Objective To date, the only study that has assessed the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2 mRNA) vaccine in systemic lupus erythematosus (SLE) observed a moderate response, but the sample size precluded an accurate analysis of the effect of individual drugs. Therefore, we evaluated the immunogenicity of an inactivated SARS‐CoV‐2 vaccine (Sinovac‐CoronaVac) and the influence of different medications in SLE. Safety was also assessed. Methods We conducted a prospective controlled study of 232 SARS‐CoV‐2–naive SLE patients and 58 SARS‐CoV‐2–naive controls who were vaccinated with 2 doses of Sinovac‐CoronaVac with a 28‐day interval (day 0/day 28 [D0/D28]). Immunogenicity analysis at D0/D28 and D69 included anti‐SARS‐CoV‐2 S1/S2 IgG seroconversion (SC) and neutralizing antibodies (NAb) positivity. The influence of individual drugs on immune response and safety was assessed. Results Patients and controls were well balanced for age (P = 0.771). At D69, SLE patients showed a moderate SC (70.2% versus 98.1%; P < 0.001) and moderate frequency of NAb positivity (61.5% versus 84.6%; P = 0.002), although both frequencies were lower than in controls. Factors associated with lower SC in univariate analysis at D69 were prednisone use (odds ratio [OR] 0.215 [95% confidence interval (95% CI) 0.108–0.427], P < 0.001) and mycophenolate mofetil (MMF) use (OR 0.201 [95% CI 0.107–0.378], P < 0.001), whereas hydroxychloroquine (HCQ) use led to a 2.5 increase in SC (P = 0.011). SLE patients who were receiving HCQ monotherapy had similar SC to controls at D69 (100% versus 98.1%; P = 1.000). In multivariate analysis, prednisone and MMF use were independently associated with lower SC (P < 0.001) and NAb positivity (P < 0.001). Safety analysis revealed no moderate/severe adverse events. Conclusion Sinovac‐CoronaVac has a moderate immunogenicity in SARS‐CoV‐2–naive SLE patients with an excellent safety profile. We further demonstrate that HCQ may improve SC, whereas prednisone and MMF had a major deleterious effect in vaccine response, reinforcing the need to investigate the role of temporary MMF withdrawal or a vaccine‐booster dose (http://clinicaltrials.gov identifier: NCT04754698).

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Introduction Influenza A (H3N2) virus is the most important cause of seasonal influenza morbidity and mortality in the last 50 years, surpassing the impact of H1N1. Data assessing immunogenicity and safety of this virus component are lacking in systemic lupus erythematosus (SLE) and restricted to small reports with other H3N2 strains. Objective This study aims to evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in SLE. Methods 81 consecutive SLE patients and 81 age- and sex-matched healthy controls (HC) were vaccinated with the influenza A/Singapore/INFIMH-16-0019/2016(H3N2)-like virus. Seroprotection (SP) and seroconversion (SC) rates, geometric mean titers(GMT), and factor increase in GMT(FI-GMT) and adverse events were assessed before and 4 weeks post-vaccination. Disease activity and therapies were also evaluated. Results Before immunization, SLE and HC groups had high SP rates (89% vs 77%, p = 0.061) and elevated GMT titer with higher levels in SLE (129.1(104.1–154.1) vs 54.8(45.0–64.6), p < 0.001). Frequency of two previous years’ influenza vaccination was high and comparable in SLE and HC (89% vs 90%, p = 1.000). Four weeks post-vaccination, median GMT increased for both groups and remained higher in SLE compared to HC (239.9(189.5–290.4) vs 94.5(72.6–116.4), p < 0.0001) with a comparable FI-GMT (2.3(1.8–2.9) vs 1.9(1.5-2.3), p = 0.051). SC rates were low and comparable for both groups (16% vs 11%, respectively, p = 0.974). Disease activity scores remained stable throughout the study ( p = 1.000) and severe adverse events were not identified. Conclusion Influenza A/Singapore (H3N2) vaccine has an adequate safety profile. The distinct immunogenicity pattern from other influenza A components characterized by a remarkably high pre- and post-vaccination SP rate and high GMT levels may be associated with previous influenza A vaccination. ( www.clinicaltrials.gov , NCT03540823).

BACKGROUNDIn the last few years, there is a large effort to minimize the use of glucocorticoids (GC) in the treatment of systemic lupus erythematosus (SLE). Although CGs greatly increased the survival of SLE patients in the past, its excessive use is responsible for a considerable amount of irreversible damage. The aim of this study was to evaluate the efficacy and safety of a lupus nephritis (LN) induction treatment scheme with lower than standard doses of GC. METHODSCYCLONES (CYClophosphamide LOw dose and No Extra Steroid) trial is a randomized controlled open-label noninferiority clinical trial with blinded endpoint adjudication. The CYCLONES group received six doses of methylprednisolone (500 mg on D0/D15 + 250 mg on D30/D45 + 125 mg on D60/D75) and low dose oral GC. Prednisone was immediately adjusted to 20 mg/day and tapered down (5 mg/month) until complete withdrawal. CYCLONES was compared with the EUROLUPUS group that received three consecutive doses of methylprednisolone (750 mg on D0, D1, D2) + prednisone 0.5 mg/kg/day with a gradual reduction of 5 mg/month. Both groups received cyclophosphamide (6 doses of 500 mg biweekly) followed by azathioprine or mycophenolate mofetil, until the completion of 6 months. The primary outcome was a partial renal at week 24 defined as urinary protein/creatinine ratio (P/C) < 3 g/g with decrease of at least 50% from baseline + increase of creatinine (mg/dL) not higher than 15% from baseline. RESULTSA total of 45 patients completed the 6 months of treatment (22 in CYCLONES and 23 in EUROLUPUS). The primary outcome was achieved in 11 (50%) patients in the CYCLONES compared to 19 (83%) patients in EUROLUPUS. The noninferiority test failed, the Cox regression hazard ratio for not achieving the primary outcome in the CYCLONES was HR = 2.69 (95%CI = 1.28-5.68, p = 0.009). Creatinine change from baseline was comparable between groups (-0.07 ± 0.31 vs. -0.13 ± 0.39, p = 0.54) as well as creatinine at 6 months (0.79 ± 0.20 vs. 0.89 ± 0.37, p = 0.27). Cumulative prednisone dose was different between both groups at 6 months (2025 ± 900 mg vs. 3704 ± 1067 mg, p < 0.0001). There were no deaths and only one serious adverse event in EUROLUPUS group. CONCLUSIONCYCLONES was inferior to EUROLUPUS in achieving the primary outcome of proteinuria at 24 weeks, although within the range reported for large nephritis induction trials. Sustained and comparable levels of creatinine were observed among groups. Alternative schemes are needed to evaluate the best approaches to reduce GC induced damage in LN treatment. This trial was registered at www.clinicaltrials.gov as #NCT 03492255.