Background Corticosteroids (CS) with or without adjuvant immunosuppressant agents are standard treatment for pemphigus vulgaris (PV). The efficacy of adjuvant therapies in minimizing steroid-related adverse events (AEs) is unproven. Objectives To utilize data collected in a French investigator-initiated, phase III, open-label, randomized controlled trial to demonstrate the efficacy and safety of rituximab and seek approval for its use in PV.Methods This was an independently conducted post hoc analysis of the moderateto-severe PV subset enrolled in the Ritux 3 study. Patients were randomized to rituximab plus 0Á5 or 1Á0 mg kg À1 per day prednisone tapered over 3 or 6 months, or 1Á0 or 1Á5 mg kg À1 per day prednisone alone tapered over 12 or 18 months, respectively (according to disease severity). The primary end point was complete remission at month 24 without CS (CRoff) for ≥ 2 months, and 24month efficacy and safety results were also reported.Results At month 24, 34 of 38 patients (90%) on rituximab plus prednisone achieved CRoff ≥ 2 months vs. 10 of 36 patients (28%) on prednisone alone. Median total cumulative prednisone dose was 5800 mg in the rituximab plus prednisone arm vs. 20 520 mg for prednisone alone. Eight of 36 patients (22%) who received prednisone alone withdrew from treatment owing to AEs; one rituximab-plus-prednisone patient withdrew due to pregnancy. Overall, 24 of 36 patients (67%) on prednisone alone experienced a grade 3/4 CS-related AE vs. 13 of 38 patients (34%) on rituximab plus prednisone. Conclusions In patients with moderate-to-severe PV, rituximab plus short-term prednisone was more effective than prednisone alone. Patients treated with rituximab had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs. What's already known about this topic?Rituximab in pemphigus vulgaris, D.M. Chen et al. 1113 CI, confidence interval; CRoff, complete remission off prednisone therapy; IQR, interquartile range; N/A, not applicable; CRmin, complete remission on minimal prednisone therapy (prednisone dose ≤ 10 mg per day). a No adjustment for multiplicity was made for any secondary end points and the P-values should be interpreted with caution. b 95% confidence interval (CI) calculated using the corrected Newcombe interval. c P-value calculated using Fisher's exact test with mid-P correction. d P-value calculated using Mann-Whitney U-test.
Previous studies have suggested that psoriasis is associated with liver disease, possibly related to metabolic co-morbidities, alcohol consumption, treatment toxicity, and chronic inflammation. The objective of this study was to determine if psoriasis increases risk for incident liver disease after controlling for traditional risk factors for liver disease. We conducted a population-based cohort study in the United Kingdom using The Health Improvement Network (THIN) data from 1994-2014 to investigate the risk of liver disease in psoriasis patients. Patients with a history of liver disease were excluded from the analyses. Diagnostic codes were used to identify psoriasis patients. Patients who received systemic or phototherapy were classified as having moderate to severe psoriasis. Each exposed patient had up to 5 matched controls. Cox proportional hazards models were used to estimate hazard ratios with 95% confidence intervals. Psoriasis patients were at a significantly higher risk for developing liver disease (mild PsO:
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