Results from the reSURFACE 1 phase 3 trial shows the biologic is beneficial to patient rates of anxiety, pain, and depression.
Tildrakizumab is associated with clinically significant and sustained improvements in overall health-related quality of life (HRQoL), according to a new assessment from the dataset of the phase 3 clinical reSURFACE 1 trial.
The analysis, presented at the American Academy of Dermatology (AAD) 2019 Annual Meeting in Washington, DC, further evidence the biologic’s benefit for patients with moderate to severe psoriasis.
Tildrakizumab, marketed as ILUMYA by Sun Pharmaceutical, was approved by the US Food and Drug Administration (FDA) as a subcutaneous therapy for patients with moderate to severe psoriasis in March 2018. The monoclonal antibody functions as an interleukin 23 (IL-23) inhibitor—limiting the cytokine’s ability in promoting patient inflammation.
In their assessment of reSURFACE clinical trial results, a global team of investigators sought to evaluate tildrakizumab’s impact on generic HRQoL measures in psoriasis patients as compared to other therapies. As such, their metrics for quality of life were selected for their emphasis of comparison.
“Although dermatology-specific instruments are the most sensitive, generic questionnaires, like the Short Form-36 (SF-36) and the European Quality of Life 5 Dimensions (EQ-5D), facilitate comparisons with other diseases,” the team wrote. “In prior studies using the SF-36, patients with psoriasis reported an impact on physical and mental health comparable to other major medical diseases like cancer, arthritis, hypertension, heart disease, diabetes, and depression.”
Investigators conducted exploratory analysis of the SF-36 and EQ-5D HRQoL scales in a patient population of 472 adults with moderate to severe chronic plaque psoriasis through a randomized, controlled, three-part, 64-week, parallel-group, double-blinded trial. They randomized 155 patients to receive placebo, 309 to tildrakizumab 100 mg, and 308 to tildrakizumab 200 mg. Mean patient HRQoL scores at baseline were similar across the treatment arms.
Weeks 0-12 were placebo controlled; placebo-treated patients were then rerandomized to either tildrakizumab treatment arm for weeks 12-28. For the last half of the trial (weeks 28-64), patients were again rerandomized to receive the same, a higher or lower tildrakizumab dose, or placebo—based on their Psoriasis Area Severity Index (PASI) response scores at week 28.
Therapy and placebo were administered at weeks 0, 4, 16, 28, 40, and 52. HRQoL was measured by SF-36 and EQ-5D questionnaire results at weeks 12, 28, 52, and 64. While the SF-36 test measures 8 different dimensions of patient quality of life, the EQ-5D provides a single index score value distinguished by 5 components of quality of life.
Investigators reported significant improvements in SF-36 at week 12 (following 2 doses) and week 28 (following 3 doses) for patients initially randomized to tildrakizumab 100 mg and 200 mg. In placebo patients, no changes were observed at week 12, but significant increases were observed in weeks 12-28 once patients switched to therapy. In part 3 of the trial, investigators observed sustained improvements to SF-36 scores up to week 64.
The EQ-5D index score—most notably, its components for pain/discomfort and anxiety/depression—improved significantly at weeks 12 and 28 in the treated patient groups as well. Investigators reported significant improvements in patients switched to therapy after week 28, with improvements sustained through week 64.
Investigators concluded the therapy was associated with improvements in HRQoL scales in patients with moderate to severe chronic plaque psoriasis—most notably for particular components of quality of life.
“Of the previously mentioned HRQoL scales, pain, anxiety, and depression were the quality of life domains that showed the greatest improvements,” they concluded.
The study, “Tildrakizumab Results in Significant and Sustained Improvements in Health-Related Quality of Life in Patients With Moderate to Severe Psoriasis in a Phase 3 trial (reSURFACE 1),” was presented at AAD 2019.