Controlled trial with chloroquine diphosphate in systemic lupus erythematosus

Meinão, Ivone Minhoto; Sato, Élcio Hideo; Andrade, Luís Eduardo Coelho; Ferraz, Marcos Bosi; Atra, E

doi:10.1177/096120339600500313

Cited by 122 publications

(69 citation statements)

References 13 publications

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“…However, we observed that, despite a lack of statistical significance, the majority of patients excluded from the study, due to severe flare, were from the CFZ group. Because of the small number of patients and the lack of a placebo group in our study, we cannot exclude the possibility that the CFZ itself could have been the cause of these lupus systemic flares or that the difference in frequency of flare between groups might have been due to the known effect of CDP in reducing lupus activity (31). Therefore, unlike antimalarials, which also prevent worsening of SLE (31), CFZ should be reserved for patients who have exclusively cutaneous manifestations of the disease.…”

Section: Discussionmentioning

confidence: 97%

Double‐blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus

Bezerra¹,

Vilar²,

Neto³

et al. 2005

Arthritis & Rheumatism

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Objective. To evaluate the efficacy of clofazimine (CFZ) compared with chloroquine diphosphate (CDP) for the treatment of cutaneous involvement in systemic lupus erythematosus (SLE).Methods. A prospective, randomized, controlled, double-blind clinical trial was carried out in SLE patients with active cutaneous lesions, of whom 16 were randomized to receive CFZ at 100 mg/day and 17 received CDP at 250 mg/day for 6 months. All drugs had a similar appearance to avoid identification. Both groups received broad-spectrum sunscreens twice a day and the prednisone dose was kept stable during the study. Cutaneous lesions were evaluated by 2 blinded observers at baseline and at months 1, 2, 4, and 6.Results. Thirty-three patients were randomized to a treatment group, of whom 27 completed 6 months of treatment. The groups were homogeneous and comparable in terms of demographic and clinical characteristics. Five CFZ-treated patients and 1 CDP-treated patient (P ‫؍‬ 0.15) dropped out due to development of severe lupus flare. At the end of the study, 12 CFZtreated patients (75%) and 14 CDP-treated patients (82.4%) had complete or near-complete remission of skin lesions; intention-to-treat analysis showed no significant difference in the response rates between groups. Side effects, mainly skin and gastrointestinal events, were frequent in both groups, but no patients had to discontinue their treatment.Conclusion. These findings suggest that CFZ is equally as effective as CDP in controlling cutaneous lesions in SLE patients. However, we cannot exclude the possibility that the CFZ itself could be the cause of systemic lupus flare. Lupus erythematosus (LE) is an autoimmune disease that can exclusively affect the skin (cutaneous LE [CLE]) or can affect other systems as well (systemic LE [SLE]). Cutaneous lesions are classified as either specific or nonspecific. Lupus-specific cutaneous lesions are divided into acute, subacute, and chronic. Acute CLE includes malar and generalized maculopapular rashes. Subacute CLE includes the annular-polycyclic and papulosquamous (psoriasiform) variants. Chronic CLE includes discoid lupus erythematosus, lupus profundus, and LE tumidus, among others. Of the nonspecific LE cutaneous lesions, Raynaud's phenomenon, bullous LE, and vasculitic lesions are most common (1-3).In the literature, there are no reports of controlled, randomized clinical trials of a treatment strategy for SLE patients with cutaneous lesions. Based on clinical experience, antimalarial drugs are considered to be the first option for treatment of these patients (4). When a safe dosage of antimalarial drugs is used, the side effects are rare and include retinopathy, corneal deposition, disturbance of visual accommodation, nausea, vomiting, urticaria, hair discoloration, skin and mucosal hyperpigmentation, headache, tinnitus, dizziness, and myopathy, among others (5,6). Unfortunately, not all SLE patients with cutaneous lesions show a good response to antimalarial drugs. Treatment of the refractory cases includes use of thalidomide...

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Section: Discussionmentioning

confidence: 97%

Double‐blind, randomized, controlled clinical trial of clofazimine compared with chloroquine in patients with systemic lupus erythematosus

Bezerra¹,

Vilar²,

Neto³

et al. 2005

Arthritis & Rheumatism

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show abstract

“…However, finding improved survival in SLE patients who used antimalarials versus those who did not could be confounding by indication, where perhaps only those patients with mild SLE were prescribed antimalarials (i.e., those with skin and joint involvement, mucositis, and mild constitutional symptoms) compared to those presenting with major organ involvement who received strong immunosuppressives and high doses of steroids. We agree that clinicians should use knowledge from the literature and their clinical experience when treating SLE and recognize the benefits of antimalarial treatment, such as a steroid-sparing effect in a randomized trial (6).…”

Section: To the Editormentioning

confidence: 96%

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Pope

Rothfield

Ramsey‐Goldman

et al. 2016

Arthritis Care & Research

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“…In the additional 3 years of followup of the same study, HCQ use reduced major flares by 57% (3). Meinao et al published a 12-month, double-blind placebo-controlled trial with chloroquine diphosphate (4). Steroid requirements and Systemic Lupus Erythematosus Disease Activity Index score were higher in the placebo group.…”

Section: To the Editormentioning

confidence: 99%

“…We speculated that in both scenarios, HCQ would be continued due to its well-known benefits, such as less flaring if continued in inactive SLE (1), improved lipid levels (2), less hypercoagulability (3,4), and potentially improved survival (4,5). However, finding improved survival in SLE patients who used antimalarials versus those who did not could be confounding by indication, where perhaps only those patients with mild SLE were prescribed antimalarials (i.e., those with skin and joint involvement, mucositis, and mild constitutional symptoms) compared to those presenting with major organ involvement who received strong immunosuppressives and high doses of steroids.…”

Section: Replymentioning

confidence: 99%