Reviews and ratings for hydroxychloroquine when used in the treatment of Plaquenil (hydroxychloroquine): "I take it for Rheumatoid Arthritis, it has been good.
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- What to Know About Plaquenil
- Plaquenil Reviews & Ratings at autonomsystems.ru
- Disease Modifying Anti-rheumatic Drugs (DMARDS)
Data from randomized placebo-controlled trials RCTs should not be combined with observational studies in a meta-analysis [ 17 , 18 ]. Since one of the observational studies was a case controlled study, we used odds ratios OR for the study variables [ 24 ]. After review of the abstracts and exclusion of non-trials and trials that did not compare pregnant women with auto-immune diseases taking HCQ with a control group, we identified 5 studies of interest [ 27 — 31 ] Figure 1.
The studies were published within the past 15 years. Clinical Trials. This was a safety study which presents considerable difficulties in obtaining sufficient numbers of patients to include in the meta-analysis. Since there are more observational studies than experimental studies in determining the safety of HCQ in pregnancy we included studies of any design for the meta-analysis. Seventy-seven articles were excluded including 68 with no non-HCQ control group and 3 with no outcomes of interest Figure 1.
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Four of the 5 studies were observational [ 27 — 30 ] and one was a randomized placebo controlled double-blinded trial [ 31 ]. Three of the 4 observational studies were published as full manuscripts [ 27 — 30 ] and one was presented as an abstract [ 30 ]. One of the observational studies was a case controlled study [ 30 ] while the other 3 were cohort studies [ 27 — 29 ]. The first observational study had 69 Lupus patients, 13 unclassified connective tissue disease and 8 patients with primary Sjogren's syndrome [ 28 ], the second observational study included women all diagnosed with Lupus [ 27 ], the third observational study also followed 86 Lupus patients [ 29 ], as well as the fourth observational study women with connective tissue diseases [ 30 ] Additional file 1 , Table S1.
Only one study was conducted in the United States [ 27 ]. The quality of the studies we identified based on the Downs and Black checklist ranged from 20 to Although the double-blinded placebo controlled trail was of the highest quality we did not include it in our analysis [ 31 ] for statistical reasons as noted previously [ 17 , 18 ]. We used the Harbord test to investigate funnel plot asymmetry in the analysis because we measured dichotomous variables [ 23 ]. This test avoids the mathematical association between log odds ratio and its standard error proposed by Egger et al [ 18 ] when there is a substantial intervention effect, while retaining power compared with alternative tests.
However, false-positives may occur in the presence of substantial between-study heterogeneity. We did not observe any substantial heterogeneity in the studies in the meta-analysis and no publication bias. Other studies have reported that HCQ is safe to use during pregnancy but had no control group [ 35 — 40 ].
All 4 of the studies [ 27 — 30 ] assessed the presence of congenital defects in babies born to women with autoimmune diseases Additional file 1 , Table S2 and Figure 2a. The OR for congenital defects for the pooled data for patients taking HCQ during pregnancy compared to no drug was 0.
OR of congenital defects and live births. The OR for congenital defects 2A and live births 2B from the pooled data in the HCQ group compared to the control group was determined. Consonant with the results obtained for the OR of congenital defects, all 4 of the included studies did not report any differences in the OR of live births comparing women who took HCQ compared to the control group Additional file 1 , Table S2 and Figure 2b.
Women with SLE have a higher incidence of spontaneous abortions and fetal loss [ 41 , 42 ]. Some investigations have shown a correlation between disease activity, spontaneous abortion, and fetal loss in pregnant SLE patients. Data were available from the 4 studies [ 27 — 30 ] that defined spontaneous abortion and fetal death defined as death occurring after 20 weeks of gestation. The pooled estimate of the OR of spontaneous abortion for the patients taking HCQ compared to placebo was 0.
OR of spontaneous abortion and fetal death. The pooled estimate of the OR of spontaneous abortion 3A and fetal death 3B for the patients taking HCQ compared to placebo was determined. In line with the results for spontaneous abortions, all 4 studies reported the OR of fetal death [ 25 — 28 ] Additional file 1 , Table S2 and Figure 3b.
The pooled OR for fetal death was 0. There is variability in the fetal death rate probably due to the small sample size. Higher incidences of premature births have been described in SLE patients especially in patients who have active disease [ 44 , 45 ]. Consistent with the results for congenital defects, live births, spontaneous abortions, and fetal deaths, there was no increased risk of pre-maturity associated with HCQ treatment. Data are available from the 4 studies regarding pre-mature death Additional file 1 , Table S2 and Figure 4. The pooled OR was 1.
OR of prematurity. The pooled estimate of prematurity for patients taking HCQ compared to placebo was determined.
Our systematic review provides evidence for the use of HCQ during pregnancy for women with auto-immune diseases. We identified 3 cohort studies [ 27 — 29 ] and 1 case-controlled study [ 30 ] comparing HCQ treatment with no HCQ treatment in pregnant women with auto-immune diseases Figure 1 and Additional file 1 , Tables S1 and S2.
We attempted to identify all relevant studies regarding HCQ and pregnancy by not restricting our literature search to the English language. It is still possible that we may have inadvertently omitted other studies that were not identified in the literature searches of the different databases. Although the Harbord test for dichotomous variables did not indicate publication bias, citation bias, and database bias, the number of studies included in our meta-analysis was only 4 so that it is possible that it may not be able to distinguish chance from real asymmetry in the funnel plot.
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The quality of the studies that were included in this meta-analysis as determined by the Downs and Black checklist was excellent despite the fact that they were no randomized placebo-controlled clinical trials [ 19 , 20 ]. The scores are listed in Additional file 1 , Table S1. We did not observe any heterogeneity in the results of the different studies Figures 2a, b , 3a , and 4 that could have arisen because of differences in doses of HCQ mg compared to mg , length of follow up after birth, and between auto-immune diseases SLE, DLE, RA, Sjogren's syndrome , allowing the use of a fixed effect model for.
The only significant heterogeneous result between the studies was the increased risk of fetal deaths Figure 3b noted where the results were analyzed by using a random-effects model. Our study was limited by the lack placebo controlled double-blinded studies that compared HCQ therapy with a control group. The patient populations included in the studies were fairly homogenous. All of the studies included pregnant females of child bearing age with autoimmune disease predominantly Lupus who met the ACR criteria for diagnosis, all of the patients and the fetuses were exposed to HCQ at the time of conception and throughout the pregnancy, all of the studies had a control group who were not exposed to the drug, and all reported similar outcomes.
We did not include the 1 RCT [ 31 ] because of the difficulties of combining different study designs in meta-analysis as noted above [ 17 , 18 ]. This study also found no differences in congenital defects, number of live births, fetal death, and pre-maturity in patients who were treated with HCQ compared to those who were not treated with HCQ.
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Despite the fact that we performed a meta-analysis, our studies were underpowered to detect an association between congenital defects congenital defects, spontaneous abortions, fetal deaths, pre-maturity and live births, if the effect of HCQ is less than 0. We did consider adding isolated case reports in our analysis given the rarity of the occurrence of congenital malformations and other obstetrical complication of this drug [ 35 — 40 ].
However, we did not include these patients in the statistical analysis because there were no control groups. There have been numerous studies using CQ prophylaxis for malaria during pregnancy. In general the doses used for malarial prophylaxis are less than those used to treat auto-immune diseases.
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There is a large meta-analysis published by the Cochrane database that included 12, patients focused on malaria prevention [ 32 ]. No increase in congenital malformations, live births, spontaneous abortions, fetal deaths or pre-maturity was noted in patients who used CQ compared to controls.
Although these studies do not directly prove that CQ is safe for pregnant women with auto-immune diseases, it is further evidence of the safety of anti-malaria drugs during pregnancy. Two of the included studies by Clowse et. One possible explanation for this discrepancy is the increased number of patients with anti-cardiolipin antibodies in the HCQ group of Clowse et al [ 27 ] and Frassi et al [ 30 ] that may have contributed to the high incidence of fetal deaths seen in both studies.
Since anti-malarials cross the placenta, they have the potential to cause congenital defects [ 12 ]. The first reports documenting congenital abnormalities and accumulation of the drug in the eye were described in infants whose mothers received chloroquine CQ [ 9 , 33 ]. However, recent reports including a Cochrane meta-analysis have demonstrated that CQ in low doses is safe as malaria prophylaxis during pregnancy [ 34 ]. In addition to the 4 studies that we included in this report, there have been several uncontrolled studies that have examined the effect of HCQ therapy on ocular toxicity in babies born to women taking the drug during pregnancy [ 35 — 37 ].
Two of these studies performed comprehensive ophthalmologic examinations of infants whose mothers took HCQ during pregnancy and found no evidence of ocular toxicity [ 29 , 31 ]. All of these studies have documented the safety of HCQ in infants whose mothers took the medication during pregnancy. The total number of infants examined in these 3 studies is Another benefit of HCQ during pregnancy is its effect on reducing disease activity. Of note Clowse et al. Clowse et al. High activity lupus was defined as a physician's estimate of activity PEA greater than 2 occurred in twice as many pregnancies in which HCQ treatment was stopped as in those in which HCQ was continued.
The rate of flare was also higher among women who stopped the medication compared with those who either continued taking it or who never took it. These flares occurred throughout pregnancy. More women who discontinued HCQ treatment had SLEDAI scores greater than 4 during pregnancy and this remained elevated when adjusted for year of delivery, anti-phospholipid antibody syndrome APS , age, ethnicity, and prior history of lupus nephritis.
The types of lupus activity that were best controlled by HCQ were arthritis and constitutional symptoms. HCQ did not prevent the more severe complications of proteinuria or thrombocytopenia. Furthermore, the authors also evaluated the use of Prednisone and fewer women who continued HCQ required high-dose corticosteroids, defined as either a daily dose of Prednisone of at least 20 mg or pulse steroids.