Rick Ascroft, North America CEO, Sun Pharma, said, “FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis.”
“As an IL-23 inhibitor administered exclusively by a healthcare provider, ILUMYA is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care,” he added.
Approximately 2.4 million Americans live with psoriatic arthritis, which can cause joint pain, swelling and stiffness that may lead to permanent joint damage. The approval expands the use of LUMYA, an IL-23 inhibitor approved by the FDA in 2018 for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
“Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualize care based on each patient’s symptoms and treatment goals. Adding an IL-23 inhibitor option that is administered by a healthcare provider gives us a new way to offer appropriate patients additional support and engagement with their healthcare team,” said Philip Mease, Director of Rheumatology Research at the Swedish Medical Center and Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine, Seattle, WA.
The approval is supported by Phase 3 INSPIRE-1 and INSPIRE-2 clinical studies, which evaluated the efficacy and safety of ILUMYA after only two doses at 24 weeks in adult patients with active psoriatic arthritis.
Safety data in the studies was consistent with the well-documented safety profile of ILUMYA. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies. ILUMYA may increase the risk of infection. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment. Most common adverse reactions are: Plaque Psoriasis (<1%): upper respiratory infections, injection site reactions, and diarrhea. Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19.
About the INSPIRE-1 and INSPIRE-2 Phase 3 Studies
INSPIRE-1 and INSPIRE-2 are 52-week, global, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis.
Learn more about the studies at clinicaltrials.gov (INSPIRE-1 NCT04314544 and INSPIRE-2 NCT04314531).
About Psoriatic Arthritis (PsA)
Psoriatic arthritis (PsA) is a chronic (long-lasting or recurring) disease related to the immune system.
It causes swelling, pain, and stiffness in joints and entheses (places where tendons and ligaments connect to bones). ‘ Psoriatic arthritis can develop at any age. Psoriatic arthritis can occur regardless of the severity of psoriasis (mild, moderate, or severe). Roughly 1 in 3 people living with psoriasis also have psoriatic arthritis?; typically, with psoriasis developing before psoriatic arthritis.? While as many as 2.4 million Americans live with psoriatic arthritis, more than 15% of people living with psoriasis may also have undiagnosed psoriatic arthritis. 4
About ILUMYA® (tildrakizumab-asmn)
ILUMYA (tildrakizumab-asmn) is a humanized IgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for the treatment of adults with active psoriatic arthritis, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in India, Australia, Canada, China and Japan, and under the brand name ILUMETRI® in Europe, where it is marketed by Almirall.
ILUMYA is the 1st biologic to earn the National Psoriasis Foundation (NPF) Seal of Recognition. The NPF Seal recognizes products that meet the Foundation’s established review criteria and reflects Sun’s continued commitment to supporting people living with psoriatic disease.
INDICATION
ILUMYA® is indicated for the treatment of:
- moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- active psoriatic arthritis in adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ILUMYA is contraindicated in patients with a history of serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ILUMYA. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor the patient closely and consider discontinuation of ILUMYA until the infection resolves.
Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Monitor patients for signs and symptoms of active TB during and after ILUMYA treatment. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with ILUMYA.
ADVERSE REACTIONS
Most common adverse reactions associated with ILUMYA treatment are:
Plaque Psoriasis (≥1%): upper respiratory infections, injection site reactions, and sordic Artis 39% uper respiradory taintecting and Covin 19.
USE IN SPECIFIC POPULATIONS
Pregnancy
Advise patients that there is a pregnancy exposure registry that monitors outcomes in women exposed to LUMYA during pregnancy.
