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PubMed1984

A single-blind comparative study of auranofin and hydroxychloroquine in patients with rheumatoid arthritis.

Forty patients with rheumatoid arthritis were randomly allocated to treatment with auranofin 3 mg b.d. or hydroxychloroquine 200 mg b.d. Twenty patients received each drug. Efficacy was analysed by comparing patients with available data at weeks 12, 24, 36 and 48 with baseline within each treatment group, and between treatment groups at each of these same time points. There were statistically significant improvements in all measured parameters of clinical efficacy among hydroxychloroquine treated patients, and in all efficacy parameters except one (time to onset of fatigue) in the auranofin treatment group. There were no significant differences between the treatment groups for any parameter of clinical efficacy. Of the laboratory parameters measured, only auranofin treatment produced statistically significant decreases in the concentration of IgA, IgG and IgM, with significant differences between treatments being detected in the case of IgA and IgG. Eight auranofin-treated and three hydroxychloroquine-treated patients were withdrawn because of adverse reactions before completing 48 weeks treatment. The commonest reason for stopping auranofin treatment was diarrhoea (5 cases). Three hydroxychloroquine-treated and two auranofin-treated patients were withdrawn from the study because of inefficacy of the trial drug. Auranofin had a more 'potent' biochemical profile than hydroxychloroquine, although more patients tolerated one year of treatment with the latter drug.

Adult↗
PubMed1999

[Occupationally-induced contact dermatitis and bronchial asthma in a unusual delayed reaction to hydroxychloroquine].

We report the case of a a 60 year-old worker in the pharmaceutical industry who suffered from recurring contact dermatitis. Initially the contact dermatitis was limited to the hands; later on it became generalized. The patient had been working on a drug filling line in a pharmaceutical plant for more than 20 years. Eight years after starting this job he had developed allergic hand dermatitis to 2,6-diaminopyridine (patch test positive); this healed upon cessation of exposure. Ten years later he again developed hand dermatitis which progressed to generalized dermatitis and conjunctivitis. Under systemic and local therapy with corticosteroids and cessation of work, it healed nearly completely. Four months after returning to work, the patient experienced a first episode of severe asthma and generalized dermatitis with conjunctivitis following exposure to hydroxychloroquine the day before. The asthma and dermatitis improved after systemic corticosteroid therapy and stopping work. His condition continued to fluctuate, when though the patient was transferred at work and now wore rubber gloves. Eight months later he again developed a generalized dermatitis. Patch testing revealed delayed-type sensitizations to hydroxychloroquine (tested in concentrations of 0. 1%, 0.5%, 1% and 2%). Equivalent tests in five healthy volunteers were negative. The patch test reactions were pustular, while a biopsy was interpreted as a multiform contact dermatitis reaction. Bronchial exposure with hydroxychloroquine dust produced a delayed bronchial obstruction over the next 20 hours, which progressed to fever and generalized erythema (hematogenous contact dermatitis). After removing exposure to 2,6-diaminopyridine and hydroxychloroquine, the patient went on to develop a contact dermatitis to latex (patch test positive). However, skin prick tests with latex and patch tests with rubber additiva were negative. Hydroxychloroquine is well known to cause drug reactions. To our knowledge, contact dermatitis to this substance has not yet been reported. It is noteworthy that the patch test reactions were pustular and of multiform morphology and that bronchial exposure to the allergen resulted in asthma and a generalized drug reaction. Pathogenetically the asthmatic reaction seems to be on a delayed-type mechanism as is also seen with ampicillin, cobalt and nickel induced asthma.

Asthma↗
PubMed1988

Hydroxychloroquine treatment of rheumatoid arthritis.

A variety of placebo-controlled and open studies have demonstrated the effectiveness of hydroxychloroquine in the treatment of rheumatoid arthritis. The excellent responses to recurrent treatment in a sample patient illustrate the value of hydroxychloroquine. Because low daily doses of hydroxychloroquine are associated with greater ophthalmologic safety, it would be advantageous to use the smallest effective daily dose, but there are no published controlled efficacy studies using daily doses of less than 400 mg. Hydroxychloroquine may best be employed to treat patients with new onset of disease or those in whom disease is not rapidly progressive. Great potential exists for the use of hydroxychloroquine in combination therapy, but optimal utilization of combination regimens will require performances of additional controlled studies.

Anti-Inflammatory Agents↗
PubMed1994

Effect of prednisone and hydroxychloroquine on coronary artery disease risk factors in systemic lupus erythematosus: a longitudinal data analysis.

PURPOSE: To determine the effect of prednisone dose and hydroxychloroquine dose on the coronary artery disease risk factors serum cholesterol level, mean arterial blood pressure, and weight in patients with systemic lupus erythematosus. PATIENTS AND METHODS: A longitudinal cohort study of 264 patients with systemic lupus erythematosus was conducted. For all patients in the cohort, serum cholesterol, mean arterial pressure, weight, prednisone dose, hydroxychloroquine dose, and other potential confounding variables were recorded at each visit. Regression analysis appropriate for longitudinal data was used to assess the effect of prednisone on serum cholesterol and mean arterial pressure. To assess the effect of prednisone on weight, patients' weights were compared 90 days before and after a 10-mg or 20-mg increase in prednisone. RESULTS: A total of 3,027 patient visits were analyzed. In the regression model for serum cholesterol, a change in prednisone dose of 10 mg was associated with a change in cholesterol of 7.5 +/- 1.46 (SE) mg% after adjustment for the other significant variables in the model, including sex, race, hydroxychloroquine dose, and proteinuria. In the regression model for hydroxychloroquine, the 200-mg and the 400-mg dose were both associated with lower serum cholesterol (8.9 +/- 3.44 SE mg%). In the regression model for mean arterial blood pressure, a 10-mg change in prednisone dose led to a change in mean arterial blood pressure of 1.1 mm Hg after adjustment for age, weight, and antihypertensive drug use. A 10-mg increase in prednisone dose was associated with a mean weight change of 5.50 +/- 1.23 (SE) lb. CONCLUSIONS: Changes in prednisone dose led to definable changes in risk factors for coronary artery disease, even after adjustment for other variables known to affect these risk factors. According to longitudinal regression analysis, hydroxychloroquine therapy was associated with lower serum cholesterol.

Adult↗
PubMed1992

High-dose hydroxychloroquine treatment of porphyria cutanea tarda.

BACKGROUND: High-dose hydroxychloroquine is rarely used in the treatment of porphyria cutanea tarda (PCT). OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a novel high-dose hydroxychloroquine regimen in patients with PCT. METHODS: Sixty-five first episodes and 28 recurrent episodes of PCT were treated with hydroxychloroquine, 250 mg three times daily, for 3 days. In patients with a high urine porphyrin concentration a single phlebotomy of 500 ml was performed before therapy of the first episode. Modified high-dose hydroxychloroquine regimens were used in patients with markedly elevated liver transaminases with or without associated chronic liver disease. RESULTS: Long-term follow-up data showed an overall relapse rate of 33%, significantly higher among male patients (45%) than among female patients (17%) (p less than 0.05). A transient hepatotoxic reaction occurred in the majority of patients. The reaction seemed to be especially severe among phlebotomized female patients. CONCLUSION: Hydroxychloroquine, 250 mg three times daily, is a rapid, efficacious, and safe treatment in patients with PCT.

Alkaline Phosphatase↗
PubMed1991

Hydroxychloroquine retinopathy.

We analyzed ocular findings from two patients (aged 49 and 60 years) with hydroxychloroquine (Plaquenil, Winthrop Pharmaceuticals, Division of Sterling Drug, Inc., New York, New York) retinopathy. Both patients were treated for systemic lupus erythematosus; one patient was treated with 400 to 800 mg of hydroxychloroquine per day (6.1 to 12.2 mg/kg of body weight/day) over a ten-year period. Cumulative doses were 1,788 and 2,920 g, respectively. Neither patient had ever been treated with chloroquine. One patient complained of glare and difficulty in adjusting to changes in illumination, whereas the other was asymptomatic. Both had bilateral visual acuities of 20/25, pericentral scotomata, and increased final dark-adapted rod thresholds in the two retinal areas that were tested. Fullfield electroretinograms were reduced and delayed, and focal cone electroretinography showed abnormal foveal responses as well. Ophthalmoscopy and fluorescein angiography showed a bull's-eye maculopathy in both eyes of one patient and perifoveal depigmentation in both eyes of the other patient. Retinal function remained stable at follow-up examinations 18 to 24 months after the cessation of hydroxychloroquine treatment. These two cases demonstrate that peripheral retinopathy, as well as maculopathy, can develop in patients who are treated with hydroxychloroquine for systemic lupus erythematosus, and that retinal function may remain stable after discontinuation of hydroxychloroquine treatment.

Electroretinography↗
PubMed1999

Hydroxychloroquine overdose: toxicokinetics and management.

BACKGROUND: The management and toxicokinetics of hydroxychloroquine overdose are poorly described. CASE REPORT: We report a case of an 18-year-old girl who ingested 20 g of hydroxychloroquine. She developed marked hypokalemia, hypotension, and ventricular tachyarrhythmias but survived with treatment including intubation, adrenaline infusion, high-dose diazepam, and aggressive potassium replacement. Plasma hydroxychloroquine level was 29.40 mumol/L (9.87 mg/L) 2 hours after ingestion and the elimination half-life of hydroxychloroquine was 22 hours. CONCLUSIONS: The clinical manifestations of this hydroxychloroquine overdose were similar to those reported for chloroquine overdose and the management principles recommended for chloroquine overdose appeared to be efficacious in this case.

Adolescent↗
PubMed2002

Controlled trial of hydroxychloroquine in schizophrenia.

Hydroxychloroquine is widely employed for the treatment of rheumatological diseases. A preliminary pilot study suggested that hydroxychloroquine may be a useful adjunct for the treatment of schizophrenia, which has been associated with abnormalities in several proinflammatory cytokines. Sixty-one patients were randomized to receive 200 mg/ day hydroxychloroquine or placebo in addition to standard typical antipsychotic treatment. After 8 weeks of double-blind treatment, there was no significant interaction between treatment status and length of treatment for positive, negative, or general symptoms according to the Positive and Negative Syndrome Scale, despite a hydroxychloroquine-associated decrease in serum interferon-gamma levels. After completion of the 8-week study, all participants were offered open treatment with hydroxychloroquine for an additional 12 weeks. Open treatment produced no further improvement in Positive and Negative Syndrome Scale scores at weeks 12, 16, and 20. Further study will be required to determine the role of anti-inflammatory treatments for schizophrenia.

Adolescent↗
PubMed1992

Treatment of cutaneous lupus erythematosus with acitretin and hydroxychloroquine.

A randomized, double-blind, multicentre study was performed to compare the efficacy of acitretin (50 mg/day) with hydroxychloroquine (400 mg/day) in 28 and 30 patients, respectively, suffering from cutaneous lupus erythematosus (LE). The study was carried out over an 8-week period. Improvement of facial LE lesions after treatment with acitretin and hydroxychloroquine was assessed using several clinical parameters. In the acitretin group there was marked improvement or clearing of erythema in 10/24 patients (42%), of infiltration in 15/24 (63%) and of scaling/hyperkeratosis in 12/20 (60%). In the hydroxychloroquine group there was complete clearing or marked improvement of erythema in 17/25 patients (68%), of infiltration in 17/25 (68%) and of scaling/hyperkeratosis in 15/23 (65%). Overall improvement occurred in 13/28 patients (46%) treated with acitretin and in 15/30 patients (50%) with hydroxychloroquine. The incidence of side-effects was higher in the acitretin group, and necessitated discontinuation of treatment in four patients. The present results demonstrate that both acitretin and hydroxychloroquine provide effective treatment in approximately 50% of cases of cutaneous LE.

Acitretin↗
PubMed1993

Hydroxychloroquine and sulphasalazine alone and in combination in rheumatoid arthritis: a randomised double blind trial.

OBJECTIVES: To compare the effects of hydroxychloroquine and sulphasalazine alone and in combination in rheumatoid arthritis. METHODS: A six month randomised, multicentre, double blind trial with three parallel groups was performed. Ninety one outpatients with active rheumatoid arthritis were included. Monthly assessments of erythrocyte sedimentation rate, morning stiffness, number of swollen joints, a pain score, and global assessments were carried out. Radiographs of hands and wrists were taken before and after the trial. RESULTS: Sixty two patients completed the study. The 29 withdrawals caused no evident bias, and there was no difference in side effects among the three groups. All variables improved significantly with time. Patients treated with a combination of hydroxychloroquine and sulphasalazine responded better and faster than those treated with hydroxychloroquine alone, but there was no statistically significant difference between the combination treatment and single drug treatment with sulphasalazine or between treatment with hydroxychloroquine and sulphasalazine given alone. CONCLUSION: The present results do not support a recommendation to use a combination of hydroxychloroquine and sulphasalazine in the treatment of rheumatoid arthritis.

Adolescent↗
PubMed1997

Hydroxychloroquine reverses thrombogenic properties of antiphospholipid antibodies in mice.

BACKGROUND: Previous studies have demonstrated that human monoclonal and polyclonal anticardiolipin antibodies have thrombogenic properties in vivo. Using such a model in which these antibodies have been shown to increase both the size of an induced thrombus and the duration of time in which such a clot lasts, we investigated whether hydroxychloroquine alters the dynamics of such thrombus formation. METHODS AND RESULTS: Three groups of nine mice were injected with purified immunoglobulin G (IgG) from a patient with the antiphospholipid syndrome (IgG-APS) and then fed with hydroxychloroquine at various doses (100, 6, and 3 mg/kg body wt). Three control groups of mice were also studied, including mice injected with IgG-APS and then fed with placebo, as well as two other groups injected with IgG from normal human serum and fed either hydroxychloroquine or placebo. A standardized thrombogenic injury was subsequently induced in the femoral vein of each mouse and the area (size) of thrombus measured as well as the total period of time that thrombus was present. Mice treated with hydroxychloroquine and IgG-APS showed significantly smaller thrombi that persisted for a shorter period of time compared with animals treated with IgG-APS and placebo. CONCLUSIONS: Hydroxychloroquine significantly diminished both thrombus size and total time of thrombus formation in mice previously injected with IgG-APS.

Animals↗
PubMedDate not supplied

[Early electroretinografic changes in elderly RA patients treated with hydroxychloroquine].

OBJECTIVE: To evaluate the effectiveness of fundoscopy, electrooculography, electroretinogram and visually evoked potentials in early detection of hydroxychloroquine retinal toxicity in RA patients and to evaluate the influence of patients' age, drug dosage, concomitant therapy (prednisone and methotrexate) and serum creatinine levels in the development of this side effect. METHODS: From september to december 1999, we have enrolled 32 RA patients (13 males, 19 females) starting hydroxychloroquine treatment. The patients underwent regular ophthalmological examination (fundoscopy, electro-oculography, electroretinogram and visually evoked potentials) every 4 months. Disease activity was evaluated every two months by clinical and routine serological examination. RESULTS: No patients developed retinopathy during 1 year's follow-up; fundoscopy, electrooculography, and visually evoked potentials did not vary from the baseline. On the other hand, electroretinogram showed early alterations of scotopic and photopic response; moreover a significant statistical correlation between patients' age (more than 65 years) and b1 photopic wave increase (p < 0,05) was observed. No correlation was found between the development of electro-retinographic alterations and hydroxychloroquine dosage, concomitant therapy and serum creatinine levels CONCLUSION: Our data show the inefficacy of fundoscopy, electrooculography and visually evoked potentials in early detection of hydroxychloroquine retinopathy. On the other hand electroretinogram allows early detection of retinal alterations during hydroxychloroquine treatment, in patients older than 65 years.

Adult↗
PubMed1993

Hydroxychloroquine compared with placebo in rheumatoid arthritis. A randomized controlled trial.

OBJECTIVE: To assess the efficacy of hydroxychloroquine, 400 mg daily, for rheumatoid arthritis. DESIGN: Six-month, double-blind, randomized trial. SETTING: Ambulatory referral clinic in a Mexico City, Mexico, teaching hospital. PATIENTS: A total of 126 patients with early rheumatoid arthritis were randomly assigned to receive hydroxychloroquine, 400 mg/d, or placebo; 121 patients completed the study. RESULTS: Hydroxychloroquine showed a clinically and statistically significant improvement over placebo in joint score (20% greater mean improvement; 10% more patients improved by > 50%); pain (40% greater mean improvement; 19% more patients improved by > 50%); grip strength (22% greater mean improvement; 21% more patients improved by > 50%); patient global assessment (16% more patients stated they had improved); and physician global assessment (12% more patients were judged to have improved). Side effects were mild, and no patients in the hydroxychloroquine group required discontinuation of therapy. Patient compliance with the study medication was high. CONCLUSION: Hydroxychloroquine is moderately effective in early rheumatoid arthritis.

Adult↗
PubMedDate not supplied

Evaluation of hydroxychloroquine retinopathy with multifocal electroretinography.

BACKGROUND AND OBJECTIVE: To describe the changes revealed by multifocal electroretinography (ERG) in patients taking hydroxychloroquine. PATIENTS AND METHODS: Six patients being treated for various inflammatory conditions with hydroxychloroquine for periods ranging from 8 months to 7 years were consecutively evaluated. Each examination included measurement of Snellen visual acuities, Amsler grid assessment, and automated visual field testing. In some cases, funduscopic examinations were complimented by photography and fluorescein angiography. Multifocal ERG was performed for all patients. RESULTS: Three patients (six eyes) were found to have distinctive abnormalities on multifocal ERG consisting of pericentral depression of ERG signals. The abnormalities on multifocal ERG corresponded with the patients' subjective descriptions and the visual field depiction of their pericentral scotomas. All affected patients had been taking hydroxychloroquine for at least 7 years. One patient with generalized depression on multifocal ERG had possible hydroxychloroquine retinopathy. Two patients (three eyes) had relatively normal results on multifocal ERG. CONCLUSION: Multifocal ERG objectively demonstrates depression of signals in the perifoveal region in visually symptomatic patients with long-term hydroxychloroquine use. Even patients with normal visual acuity and no fundus abnormalities can have abnormal results. Although we have not yet identified patients with abnormalities on multifocal ERG before the onset of symptoms, multifocal ERG may be useful in monitoring patients at risk and may provide an earlier opportunity to identify maculopathy.

Adult↗
PubMed1993

The lipid, lipoprotein, and apolipoprotein effects of hydroxychloroquine in patients with systemic lupus erythematosus.

Lipid, lipoprotein, and apolipoprotein effects of hydroxychloroquine were studied in 18 female patients with systemic lupus erythematosus (SLE) with mild or inactive disease. Patients were case matched (200-400 mg hydroxychloroquine daily vs no hydroxychloroquine) on several factors including daily corticosteroid dose in this cross sectional study. All had normal menstrual cycles; none smoked, used alcohol, were taking lipid altering medications or had other concurrent diseases. Patients taking hydroxychloroquine had 35-54% lower total triglyceride, VLDL-triglyceride, LDL-triglyceride, HDL-triglyceride, VLDL-cholesterol, and apolipoprotein CIII levels (p < 0.03). These results are encouraging in that hydroxychloroquine, in addition to being useful for alleviating the primary symptoms of SLE, may also be useful for ameliorating the adverse effects of corticosteroid therapy on triglyceride-rich lipoprotein metabolism.

Adult↗
PubMed2006

Early paracentral visual field loss in patients taking hydroxychloroquine.

OBJECTIVE: To review the natural history and ocular and systemic adverse effects of patients taking hydroxychloroquine sulfate who attended an ophthalmic screening program. DESIGN: Retrospective study. RESULTS: Records of 262 patients who were taking hydroxychloroquine and screened in the Department of Ophthalmology were reviewed. Of the 262 patients, 14 (18%) of 76 who had stopped treatment at the time of the study experienced documented adverse effects. Systemic adverse effects occurred in 8 patients (10.5%) and ocular adverse effects, in 5 (6.5%). Thirty-five patients (13.4%) had visual field abnormalities, which were attributed to hydroxychloroquine treatment in 4 patients (1.5%). Three of the 4 patients were taking less than 6.5 mg/kg per day and all patients had normal renal and liver function test results. CONCLUSIONS: The current study used a protocol of visual acuity and color vision assessment, funduscopy, and Humphrey 10-2 visual field testing and shows that visual field defects appeared before any corresponding changes in any other tested clinical parameters; the defects were reproducible and the test parameters were reliable. Patients taking hydroxychloroquine can demonstrate a toxic reaction in the retina despite the absence of known risk factors. Screening, including Humphrey 10-2 visual field assessment, is recommended 2 years after the initial baseline and yearly thereafter.

Adolescent↗
PubMed2001

Treatment of early seropositive rheumatoid arthritis: a two-year, double-blind comparison of minocycline and hydroxychloroquine.

OBJECTIVE: To compare the efficacy of minocycline with that of a conventional disease-modifying antirheumatic drug (DMARD), hydroxychloroquine, in patients with early seropositive rheumatoid arthritis (RA). METHODS: Sixty patients with seropositive RA of <1 year's duration who had not been previously treated with DMARDs were randomized to receive minocycline, 100 mg twice per day, or hydroxychloroquine, 200 mg twice per day, in a 2-year, double-blind protocol. All patients also received low-dose prednisone. The primary end points of the study were 1) the percentage of patients with an American College of Rheumatology (ACR) 50% improvement (ACR50) response at 2 years, and 2) the dosage of prednisone at 2 years. RESULTS: Minocycline-treated patients were more likely to achieve an ACR50 response at 2 years compared with hydroxychloroquine-treated patients (60% compared with 33%, respectively; P = 0.04). Minocycline-treated patients were also receiving less prednisone at 2 years compared with the hydroxychloroquine group (mean 0.81 mg/day compared with 3.21 mg/day, respectively; P < 0.01). In addition, patients treated with minocycline were more likely to have been completely tapered off prednisone (P = 0.03). Trends favoring the minocycline treatment group were seen when outcomes were assessed according to components of the ACR core criteria set, with the differences reaching statistical significance for patient's global assessment of disease activity (P = 0.004). CONCLUSION: Minocycline is an effective DMARD in patients with early seropositive RA. Patients treated with minocycline were more likely to achieve an ACR50 response and did so while receiving less prednisone. In addition, minocycline-treated patients were more likely to have discontinued treatment with prednisone at 2 years.

Adult↗
PubMed1983

Animal toxicity and pharmacokinetics of hydroxychloroquine sulfate.

Chloroquine is two to three times as toxic in animals as hydroxychloroquine, even though various single and repeated oral dosage regimens in man have given nearly identical plasma level curves. Tissue distributions are qualitatively similar for both drugs in albino rats--namely, bone, fat, and brain less than muscle less than eye less than heart less than kidney less than liver less than lung less than spleen less than adrenal--but the absolute distribution values are about 2.5 times higher for chloroquine. The metabolism of chloroquine and hydroxychloroquine differs only in that the latter drug gives two first-stage metabolites, whereas chloroquine gives one. Oral absorption of both drugs in man is nearly complete. However, three times as much chloroquine as hydroxychloroquine appears in the urine, and three times as much hydroxychloroquine as chloroquine appears in the feces.

Animals↗