The approval of Taltz is based on the Phase 3 clinical trials that demonstrated efficacy on both joints and skin symptomsi
TORONTO, June 20, 2018 /CNW/ - Eli Lilly Canada Inc. announced that Health Canada has approved Taltz® (ixekizumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to one or more disease-modifying antirheumatic drugs (DMARD). It can be used alone or in combination with a conventional DMARD, such as methotrexate.i Taltz was granted a Notice of Compliance on March 29, 2018 based on results from the pivotal SPIRIT-P1 and SPIRIT-P2 clinical trials.i Taltz was first approved in Canada in 2016 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.i
PsA is a form of chronic, immune-mediated inflammatory arthritis which affects people with psoriasis. It is characterized by pain, swelling and stiffness in and around the joints, as well as impaired physical function.ii Patients also typically show evidence of psoriasis, which appears as raised, red patches of skin covered with a silvery white build-up of dead skin cells that are often painful or itchy.iii It is estimated that up to one million Canadians are affected by psoriasis, and up to 30 per cent of people with psoriasis will develop psoriatic arthritis.iv,v While there is no cure for PsA, early diagnosis and treatment can improve a patient's quality of life and help them avoid severe joint damage.vi
Comorbidities linked to PsA: Dr. Dafna Gladman, rheumatologist and a senior author of the SPIRIT-P1 primary publication, Toronto, ON: "It is important to remember that psoriatic arthritis does not only affect the skin and joints. Patients with psoriatic arthritis are at increased risk of developing comorbidities including diabetes, heart disease, depression, obesity and metabolic syndrome. As the development of these comorbidities is related to the inflammatory process, it is important to treat the skin and joint manifestations early and adequately, so that not only do patients feel better and have less joint damage, but also are less likely to develop comorbidities."
Treatment in clinical practice: Dr. Kim Papp, dermatologist and principal investigator (Taltz), Waterloo, ON: "The SPIRIT-P1 clinical trial found that at 12 weeks, three-quarters of patients who received Taltz experienced improvement of at least 75 per cent in the Psoriasis Area Severity Index, or PASI, which measures the extent and severity of psoriasis — and almost a third achieved a score of 100, a complete resolution of their disease. This skin clearance is similar to what I have seen in my own clinical practice."
PsA everyday moments: Kathryn Andrews-Clay, Executive Director, Canadian Association of Psoriasis Patients: "People living with psoriatic arthritis often miss out on everyday moments with their loved ones due to joint pain or to the disfiguring red plaques on their skin. The availability of Taltz is great news because it provides a new choice for Canadians living with this disease."
Supporting advancement in research: Gerald Major, President, Canadian Spondylitis Association: "Advancements in research for psoriatic arthritis are incredibly important as it can be a debilitating disease for people, like myself, who live with it. We are excited to hear Taltz is now approved for the treatment of this disease."
Access to more options: Linda Wilhelm, President of the Canadian Arthritis Patient Alliance: "People who live with psoriatic arthritis will have access to another needed treatment option. Access to more options provides more possibilities for these individuals to live their lives how they wish with a chronic disease."
Development of innovative treatments: Dr. Doron Sagman, Vice President, Research & Development at Lilly Canada: "The approval of Taltz is an important milestone for patients and their doctors as they seek treatments to address the challenges of this chronic illness. Lilly is committed to the development of innovative treatments in immunology because every patient responds to therapies differently. New options are needed to help patients improve and manage their life-long condition."
Taltz® is an interleukin (IL) 17A inhibitor containing the active substance ixekizumab. This monoclonal antibody (protein) recognizes and binds specifically to certain proteins.vii IL-17A is a protein that is found to be present in high levels in inflammatory diseases such as plaque psoriasis and psoriatic arthritis.vii Taltz neutralizes IL-17A, thus reducing the signs and symptoms of psoriatic arthritis and plaque psoriasis, such as itching, pain, and scaling.vii The full Canadian Product Monograph for Taltz (ixekizumab) is available here. The approval of Taltz for PsA is based on data from the double blind, multi-centre, randomized, placebo-controlled SPIRIT-P1 and SPIRIT-P2 clinical trials, which assessed the safety and efficacy of Taltz compared to placebo in 780 adults with active PsA.vii
SPIRIT-P1 evaluated the safety and efficacy of ixekizumab compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug.
SPIRIT-P2 evaluated the safety and efficacy of ixekizumab compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors or were intolerant to a TNF inhibitor.
In both studies, the primary efficacy endpoint was the proportion of patients who, at 24 weeks, had achieved ACR20 response, which represents at least a 20 per cent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR).
Results from both studies demonstrated that more than half of patients treated with Taltz reached ACR20 by Week 24 and showed significant improvement in joint symptoms, compared to placebo:
SPIRIT-P1: 58 per cent of patients treated with Taltz reached ACR20 compared to 30 per cent on placebo.
SPIRIT-P2: 53 per cent of patients treated with Taltz reached ACR20 compared to 20 per cent on placebo.
Additionally, both studies evaluated improvement in psoriasis plaques at 12 weeks, as measured by improvement in the Psoriasis Area Severity Index (PASI) of at least a 75 per cent. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaling of skin lesions, weighted by the body surface area of involved skin.
The following proportion of patients achieved PASI 75 responses:
SPIRIT-P1: 75.3 per cent of patients treated with Taltz compared to placebo (7.5 per cent). In SPIRIT-P1, patients experienced improvement in itch severity, when compared to placebo at Week 12.
SPIRIT-2: 57.4 per cent of patients treated with Taltz compared to placebo (10.4 per cent).vii
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, progressive form of inflammatory arthritis that can cause pain, swelling and stiffness in and around the joints, as well as impaired physical function.viii It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons.viii PsA can also cause inflammation with swelling and pain in areas where tendons and ligaments attach to bones, known as enthesitis, or with swelling of an entire finger or toe, which is usually painful and associated with reduced mobility, known as dactylitis.ix In some patients, the inflammation may involve joints of the spine and the sacroiliac joints that link the spine to the pelvis, and may cause back pain and stiffness.ix If left untreated, PsA can cause permanent joint damage.ix
About Eli Lilly Canada Inc.
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
i Taltz® Canadian Product Monograph, March 29, 2018.
ii Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis. N Engl J Med. 2017;376(10):957-970.