Biosimilars in dermatology: identifying myths and knowledge gaps

Biosimilars are beginning to gain regulatory approval in the United States. Biosimilars are structurally near identical to the innovator and must demonstrate identical pharmacokinetics via the same binding affinity and biological function on assays. However, biologics are so complex that even the innovator company cannot produce exact duplicates; there is batch-to-batch variation. The International Psoriasis Council has outlined a biosimilarity index, which aims to standardize preclinical definitions of biosimilarity. Such an index, paired with post-approval monitoring, could provide a transparent, quantitative definition of biosimilarity. Such an index could increase trust in biosimilar medicines and the preclinical assessment process without increasing costs. As preclinical analyses are critical to biosimilar approval, manufacturers should devote proportionate resources to completing them. Dermatologists, who might reflexively look for indication-specific clinical data, might also shift their focus to preclinical variables. Finally, it should be noted that biosimilars provide more evidence of similarity than we have for different batches of the innovator product. Thus, any clinical testing standards, or lack thereof, for different batches of innovator products should also apply to biosimilars

Ocular manifestations of sickle cell disease and genetic susceptibility for refractive errors

Purpose: Sickle cell disease (SCD) is the most common and serious form of an inherited blood disorder that lead to higher risk of early mortality. SCD patients are at high risk for developing multiorgan acute and chronic complications linked with significant morbidity and mortality. Some of the ophthalmological complications of SCD include retinal changes, refractive errors, vitreous hemorrhage, and abnormalities of the cornea. Materials and Methods: The present study includes 96 SCD patients. A dilated comprehensive eye examination was performed to know the status of retinopathy. Refractive errors were measured in all patients. In patients with >10 years of age, cycloplegia was not performed before autorefractometry. A subset of fifty patients' genotyping was done for NOS3 27-base pair (bp) variable number of tandem repeat (VNTR) and IL4 intron-3 VNTR polymorphisms using polymerase chain reaction-electrophoresis. Chi-square test was performed to test the association between the polymorphisms and refractive errors. Results: The results of the present study revealed that 63.5% of patients have myopia followed by 19.8% hyperopia. NOS3 27-bp VNTR genotypes significantly deviated from Hardy–Weinberg equilibrium (P < 0.0001). Although IL4 70-bp VNTR increased the risk of developing refractive errors, it is not statistically significant. However, NOS3 27-bp VNTR significantly reduced the risk of development of myopia. Conclusion: In summary, our study documents the prevalence of refractive errors along with some retinal changes in Indian SCD patients. Further, this study demonstrates that the NOS3 VNTR contributes to the susceptibility to development of myopia in SCD cases

18 ACUTE MESENTERIC ISCHEMIA DUE TO SMA THROMBOSIS- A CASE report

&lt;p&gt;24A | 38 | JAN 2022 | IJABMS&lt;/p&gt;&lt;p&gt;Medical Journal Research Article&lt;/p&gt;&lt;p&gt;18 ACUTE MESENTERIC ISCHEMIA DUE TO SMA THROMBOSIS- A CASE report&lt;/p&gt

Outcomes of Peripheral Endovascular Interventions Based on Hospital Volume: A Mini Review of Published Literature

Previous literature showed hospital procedural volume is an independent predictor for outcomes of various cardiac procedures. However, very few studies shown similar results for peripheral endovascular interventions especially peripheral atherectomy. Here we are reviewing previously published articles to provide volume-outcome relationship for peripheral atherectomy and angioplasty with or without endovascular stenting. We found higher hospital volume significantly and independently lowers in-hospital mortality, amputation rates, peri-procedural complications, length and cost of hospitalization for peripheral endovascular interventions

High risk for obstructive sleep apnea hypopnea syndrome predicts new onset atrial fibrillation after cardiac surgery: a retrospective analysis

Obstructive sleep apnea hypopnea syndrome (OSAHS) is highly prevalent in patients undergoing coronary artery bypass surgery (CABG). OSAHS is a risk factor for the development of atrial fibrillation (AF), but the risk of AF in patients who are high risk for OSAHS is unclear. A retrospective study was conducted on consecutive patients undergoing CABG from 2013 to 2015 without AF pre-operatively. Patients were categorized as low risk for OSAHS, high risk for OSAHS, or diagnosed OSAHS based on medical records review. All diagnosed OSAHS patients were on active treatment with positive airway pressure. Outcomes assessed were postoperative AF (POAF), postoperative length of stay, re-intubation, in-hospital mortality, and cost of hospitalization. Out of 209 eligible patients, 66.5% were low-risk for OSAHS, 18.7% high-risk for OSAHS, and 14.8% diagnosed/treated for OSAHS. POAF developed in 96 patients (45.9%) with greater frequency in high-risk OSAHS patients (69.2% high risk, 41.9% low risk, 40.3% diagnosed/treated, p = 0.01). In analyses adjusted for age, sex, ethnicity and comorbidities, high risk for OSAHS was associated with 2.9 greater odds (95% CI [1.2, 7.3], p = 0.02) for POAF while diagnosed/treated OSAHS was not associated with elevated risk (OR = 1.4, 95% CI [0.6, 3.6], p = 0.50) compared to patients at low risk for OSAHS. High risk for OSAHS is an independent predictor for POAF in patients undergoing CABG. In contrast, patients diagnosed and treated for their OSAHS are not at elevated risk of POAF. These findings support evaluation of a standardized OSAHS screening and treatment program as part of the pre-operative evaluation for elective CABG

TABLE S1 - Supplemental material for Colchicine for Erythema Nodosum: A Retrospective Case Series

Supplemental material, TABLE S1, for Colchicine for Erythema Nodosum: A Retrospective Case Series by Matthew L. Hrin, Palak V. Patel, Joseph L. Jorizzo, Steven R. Feldman and William W. Huang in Journal of Cutaneous Medicine and Surgery</p