The quality of RCT reporting in general endocrine literature is suboptimal. We discuss our results, highlight the areas where improvements are needed, and provide some recommendations.

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.

We found that CD4 cell progression is negatively affected by the presence of ongoing HCV replication in coinfected individuals initiating ART which persisted throughout stable ART suggesting active HCV infection affects immune restoration even after years of ART exposure.

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