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PubMed1981

Biochemical indices of response to hydroxychloroquine and sodium aurothiomalate in rheumatoid arthritis.

Biochemical and clinical changes have been monitored in 30 patients with rheumatoid arthritis treated with either hydroxychloroquine or sodium aurothiomalate over a period of 6 months. Acute-phase reactants improved in both treatment groups, while serum sulphydryl and serum histidine improved only in the gold-treated patients. Correlation matrices were constructed from mean clinical and biochemical data at successive clinic visits. Correlations obtained with gold were more frequent and of a higher level of significance than those obtained with hydroxychloroquine at the doses we studied. This lends support to the use of correlation matrices as a screening test for potential long-term antirheumatoid activity of drugs in man.

Adult↗
PubMed1987

Uptake of chloroquine and hydroxychloroquine by human blood leucocytes in vitro: relation to cellular concentrations during antirheumatic therapy.

The accumulation of chloroquine and hydroxychloroquine in unfractionated mononuclear cells and in purified monocytes, lymphocytes, and neutrophil polymorphonuclear leucocytes (PMN) was measured in vitro. Accumulation of both drugs in leucocytes was time and dose dependent. Cellular levels comparable to those found during antirheumatic therapy were achieved by preincubation for 60 minutes with up to 0.1 mM chloroquine or hydroxychloroquine.

Arthritis, Rheumatoid↗
PubMed1989

Hydroxychloroquine sulphate in the treatment of rheumatoid arthritis: a double blind comparison of two dose regimens.

A controlled, double blind, parallel group, long term study of hydroxychloroquine sulphate in the treatment of rheumatoid arthritis, comparing daily doses of 200 mg and 400 mg, is described. The trial involved 54 patients with moderate disease activity who had not previously received antimalarial drugs. Forty three patients completed the one year treatment. The groups receiving different doses were homogeneous and did not differ in any of the 25 monitored indicators. Both dose regimens were effective, and a significant reduction of disease activity was observed after one year's treatment. Of the nine laboratory and 11 clinical indices of efficacy monitored, no statistically significant differences were reported, but in the group of patients treated with the 400 mg daily dose the number of side effects was three times greater. As there have been no reports of retinopathy with hydroxychloroquine at daily doses of 200 mg the effectiveness of this dose is of practical importance.

Arthritis, Rheumatoid↗
PubMed2002

Protective effect of hydroxychloroquine in systemic lupus erythematosus. Prospective long-term study of an Israeli cohort.

Systemic lupus erythematosus-associated irreversible organ/system damage was previously associated with various clinical and demographic features. We analysed the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) in a cohort of 151 Israeli patients followed for a mean (+/- s.d.) period of 45.7 +/- 37.4 months. Mean score of SLICC/ACR DI at the first and last encounters were 0.17 +/- 64 and 1.64 +/- 2.1, respectively (P < 0.0001). Multiple logistic regression analyses disclosed a statistically significant positive correlation with corticosteroid and cyclophosphamide therapy. Hydroxychloroquine therapy was significantly associated with lower SLICC/ACR DI. Although the size of our study group did not allow us to find specific organs/systems which were associated with the protective effect of hydroxychloroquine, we suggest this is due to the antiatherogenic effects attributed to antimalarial therapy in SLE.

Adolescent↗
PubMed2006

Hydroxychloroquine-induced retinopathy: a dermatologic perspective.

Dermatologists use antimalarials to treat conditions such as cutaneous lupus erythematosus. One potentially serious adverse effect of these agents is irreversible maculopathy. Although there is some evidence that hydroxychloroquine and chloroquine have similarly narrow therapeutic indices with regard to retinal toxicity, the former is thought to be less damaging to the retina and is thus more widely employed by dermatologists. The current recommended maximal dose for hydroxychloroquine is 6.5 mg/kg/day, with the weight in kilograms used for this calculation being the ideal bodyweight rather than actual bodyweight. Ophthalmologic follow-up is an important component of monitoring patients taking antimalarials. Recommendations for follow-up frequency have varied, and we present the recent guidelines from the American Academy of Ophthalmology. Despite dose limitations and ophthalmologic monitoring, irreversible retinal damage can occur. Among the reported cases, there does not seem to be any obvious predictor of the development of maculopathy. The idiosyncratic nature of this adverse effect may be related to interindividual differences in drug metabolism. To understand why only some patients develop retinopathy, better pharmacokinetic models need to be developed, and further elucidation of the precise mechanism of retinal damage is required.

Antimalarials↗
PubMed1993

A double-blind comparative study of hydroxychloroquine and dapsone, alone and in combination, in rheumatoid arthritis.

Eighty patients with active rheumatoid arthritis (RA) entered a double-blind randomized study of 24 weeks duration, to compare the efficacy and toxicity of hydroxychloroquine, dapsone, and a combination of both drugs in treatment of RA. Evaluation of changes in clinical, laboratory and radiologic variables was based on 63 patients completing the trial. There was no clear difference between the three therapy groups in most inflammatory variables after 24 weeks. However, only patients receiving the combination therapy improved significantly in all clinical and laboratory variables. Nine patients in the combination group and four in each single drug group discontinued during the trial, mainly because of toxicity. Four patients taking the combination therapy withdrew because of hemolytic anemia, and none in the dapsone group. These findings suggest that hydroxychloroquine in combination with dapsone is somewhat more effective and less tolerated than single drug treatments.

Adult↗
PubMed1998

A relapsed case of imported tertian malaria after a standard course of hydroxychloroquine and primaquine therapy.

Resistance of Plasmodium species to antimalarial agents has become increasingly challenging to the management and prevention of malaria. We experienced an imported case of tertian malaria due to Plasmodium vivax relapsed after a seemingly successful treatment with conventional course of hydroxychloroquine and primaquine. A 35-year-old man developed fever three days after return from India and mainland China. After his illness was diagnosed as tertian malaria, he was managed with hydroxychloroquine and then primaquine (primaquine base 15 mg/day for 14 days). Thereafter peripheral blood smears showed no malarial parasites, and there was no relapse of symptom until the 55th post-treatment day, however, six months after the above treatment tertian malaria relapsed. He was managed with the same medications again and malaria did not relapse for 10 months.

Adult↗
PubMed1975

[Lupus nephropathy. Treatment with the indomethacin-hydroxychloroquine combination and comparison with corticoids].

The authors report their comparative experience of the treatment of proliferative lupus glomerulonephritis using prednisone (16 patients) or the indomethacin-hydroxychloroquine association (12 patients). Prednisone in high dosage was associated in this series with 9 deaths and in 6 patients, with renal failure or an extra-renal complication. By contrast, the indomethacin-hydroxychloroquine association proved to be highly effective, without side-effect. In the endocapillary glomerulonephritis group (8 cases) the authors obtained 7 durable remissions (36.3 months on average) and 1 temporary remission of 24 months, with an average length of treatment of 45.8 months. In the extracapillary glomerulonephritis group (4 cases) the authors obtained 1 remission, 2 improvements and I death, with an average length of treatment of 16.8 months. This combination has a highly significant anti-proteinuric and anti-haematuric action, with a constant efficiency on renal function and on the extra-renal signs of lupus. Its effect is less constant on the immunological disorders. Study of iterative renal biopsies confirms this favourable impression. According to these results, the authors propose a provisional scheme of management of proliferative lupus glomerulonephritis.

Adolescent↗
PubMed2002

Hydroxychloroquine reverses platelet activation induced by human IgG antiphospholipid antibodies.

Prothrombotic properties of antiphospholipid (aPL) antibodies may be explained in part by their ability to enhance the activation of platelets pre-treated with low doses of ADP or thrombin. The antimalarial drug hydroxychloroquine (HQ) has been used successfully in prevention of postoperative thrombosis and in treatment of patients with SLE or APS. In one study, administration of HQ reversed the thrombogenic properties of aPL in mice. However, the mechanism of action of HQ in preventing thrombosis is not clearly understood. In order to explore this further, the effects of HQ on activation of platelets by aPL in the presence of a thrombin agonist was studied. The changes in the expression of GPIIb/IIIa (CD41a) and GPIIIa (CD61) on platelet membrane by flow cytometry were used as indicators of platelet activation. Citrated whole blood from a healthy donor was treated at room temperature with suboptimal doses of a thrombin agonist receptor peptide (TRAP) and affinity-purified aPL antibodies, in the presence and in the absence of hydroxychloroquine (1 mM). TRAP increased the expression of GPIIb/IIIa and GPIIIa on platelet surface. The treatment of the platelets with the six aPL antibodies in the presence of 12 nMol/ml TRAP further increased the expression of GPIIb/IIIa by 42.3+/-12.3% and the expression of GPIIIa was further incremented by 46.8+/-13.5%. The effects of aPL and TRAP on expression of platelet surface markers of activation was completely abrogated by HQ in a dose-dependent fashion and was effective at concentrations of HQ as low as 25 microg/ml (0.0125 mM). This suggests at least one possible mechanism by which HQ may prevent thrombosis. This may have important implications in treatment of thrombosis in APS patients.

Antibodies, Antiphospholipid↗
PubMed1992

Pigmentation of the gums following hydroxychloroquine therapy.

The authors describe a case of pigmentation of the gums occurring after therapy with hydroxychloroquine. A twenty-eight-year-old woman with discoid lupus erythematosus was treated only with hydroxychloroquine. After seven months of this therapy, a diffuse bluish-gray pigmentation was apparent on the vestibular surface of the gums of both dental arches. No pigmented lesions were noticed on either the skin or the nails.

Adult↗
PubMed1991

[Chloroquine and hydroxychloroquine: side effect profile of important therapeutic drugs].

Precise knowledge of the undesirable effects of chloroquine and hydroxychloroquine allows better exploitation of their therapeutic effects. Retinopathy can be avoided by observing a maximum daily dosage of 3.5-4 mg/kg ideal body weight for chloroquine and 6-6.5 mg/kg for hydroxychloroquine. In this way, both can be used for long-term therapy. The pharmacokinetics of chloroquine (storage in deep compartments with long plasma half-life) means that it can cumulate, especially with higher dosages and in the presence of renal or hepatic insufficiency. A high plasma concentration reinforces the side-effects without reinforcing the therapeutic effects. Besides subjective symptoms (e.g. anorexia, diarrhoea, nausea), the following undesirable reactions are significant. On the skin exanthema, hyperpigmentation and photodynamic reactions can develop. The hair can become white in blonde and red-haired men. In the eye, chloroquine deposits in the cornea and disturbances of accommodation can occur, besides retinopathy. Neuromyopathy and central nervous system disturbances (e.g. psychosis) are rare, as is impairment of auditory function or blood cells. During pregnancy there is a risk of potential fetal damage (hearing loss, abortion). An acute overdose is extremely dangerous: the lethal dose is 1 g for children and 4 g for adults. As death occurs rapidly, chloroquine has to be stored where it is absolutely inaccessible to children.

Chloroquine↗
PubMed1987

[Primary Gougerot-Sjögren syndrome with necrotizing polymyositis: favorable effect of hydroxychloroquine].

A 61-year-old woman was admitted for acute arthralgias and proximal weakness in all four limbs. Clinical examination found xerostomia, xerophthalmia, enlarged parotid glands. The Schirmer test was positive and the salivary gland biopsy showed a mononuclear, lymphoid, sometimes nodular infiltrate. A muscle biopsy showed necrotizing myopathy with perifascicular atrophy. The patient refused steroids and was given hydroxychloroquine (600 mg daily). She improved gradually, and one year later there were no further complications. The favorable course both of Sjögren's syndrome and polymyositis with hydroxychloroquine treatment is unexpected. This led us to suppose that both could have had a common cause.

Female↗
PubMed1986

Treatment of intractable rheumatoid arthritis with combined cyclophosphamide, azathioprine, and hydroxychloroquine. A follow-up study.

Cyclophosphamide, azathioprine, and hydroxychloroquine sulfate were prescribed for 31 patients (26 women and five men) with rheumatoid arthritis refractory to conventional therapy. Maintenance drug dosages (mean +/- SD) were as follows: cyclophosphamide, 30 +/- 24 mg/day; azathioprine, 74 +/- 44 mg/day; and hydroxychloroquine sulfate, 210 +/- 92 mg/day. Disease suppression began in 30 patients within three to 24 months (mean, nine months). Results after 43 months (range, 12 to 102 months) were as follows: 16, complete remission; seven, near remission; seven, partial disease suppression; one, no response. None remained in prolonged remission without some form of therapy. Treatment was discontinued in three patients because of pulmonary infection (two) or thrombocytopenia (one). Four patients had five malignant neoplasms (surgical cures) before therapy (two breast, one colon, one melanoma, one endometrial); four patients developed a malignant neoplasm during combined drug therapy (one colon, one endometrial, one lung, one erythroleukemia); and three died. The absolute risk of malignancy from combined drug therapy is still unclear. We concluded that combined use of remittive agents may have promise in treatment of severe rheumatoid arthritis; cyclophosphamide should be replaced with a nonalkylating agent; and the place of combined drug therapy remains uncertain in the absence of controlled trials.

Adult↗
PubMedDate not supplied

Treatment complications of rheumatoid arthritis with gold, hydroxychloroquine, D-penicillamine, and levamisole.

One hundred and twenty-five patients with active rheumatoid arthritis unresponsive to nonsteroidal antiinflammatory drugs were treated at the same center with 156 courses of either hydroxychloroquine (43), gold (29), D-penicillamine (40), or levamisole (44). Life table analysis was used to compare the risks of developing various side effects with treatment termination being the endpoint instead of death. Patients treated with levamisole had the highest risk of developing a complication (67%) and antimalarials the lowest (30%). In terms of long term acceptability, hydroxychloroquine showed fewer complications, gold and D-penicillamine were similar with rash and proteinuria being the main difficulties; however, levamisole caused the most frequent terminations mainly due to rash and leukopenia.

Arthritis, Rheumatoid↗
PubMed1981

Assessment of the retinal toxicity of hydroxychloroquine.

A survey of 347 patients on treatment with hydroxychloroquine showed that a mild pigmentary maculopathy was present in 29 per cent of cases if a cumulative dose of more than 800 g of the drug had been ingested. Most of the affected patients showed no deterioration in visual function. The significance of these findings is discussed with particular regard to the screening of patients on hydroxychloroquine therapy.

Adult↗
PubMed1993

Hydroxychloroquine.

The only antimalarial drug approved by the Food and Drug Administration for the treatment of lupus erythematosus is hydroxychloroquine (Plaquenil) sulfate. The dosage recommended officially for this disease is vague. Retinopathy has been caused by hydroxychloroquine but not in less than six months, nor when a total dosage of less than 72 gm or a daily dose of 200 mg or less is used. The ocular risk depends on the dose/weight ratio and is almost negligible at a dosage of less than 6 mg/kg/day. At a dosage of 400 mg or more daily, the risk/benefit ratio is acceptable for a person of average weight, provided that ophthalmologic monitoring is adequate. Risk of retinal toxicity is then proportional to duration of therapy and consequent cumulative dose. Ophthalmoscopic examinations at six-month intervals should be sufficient to detect occasional adverse reactions. Such tests could be conducted by the attending physician directly, as long as no pre-existing ocular abnormality exists.

Humans↗
PubMed1995

Hypergammaglobulinemic purpura in systemic autoimmune rheumatic diseases: predictive value of anti-Ro(SSA) and anti-La(SSB) antibodies and treatment with indomethacin and hydroxychloroquine.

OBJECTIVE: To define the clinical manifestations, autoantibody associations, optimal treatment, and prognosis of hypergammaglobulinemic purpura associated with systemic autoimmune rheumatic diseases. METHODS: Of 303 consecutive patients with systemic autoimmune rheumatic diseases evaluated over 5 years, 17 French Canadian patients with hypergammaglobulinemic purpura with systemic lupus erythematosus (SLE) (n = 12) or another systemic autoimmune rheumatic disease (n = 5) were identified and followed prospectively. Mild secondary Sjörgren's syndrome developed in 9 (53%) patients. RESULTS: Sixteen (94.1%) patients were women. Attacks of hypergammaglobulinemic purpura occurred in the pretibial (76.5%) or perimalleolar (70.5%) areas or the dorsal aspect of the feet (52.9%). Triggering factors included walking, prolonged standing, and alcohol intake. The mean duration of attacks was 6.1 days. Systemic manifestations consistent with a flare of the underlying systemic autoimmune rheumatic diseases accompanied hypergammaglobulinemic purpura attacks in 15 (88%) patients. Arthralgias (n = 13, 86.6%), arthritis (n = 9, 69.2%), and periarthritis were characterstically localized adjacent to the purpura. Anti-Ro antibodies were expressed in all (100%) patients with hypergammaglobulinemic purpura with SLE, but in only 11 (28.9%) of 38 consecutive patients with SLE without hypergammaglobulinemic purpura (P < 0.000001, odds ratio 84, 95% confidence interval 4.6, 1525). The positive predictive values for hypergammaglobulinemic purpura in SLE were: anti-Ro plus anti-La 73%, anti-La 57%, and anti-Ro 52%. The negative predictive value of anti-Ro was 100%. Although 11 (92%) patients with SLE with anti-Ro expressed anti-52 kDa Ro [4 (36.3%) of whom also expressed anti-60 kDa Ro], this frequency was not greater than in anti-Ro positive patients with SLE without hypergammaglobulinemic purpura. The effects of indomethacin or hydroxychloroquine were assessed over 6 months in 8 patients with recurrent incapacitating hypergammaglobulinemic purpura. Complete (n = 4) or partial (n = 4) remission of hypergammaglobulinemic purpura occurred. In 5 additional patients with severe hypergammaglobulinemic purpura, attacks stopped with prednisone 25 to 60 mg daily. The mean duration of hypergammaglobulinemic purpura followup was 5.4 years (range 1-6 years). At last followup, hypergammaglobulinemic purpura had resolved in 11 (64.7%) patients despite persistently abnormal serology. CONCLUSION: In the absence of anti-Ro antibodies, a presumptive diagnosis of hypergammaglobulinemic purpura secondary to SLE should be questioned. Prednisone should be used only in severe hypergammaglobulinemic purpura. Indomethacin and hydroxychloroquine are of value in the treatment of milder hypergammaglobulinemic purpura.

Adult↗
PubMed1996

Pharmacokinetics of hydroxychloroquine and chloroquine during treatment of rheumatic diseases.

Hydroxychloroquine (HCQ) and chloroquine (CQ) are well absorbed (0.7-0.8 bioavailability) when given orally. Severe malnutrition (such as kwashiorkor) effects absorption but diahrrea does not. Both HCQ and CQ have prolonged half-lives, between 40 and 50 days, and low blood clearance (e.g. hydroxychloroquine's blood clearance is 96 ml/min). There is great variability of blood concentrations with an eleven-fold range of drug concentrations found after similar doses in RA patients. Protein binding ranges between 30 and 40% with binding to both albumin and alpha, glycoprotein. There is differential binding and metabolism of the (R) and (S) stereoisomers. Both drugs bind strongly to pigmented tissues but also bind to mononuclear cells, muscles, etc. There is stereo-selective excretion of both drugs and 40-50% of the drug is excreted renally. Between 21 and 47% is excreted unchanged. There is a suggestion of concentration response and concentration toxicity relationships with decreased morning stiffness as HCQ concentrations increase and increased EKG abnormalities as CQ concentrations become higher, but further testing is required. Pharmacokinetic interaction studies are limited. Potentially important kinetic interactions have been documented for d-penicillamine and cimetidine but have not been found for aspirin, ranitidine or imipramine.

Antirheumatic Agents↗