Author Archives: Andrea Lobo

In early trial, AVT05 shows similar pharmacological profile to Simponi

AVT05, Alvotech’s biosimilar candidate to treat ankylosing spondylitis (AS) and other chronic inflammatory diseases, showed a similar pharmacological profile to the reference medication Simponi (golimumab) in a clinical trial. The Phase 1 trial (NCT05632211) compared the safety, tolerability, and pharmacokinetics — movement into, through, and out…

Bimekizumab shows benefits in treating axSpA at 1 year in trials

A year of treatment with bimekizumab was safe and significantly eased symptoms of axial spondyloarthritis (axSpA) in participants from two Phase 3 clinical trials, data show. “Results at [one year] from the BE MOBILE trials suggest that [bimekizumab] is an effective treatment option resulting in sustained efficacy across…

Cimzia clinical response, disease activity tied to productivity gains

Long-term use of Cimzia (certolizumab pegol) is associated with a higher clinical response to treatment and lower disease activity in people with axial spondyloarthritis (axSpA). This translated to increased productivity for patients, both at work and in household activities. “This highlights the importance of targeting these thresholds to limit…

Bone disease blood test may help predict AS radiographic progression

A blood test for bone disease that measures the levels of an enzyme called alkaline phosphatase (ALP) may predict disease progression of ankylosing spondylitis five years before abnormalities can be observed on radiographic exams, according to a new study. “This is not only useful for finding bone-specific biomarkers that…

FDA approves Yuflyma, a Humira biosimilar

The U.S. Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high concentration biosimilar of Humira (adalimumab), for the treatment of ankylosing spondylitis. Other approved indications for Yuflyma are rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. According…

Potential blood biomarkers for AS identified in study

Proteins associated with inflammation and immune system function were identified as potential blood biomarkers for the diagnosis and monitoring of ankylosing spondylitis (AS). “Better biomarkers would address a significant unmet need both in clinic, where earlier diagnosis and referral might be improved, as well as in bettering our understanding…

AVT02, an Humira Biosimilar, Approved in Australia to Treat AS

AVT02, a high-concentration and low-volume biosimilar to AbbVie’s Humira (adalimumab), was approved by health regulators in Australia to treat inflammatory disorders such as ankylosing spondylitis (AS). A biosimilar is a biological medicine with a high degree of similarity — in terms of quality, safety, and efficacy —…

Early Anti-TNF Therapy May Raise Risk of Cardiovascular Disease in AS

Early initiation of anti-tumor necrosis factor (TNF) medications may be associated with an increased risk of cardiovascular events in people with ankylosing spondylitis (AS), a study suggests. “We designed the study with the overall hypothesis that the use of TNF inhibitors, which reduce inflammation and thus cardiovascular risk,…