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Adalimumab safe and effective in children with UC

Adalimumab is effective and well-tolerated in children with moderate-to-severe ulcerative colitis (UC), with “clinically meaningful” rates of clinical remission and response, including steroid-free remission and mucosal healing, according to results of the ENVISION I study.

Adalimumab is a monoclonal TNF inhibitor long used to treat adults with UC. Earlier this year, the U.S. Food and Drug Administration (FDA) approved its use in children age 5 years and older with moderately to severely active UC.

The ENVISION I study was a phase-3, randomized, double-blind, multicenter study testing high-dose and standard-dose subcutaneously administered adalimumab in 93 children aged 4 to 17 years with moderate to severe UC, defined as a full Mayo score (FMS) of six to 12 with endoscopy subscore of 2 to 3 points, despite stable oral corticosteroid of immunosuppressant therapy.

Source: Reuters Health

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What’s best for diabetes after metformin? GRADE trial states

Liraglutide and insulin glargine outperformed glimepiride and sitagliptin as single add-on agents to metformin for treating patients with type 2 diabetes in a multicenter US trial that randomized just over 5000 patients.

The GRADE trial ran for roughly 5 years at 36 US centers and was designed to answer the question of which is the best second-line agent for patients with type 2 diabetes already taking metformin. Results were reported at the virtual American Diabetes Association (ADA) 81st Scientific Sessions.

The comparison included two oral medications — the sulfonylurea glimepiride and dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin — and two injectable medications — insulin glargine and glucagon-like peptide 1 (GLP-1) receptor agonist liraglutide.

The primary endpoint was change in A1c level and overall glycemic control. Secondary endpoints include changes in weight, as well as cardiovascular, renal, gastrointestinal, and other complications.

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Hepatitis C antivirals may fight SARS-CoV-2

Sofosbuvir/ledipasvir and nitazoxanide both appeared to clear SARS-CoV-2, the virus that causes COVID-19 in a preliminary trial, said Mohamed Medhat, lecturer in the department of gastroenterology and tropical medicine at Assiut University Hospitals in Assiut, Egypt.

SARS-CoV-2 shares similarities to the hepatitis C virus in the way it replicates, Medhat said. Molecular docking studies, which use computation to find ligands that bind to proteins, suggested that both sofosbuvir/ledipasvir and nitazoxanide might block key proteins in SARS-CoV-2.

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EC approves Cemiplimab for advanced or metastatic BCC after HHI therapy

The European Commission (EC) has approved cemiplimab (Libtayo) for the treatment of adults with locally advanced or metastatic basal cell carcinoma (BCC) who progressed on or could not tolerate treatment with a hedgehog pathway inhibitor (HHI).

The safety profile of cemiplimab has been generally consistent across approved indications. Serious adverse events have been reported in 30% of 816 patients from all four cemiplimab monotherapy pivotal trials, and these led to permanent discontinuation of treatment in 8% of patients.

Immune-related adverse reactions occurred in 22% of patients, and led to permanent discontinuation in 4%. The most common such reactions were hypothyroidism (8%), hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis (2%) and immune-related skin adverse reactions (2%).

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FDA approves first oral anticoagulant for children

The US Food and Drug Administration (FDA) has approved dabigatran etexilate (Pradaxa) oral pellets for the treatment of venous thromboembolism (VTE) in children aged 3 months to less than 12 years. The drug is to be administered immediately after patients have completed a 5-day course of an anticoagulant given by injection.

The most common side effects include digestive system symptoms and bleeding. Dabigatran etexilate can cause serious and fatal bleeding and is not recommended for patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome.

A boxed warning cautions that stopping treatment early may increase the risk for clots and that spinal or epidural hematomas in patients undergoing spinal procedures may cause serious side effects.

Dabigatran etexilate was originally approved in 2010 for adults with nonvalvular atrial fibrillation to reduce risk for stroke and systemic embolism.

Source: FDA

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FDA approves StrataGraft for deep skin burns

The US FDA has approved a novel regenerative therapy that could be an alternative to autografting for treating adults with severe burns. The new treatment, StrataGraft, is a bilayer tissue-engineered to mimic the epidermal and dermal layers of the human skin and act as a scaffold for a burn patient’s own skin cells to grow and heal.

The approval was based on the results of two randomized clinical trials (NCT01437852 and NCT03005106) that demonstrated the effectiveness and safety of StrataGraft in 101 adult patients with deep partial thickness thermal burns. These are burns caused by contact with an external heat source such as steam that results in damage throughout the epidermis and dermis.

Source: FDA

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‘COVID Toes’ Chilblain-like lesions not related to COVID-19

Chilblain-like lesions seen in adolescents during the COVID-19 pandemic are nonischemic and not related to systemic or localized SARS-CoV-2 infection, suggests a case series from Italy.

These lesions “most likely are benign” and resolve on their own after 2 to 6 weeks, Valentina Discepolo, MD, PhD. “They do not seem to be the manifestation of systemic inflammatory or autoimmune phenomena.

Source: Medscape

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Saliva test to detect HPV-associated throat cancer

A novel saliva test has been shown to detect HPV-associated oropharyngeal squamous cell carcinoma (OPSSC) with high accuracy in a small study. If the results are validated in subsequent studies, the test has the potential to be used as a screening tool in the general population, say the investigators.

In the small study, the NavDx (Naveris) detected tumor-tissue-modified virus DNA (TTMV) in 43 of 46 plasma samples and in 44 of 46 saliva samples. One plasma sample failed quality control measures, one of each sample type had undetectable TTMV, and one of each type was indeterminate.

Source: Medscape

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Noninvasive ventilation tied to higher mortality than CPAP in COVID-19 Pneumonia

Compared with continuous positive airway pressure (CPAP), the use of non-invasive ventilation (NIV) to treat acute respiratory failure secondary to COVID-19 pneumonia is tied to higher mortality, according to a new review.

The researchers examined data from 23 studies published between December 2019 and November 2020. These included 4,776 patients and contained data on in-hospital mortality in COVID-19 patients treated with NIV or CPAP.

Forty-six percent of the patients (2,192) received non-invasive respiratory support. Of these, 48.4% received CPAP, 46% had NIV, and 4% had either CPAP or NIV. This support failed in 47.7% of patients, of whom 582 (26.5%) were intubated. Among the reasons for intubation were decreased level of consciousness, refractory hypoxemia, sepsis, and hemodynamic instability.

Source: Reuters Health

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FDA approves Brincidofovir to treat smallpox

The US FDA has approved Chimerix’s brincidofovir (BCV, Tembexa) to treat smallpox. Fearful of a possible bioweapon attack, the United States has been steadily preparing a defense through the Biomedical Advanced Research and Development Authority. BCV is neither a new nor unknown drug. It is a lipid conjugate of cidofovir, a drug used to treat cytomegalovirus (CMV) in patients with AIDS.

Dose:

≥48 kg (tablet or oral suspension): 200 mg PO qWeek x 2 doses (on Days 1 and 8)
<48 kg (oral suspension): 4 mg/kg PO qWeek x 2 doses (on Days 1 and 8)

Adverse Effect: Diarrhea (8%), Nausea (5%), Vomiting (4%), Serum creatinine elevated (>1.5-3x ULN) (4%), Abdominal pain (3%), ALT elevated (>3 to 20x ULN) (2-3%), Total bilirubin elevated (>1.5 to 10x ULN) (1-3%), AST elevated (>3 to 20x ULN) (1-2%)

Tecovirimat was the first drug for smallpox, approved in 2018.

Source: FDA