Real-World Investigation of the Efficacy and Safety of Secukinumab for Psoriasis Treatment in a Chinese Population
Psoriasis is a chronic inflammatory proliferative disease mediated by T lymphocytes under a multifactorial genetic background. Although its pathogenesis remains incompletely understood, recent research underscores the critical role of T cell-mediated immune inflammation, with interleukin (IL)-17 emerging as the primary effector cytokine driving disease progression. Secukinumab, a fully humanized monoclonal antibody targeting IL-17A, has demonstrated rapid and sustained efficacy in global clinical trials. However, its real-world performance in Chinese populations remained unexplored prior to this study. This investigation evaluates the 16-week efficacy and safety profile of secukinumab in Chinese patients with moderate-to-severe psoriasis, offering critical insights into its clinical utility in this demographic.
Study Design and Patient Characteristics
This single-arm, observational study enrolled 54 patients diagnosed with moderate-to-severe psoriasis from two tertiary dermatology centers in Guangzhou, China, between May 2019 and March 2020. Participants comprised 41 males and 13 females, with a mean age of 36.5 ± 3.6 years (range: 18–58 years) and an average disease duration of 9.6 ± 5.5 years (range: 2–32 years). Key exclusion criteria included recent use of systemic therapies (e.g., methotrexate, acitretin, immunosuppressants, or biologics within the prior six months), active infections, pregnancy, malignancies, immunodeficiency, and comorbidities such as hepatitis B/C, tuberculosis, or renal/hepatic dysfunction.
Patients received subcutaneous secukinumab (150 mg per injection) administered at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing until week 16. Efficacy was assessed using the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Physician’s Global Assessment (PGA). Safety monitoring included adverse event documentation and specialized management for high-risk subgroups, such as patients with latent tuberculosis or hepatitis B virus (HBV) infection.
Rapid and Sustained Efficacy
Secukinumab demonstrated remarkable efficacy, with significant improvements observed as early as two weeks post-treatment. By week 2, three patients (5.6%) achieved PASI 75, and three additional patients (5.6%) attained PASI 90 by week 3. Efficacy escalated rapidly: at week 4, 63.0% (34/54) of patients achieved PASI 75, and one patient (1.7%) reached PASI 100. By week 8, all patients (100%) achieved ≥PASI 50, while 53.7% (29/54) attained PASI 90.
Long-term responses further improved, with 96.3% (52/54) achieving PASI 75 and 85.2% (46/54) reaching PASI 90 by week 16. Notably, 31.5% (17/54) of patients achieved complete clearance (PASI 100) at the study endpoint. The mean PASI score declined by >50% within three weeks, underscoring the drug’s rapid onset of action (Figure 1A–B).
Quality of Life and Clinical Assessments
Secukinumab significantly improved patient-reported outcomes. The DLQI score, reflecting disease-related quality of life impairment, decreased from a baseline of 13.4 ± 4.2 to 1.25 ± 0.96 at week 16 (t = 10.88, P < 0.0001) (Figure 1C). Similarly, PGA scores improved markedly, decreasing from 4.2 ± 0.8 at baseline to 0.6 ± 0.5 at week 16 (t = 14.83, P < 0.0001) (Figure 1D). These results highlight the drug’s capacity to alleviate both clinical symptoms and psychosocial burden.
Safety Profile and Special Populations
No serious adverse events (SAEs), treatment discontinuations, or deaths occurred during the study. Mild adverse reactions were reported in 18.5% (10/54) of patients, including pharyngitis (n = 3), nasopharyngitis (n = 3), pruritus (n = 2), and dry mouth (n = 2). All events resolved without intervention.
Notably, the study included high-risk subgroups: seven patients with latent tuberculosis and two with HBV infection. Prophylactic anti-tuberculosis therapy and antiviral treatment (for HBV) were administered alongside secukinumab, with no cases of tuberculosis reactivation or HBV flare. Regular monitoring of liver function and HBV DNA levels revealed no abnormalities.
During the COVID-19 pandemic, eight patients self-administered secukinumab at home under remote medical guidance. None reported injection-site reactions or infections, demonstrating the feasibility of home-based therapy during public health crises.
Comparative Efficacy and Mechanistic Insights
The study’s 16-week PASI 75 and PASI 90 response rates (96.3% and 85.2%, respectively) exceeded those reported in Western populations (93.1% and 79.0% in phase III trials), suggesting potential ethnic or genetic variations in treatment response. Secukinumab’s mechanism—neutralizing IL-17A to inhibit downstream pro-inflammatory cytokines and chemokines—appears particularly effective in attenuating the IL-17-driven inflammation prevalent in Asian psoriasis patients.
Limitations and Future Directions
While the 16-week observation period confirmed secukinumab’s short-term efficacy and safety, longer-term data are needed to assess sustained remission and late-onset adverse events. Additionally, the study’s single-arm design limits direct comparisons with other biologics or conventional therapies. Future randomized controlled trials in Chinese populations could further validate these findings and explore combination therapies.
Clinical Implications
This real-world study positions secukinumab as a first-line biologic for moderate-to-severe psoriasis in Chinese patients, particularly those refractory to traditional therapies. Its rapid action, high efficacy, and favorable safety profile address unmet needs in this population, while its subcutaneous administration protocol enhances treatment adherence. The successful management of high-risk subgroups (e.g., latent tuberculosis, HBV) further supports its use in complex clinical scenarios.
Conclusion
Secukinumab monotherapy demonstrated robust efficacy and an excellent safety profile in Chinese patients with moderate-to-severe psoriasis, achieving rapid and sustained skin clearance within 16 weeks. These findings align with global data while suggesting enhanced responsiveness in Asian populations. As the first real-world evaluation of secukinumab in China, this study provides a critical foundation for its inclusion in regional treatment guidelines and underscores the importance of IL-17-targeted therapies in psoriasis management.
doi.org/10.1097/CM9.0000000000001179
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