Aim Hydroxychloroquine (HCQ), commonly used to treat patients with primary Sjögren's syndrome (pSS), has been shown to delay the development of systemic lupus erythematosus (SLE). This study aimed to explore the association between HCQ use and future development of SLE in pSS patients based on a nationwide nested case–control study. Method Based on the National Health Insurance Research Database of Taiwan, those patients who were diagnosed with SLE at least 1 year after the diagnosis of pSS were identified as cases. Matched controls were randomly selected from pSS patients without a later diagnosis of SLE in a 1:10 ratio. The odds ratios (ORs) of HCQ exposure between cases and controls were analyzed by unconditional logistic regression after adjustment for age. Results A cohort of 11 772 pSS patients were extracted from the database during the period from January 1, 2000 to December 31, 2010. A total of 111 (0.9%) pSS patients developed SLE during the follow‐up period. Most (79%) of them developed SLE within 5 years after the diagnosis of pSS. There was no significant difference in the odds of HCQ exposure between cases and controls, with an adjusted OR of 2.43 (95% CI: 0.73–8.05). Neither did we observe a significant difference in the odds of exposure to a higher average dose of HCQ (≥100 mg/d vs non‐exposed) between cases and controls in the sensitivity analysis. Conclusion Nearly 1% of pSS patients may develop SLE. HCQ use in pSS patients was not associated with a lower possibility of the future development of SLE.
Direct‐acting antivirals (DAAs) have become an effective first‐line treatment for chronic hepatitis C (CHC), and the fixed‐dose combination of sofosbuvir (SOF) and velpatasvir (VEL) is one of the most important pangenotypic DAA regimen according to present treatment guideline. The association between SOF‐based regimens and renal toxicity remains controversial. A total of 953 patients including 130 with estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 and 823 with eGFR > 60 mL/min/1.73m2 receiving SOF/VEL therapy for 12 weeks were enrolled in this study. The eGFR was assessed at baseline, end of treatment (EOT), and 12 weeks after completion of the therapy (end of follow‐up, EOF). The eGFR in patients with eGFR ≤ 60 mL/min/1.73m2 increased from baseline (47.89 ± 10.25 mL/min/1.73m2) to EOT (51.65 ± 15.92; P < .001) and EOF (51.51 ± 14.46 mL/min/1.73m2; P < .05). The eGFR in patients with eGFR > 60 mL/min/1.73m2 at baseline (91.52 ± 22.06 mL/min/1.73m2) was lower at EOT (90.37 ± 22.3; P < .05), with no difference between EOT and EOF (P = .06). Multivariable analysis showed that a higher serum albumin level was associated with a lower risk of eGFR decrease at EOT, and the patients with baseline eGFR > 60 mL/min/1.73m2 were associated with a higher risk of eGFR decrease at EOF. The rates of sustained virologic response 12 weeks after treatment cessation (SVR12) were 99.2% in per‐protocol analysis, and the most common adverse events were fatigue (4.7%), abdominal discomfort (4.5%), and skin itching (3.7%). In conclusion, renal function improved after the SOF/VEL treatment in patients with CHC and chronic kidney disease. Thus, SOF/VEL was safe, effective, and tolerable in these patients.
Objective In trials of systemic lupus erythematosus (SLE), the SLE Responder Index (SRI) is the most commonly used primary efficacy end point but has limited validation against long‐term outcomes. We aimed to investigate associations of attainment of a modified version of the SRI (mSRI) with key clinical outcomes in SLE patients with up to 5 years of follow‐up. Methods We used data from a large multicenter, longitudinal SLE cohort in which patients received standard of care. The first visit with active disease (defined as SLE Disease Activity Index 2000 [SLEDAI‐2K] score ≥6) was designated as baseline, and mSRI attainment (defined as a reduction in SLEDAI‐2K ≥4 points with no worsening in physician global assessment ≥0.3 points) was determined at annual intervals from baseline up to 5 years. Associations between mSRI attainment and outcomes including disease activity, glucocorticoid dose, flare, damage accrual, Lupus Low Disease Activity State (LLDAS), and remission were studied. Results We included 2,060 patients, with a median baseline SLEDAI‐2K score of 8. An mSRI response was attained by 56% of patients at 1 year, with similar responder rates seen at subsequent annual time points. Compared to nonresponders, mSRI responders had significantly lower disease activity and prednisolone dose and higher proportions of LLDAS and remission attainment at each year, and less damage accrual at years 2 and 3. Furthermore, mSRI responder status at 1 year predicted clinical benefit at subsequent years across most outcomes, including damage accrual (odds ratio [OR] range 0.58–0.69, P < 0.05 for damage accrual ORs at all time points). Conclusion In SLE patients with active disease receiving standard of care, mSRI attainment predicts favorable outcomes over long‐term follow‐up, supporting the clinical meaningfulness of SRI attainment as an SLE trial end point.
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