ACR 2019: Lilly presents 52-week head-to-head (SPIRIT-H2H) data from TALTZ® (ixekizumab) versus Humira® (adalimumab) trial in psoriatic arthritis
TALTZ demonstrated sustained effect when compared to Humira through 52 weeks in patients with active psoriatic arthritis
TORONTO, ON – November 26, 2019 - Eli Lilly and Company announced the 52-week results from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study of TALTZ® (ixekizumab) versus Humira® (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). The results were presented as a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting in Atlanta, Georgia.
TALTZ met the primary and all major secondary endpoints of the study. TALTZ was superior to Humira at Week 24 as measured by the primary endpoint of simultaneous achievement of a reduction by at least 50% 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). At Week 52, 39% of patients treated with TALTZ had sustained simultaneous joint and skin improvement (ACR50 and PASI 100), compared with 26% of patients treated with Humira.
A total of 566 patients with active PsA were enrolled in the SPIRIT-H2H study and were randomized to receive TALTZ or Humira at the approved dose for PsA. PsA patients who also met the study criteria for moderate to severe plaque psoriasis received TALTZ or Humira at the approved dose for psoriasis. Of the enrolled patients, 87% of patients treated with TALTZ (N=246) and 84% of patients treated with Humira (N=237) participated in the study through 52 weeks.
“Results of the SPIRIT head-to-head trial showed consistent efficacy over time; 39% of patients on TALTZ had continued and concurrent joint and skin improvement at week 52, compared to 26% of patients on Humira,” says Dr. Louis Bessette, MD, MSc, FRCPC, Assistant Professor, Faculty of Medicine, Université Laval, and the SPIRIT-H2H study investigator. “This reliability is a crucial variable for physicians when determining treatment options for patients with active psoriatic arthritis.”
TALTZ performed at least as well as Humira at Week 52 in other secondary endpoints, including:
ACR50: 50% of patients treated with TALTZ and 50% of patients treated with Humira achieved ACR50 at Week 52;
ACR70: 35% of patients treated with TALTZ and 34% of patients treated with Humira achieved ACR70 at Week 52;
PASI 100: 64% of patients treated with TALTZ and 41% of patients treated with Humira achieved PASI 100 at Week 52 (statistically significant greater response in favour of ixekizumab)
“We're very pleased that TALTZ demonstrated superiority in the simultaneous achievement of ACR50 and PASI100 over Humira at 24 weeks, the primary endpoint," says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Lilly Canada. “The data results at 52-weeks confirms that TALTZ maintained consistent efficacy over the full, one year period. These results further build on our belief that patients with psoriatic arthritis could benefit from TALTZ as a meaningful and sustainable treatment option.”
The SPIRIT-H2H trial utilized on-label dosing for both TALTZ and Humira and allowed inclusion of concomitant conventional DMARDs. More patients achieved simultaneous ACR50 and PASI 100 response with TALTZ than Humira, regardless of concomitant methotrexate use.
In SPIRIT-H2H, the safety profile of TALTZ was consistent with previously reported results. The most common adverse reactions included infections (42.0% for TALTZ and 39.2% for Humira), injection site reactions (10.6% for TALTZ and 3.5% for Humira), allergic/hypersensitivity reactions (3.9% for TALTZ and 4.6% for Humira), cytopenias (3.2% for TALTZ and 4.2% for Humira) and cerebrocardiovascular events (1.8% for TALTZ and 2.5% for Humira). Most adverse reactions were mild to moderate in severity. Serious adverse events were reported in 4.2% for TALTZ and 12.4% for Humira. Discontinuations due to adverse events were reported in 4.2% for TALTZ and 7.4% for Humira.
Most recently, the twenty-four-week results from the SPIRIT-H2H study were presented at the European Congress of Rheumatology (EULAR) in June 2019 and published in Annals of the Rheumatic Diseases in September 2019:
SPIRIT-H2H 24 Weeks
Mease PJ, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded assessor trial. Ann Rheum Dis Epub ahead of print: 28 September 2019. doi:10.1136/annrheumdis-2019-215386.
Other major publications from the TALTZ PsA clinical development program include:
SPIRIT-P1 24 Weeks
Mease PJ, et al. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naïve patients with active psoriatic arthritis: results from the 24-week randomized, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis 2017;76:79-87.
SPIRIT-P2 24 Weeks
Nash P, et al. (2017). Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet 2017;389(10086): 2317-2327.
SPIRIT-P1 52 Weeks
Van der Heijde D, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol 2018;45(3): 367-377.
SPIRIT-P2 52 Weeks
Genovese MC, et al. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford) 2018; 57(11):2001-2011.
TALTZ (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. 1 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. TALTZ inhibits the release of pro-inflammatory cytokines and chemokines. 1
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, progressive form of inflammatory arthritis that can cause swelling, stiffness and pain in and around the joints and impaired physical function. 2 It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons. 2 PsA can affect peripheral joints in the arms and legs (elbows, wrists, hands and feet). 2 If left untreated, PsA can cause permanent joint damage. Up to 30% of people with psoriasis also develop PsA. 2
About the SPIRIT-H2H Study
SPIRIT-H2H study is a Phase 3b/4, multicenter, 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 at week 24. Patients with active PsA and plaque psoriasis with a body surface area involvement of at least three percent, who had inadequate response to at least one conventional DMARD, were enrolled in the study.
About Lilly in Rheumatology
Lilly in rheumatology aims to create a brighter future for people with debilitating rheumatologic diseases through innovative discoveries and patient-centered solutions.
About Eli 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.
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.
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1. TALTZ Product Monograph January 8, 2019.
2. Ritchlin C, et. al. Psoriatic Arthritis. New England Journal of Medicine. 2017;376:957-70.