Secukinumab Demonstrates Efficacy in Chinese Psoriasis Patients

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Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis

Psoriasis, a chronic inflammatory skin disease characterized by red, scaly plaques, affects approximately 0.6% of the Chinese population—around 8.4 million people. While mild cases can be managed with topical creams or traditional Chinese medicine (TCM), over half of Chinese psoriasis patients have moderate to severe disease that doesn’t respond well to standard treatments. This not only causes physical discomfort (e.g., itching, pain) but also takes a toll on mental health and quality of life: psoriasis is linked to conditions like psoriatic arthritis, heart disease, and depression, and many patients report feeling isolated or self-conscious about their skin.

In recent years, researchers have identified the IL-23/IL-17 pathway as a key driver of psoriasis inflammation. IL-17A, a cytokine (immune system protein), fuels the overgrowth of skin cells and inflammation that define psoriasis. Secukinumab, a fully human monoclonal antibody, blocks IL-17A directly—targeting the root cause of the disease. While secukinumab has shown promise in Western patients, its efficacy and safety in Chinese patients—who often have more severe disease—were not well studied until now.

The Study: A 52-Week Phase 3 Trial in Chinese Patients

To fill this gap, a team of dermatologists from top Chinese hospitals (including Peking University People’s Hospital and the Chinese Academy of Medical Sciences) and researchers from Novartis conducted a 52-week Phase 3 clinical trial. Published in the Chinese Medical Journal in 2020, the study is registered on ClinicalTrials.gov (NCT03066609) and included 441 Chinese adults with moderate to severe plaque psoriasis (defined as a PASI score ≥12, IGA score ≥3, and ≥10% body surface area affected).

Trial Design

The trial was:

  • Randomized: Patients were assigned to one of three groups by chance.
  • Double-blind: Neither patients nor doctors knew who was getting secukinumab or placebo.
  • Placebo-controlled: A third of patients received an inactive injection (placebo) for comparison.

Groups:

  1. Secukinumab 300mg: 221 patients.
  2. Secukinumab 150mg: 110 patients.
  3. Placebo: 110 patients.

Treatments were given as subcutaneous injections (under the skin) weekly for the first 4 weeks, then every 4 weeks until Week 48. At Week 12, placebo non-responders (who didn’t achieve a 75% reduction in symptoms) switched to secukinumab 300mg—an ethical standard to ensure all patients get access to effective treatment.

Key Endpoints

The trial’s main goals (co-primary endpoints) were to measure:

  1. PASI 75: A 75% or greater reduction in the Psoriasis Area and Severity Index (PASI)—a score that combines the area of skin affected and the severity of plaques (redness, scaling, thickness).
  2. IGA 0/1: A rating of “clear” (0) or “almost clear” (1) skin from an investigator using the Investigator’s Global Assessment (IGA) scale.

Secondary goals included:

  • PASI 90: 90% reduction in symptoms (a stricter measure of success).
  • Long-term efficacy at 52 weeks.
  • DLQI 0/1: No impact on quality of life, measured by the Dermatology Life Quality Index (DLQI)—a survey of how skin disease affects daily activities, mood, and relationships.

Results: Secukinumab Delivers Rapid, Sustained Relief

The trial’s findings were dramatic—secukinumab outperformed placebo by every measure, with sustained benefits for a full year.

12-Week Efficacy (Induction Phase)

By Week 12, nearly all secukinumab patients saw significant improvement:

  • PASI 75: 97.7% of 300mg patients and 87.2% of 150mg patients achieved this milestone—26x higher than placebo (3.7%).
  • IGA 0/1: 82.3% of 300mg patients and 69.7% of 150mg patients had clear or almost clear skin—30x higher than placebo (2.7%).
  • PASI 90: 81.0% of 300mg patients and 65.7% of 150mg patients saw a 90% reduction in symptoms—90x higher than placebo (0.9%).
  • PASI 100: One-third (32.9%) of 300mg patients had complete skin clearance—something no placebo patients achieved.

The 300mg dose consistently outperformed 150mg: more patients had clear skin, faster response times (median 52 days to PASI 75 vs. 57 days for 150mg), and lower average PASI scores (1.5 vs. 2.7 at Week 12).

52-Week Efficacy (Maintenance Phase)

Secukinumab’s benefits didn’t fade over time. At 52 weeks:

  • PASI 75: 95.4% of 300mg patients and 85.0% of 150mg patients maintained their response.
  • IGA 0/1: 75.8% of 300mg patients and 60.5% of 150mg patients still had clear/almost clear skin.
  • PASI 100: Complete clearance rose to 42.1% in the 300mg group—1.3x higher than at Week 12.

Even placebo patients who switched to secukinumab at Week 12 caught up quickly: by Week 28 (16 weeks of active treatment), their response rates matched the original 300mg group.

Quality of Life Improvements

Psoriasis takes a huge toll on mental health—and secukinumab reversed this. By Week 12:

  • DLQI 0/1: 41.6% of 300mg patients reported no impact of skin disease on their daily life—23x higher than placebo (1.8%).
  • By Week 52: 47.5% of 300mg patients and 34.5% of 150mg patients had restored quality of life.

For many patients, this meant being able to work, socialize, and feel confident again—something they hadn’t experienced in years.

Safety: Secukinumab Is Well-Tolerated Long-Term

A treatment’s efficacy only matters if it’s safe—and secukinumab passed this test with flying colors.

Adverse Events (AEs)

While more patients in the secukinumab groups reported AEs (90.1%) than placebo (60.0%), this was because they were on treatment longer. When adjusted for exposure (how much time patients spent on treatment), the rate of AEs was lower in secukinumab groups (345.5 per 100 patient-years) than placebo (536.9 per 100 patient-years).

The most common side effects were mild infections (e.g., colds, sinusitis), which were similar in frequency to placebo (107.4 vs. 110.9 per 100 patient-years).

Severe Adverse Events (SAEs)

Severe side effects were rare:

  • 2.1% of secukinumab patients reported SAEs (e.g., appendicitis, mild pemphigus).
  • 0.9% of placebo patients reported SAEs.

No deaths were reported, and anti-drug antibodies (which can reduce treatment effectiveness) were found in only 12 patients—with no impact on how well secukinumab worked.

Why This Matters for Chinese Psoriasis Patients

This trial is a breakthrough for several reasons:

  1. It’s Designed for Chinese Patients: Most psoriasis research focuses on Western populations, but Chinese patients often have more severe disease (mean PASI 26.8 vs. 22-23 in Western trials) and different treatment needs. This study confirms secukinumab works for them too.

  2. It’s More Effective Than Other Biologics: Compared to other biologics used in China—like adalimumab (77.8% PASI 75 at 12 weeks) or ustekinumab (82.5%)—secukinumab’s 97.7% rate is far higher.

  3. It Offers Long-Term Relief: Many treatments work short-term but stop being effective over time. Secukinumab maintained results for a full year—critical for a chronic disease like psoriasis.

  4. It Restores Quality of Life: For patients, clear skin isn’t just about physical health—it’s about regaining control of their lives. The DLQI results show secukinumab does exactly that.

Conclusion: A New Standard for Psoriasis Treatment in China

This 52-week trial provides strong evidence that secukinumab is a safe and effective long-term treatment for Chinese patients with moderate to severe plaque psoriasis. The 300mg dose offers the best results—with nearly all patients seeing significant improvement at 12 weeks and sustained benefits for a year.

For patients tired of treatments that don’t work, secukinumab is a game-changer. For doctors, it’s a powerful tool to help their patients achieve clear skin and a better quality of life.

The trial’s results align with global research: secukinumab is one of the most effective treatments for psoriasis, and this study confirms it works for Chinese patients too.

Original Study Citation

Cai L, Zhang JZ, Yao X, et al. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis. Chinese Medical Journal 2020;133(22):2665-2673.

Trial Registration: ClinicalTrials.gov NCT03066609

doi:10.1097/CM9.0000000000001163
doi.org/10.1097/CM9.0000000000001163

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