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  • 1
    In: Lupus Science & Medicine, BMJ, Vol. 9, No. 1 ( 2022-03), p. e000651-
    Abstract: Multiple guidelines recommend continuing hydroxychloroquine (HCQ) for SLE during pregnancy based on observational data. The goal of this individual patient data meta-analysis was to identify the potential benefits and harms of HCQ use within lupus pregnancies. Methods Eligible studies included prospectively collected pregnancies in women with lupus. After a systematic literature search, seven datasets meeting inclusion criteria were obtained. Pregnancy outcomes and lupus activity were compared for pregnancies with a visit in the first trimester in women who did or did not take HCQ throughout pregnancy. Birth defects were not systematically collected. This analysis was conducted in each dataset, and results were aggregated to provide a pooled OR. Results Seven cohorts provided 938 pregnancies in 804 women. After selecting one pregnancy per patient with a first trimester visit, 668 pregnancies were included; 63% took HCQ throughout pregnancy. Compared with pregnancies without HCQ, those with HCQ had lower odds of highly active lupus, but did not have different odds of fetal loss, preterm delivery or pre-eclampsia. Among women with low lupus activity, HCQ reduced the odds of preterm delivery. Conclusions This large study of prospectively-collected lupus pregnancies demonstrates a decrease in lupus activity among woman who continue HCQ through pregnancy and no harm to pregnancy outcomes. Like all studies of HCQ in lupus pregnancy, this study is confounded by indication and non-adherence. As this study confirms the safety of HCQ and diminished SLE activity with use, it is consistent with current recommendations to continue HCQ throughout pregnancy.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2779620-6
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  • 2
    In: Lupus Science & Medicine, BMJ, Vol. 9, No. 1 ( 2022-08), p. e000705-
    Abstract: We have developed a new conceptual model to characterise the signs and symptoms of SLE: the Type 1 and 2 SLE Model. Within the original model, Type 1 SLE consists of inflammatory manifestations like arthritis, nephritis and rashes; Type 2 SLE includes symptoms of fatigue, myalgia, mood disturbance and cognitive dysfunction. Through in-depth interviews, we explored how the Type 1 and 2 SLE Model fits within the lived experience of patients with SLE, with a focus on the connection between Type 1 and Type 2 SLE symptoms. Methods Semistructured in-depth interviews were conducted among adult participants meeting 1997 American College of Rheumatology or Systemic Lupus International Collaborating Clinics criteria for SLE. Participants were purposefully selected for age, race, sex and nephritis history. All interviews were audio-recorded and transcribed. Data were analysed through episode profile and thematic analysis. Results Through interviews with 42 patients with SLE, two patterns of Type 2 SLE emerged: Intermittent (n=18) and Persistent (n=24). Participants with Intermittent Type 2 SLE described feeling generally well when Type 1 is inactive; these participants were younger and had more internal SLE manifestations. Participants with Persistent Type 2 described always experiencing Type 2 symptoms despite inactive Type 1, although the severity may fluctuate. Participants with Persistent Type 2 SLE experienced traditional lupus symptoms of joint pain, hair loss and rash, but less often had severe organ system involvement. Conclusions By listening to the stories of our patients, we found two underlying patterns of Type 2 SLE: Intermittent Type 2 symptoms that resolve in synchrony with Type 1 inflammatory symptoms, and Persistent Type 2 symptoms that continue despite remission of Type 1 symptoms.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 3
    In: BMJ Open Quality, BMJ, Vol. 7, No. 3 ( 2018-07), p. e000269-
    Abstract: Teratogenic medications are often prescribed to women of childbearing age with autoimmune diseases. Literature suggests that appropriate use of contraception among these women is low, potentially resulting in high-risk unintended pregnancies. Preliminary review in our clinic showed suboptimal documentation of women’s contraceptive use. We therefore designed a quality improvement initiative to target three process measures: documentation of contraception usage and type, contraception counselling and provider action after counselling. We reviewed charts of rheumatology clinic female patients aged 18–45 over the course of 10 months; for those who were on teratogenic medications (methotrexate, leflunomide, mycophenolate and cyclophosphamide), we looked for evidence of documentation of contraception use. We executed multiple plan-do-study-act (PDSA) cycles to develop and evaluate interventions, which centred on interprofessional provider education, modification of electronic medical record (EMR) templates, periodic provider reminders, patient screening questionnaires and frequent feedback to providers on performance. Among eligible patients (n=181), the baseline rate of documentation of contraception type was 46%, the rate of counselling was 30% and interventions after counselling occurred in 33% of cases. Averaged intervention data demonstrated increased provider performance in all three domains: documentation of contraception type increased to 64%, counselling to 45% and provider action to 46%. Of the patients with documented contraceptives, 50% used highly effective, 27% used effective and 23% used ineffective contraception methods. During this project, one unintentional pregnancy occurred in a patient on methotrexate not on contraception. Our interventions improved three measures related to contraception counselling and documentation, but there remains a need for ongoing quality improvement efforts in our clinic. This high-risk population requires increased provider engagement to improve contraception compliance, coupled with system-wide EMR changes to increase sustainability.
    Type of Medium: Online Resource
    ISSN: 2399-6641
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2952859-8
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  • 4
    In: BMJ Open, BMJ, Vol. 4, No. 2 ( 2014-02), p. e004081-
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2014
    detail.hit.zdb_id: 2599832-8
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  • 5
    Online Resource
    Online Resource
    BMJ ; 2021
    In:  Lupus Science & Medicine Vol. 8, No. 1 ( 2021-04), p. e000491-
    In: Lupus Science & Medicine, BMJ, Vol. 8, No. 1 ( 2021-04), p. e000491-
    Abstract: Many rheumatologists and women with rheumatic disease worry that the disease or treatment will prevent breast feeding. International guidelines establish, however, that most antirheumatic medications are compatible with breast feeding. We sought to identify the frequency and predictors of desire to and actually breast feeding in women with rheumatic diseases. Methods Pregnant women with rheumatic disease were enrolled prospectively. Demographics and breastfeeding intention were collected at study entry, while actual breastfeeding decision was recorded postpartum. Maternal diagnosis, demographics and medication use was collected throughout the study. Predictors of breast feeding and intention were identified using stepwise logistic regression. Results A total of 265 pregnancies were included in the study, 88 with SLE, 33 with undifferentiated connective tissue disease, 100 with arthritis and 44 with other rare rheumatic diagnoses. Of these, 79% intended to breastfeed, 84% of women ever breast fed and 65% were still breast feeding at an average of 7.6 weeks postpartum. Medication concern was the most commonly cited reason not to breastfeed though only 5% of women were taking or planning to start a non-lactation compatible medication at their postpartum visit. In multivariate analysis, women with a college degree were more likely and women with SLE were less likely to intend to breastfeed. Actual breast feeding was most strongly predicted by the woman’s intention to breastfeed, but also increased with maternal age, decreased if the baby was born preterm and decreased the further the postpartum appointment occurred from delivery. Conclusion This study demonstrates that the majority of women with rheumatic disease want to and can breastfeed successfully. Additionally, very few women required a medication that was not compatible with breast feeding to control their rheumatic disease in the postpartum period. Despite this, an important minority of patients did not continue breast feeding due to their personal concerns about the risks of antirheumatic medications to their infant.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 6
    Online Resource
    Online Resource
    BMJ ; 2020
    In:  Lupus Science & Medicine Vol. 7, No. 1 ( 2020-11), p. e000455-
    In: Lupus Science & Medicine, BMJ, Vol. 7, No. 1 ( 2020-11), p. e000455-
    Type of Medium: Online Resource
    ISSN: 2053-8790
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2779620-6
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  • 7
    In: Annals of the Rheumatic Diseases, BMJ
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 1481557-6
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  • 8
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 82, No. 2 ( 2023-02), p. 217-225
    Abstract: Describe available data on birth defects and pregnancy loss in women with systemic lupus erythematosus (SLE) exposed to belimumab. Methods Data collected from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports up to 8 March 2020 were described. Belimumab exposure timing, concomitant medications and potential confounding factors were summarised descriptively. Results Among 319 pregnancies with known outcomes (excluding elective terminations), 223 ended in live births from which birth defects were identified in 4/72 (5.6%) in belimumab-exposed pregnancies and 0/9 placebo-exposed pregnancies across 18 clinical trials, 10/46 (21.7%) belimumab-exposed pregnancies in the BPR prospective cohort (enrolled prior to pregnancy outcome) and 0/4 belimumab-exposed pregnancies in the BPR retrospective cohort (enrolled after pregnancy outcome), and 1/92 (1.1%) in belimumab-exposed pregnancies from postmarketing/spontaneous reports. There was no consistent pattern of birth defects across datasets. Out of pregnancies with known outcomes (excluding elective terminations), pregnancy loss occurred in 31.8% (35/110) of belimumab-exposed women and 43.8% (7/16) of placebo-exposed women in clinical trials; 4.2% (2/48) of women in the BPR prospective cohort and 50% (4/8) in the BPR retrospective cohort; and 31.4% (43/137) of belimumab-exposed women from postmarketing/spontaneous reports. All belimumab-exposed women in clinical trials and the BPR received concomitant medications and had confounding factors and/or missing data. Conclusions Observations reported here add to limited data published on pregnancy outcomes following belimumab exposure. Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 1481557-6
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  • 9
    Online Resource
    Online Resource
    BMJ ; 2013
    In:  Annals of the Rheumatic Diseases Vol. 72, No. 9 ( 2013-09), p. 1536-1539
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 72, No. 9 ( 2013-09), p. 1536-1539
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    RVK:
    Language: English
    Publisher: BMJ
    Publication Date: 2013
    detail.hit.zdb_id: 1481557-6
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  • 10
    In: Lupus Science & Medicine, BMJ, Vol. 9, No. 1 ( 2022-01), p. e000602-
    Abstract: Evaluate the impact of pregnancy physiology and medication non-adherence on serum hydroxychloroquine (HCQ) pharmacokinetics (PK) and exposure-response in SLE. Methods We conducted a PK analysis using data from two observational pregnancy registries. We enrolled pregnant women with SLE taking HCQ at least 3 months prior to, and throughout pregnancy, and excluded those with multiple gestations. Using the PK model, we conducted dosing simulations and imputed 0%/20%/40%/60% non-adherence to evaluate the impact of adherence versus physiological changes on HCQ concentrations. We compared the effect of pregnancy-average non-adherent concentrations (≤100 ng/mL vs 〉 100 ng/mL) on preterm birth using adjusted logistic regression. Results We enrolled 56 women who had 61 pregnancies. By the third trimester, mean apparent HCQ clearance increased by 59.6%. At a dosage of 400 mg/day, fully adherent patients are expected to have HCQ concentrations ≤100 ng/mL only 0.3% of the time, compared with 24.2% when 60% of doses are missed. Persistently low HCQ concentrations throughout pregnancy were associated with a significantly higher odds of preterm birth, controlling for lupus nephritis and race (OR 11.2; 95% CI 2.3 to 54.2; p=0.003). Conclusions We observed significant changes in HCQ PK during pregnancy, resulting in a shortening in the drug’s half-life by 10 days; however, medication non-adherence had a more pronounced effect on HCQ exposure compared with physiological changes alone. Moreover, pregnant women with non-adherent HCQ concentrations had significantly higher rates of preterm birth. Accordingly, optimising adherence in pregnancy may be more clinically meaningful than adjusting HCQ dosage to account for physiological changes. PK modelling indicates that serum HCQ concentrations ≤100 ng/mL are suggestive of non-adherence regardless of trimester and may help identify pregnancies at risk for poor outcomes.
    Type of Medium: Online Resource
    ISSN: 2053-8790
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2779620-6
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