of screening. Regular screening may be necessary to detect reversible premaculopathy. Cessation of the drug is the only effective management of the toxicity. CONCLUSION: Consensus with regard to various important aspects of hydroxychloroquine ocular toxicity is limited, especially the definition of true hydroxychloroquine retinopathy, the most effective ophthalmological assessment, and frequency of screening. Decisions to stop medication must be made in conjunction with the rheumatologist or physician managing the patient. Management of hydroxychloroquine retinopathy remains a clinical challenge.

Antimalarials↗