Lilly presents positive results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a head-to-head (SPIRIT-H2H) superiority study in patients with active psoriatic arthritis at the European Congress of Rheumatology
TORONTO, ON – June 14, 2019 - Eli Lilly and Company announced today that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study in patients with active psoriatic arthritis (PsA) as a late-breaking abstract at the European Congress of Rheumatology (EULAR) in Madrid, Spain on June 15.
The open label, assessor-blinded, randomized, controlled trial is the first and only H2H study that utilizes on-label dosing for both Taltz® (ixekizumab) and Humira® (adalimumab) and allows inclusion of concomitant conventional DMARDs. Topline results from the study, which demonstrated Taltz met the primary and all major secondary endpoints, were announced in December 2018.
“SPIRIT–H2H provides physicians with important new data that can inform treatment decisions for patients who are searching for options that can have a positive impact in the management of their disease,” says Dr. Louis Bessette, MD, MSc, FRCPC, Assistant Professor, Faculty of Medicine, Université Laval. “Patients in the SPIRIT-H2H trial who were treated with Taltz experienced improvements in the signs and symptoms of their psoriatic arthritis, demonstrating Taltz as an important option for this patient population.”
The primary endpoint of the study was superiority for Taltz compared to Humira in the proportion of patients who simultaneously achieved a reduction by at least 50 per cent in disease activity as defined by the American College of Rheumatology (ACR50) and complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI 100). Key secondary endpoints included non-inferiority in the proportion of patients who achieved ACR50 and superiority in the proportion of patients who achieved PASI 100.
“Canadians with active psoriatic arthritis have two main goals with treatment, to alleviate the debilitating joint symptoms while providing skin clearance and this is exactly what the SPIRIT-H2H study demonstrated,” says Doron Sagman, Vice President, Medical Affairs, Lilly Canada. “We are pleased with the study results that show Taltz was more effective than Humira in the simultaneous improvement of joint and skin symptoms after 24 weeks of treatment.”
A total of 566 patients with active PsA were enrolled in the SPIRIT-H2H study. Patients were randomized to receive Taltz (n=234) or Humira (n=231) at the approved dose for PsA for a total of 52 weeks, with the primary analysis conducted at 24 weeks. PsA patients who also met the study criteria for moderate- to severe plaque psoriasis received Taltz (n=49) or Humira (n=52) at the approved dose for psoriasis.
At 24 weeks, the proportion of patients achieving both a reduction by at least 50 per cent in disease activity as defined by ACR50 as well as complete skin clearance as measured by PASI 100, was significantly higher for Taltz (36 per cent) than for Humira (28 per cent) (P<0.05).
Taltz also met the key secondary endpoints, including non-inferiority compared to Humira for the percentage of patients achieving ACR50 (51% vs. 47%) (95% CI [-4.3%, 12.1%]) (for non-inferiority with -12.0% margin) and superiority compared to Humira for the percentage of patients achieving PASI 100 (60% vs. 47%) (P=0.001).
In SPIRIT-H2H, the safety profile of Taltz was consistent with previously reported results. The most common adverse reactions were mild to moderate in severity, and included infections (36.0% for Taltz vs. 30.7% for Humira), injection site reactions (9.5% for Taltz vs. 3.2% for Humira), allergic/hypersensitivity reactions (2.5% for Taltz vs. 3.9% for Humira) and cerebrocardiovascular events (1.1% for Taltz vs. 1.8% for Humira). No new safety signals were detected.
About the SPIRIT-H2H Study
SPIRIT H2H study is a Phase 3b/4, multicentre, randomized, open-label, parallel-group study with blinded outcomes assessments evaluating the efficacy and safety of Taltz versus Humira in patients with PsA who are biologic DMARD-naive during a 52-week treatment period. The primary endpoint of the study was the simultaneous achievement of ACR50 and PASI 100 response at Week 24. This primary endpoint is an innovative approach that comprehensively measures clinically meaningful improvements across multiple domains of PsA. The major secondary endpoints were the demonstration of non-inferiority in ACR50 and superiority in PASI 100 in Taltz compared to Humira. Patients with active PsA and plaque psoriasis with a body surface area involvement of at least three per cent, who had inadequate response to at least one conventional DMARD, were enrolled in the study.
Taltz® is an interleukin (IL) 17A inhibitor containing the active substance ixekizumab. This monoclonal antibody (protein) recognizes and binds specifically to certain proteins. i IL-17A is a protein that is found to be present in high levels in inflammatory diseases such as plaque psoriasis and psoriatic arthritis. i Taltz neutralizes IL-17A, thus reducing the signs and symptoms of psoriatic arthritis and plaque psoriasis, such as itching, pain, and scaling. i 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. i
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 tumour 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-P2: 57.4 per cent of patients treated with Taltz compared to placebo (10.4 per cent).
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. ii It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons. iii 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. iv 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. v If left untreated, PsA can cause permanent joint damage. vi
About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking, novel science to immunology and is driven to change what's possible for people living with autoimmune diseases. There are still significant unmet needs, as well as personal and societal costs, for people living with a variety of autoimmune diseases and our goal is to minimize the burden of disease. Lilly is investing in leading-edge clinical approaches across our immunology portfolio in hopes of transforming the autoimmune disease treatment experience. We've built a deep pipeline and are focused on advancing cutting edge science to find new treatments that offer meaningful improvements to support the people and the communities we serve.
About Lilly Canada
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.
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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.
iii. Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis. N Engl J Med. 2017;376(10):957-970.
iv. Gladman DD. Clinical Features and Diagnostic Considerations in Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):569-79.
v. Gladman DD. Clinical Features and Diagnostic Considerations in Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):569-79.
vi. Gladman DD. Clinical Features and Diagnostic Considerations in Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):569-79.