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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
Elaine Soliven, 27 Sep 2017
A second dose of kisspeptin-54 improves oocyte yield in women at high risk of ovarian hyperstimulation syndrome (OHSS) during in vitro fertilization (IVF) treatment, according to a recent study.
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Rachel Soon, Yesterday

Pharmacists can and should utilize their positions within communities to provide access to an extended range of healthcare services, says an expert.

01 Aug 2017
New drug applications approved by US FDA as of 1 - 15 June 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.