What’s Happening In Research?
Aurinia’s Voclosporin receives a priority new drug application review from the US Food and Drug Administration (FDA) for the treatment of Lupus Nephritis (LN)
Voclosporin is an immunosuppressant that blocks the IL-2 expression and T- cell-mediated immune responses in Lupus Nephritis. Voclosporin results in stabilizing the podocytes and reducing proteinuria. Clinical data from Phase II AURA-LV and Phase III AURORA have demonstrated significant improvements in renal function in LN patients, especially in Hispanic/Latino ethnicity patients.
AstraZeneca’s Anifrolumab demonstrated early and sustained reduction of disease activity in SLE patients in the Phase III Tulip clinical trial
The Phase III Tulip trial on Anifrolumab (a monoclonal antibody that blocks type 1 interferons) evaluated the efficacy and safety of anifrolumab in autoantibody-positive SLE who are receiving standard of care. Besides meeting the primary endpoint, the Tulip 2 trial provides encouraging results for the efficacy of Anifrolumab in moderately to severe SLE.
GSK’s Belinumab shows significant improvement in renal function in the largest Lupus Nephritis (LN) clinical study
In the most extensive study to date, GSK’s Belinumab (alongside Standard therapy) vs. placebo showed a significant improvement in LN renal response, such as renal filtration and urine protein creatinine. Moreover, Belinumab also demonstrated a favorable safety profile. The results were presented at the 2020 EULAR e-congress.
Promising clinical data from the clinical investigations of Eli Lilly’s Olumiant were highlighted at the 2020 EULAR e-congress
Olumiant (Baricitinib) is a JAK kinase inhibitor that is being investigated in SLE patients. It results from a Phase II clinical trial JAHH study, was presented at the 2020 EULAR e-congress. In the Phase II clinical trial, a 4mg dose of Baricitinib showed an improvement in SLE patients who weren’t responding to the standard care.
Canadian Rheumatology Association Improves Outcomes In SLE
This working group includes 23 adult and 4 pediatric rheumatologists, 1 immunologist, 4 general internal medicine and rheumatology trainees, and 1 representative from the Canadian Arthritis Patient Alliance. These recommendations are meant to help lupus healthcare providers in the evaluation of their patients, and help identify how and what to assess over time. These are the first lupus recommendations internationally to use a method called GRADE (Grading of Recommendations, Assessment, Development and Evaluation). This method carefully looks at the evidence behind each recommendation, and considers how it benefits or harms the patient, what resources would be required and if it is something that can be delivered equally to patients across the country. The working group looks forward to considering future recommendations in lupus treatments as a next step.
These recommendations confirm things that we already knew – that patients need to ensure their lupus healthcare provider is performing a thorough assessment per visit. In some cases, patients might notice over time that the practitioner is using a score to quantify this, which they can compare over time. The recommendations also help remind everyone how important heart health and the annual flu shot is. The recommendations do suggest that cervical cancer screening (aka PAP smears) should be done more frequently (eg. annually) rather than every 3 years as is stated in the Canadian guidelines for the general population. Pregnancy is definitely highlighted in these recommendations, with a strong recommendation to ensure a special set of antibodies called anti-Ro and anti-La have been done to evaluate the risk for a rare but important problem called neonatal lupus, where babies can have a serious problem known as congenital heart block. Close monitoring of women during the pregnancy period with coordinated care between physicians including obstetricians, maternal-fetal-medicine and other specialists and the lupus healthcare provider are encouraged.
Health Canada Approves First New Treatment For Lupus In Almost 50 Years
Health Canada’s recent approval of BENLYSTA™ marks the first new treatment available in almost 50 years to the over 1:1000 Canadian men, women and children who are living with Systemic Lupus Erythematosus (SLE) an autoimmune disease with no known cause or cure. Lupus most often affects women of child-bearing age (15-45) but can affect men, children and the elderly. Nine times more women than men will however be diagnosed with lupus.
“Lupus is a life-altering and life-threatening diagnosis” says Catherine Madden, Executive Director of Lupus Canada. “This incurable disease impacts and destroys many organs in the body and can cause constant pain, immobility, organ failure and even death. Lupus is seriously under-recognized and under-funded, but dedication to new therapies and new research fuels our hope for a cure. While Lupus Canada works towards a vision of life without lupus, we concentrate our efforts on ensuring people with lupus are living well. The approval of BENLYSTA™ means there is a new treatment option for Canadians living with lupus.”
Known as the “disease with 1000 faces”, because its symptoms vary so greatly from person to person, lupus affects over 1:1000 Canadian men, women and children, yet many people are still unaware of the disease. Because of the varied symptoms, lupus can be extremely difficult to diagnose. The symptoms of lupus often mimic other illnesses, and it can attack any tissue or organ in the body including skin, muscles, joints, blood and blood vessels, lungs, heart, kidneys and the brain. Common and often chronic symptoms of lupus include joint pain and inflammation, skin rashes, sun sensitivity, extreme fatigue, fever, chest pain and hair loss.
“As a child, I understood only that my father suffered from lupus – he couldn’t play ball, ride a bike or walk to the store… many days he was in too much pain to be able to get out of bed” says Kendra MacDonald, President, Board of Directors, Lupus Canada. “It was not only my father that suffered from lupus for over 20 years, our entire family was touched by the disease and the constant fear that the next complication would take his life which it ultimately did in 2001. The arrival of a new treatment helps to bring hope for other families like ours!”
Lupus Canada, working together with its provincial partners, is a national voluntary organization dedicated to improving the lives of people living with lupus through advocacy, education, public awareness, support and research. We provide educational and support resources for people whose lives are touched by lupus, raise awareness of Lupus and provide funding for research. Through the support of events such as Walk for Lupus and generous, engaged individual and corporate donors, we are able to continue our work on behalf of people living with lupus.
To learn more about lupus, Lupus Canada, our member organizations and divisions, visit our website or contact us at 1-800-661-1468. To learn more about BENLYSTA™, contact your doctor.