Effectiveness and Safety of Secukinumab in Chinese Patients with Plaque Psoriasis in a Clinical Practice Setting: A Pilot Study
Plaque psoriasis, a chronic immune-mediated inflammatory disorder affecting the skin, nails, and joints, represents over 80%–90% of psoriasis cases. Secukinumab, a fully human IgG monoclonal antibody targeting interleukin-17A (IL-17A), received approval from the US Food and Drug Administration in 2015 for moderate-to-severe plaque psoriasis. While a Chinese phase III randomized clinical trial (RCT) confirmed its efficacy and safety, real-world data remain limited, particularly for patients excluded from RCTs due to comorbidities or concurrent conditions. This pilot study evaluated the real-world effectiveness and safety of secukinumab in Chinese patients, including those typically excluded from clinical trials.
Study Design and Patient Characteristics
This retrospective analysis included 20 inpatients with plaque psoriasis treated with secukinumab at Peking University Third Hospital between June and December 2019. Patients received subcutaneous secukinumab 300 mg weekly for four weeks, followed by monthly maintenance dosing. Data collected included demographics, clinical features (disease duration, comorbidities, prior treatments), and severity scores such as the Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Psoriasis Scalp Severity Index (PSSI), Nail Psoriasis Severity Index (NAPSI), and Palmoplantar Psoriasis Area and Severity Index (ppPASI).
Notably, 60% (12/20) of patients would have been excluded from the phase III RCT. Ten failed to meet inclusion criteria, one had concurrent hepatitis B/C virus (HBV/HCV) infection, and one had pre-existing idiopathic thrombocytopenia. Baseline PASI and BSA scores indicated lower disease severity compared to the RCT cohort (median baseline PASI: 11.10 vs. 19.9 in the RCT).
Efficacy Outcomes
Skin and Scalp Involvement
Secukinumab demonstrated rapid and sustained improvements in skin clearance. Median PASI decreased from 11.10 at baseline to 0.50 at week 12, representing a 95.74% improvement. By week 12, 87.5% achieved PASI 75 (≥75% improvement), 68.8% PASI 90, and 43.8% PASI 100. The median time to PASI 75 response was eight weeks.
For scalp psoriasis (13 patients), median PSSI improved from 5.0 at baseline to 0 at week 12, with 83.3%, 75.0%, and 66.7% achieving PSSI 75, 90, and 100 responses, respectively. A patient with hyperkeratotic palmoplantar psoriasis (baseline ppPASI 16.6) achieved complete clearance by week 8.
Nail Psoriasis
Three patients with fingernail involvement showed NAPSI improvements of 100%, 53.3%, and 28.6% at week 12. One patient with toenail psoriasis achieved a 45% improvement.
Quality of Life and Body Surface Area
BSA involvement decreased from 20.3% at baseline to 1.0% at week 12. By week 12, 81.3% achieved BSA ≤3% (mild involvement), and 62.5% reached BSA ≤1% (minimal involvement). DLQI scores improved from 11.0 (moderate-to-severe impact) to 0 (no impact) at week 12, with 66.7% reporting DLQI 0/1 (no quality-of-life impairment).
Safety Profile
Secukinumab was well-tolerated. Adverse events (AEs) occurred in 45% (9/20) of patients, predominantly mild infections (upper respiratory tract infections: 4 cases), tinea pedis (2), and facial dermatitis (2). No serious AEs or treatment discontinuations occurred.
Special Cases
HBV/HCV Coinfection: A patient with baseline HCV-IgM and HBcAb positivity (HBsAg and viral DNA negative) completed 48 weeks of secukinumab without HBV/HCV reactivation or elevated transaminases. While this case suggests safety in virally suppressed patients, existing literature reports rare instances of HBV reactivation and HCV replication under secukinumab, underscoring the need for vigilant monitoring.
Idiopathic Thrombocytopenia: A patient with pre-existing thrombocytopenia (baseline platelets: 52×10⁹/L) showed platelet counts rising to 84×10⁹/L by week 12 and 82×10⁹/L at week 32, alongside sustained PASI 100 response. This suggests secukinumab may not exacerbate thrombocytopenia and could have a neutral or beneficial effect, though larger studies are needed.
Comparison to Clinical Trials and Real-World Evidence
This study’s week-12 PASI 75/90/100 responses (87.5%/68.8%/43.8%) exceeded those reported in the Chinese phase III RCT (72%/50%/36%). Superior outcomes may stem from differences in patient demographics: 64.3% of the real-world cohort were biologic-naïve (vs. 53.7% in RCT meta-analyses), and fewer had obesity (14.3% vs. 25.2%), a known predictor of reduced biologic response. DLQI 0/1 rates (66.7%) also surpassed RCT findings (57%), highlighting secukinumab’s real-world effectiveness in restoring quality of life.
Clinical Implications
This study addresses the “efficacy-effectiveness gap” by confirming secukinumab’s real-world utility in diverse patients, including those with comorbidities or milder disease. Rapid responses (significant PASI reductions by week 2) and high rates of complete clearance support its use in clinically complex scenarios. The favorable safety profile, even in patients with viral infections or hematologic conditions, reinforces secukinumab as a versatile therapeutic option.
Limitations and Future Directions
The small sample size and single-center design limit generalizability. Long-term data beyond 12 weeks are needed to assess sustained efficacy and safety, particularly in special populations. Prospective studies with standardized monitoring protocols for viral reactivation and hematologic parameters are recommended.
Conclusion
In a real-world Chinese cohort, secukinumab exhibited rapid, robust efficacy across skin, scalp, nail, and palmoplantar psoriasis, with significant quality-of-life improvements. Its safety profile remained favorable, even in patients excluded from RCTs. These findings underscore secukinumab’s value as a first-line biologic for moderate-to-severe plaque psoriasis, particularly in clinically heterogeneous populations.
doi.org/10.1097/CM9.0000000000001258
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