Secukinumab improves PASI score for paediatric psoriasis
Treatment with low-dose (LD) or high-dose (HD) secukinumab significantly improved Psoriasis Area and Severity Index (PASI)* scores in paediatric patients with severe chronic plaque psoriasis, according to a study presented at EADV 2020.
This phase III, multicentre, double-blind study involved 162 paediatric patients (aged 6 to <18 years) diagnosed with severe plaque psoriasis (mean baseline PASI score 28.0). The patients were randomized to receive subcutaneous secukinumab according to weight categories (<25 kg, 25 to <50 kg, and ≥50 kg; LD: 75/75/150 mg [n=40] or HD: 75/150/300 mg [n=40]), etanercept 0.8 mg/kg (n=41), or placebo (n=41) for an induction period (up to week 12) and a maintenance period (week 12–52). [EADV 2020, abstract FC02.08]
At week 12, significantly more patients treated with secukinumab than placebo achieved PASI 75 (80.0 percent [LD] and 77.5 percent [HD] vs 14.6 percent [placebo]; p<0.0001) and PASI 90 responses (72.5 percent [LD] and 67.5 percent [HD] vs 2.4 percent [placebo]; p<0.0001).
A significantly higher percentage of patients on either secukinumab LD or HD also experienced an IGA** modified 2011 score of 0/1 at week 12 than those on placebo (70.0 percent and 60.0 percent, respectively, vs 4.9 percent; p<0.0001).
At week 52, when compared with etanercept recipients, more secukinumab recipients experienced sustained improvement in PASI 75 (87.5 percent [LD] and 87.5 percent [HD] vs 68.3 percent), PASI 90 (75.0 percent [LD] and 80.0 percent [HD] vs 51.2 percent), and PASI 100 responses (40.0 percent [LD] and 47.5 percent [HD] vs 22.0 percent).
Improved IGA modified 2011 score 0/1 was also sustained in the secukinumab compared with the etanercept group at week 52 (72.5 percent [LD] and 75.0 percent [HD] vs 56.1 percent). “Of note, patients in the ≥50 kg weight category … [treated with secukinumab] HD showed high efficacy on IGA responses,” said lead author Professor Christine Bodemer from Hôpital Necker-Enfants Malades in Paris, France.
In addition, a numerically, but not significantly, higher percentage of secukinumab- than etanercept-treated patients achieved a CDLQI** score of 0 or 1 at week 52, indicating an improved quality of life (QoL; 60.6 percent [LD] or 66.7 percent [HD] vs 44.4 percent).
The incidence of adverse events (AEs) was comparable between the secukinumab LD and HD arms. “Majority of the AEs were of mild-to-moderate severity, … with no new safety signals observed,” Bodemer noted.
“Current approved treatment options for psoriasis in children and adolescents are few, … with only limited use of approved biologics for paediatric psoriasis, resulting in unmet medical need,” said Bodemer. “[This study showed that] both doses of secukinumab demonstrated high and sustained efficacy up to week 52 in clearing skin and improving QoL with a favourable safety profile in paediatric patients with severe chronic plaque psoriasis,” she said.
“[Although] the study was not powered vs the active comparator etanercept, … IGA modified 2011 0/1 and PASI 90 responses at week 12 in both secukinumab dose groups were significantly higher (p<0.05 for all comparisons) … and PASI 75 [response] was numerically higher compared with the etanercept group,” she added.
*PASI: Combined assessment of lesion severity and affected area (head, arms, trunk, legs). For each area, percent of skin involved is estimated: 0 (0 percent) to 6 (90–100 percent)
**IGA: Investigator’s Global Assessment***CDLQI: Children’s Dermatology Life Quality Index