Tildrakizumab Shows Significant Efficacy in Psoriatic Arthritis Phase 3 Trials
Phase 3 trials have demonstrated that tildrakizumab 100mg significantly improved ACR20 response rates in patients with active psoriatic arthritis at 24 weeks compared to placebo, marking a promising advancement in PsA treatment.
Treatment with tildrakizumab 100 mg (ILUMYA) resulted in greater improvements in PsA signs and symptoms at
Week 24 compared to treatment with placebo. Both the INSPIRE-1 and INSPIRE-2 studies achieved the primary
endpoint, with a higher proportion of patients in the INSPIRE-1 and INSPIRE-2 studies treated with tildrakizumab
achieving ACR20 responses at week 24, compared to those receiving placebo (p < 0.05).
“We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary
endpoints. These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients
with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and
administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data
in the near future,” said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty
Development at Sun Pharma.
Safety data in the studies was consistent with the well-documented safety profile of ILUMYA, which is approved for
the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or
phototherapy. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies.
Findings from the INSPIRE studies will be presented at upcoming medical conferences and published in a peerreviewed medical journal. Use of tildrakizumab 100 mg (ILUMYA) in psoriatic arthritis is not approved, and its
safety and efficacy have not been evaluated by regulatory authorities.
About the INSPIRE-1 and INSPIRE-2 Phase 3 studies
placebo-controlled Phase 3 studies aimed at assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA®)
in adult patients with active psoriatic arthritis. The INSPIRE-1 enrolled patients having prior exposure to an antiTNF agent while the INSPIRE-2 enrolled anti-TNF naïve patients. A total of over 800 adult patients were enrolled
for the two studies from clinical sites in the US, Europe and Asia. Patients were randomized to receive either
tildrakizumab 100 mg (ILUMYA®) or placebo.
participants were permitted to use concomitant methotrexate or leflunomide, provided the dose remained stable
throughout the trial. In the INSPIRE-1 and INSPIRE-2 studies, tildrakizumab 100 mg (ILUMYA®) was administered
at Week 0 and then every 12 weeks. In contrast, in Phase 3 studies for chronic plaque psoriasis, the treatment schedule
included doses in Week 0, Week 4, and then every 12 weeks thereafter. ILUMYA® is approved by the regulatory
Agencies for the indication of chronic plaques psoriasis.
The key secondary efficacy endpoints at 24 weeks include ACR50, ACR70, and PASI75 and improvement. Learn
more about the studies at clinicaltrials.gov (INSPIRE-1 NCT04314544 and INSPIRE-2 NCT04314531).
of swollen joints and a 20 percent improvement in three of the following five criteria: patient global assessment,
physician global assessment, functional ability measure (most often HAQ-DI), visual analog pain scale, and
erythrocyte sedimentation rate or C-reactive protein (CRP). ACR50 and ACR70 are the same measurement with
improvement levels of 50 percent and 70 percent, respectively.
About Psoriatic Arthritis (PsA)
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 [3]; 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.
About ILUMYA® (tildrakizumab-asmn)
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, in the United States and other countries.
