Page 35 - RP-MAY-2021

30 ETHICAL NEWS
BACK-PAIN BREAKTHROUGH WITH NOVEL ANTI-IL-17A ANTIBODY
Novartis Australia has announced the listing of Cosentyx (secukinumab) on the PBS for the treatment of adult patients (≥ 18 years) with active non-radiographic axial spondyloarthritis (nr-axSpA).
Eligible patients must have objective signs of inflammation – evidenced by elevated C-reactive protein and magnetic resonance imaging – and have had an inadequate response to, or are intolerant to, at least two NSAIDs, while completing an appropriate exercise program, for a period of three months.
Cosentyx is a fully human monoclonal antibody that recognises and binds to the IL-17A protein in the body,
a specific protein elevated in people with inflammatory conditions, such as axial spondyloarthritis (axSpA), psoriasis and psoriatic arthritis.
Increased IL-17 protein levels in the body cause inflammation, which can cause pain in the spine and pelvis in axSpA; itching, pain and scaling in psoriasis; and swollen and tender joints in psoriatic arthritis. Cosentyx works by neutralising the activity of the IL-17A protein, helping to reduce inflammation and the symptoms of these conditions.
“Until now, we’ve only had access to one class of biologic therapy, to treat patients with nr-axSpA,” said Stephen Hall, Adjunct Clinical Professor, Monash University. “While current advanced therapies have transformed the management of nr-axSpA, around 30-40 per cent of patients don’t achieve a good clinical response, either failing to respond or tolerate the treatment, only achieving a partial response or seeing the treatment lose efficacy over time.
“As a chronic, debilitating and lifelong condition, there is a significant unmet need for additional biologic treatments for nr-axSpA that can help to improve the signs and symptoms
of the disease and prevent joint damage.”
As part of the axSpA disease spectrum, which also includes
ankylosing spondylitis (AS, the radiographic form of axSpA); nr-axSpA is an autoimmune condition that causes arthritis
in the spine and sacroiliac joints and is associated with chronic inflammatory back pain. As it’s ‘non-radiographic’, inflammation of the spinal and sacroiliac joints is not visible with a traditional X-ray but may be identified through an MRI.
“Cosentyx is a fully human monoclonal antibody that recognises and binds to the IL-17A protein in the body.”
While the medical community has been treating AS for some time, increased use of MRIs has led to identification of the disease at an earlier stage, before structural damage of the spine and sacroiliac joints has occurred. It has now widely accepted nr-axSpA and AS are two consecutive stages of the same disease, with earlier diagnosis and management of nr-axSpA critical to limiting spinal damage and improving a patient’s long-term, health-related quality of life.
“As nr-axSPA typically manifests as general back
pain, it can often go undiagnosed for long periods of
time, leading to disease progression before effective management and treatment can be administered,” Mr Hall said. “Many nr- axSpA patients experience a delay in diagnosis of up to eight years, with 50 per cent expected to see their disease progress and develop into AS, causing significant inflammation, pain and structural damage of
the spine.”
XTANDI APPROVAL LIFTS HOPES FOR PROSTATE CANCER GROUP
Astellas Pharma has welcomed the TGA approval of
Xtandi (enzalutamide) as an oral once-daily therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in Australia.
The company says that in 2020, 16,741 men were diagnosed with prostate cancer, and as many as one third of patients with prostate cancer will develop metastases at some point over their disease course.
Prostate cancer is considered metastatic once the cancer has spread beyond the prostate. The disease is considered hormone-sensitive if it still responds to androgen deprivation therapy or surgical treatment to lower testosterone levels.
According to Astellas, men diagnosed with metastatic hormone-sensitive prostate cancer tend to have a poor prognosis, with a median survival of three to four years, underscoring the need for new treatment options.
“New treatment options are very welcome for this group of patients,” said Associate Professor Arun Azad, a medical oncologist from Peter MacCallum Cancer Centre, an investigator on the ARCHES clinical trial and a member of
Australian New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).
“For many decades we had limited treatment options
for men who have a cancer that has spread beyond the prostate but is still sensitive to hormone therapy. Androgen deprivation therapy was the mainstay, but the development of treatment resistance is inevitable and, in some cases, very quick. Now we’re seeing additional effective oral medications being approved for these patients and that really is excellent news.
“It’s especially pleasing to see that the approval was in part based on new research from the phase 3 ENZAMET clinical trial, sponsored by ANZUP and led by Professor Ian Davis and Professor Chris Sweeney. The ENZAMET and ARCHES trials both demonstrated the effectiveness of enzalutamide in men with metastatic hormone-sensitive prostate cancer and provide evidence of the benefit of adding enzalutamide to androgen deprivation therapy in these patients.”
Prostate Cancer Foundation of Australia CEO Professor Jeff Dunn welcomed the TGA’s approval.
RETAIL PHARMACY • MAY 2021