Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study.

Background: The optimal treatment for pemphigus vulgaris (PV) has not been clearly determined yet. Rituximab (RTX) was recently approved for the management of adults with moderate to severe PV. Objectives: This prospective observational study was designed to evaluate the efficacy and safety of biosimilar RTX in PV patients.Methods: The efficacy and safety were evaluated by assessing the pemphigus disease area index (PDAI) score, clinical response and any adverse events (AEs) during at least 12-month follow-up. We evaluated anti-desmoglein (Dsg) 1,3 level at baseline, 3 months and 12 months after RTX infusion.Results: A total of 110 patients treated with biosimilar RTX were enrolled between May 2016 and July 2017. The mean age was 43.58 ± 11.77 years and the mean follow-up time was 16.22 ± 3.45 months. A notable decrease in PDAI score, anti-Dsg 1,3 level and prednisolone dosage was observed. Median delay to achieve complete remission (CR), median duration of CR, and median time to relapse were 3, 9, and 12 months, respectively. Newly diagnosed patients (NDPs) experienced higher rate of CR, longer duration of remission and lower risk of relapse, compared to previously treated patients (PTPs). A total of 47 AEs were observed in 33 (30%) patients, which were mostly mild infusion-related reactions.Conclusion: Administration of biosimilar RTX in PV patients was associated with desirable outcomes in terms of efficacy and safety in both NDPs and PTPs.First-line use of RTX in NDPs was more effective and allowed a rapid tapering of corticosteroid doses compared to PTPs.

Short-term clinical and serological follow-up with conventional and conformational anti-desmoglein antibodies in treatment-naïve and previously treated patients with pemphigus vulgaris after receiving rituximab.

BACKGROUND: Pemphigus vulgaris (PV) is a blistering, life-threatening autoimmune disease. Ethylenediaminetetraacetic acid (EDTA)-treated desmoglein (Dsg) enzyme-linked immunosorbent assay (ELISA) has recently been suggested to detect nonpathogenic antibodies. Rituximab (RTX) is now considered a first-line treatment for PV. OBJECTIVE: The primary and secondary aims were to evaluate anti-Dsg and EDTA-treated anti-Dsg ELISA and clinical response before and 3 months after RTX in treatment-naïve and previously treated patients, respectively. In addition, we compared the short-term efficacy of RTX between these groups. METHODS: Seventy-five patients with PV who received RTX (500 mg weekly for 4 weeks or 1000 mg 2 weeks apart) and prednisolone were followed for 3 months. Thirty-seven treatment-naïve newly diagnosed (group A) and 38 relapsed patients (group B) were included. Disease activity was scored with the Pemphigus Disease Area Index (PDAI). Clinical response was also assessed. Serum samples were collected at two points and examined for anti-Dsg1/3 and EDTA-treated anti-Dsg1/3. Conformational anti-Dsg values were calculated by subtracting EDTA-treated from conventional anti-Dsg values. RESULTS: The correlation of conventional and conformational anti-Dsg values was perfect (correlation coefficient > 0.98; p < .001) at every time point for both anti-Dsgs. There was no difference with regard to PDAI and anti-Dsg values between the two groups at baseline. The frequency of responders was significantly higher in group A (100%) than in group B (89%; p = .006). Three patients relapsed, and five patients had persistent disease activity in group B. After 3 months, conventional and conformational anti-Dsg values were significantly higher in group B compared with group A (anti-Dsg3: p = .017 and .021, respectively; anti-Dsg1: p = .014 and .016, respectively). Total and scalp PDAI were significantly lower in group A than in group B (p = .042 and .016, respectively). CONCLUSION: EDTA-treated anti-Dsg ELISA had no added value. Using RTX as first-line treatment in patients with PV appears to be associated with better clinical response and immunologic profile than delayed treatment in the short term.

Evaluation of the diagnostic potential of trans abdominal ultrasonography in detecting intra-abdominal adhesions: A double-blinded cohort study.

BACKGROUND: Intra-abdominal adhesion is one of the most important complications of abdominopelvic surgery. It increases morbidity and mortality for patients. Although laparoscopy is the gold standard of adhesion diagnosis, it can cause visceral damage during the operation. Therefore, surgeons prefer to use non-invasive methods for planning the operation. We designed this study to evaluate transabdominal ultrasonography ( TAU) accuracy for diagnosing Intra-abdominal Adhesions. MATERIAL & METHODS: This double-blinded cohort study was conducted on 47 patients with previous laparotomy who undergo another surgery. Spontaneous visceral slide (SVS) and induced visceral slide (IVS) were measured during TAU. RESULTS: The mean age and BMI of 47 patients were 43.21±10.3 and 27.545±5.76. The majority of the patients were female (76%). Mean SVS and IVS in patients with intra-abdominal adhesion were 8.73±1.60 and 44.84±11.60. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of TAU in intra-abdominal diagnosis were 83.33%, 51.72%, 51.72%, 83.33%, 63.83%. CONCLUSIONS: Although TAU is an appropriate method for detecting the intra-abdominal adhesion, it isn't good enough for diagnosing free adhesion area. We recommended further researches with greater sample size and other non-invasive techniques.