Most Read Articles
05 Aug 2017
Discontinuation of antihypertensive drugs appears to have a detrimental effect, with a recent study reporting that the risk of acute myocardial infarction (AMI) substantially increases after more than 90 days of discontinuation.
Roshini Claire Anthony, 15 hours ago

Once-weekly doses of the glucagon-like peptide-1 receptor agonist exenatide plus insulin glargine improved glucose control and weight loss in patients whose type 2 diabetes (T2D) was uncontrolled on basal insulin and metformin, according to findings from the DURATION-7* trial.

03 Aug 2017
Cetuximab and docetaxel is safe and effective during postoperative radiotherapy for high-risk head and neck cancer patients who cannot receive cisplatin, a new study has found.
08 Sep 2017
Prediagnostic statin exposure appears to be associated with a significant reduction in breast cancer-specific mortality, with the survival benefit being more pronounced in women with oestrogen receptor (ER)-positive tumours, according to a study.

Dekavil shows initial signs of safety and efficacy in rheumatoid arthritis

Jackey Suen
23 Jun 2017

The fully-human immunocytokine dekavil (also known as F8-IL10) has demonstrated signs of safety and efficacy in patients with active rheumatoid arthritis (RA) in a phase I study presented at the European League Against Rheumatism (EULAR) Annual Congress 2017.

 “A total of 35 patients were enrolled in the study. They had a median age of 63 years, median disease duration of 17.5 years, and median Disease Activity Score in 28 joints [DAS 28 score] of 5.75,” said co-investigator Professor Mauro Galeazzi of the University Hospital Siena, Italy. “All patients had received prior treatment with methotrexate and at least one anti-tumour necrosis factor [anti-TNF] therapy. Most of them had also received steroids previously.” [EULAR 2017, abstract OP0099]

In this phase Ib dose escalation study, patients with active RA received four weekly subcutaneous injections of dekavil 6–600 µg/kg plus methotrexate. They were given an option to receive an additional 4 weeks of treatment. [https://clinicaltrials.gov/ct2/show/NCT02076659]

“Overall, dekavil was well tolerated up to the highest investigated dose of 600 µg/kg,” reported Galeazzi. “Mild injection site reactions occurred in 60 percent of the patients. Two patients had treatment-related anaemia [grade 2 and grade 3, respectively]. One patient experienced dose-limiting grade 2 purpura.”

“At the first efficacy assessment after 4 weeks of treatment, 60 percent of the patients demonstrated responses according to the American College of Rheumatology [ACR] criteria and/or EULAR criteria. The response rate improved to 62.5 percent after 8 weeks of treatment,” he continued. “Notably, two patients achieved 70 percent improvement according to the ACR criteria [ACR70], and the responses were maintained for more than 1 year after the end of treatment. These patients received dekavil 30 µg/kg and 60 µg/kg, respectively, during the study period.”

In view of the good tolerability and promising signs of efficacy of dekavil as shown in the current study, the investigators have initiated a randomized, double-blind, multicentre, placebo-controlled phase II study to further evaluate the safety and efficacy of dekavil 30 µg/kg and 160 µg/kg in combination with methotrexate in patients with active RA. [https://clinicaltrials.gov/ct2/show/NCT02270632]

“Chronic inflammatory and autoimmune conditions such as RA can cause severe pain and affect patient’s quality of life. However, currently available medical treatments for the disease help only a subset of patients,” noted Geleazzi. “Immunocytokines are antibody–cytokine fusion proteins that allow for selective induction of immunologic tolerance at the site of inflammation while sparing healthy tissue. They represent a novel class of drugs for the treatment of chronic inflammation and autoimmune conditions.” [Drug Discov Today 2016;21:180-189]

Dekavil is a fully-human immunocytokine comprising F8 antibody, which brings the fusion protein to synovial tissue by binding selectively to oncofaetal fibronectin, and interleukin-10, which exhibits immunosuppressive effects. The drug was previously shown to stabilize RA in a mouse model. [Arthritis Res Ther 2009;11:R142]

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Most Read Articles
05 Aug 2017
Discontinuation of antihypertensive drugs appears to have a detrimental effect, with a recent study reporting that the risk of acute myocardial infarction (AMI) substantially increases after more than 90 days of discontinuation.
Roshini Claire Anthony, 15 hours ago

Once-weekly doses of the glucagon-like peptide-1 receptor agonist exenatide plus insulin glargine improved glucose control and weight loss in patients whose type 2 diabetes (T2D) was uncontrolled on basal insulin and metformin, according to findings from the DURATION-7* trial.

03 Aug 2017
Cetuximab and docetaxel is safe and effective during postoperative radiotherapy for high-risk head and neck cancer patients who cannot receive cisplatin, a new study has found.
08 Sep 2017
Prediagnostic statin exposure appears to be associated with a significant reduction in breast cancer-specific mortality, with the survival benefit being more pronounced in women with oestrogen receptor (ER)-positive tumours, according to a study.