TORONTO, June 05, 2020 (GLOBE NEWSWIRE) -- TALTZ® (ixekizumab) demonstrated consistent efficacy and long-term potential to help patients with psoriatic arthritis (PsA) in new data presented virtually today at the European Congress of Rheumatology 2020 (EULAR).

Eli Lilly and Company shared new results from a subgroup analysis of the Phase 3b/4, 52-week SPIRIT-Head-to-Head (SPIRIT-H2H) study of TALTZ versus HUMIRA (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA). SPIRIT-H2H was the first superiority study versus HUMIRA in PsA with a primary endpoint of simultaneous achievement of ACR50 (at least 50% improvement in disease activity as defined by the American College of Rheumatology) and PASI 100 (100% improvement in the Psoriasis Area and Severity Index, i.e. complete skin clearance) at Week 24. To date, TALTZ has reported positive results from five H2H superiority studies across PsA and PsO.

In this prespecified analysis, efficacy outcomes through Week 52 were compared between TALTZ and HUMIRA in subgroups of patients on monotherapy, concomitant methotrexate (MTX), or concomitant MTX along with an additional conventional synthetic disease-modifying antirheumatic drug (csDMARD), including sulfasalazine, leflunomide, or cyclosporine. Results at 52 weeks showed improvements were seen with TALTZ across multiple endpoints, with or without the use of MTX or other csDMARDs.

A higher proportion of patients treated with TALTZ achieved Minimal Disease Activity (MDA) compared to HUMIRA in the monotherapy subgroup (49% versus 33%), while response rates were similar between TALTZ and HUMIRA in the concomitant MTX subgroup (47% vs 47%) and concomitant csDMARD subgroup (47% vs 44%). MDA is an endpoint that includes fulfilling at least five of seven rheumatology outcome measures and is the treatment target according to multiple professional organizations.

More TALTZ patients achieved the endpoint of simultaneous achievement of ACR50 and PASI 100 at Week 52 in all three subgroups:

  • Monotherapy: TALTZ 38%, HUMIRA 19%
  • Concomitant MTX: TALTZ 39%, HUMIRA 30%
  • Concomitant csDMARDs: TALTZ 40%, HUMIRA 29%

A greater proportion of patients treated with TALTZ versus HUMIRA achieved PASI 100 when used as monotherapy (66% vs 35%), in combination with MTX (63% vs 44%), or in combination with csDMARDs (64% vs 44%) and the proportion of patients achieving ACR50 was comparable between TALTZ and HUMIRA, regardless of monotherapy (51% vs 42%), concomitant MTX (48% vs 56%), or concomitant csDMARD use (49% vs 53%).
 
“This analysis will offer key insights to physicians when they are determining appropriate treatment options for their biologic-naïve patients living with active PsA,” says Dr. Louis Bessette, MD, MSc, FRCPC, Associate Professor, Faculty of Medicine, Université Laval. “A higher proportion of patients treated with TALTZ achieved the endpoint of simultaneous achievement of ACR50 and PASI 100 at Week 52 in each of the three subgroups including, 66 percent of TALTZ patients on monotherapy achieving PASI 100, compared to 35 percent of patients on HUMIRA.”

The observed safety profile for TALTZ in the SPIRIT-H2H study was consistent with that reported for ixekizumab in patients with moderate- to severe plaque psoriasis (PsO) and PsA. 

Lilly also highlighted notable results from two additional studies. The SPIRIT-P2 study demonstrated sustained improvement in signs and symptoms of PsA, as measured by ACR responses, as well as manifestations of PsA, including enthesitis, dactylitis, and skin outcomes, for up to three years in patients with prior inadequate response or intolerance to one or two tumor necrosis factor inhibitors (TNFi). In the Phase 3 COAST-X study of patients with active non-radiographic axial spondyloarthritis (nr-axSpA), patients treated with TALTZ saw improvement in fatigue, spinal pain and stiffness at Week 16. In both studies, the safety profile of TALTZ was consistent with previously reported results and no unexpected safety signals were found.

“We are pleased to share this subgroup data from SPIRIT-H2H, which is the fifth positive head-to-head superiority study of TALTZ across PsA and PsO,” says Dr. Doron Sagman, Vice President, Medical Affairs, Lilly Canada. “These data, and the clinical outcomes they represent, reinforce TALTZ’s potential to help people with psoriatic disease.”

About TALTZ® 
TALTZ 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 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 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 the SPIRIT-P2 Study
SPIRIT-P2 is a Phase 3 multicenter, randomized, double-blind, placebo-controlled, 24-week study followed by long term evaluation of efficacy and safety of TALTZ in patients with prior inadequate response or intolerance to 1 or 2 tumor necrosis factor inhibitors (TNFi). The primary endpoint of the study was percentage of patients achieving ACR20 at Week 24. The 24-week study was followed by an extension period through three years.

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 percent of people with psoriasis also develop PsA.2

About the COAST-X Study
COAST-X is a multicenter, randomized, double-blind, placebo-controlled 52-week study evaluating the efficacy and safety of TALTZ for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Patients were required to have an established diagnosis of nr-axSpA and active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and total back pain ≥4 at screening and baseline, and were required to have objective signs of inflammation by presence of sacroiliitis on MRI or presence of elevated CRP.

About the TALTZ Program in axSpA
The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of TALTZ across various population subsets of patients with axSpA. The COAST program includes three registration studies each of one year duration: COAST-V in patients with ankylosing spondylitis (AS)/radiographic axSpA who are biologic-naive; COAST-W in patients with AS/radiographic axSpA who previously had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors; and COAST-X in biologic-naive nr-axSpA patients with objective signs of inflammation. Patients may enroll into a long-term extension study (COAST-Y) after completion of any of these registration studies to receive TALTZ treatment for up to an additional two years.

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 its 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 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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Media Contact:
Samira Rehman
Rehman_Samira@lilly.com
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REFERENCES
1 TALTZ Product Monograph, February 4, 2020.
2 Ritchlin C, et. al. Psoriatic Arthritis. New England Journal of Medicine. 2017;376:957-970.