Efficacy and Safety of Secukinumab Over 52 Weeks in Chinese Psoriasis Patients with Psoriatic Arthritis

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Efficacy and Safety of Secukinumab Over 52 Weeks in Chinese Psoriasis Patients with Concomitant Psoriatic Arthritis

Psoriasis is a chronic, systemic inflammatory disorder characterized by well-demarcated, erythematous, and scaly skin plaques. Among its comorbidities, psoriatic arthritis (PsA) is the most prevalent, affecting approximately 25%–30% of psoriasis patients during their lifetime. In China, while the prevalence of psoriasis is relatively low (0.6%), the disease burden is significant, with patients often presenting higher baseline severity compared to Western populations. A Phase 3 clinical trial (CAIN457A2318, NCT03066609) previously demonstrated the efficacy and safety of secukinumab, an interleukin (IL)-17A inhibitor, in a predominantly Chinese cohort of moderate to severe psoriasis patients. This analysis focuses on the subgroup of Chinese psoriasis patients with concurrent PsA from the same trial, evaluating the 52-week outcomes of secukinumab in addressing both cutaneous and joint manifestations.

Study Design and Patient Population

The CAIN457A2318 trial was a 52-week, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. Eligible participants were adults (≥18 years) with moderate to severe chronic plaque psoriasis (duration ≥6 months) inadequately controlled by topical treatments, phototherapy, or systemic therapies. PsA diagnosis required fulfillment of classification criteria for PsA and the presence of ≥3 tender and swollen joints at baseline. Patients were randomized (2:1:1) to receive secukinumab 300 mg, 150 mg, or placebo. At week 12, placebo non-responders (failure to achieve ≥75% improvement in Psoriasis Area and Severity Index [PASI 75]) were switched to secukinumab 300 mg, while responders continued placebo until week 52.

The subpopulation of Chinese psoriasis patients with PsA comprised 24 out of 441 participants (5.4%), distributed across treatment arms: secukinumab 300 mg (n=14), 150 mg (n=6), and placebo (n=4). Baseline demographics were comparable between groups. The mean age ranged from 40 to 45 years, with body mass index (BMI) values of 24.0 kg/m² (300 mg), 24.7 kg/m² (150 mg), and 27.0 kg/m² (placebo). Patients exhibited high baseline disease severity: mean PASI scores were 29.3 (300 mg), 25.1 (150 mg), and 24.2 (placebo), while affected body surface area (BSA) averaged 45.1%, 41.8%, and 36.6%, respectively. PsA duration was longest in the 300 mg arm (mean 6.8 years) compared to 6.9 years (150 mg) and 2.3 years (placebo). A majority of patients in the 300 mg and 150 mg arms had severe psoriasis (Investigator’s Global Assessment [IGA] score 4: 57.1% and 66.7%, respectively).

Efficacy Outcomes

Psoriatic Arthritis Responses

Secukinumab demonstrated rapid and sustained efficacy in PsA. By week 12, 92.3% (12/13) of patients receiving secukinumab 300 mg achieved an American College of Rheumatology 20% improvement (ACR20) response, compared to 66.7% (4/6) with 150 mg and 0% (0/4) with placebo. Responses were maintained through week 52, with 84.6% (11/13) and 50.0% (3/6) sustaining ACR20 in the 300 mg and 150 mg arms, respectively. Higher thresholds of improvement (ACR50 and ACR70) also favored the 300 mg dose:

  • ACR50: 76.9% (10/13) with 300 mg vs. 33.3% (2/6) with 150 mg at week 52.
  • ACR70: 53.8% (7/13) with 300 mg vs. 16.7% (1/6) with 150 mg at week 52.

Psoriasis Responses

Secukinumab showed robust efficacy in skin clearance. At week 12, PASI75 responses were achieved by 92.9% (13/14) of the 300 mg group, 83.3% (5/6) of the 150 mg group, and none in the placebo group. Responses improved or were sustained through week 52:

  • PASI75: 92.9% (300 mg) and 97.3% (150 mg).
  • PASI90: 85.7% (12/14) with 300 mg vs. 56.0% (3/6) with 150 mg.
  • PASI100: 50.0% (7/14) with 300 mg vs. 10.3% (1/6) with 150 mg.

IGA 0/1 (clear or almost clear skin) responses were superior with the 300 mg dose (78.6% [11/14]) compared to 23.7% (1/6) with 150 mg at week 52.

Patient-Reported Outcomes

Improvements in quality of life and functional disability were notable. At week 12, 21.4% (300 mg) and 33.3% (150 mg) achieved Dermatology Life Quality Index (DLQI) 0/1 (no impact on daily life), increasing to 50.0% (300 mg) and 66.7% (150 mg) by week 52. The Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, reflecting PsA-related disability, improved by 64.2% (300 mg) and 40.5% (150 mg) from baseline to week 52.

Safety Profile

Over 52 weeks, secukinumab exhibited a safety profile consistent with its established tolerability. All 24 PsA patients experienced ≥1 treatment-emergent adverse event (TEAE). Key findings included:

  • Gastrointestinal AEs: 41.7% (10/24) in secukinumab groups vs. 50% (2/4) in placebo.
  • Non-serious infections: 83.3% (20/24) with secukinumab vs. 25% (1/4) with placebo.
  • Hypersensitivity reactions: 33.3% (8/24) with secukinumab, including eczema (12.5%), urticaria (12.5%), dermatitis (4.2%), and eyelid edema (4.2%).

Most events were mild to moderate. Serious adverse events (SAEs) were rare, with one case of hemorrhoids (unrelated to treatment). No new safety signals were identified.

Discussion

This subanalysis highlights secukinumab’s dual efficacy in managing both psoriasis and PsA in Chinese patients. The 300 mg dose demonstrated superior outcomes, with 93% achieving PASI75, 79% IGA 0/1, and 85% ACR20 responses at week 52. These results align with global studies, such as the FUTURE 5 trial, which reported sustained inhibition of radiographic progression in PsA patients. The higher efficacy of the 300 mg dose underscores its suitability for patients with severe disease or concomitant PsA.

The safety profile was consistent with previous reports, emphasizing secukinumab’s favorable risk-benefit ratio. While gastrointestinal AEs and infections were common, most were manageable and did not lead to treatment discontinuation.

Conclusion

Secukinumab 300 mg provided rapid and sustained improvements in skin and joint symptoms, quality of life, and functional disability over 52 weeks in Chinese psoriasis patients with PsA. The safety findings reinforce its established profile, supporting its use as a first-line biologic for this population.

doi.org/10.1097/CM9.0000000000001710

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