Methods: We report a case of a 20-year-old Nigerian male who presented with acquired thrombotic thrombocytopenic purpura (aTTP) and sickle cell trait. The coexistence of published cases of TTP and sickle cell hemoglobinopathies is rare. Results: Despite the initial treatment with plasma exchange and glucocorticoids, our patient relapsed and also required caplacizumab which resulted in successful remission. Discussion: We conclude by reviewing the cases of TTP in patients with sickle cell hemoglobinopathies and review how vaso-occlusive crises with multiorgan injury can mimic TTP. Conclusion: Ours is the first published case of aTTP with confirmed ADAMTS13 autoantibodies in a patient with a sickle cell hemoglobinopathy and contributes to the literature on the successful use of caplacizumab in clinical practice.
Biologic agents are among the fastest-growing classes of therapeutic products. A biosimilar therapeutic product is defined as one that is similar to an already licensed reference product in regard to quality, safety, and efficacy and is often priced more competitively (Expert Committee on Biological Standardization, 2009; Publicover, et al., 2013). In 2016, the Saskatchewan Cancer Agency effectively changed from a granulocyte colony-stimulating factor (G-CSF) brand name product (Neupogen®) to a biosimilar (Grastofil®) for stem cell mobilization prior to autologous stem cell transplants (ASCT). However, because its efficacy in this setting is currently unknown, many institutions continue to use the brand name product. To address this, we reviewed patient charts and compared the efficacy of CD34+ collection in 170 patients who received Neupogen® and 47 patients who received Grastofil® between 2012 and 2018. Additionally, we analyzed efficacy of mobilization with both G-CSF products either alone or in combination with chemotherapy, patients requiring more than one apheresis day and requirement for Plerixafor®. Time to engraftment, and length of stay in hospital post ASCT were used as clinical efficacy parameters. This analysis is important to ensure that patient outcome is not compromised upon use of Grastofil® as opposed to the already approved reference, Neupogen®. The increased use of biosimilars would allow for decreased costs and more sustainable healthcare. Results Neupogen® and Grastofil® had similar efficacy for stem cell mobilization as 92.4% of the patients harvested with the brand name had a successful harvest compared to 100% of the patients given the biosimilar. A successful harvest is defined as a collection of ≥2x106 CD34+ cells for patients planned for one stem cell transplant and ≥4x106 CD34+ cells for patients planned for two transplants. Additionally, the two drugs did not display a statistically significant difference in Plerixafor requirement in a situation with low CD34+ count. Amongst all 217 patients, 25.9% of patients given Neupogen® required Plerixafor® as compared to 23.4% of Grastofil® patients. As seen from Table 1, by using the Wilcoxon test to compare the efficacy of Neupogen® and Grastofil® without chemotherapy for stem cell mobilization, there was no significant difference seen with a p-value of 0.53. Similarly, in patients mobilized with chemotherapy in addition to either Neupogen® or Grastofil®, similar efficacy was seen between the groups given a p-value of 0.95. There was no statistically significant difference between the patient groups with respect to requiring more than 1 day of apheresis. 59.4% of patients mobilized with Neupogen® required more than 1 apheresis day compared to 76.9% of Grastofil® patients (p = 0.11). Similarly, of the Neupogen® and Grastofil® groups mobilized with chemotherapy, 42.5% and 38.1%, respectively, required more than one apheresis day which was not statistically different (p = 0.71). Table 2 presents the engraftment data which also suggests that the two drugs behave with similar efficacy in this respect. Length of stay in hospital post autologous stem cell transplant was an additional variable analyzed. Again, there was no significant difference in length of stay between patients who received Neupogen® (median=18.5 days, IQR=17.0-21.0) or Grastofil® (median=19.0 days, IQR =17.0-22.0) without chemotherapy (p = 0.75). When chemotherapy was added to the mobilizing regimen, lengths of stay post autologous stem cell transplant increased but there was no statistically significant difference in length of stay between Neupogen® plus chemotherapy mobilization (median=22.0, IQR =20.0-26.0) versus Grastofil® plus chemotherapy (median=24.0 days, IQR =21.0-29.0) mobilization (p-value =0.10). In conclusion, when comparing the use of either a Neupogen® or Grastofil® based mobilization regimen in terms of stem cell harvest success, Plerixafor® use, more than one apheresis day required, time to engraftment, and length of stay in hospital, no significant difference was found indicating that both products, the reference agent and its biosimilar have similar efficacy. The use of such biosimilars can provide substantial cost savings to the health care system. Disclosures Elemary: Roche: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Lundbeck: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding.
Introduction: Granulocyte colony-stimulating factor (G-CSF) is the first line treatment for mobilization, most commonly using a regimen of daily filgrastim. The use of biosimilars can provide substantial cost savings to the health care system while delivering comparable efficacy outcomes. In 2016, the Saskatchewan Cancer Agency was a leader in Canada, instituting formulary changed from a G-CSF originator product to a cost savings alternative biosimilar for stem cell mobilization prior to autologous stem cell transplant (ASCT) and for engraftment. The purpose of this study was to investigate the clinical comparability of biosimilar G-CSF to its reference product in a real-world clinical setting and to validate use of the biosimilar in mobilization and engraftment—an indication which had been granted by extrapolation. Methods: A retrospective chart review was completed including all patients diagnosed with a hematological malignancy between 2012 and 2018 who underwent ASCT. To assess real-world outcomes across a diverse population, successful CD34+ stem cell collection was compared between patients mobilized with originator filgrastim, Neupogen, and biosimilar filgrastim, Grastofil. Additional comparisons included the number of apheresis required, time to absolute neutrophil count (ANC) engraftment, platelet engraftment, length of hospital stay, and Plerixafor use. Results: 217 patients were mobilized and transplanted during the study period. There was no statistically significant difference in success rate between patients mobilized with biosimilar filgrastim and those who had received originator G-CSF (100% vs. 92.4%, p = 0.075). Neither disease type, nor concurrent chemomobilization regimen resulted in a detectable difference between the two G-CSF products in successful stem cell harvest. Engraftment was highly similar between groups, as demonstrated by ANC recovery (11.6 days Neupogen vs. 11.6 days Grastofil), platelet recovery (14.0 days Neupogen vs. 14.2 days Grastofil), and total length of hospital stay (22.4 days Neupogen vs. 22.3 days Grastofil). No statistically significant difference in adjunctive use of Plerixafor® was observed between Neupogen and Grastofil patients (25.9% vs. 23.4%, p = 0.72). Conclusion: Extrapolation of indications for biosimilars is justified. This real-world evidence builds upon registrational studies to confirm that no clinically meaningful differences were detected between originator Neupogen and biosimilar Grastofil in the setting of PBSC mobilization and engraftment post ASCT. Biosimilars are as safe and effective as originator products. Implementation across all approved indications without hesitation maximizes cost savings to the provincial system, allowing for more optimal allocation of health care resources.
A large variety of spices can be found in kitchens worldwide. The usage varies from region to region as per the cuisine. They hold nutritional values and are being exploited for their anticancer, antifungal, antibacterial, antiulcer, anti-inflammatory properties. This study highlights some of the commonly used Indian spices for their antifungal properties and summarizes their potential antifungal activity. Fungal diseases are deep-rooted and cause acute/chronic infections in humans, mainly Aspergillus and Candida species. As the tropical climate provides a breeding ground for fungal infections, such regions share a huge load of mycoses. Various spices have been shown to be effective against treating fungal diseases. The current study focuses on the potential anti-fungal role of the spices and reviews the current literature on the possible mechanism of action of the active compounds of these spices concerning the commonly used antifungal drugs. The spices consist of essential oils that work by inhibition mycotoxin biosynthesis, or disrupting and inhibiting cell wall formation and inhibiting efflux pumps and are comparable to the currently available antifungal drugs.
In such an unfortunate situation of a medical emergency, a lot of people tend to lose their lives which can be a result of misplaced/delayed paperwork. Thus it is essential to have the patient’s medical record history before going into major surgery and it is often unavailable at the required time due to the chain of communication between different hospitals. As a possible solution to this problem we propose a central chain of all medical records of a patients in an electronic format. The electronic health records (EHRs) are patient-centered, real-time records that make information available to authorized users and help doctors diagnose cases more quickly, reduce medical errors, and deliver safer care. EHRs improve the communication gap and make the process of getting medical attention quicker. Our methodology includes an easy to use 2 module approach (doctor portal and patient portal) with multiple sub modules all linked to a common database. We create a secure and centralized database for EHRs with an easy approach and manageable methodology. Security is important in our use case and we thus include- Secure authentication (and verification of doctor’s ID while creating a new account) , two factor authentication and OTP verification while accessing patient reports. We are using block chain for safely storing multiple patient records for maintaining a safe storage of multiple records. The doctors will be able to access the patients with few clicks and verification and understand the patient background. This will majorly help in maintaining records, accessing prescription and getting an overview of the patient's medical history while saving a lot of manual paper work.
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