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IN.PACT 018 Drug-Coated Balloon approved for PAD

The US FDA has approved the IN.PACT 018 drug-coated balloon (DCB) for the treatment of peripheral arterial disease.

The paclitaxel-coated balloon is indicated for percutaneous transluminal angioplasty of de novo, restenotic, or in-stent restenotic lesions up to 360 mm in length with vessel diameters of 4 to 7 mm, located in the superficial femoral and popliteal arteries.

The IN.PACT 018 DCB is built on the same technology as the IN.PACT Admiral DCB (0.035 inch guidewire compatible), but is engineered to cross tight lesions, provide better deliverability, and is 0.018 inch guidewire compatible.

Source: Medscape

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First Line for Esophageal Cancer is now Immunotherapy

Immunotherapy with nivolumab (Opdivo) is now approved in the United States for first-line use in the treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The new approval for the drug, a programmed cell death ligand-1 (PD-L1) inhibitor, is for use in this patient population regardless of PD-L1 status. The indication also specifies that nivolumab is to be used together with chemotherapy (with a fluoropyrimidine- and platinum-containing regimen) or in combination with ipilimumab (Yervoy), an immunotherapy with a different mechanism of action.

Source: Medscape

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Rare monkeypox detected in UK: Check symptoms, treatment & other details

A patient was found to be infected with monkeypox virus in the United Kingdom, who traveled to the country from Nigeria.

Monkeypox is caused by monkeypox virus, a member of the Orthopoxvirus genus in the family Poxviridae. Monkeypox is a viral zoonotic disease that occurs primarily in tropical rainforest areas of Central and West Africa and is occasionally exported to other regions.

The incubation period (interval from infection to onset of symptoms) of monkeypox is usually from 6 to 13 days but can range from 5 to 21 days.

Monkeypox typically presents clinically with fever, rash and swollen lymph nodes.

Monkeypox virus is mostly transmitted to people from wild animals such as rodents and primates, but human-to-human transmission also occurs.
Monkeypox virus is transmitted from one person to another by contact with lesions, body fluids, respiratory droplets and contaminated materials such as bedding.

The clinical presentation of monkeypox resembles that of smallpox, a related orthopoxvirus infection which was declared eradicated worldwide in 1980.

Vaccinia vaccine used during the smallpox eradication programme was also protective against monkeypox. A new third generation vaccinia vaccine has now been approved for prevention of smallpox and monkeypox. Antiviral agents are also being developed.

Source: WHO

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Saliva test for diagnosing endometriosis

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

The respective sensitivity & specificity for the diagnostic miRNA signature were 96.7%, 100% respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

Source: Medscape

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Langerhans-cell histiocytosis case

History: A female infant delivered at term had a “blueberry muffin” rash at birth. Laboratory tests and imaging studies were normal. Skin biopsy showed a dense infiltrate of cells with kidney-shaped nuclei and positive S100+ and CD1a+ on immunohistochemistry. What is the most likely diagnosis?

Answer:

Langerhans cell histiocytosis (LCH) is an abnormal clonal proliferation of Langerhans cells, abnormal cells deriving from bone marrow and capable of migrating from the skin to lymph nodes.

Symptoms range from isolated bone lesions to multisystem disease. LCH is part of a group of syndromes called histiocytoses, which are characterized by an abnormal proliferation of histiocytes.

The disease has gone by several names, including Hand–Schüller–Christian disease, Abt-Letterer-Siwe disease, Hashimoto-Pritzker disease (a very rare self-limiting variant seen at birth) and histiocytosis X, until it was renamed in 1985 by the Histiocyte Society.

Diagnosis: Assessment of endocrine function and bone marrow biopsy is also performed when indicated. S-100 protein, CD1a, langerin (CD207).

Treatment: Radiation therapy or chemotherapy

Source: NEJM, Wikipedia

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FDA approves new immunotherapy for metastatic melanoma

The FDA approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older.

Dose: 480 mg nivolumab + 160 mg relatlimab IV every 4 weeks.

Adverse effects: Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants. Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial due to hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.

Source: BMS

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Ehlers Danlos Syndrome case

A 20-year-old male presented to an outpatient headache clinic with a 10-year history of headache, which had become daily over the past 3 months and awakened her in the middle of the night. Past history also revealed chronic musculoskeletal pain, syncope, fatigue, and hypermobility of joints.

Ehlers–Danlos syndromes (EDS) are a group of thirteen genetic connective-tissue disorders that are in the current classification, with a fourteenth type discovered in 2018.

Symptoms may include loose joints, joint pain, stretchy velvety skin, and abnormal scar formation. These may be noticed at birth or in early childhood.

Complications may include aortic dissection, joint dislocations, scoliosis, chronic pain, or early osteoarthritis.

EDS occurs due to variations of more than 19 genes that are present at birth.[1] The specific gene affected determines the type of EDS. Some cases result from a new variation occurring during early development, while others are inherited in an autosomal dominant or recessive manner. Typically, these variations result in defects in the structure or processing of the protein collagen.

Diagnosis is often based on symptoms and confirmed with genetic testing or skin biopsy but people may initially be misdiagnosed with hypochondriasis, depression, or chronic fatigue syndrome.

No cure is currently known and treatment is supportive in nature. Physical therapy and bracing may help strengthen muscles and support joints. While some forms of EDS result in a normal life expectancy, those that affect blood vessels generally decrease it.

Source: Wikipedia

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FDA approves Anifrolumab as first new Lupus treatment in more than 10 years

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Dose: 300 mg concentrate for solution for infusion.

Adverse Effects: The most common adverse reactions are upper respiratory tract infection, bronchitis, infusion-related reaction, and herpes zoster. The most common serious adverse reaction was herpes zoster.

Source: FDA

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First drug for cold agglutinin disease

The US FDA approves first drug for Cold Agglutinin Disease. Sutimlimab-jome (Brand name: ENJAYMO) is a classical complement inhibitor indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease.

Dose: Injection: 1,100 mg/22 mL (50 mg/mL) in a single-dose vial

Adverse effects: Most common adverse reactions (incidence ≥10%) are respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and
peripheral edema.

Source: FDA

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First treatment for rare Uveal Melanoma

The drug is tebentafusp-tebn (Kimmtrak, from Immunocore Limited), which acts as a bispecific gp100 peptide-HLA-directed CD3 T-cell engager. It is the first of a novel class of T-cell receptor (TCR) bispecific immunotherapies under development at the company.

It is also the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA, and it is the first therapy to demonstrate a survival benefit to patients with this disease. However, the indication specifies that the drug is for use only in patients who are HLA-A*02:01-positive.

Source: Immunocore