Article Archives - Page 10 of 21

Lenvatinib-Pembrolizumab combo promising in advanced kidney cancer

The combination of the multikinase inhibitor lenvatinib and the anti-PD-1 antibody pembrolizumab has “encouraging” antitumor activity and a manageable side effect profile and might be an option following immune-checkpoint inhibitor (ICI) therapy in patients with metastatic renal-cell carcinoma (RCC), researchers report.

Pembrolizumab and lenvatinib are active as monotherapies in RCC. The phase-1b/2 Study 111/KEYNOTE-146 trialists tested the combination in 145 patients with metastatic RCC. Two patients with non-clear-cell RCC were excluded from the efficacy analysis but included in the safety analysis.

Source: Reuters Health

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Study shows tocilizumab and sarilumab reduce COVID-19 deaths

Treating critically ill COVID-19 patients with arthritis drugs tocilizumab and sarilumab significantly improves survival rates and reduces the amount of time patients need intensive care.

The immunosuppressive drugs, Actemra, also known as tocilizumab, and Kevzara, also known as sarilumab, reduced death rates by 8.5 percentage points among patients hospitalised and severely ill with the pandemic disease.

Among hospitalised Covid patients, administering one of the drugs in addition to corticosteroids reduced the risk of death by 17 percent, compared to the use of corticosteroids alone.

In patients who were not on ventilators, the risk of progressing to mechanical ventilation or death was reduced by 21 percent, compared to the use of corticosteroids alone.

Severely ill COVID patients experience an immune system overreaction known as a “cytokine storm” that can cause severe organ damage and death.

Tocilizumab and sarilumab are used to treat rheumatoid arthritis, an autoimmune condition, by inhibiting the effects of interleukin (IL)-6, a type of protein called a cytokine that signals the body to mount an inflammatory response.

But previous research on whether IL-6 inhibitors can be useful against severe COVID have variously reported benefit, no effect, and harm.

This prompted the WHO to coordinate the new study that combined data from 27 randomized trials conducted across 28 countries.

Source: Journal of the American Medical Association

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Insulin-Pramlintide combo improves type 1 diabetes control

A novel investigational coformulation of prandial insulin and pramlintide improves blood glucose control and reduces body weight in people with type 1 diabetes, early research suggests.

The injectable product combines a novel human prandial (pre-meal) insulin (A21G) with the amylin analog pramlintide. The latter reduces post-meal glucose spikes by slowing gastric emptying, reducing postprandial glucagon production, and increasing satiety.

Source: Medscape

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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