The study examined the efficacy and safety of secukinumab after 52 weeks of treatment in children and adolescents with moderate to severe psoriasis. We present the efficacy of secukinumab by body weight, disease severity, and dose groups. In children and adolescents with moderate to severe psoriasis, the clinical benefit of secukinumab observed during the first 24 weeks of treatment was maintained through 52 weeks. In addition, the efficacy of secukinumab for skin clearance was consistent across weight and age subgroups. |
Secukinumab was generally well tolerated in children and adolescents after 52 weeks of treatment, with no new safety concerns observed. The safety profile of secukinumab was consistent with previous psoriasis clinical studies in adult patients. |
1 Introduction
2 Methods
2.1 Study Design
2.2 Participants
2.2.1 Inclusion and Exclusion Criteria
2.3 Intervention
2.4 Outcome Measures
2.5 Statistical Methods
3 Results
3.1 Participants
3.2 Efficacy
3.3 Subgroup Analyses
3.3.1 Age
3.3.2 Body Weight and Dose
3.3.3 Disease Severity and Dose
3.4 Safety
Characteristic | Secukinumab | ||
---|---|---|---|
Low dose (N = 42) | High dose (N = 42) | Total (N = 84) | |
Any TEAEs | 28 (66.7) | 27 (64.3) | 55 (65.5) |
Any nonfatal TE SAEs | 2 (4.8)a | 1 (2.4)a | 3 (3.6) |
Discontinued study treatment because of any AE | 0 | 2 (4.8) | 2 (2.4) |
Any death | 0 | 0 | 0 |
Most frequent AEs (by SOC)b | |||
Infections and infestations | 19 (45.2) | 21 (50.0) | 40 (47.6) |
Gastrointestinal disorders | 4 (9.5) | 8 (19.0) | 12 (14.3) |
Skin and SC tissue disorders | 8 (19.0) | 4 (9.5) | 12 (14.3) |
Most frequent AEs (by PT)c | |||
Nasopharyngitis | 9 (21.4) | 6 (14.3) | 15 (17.9) |
Acne | 5 (11.9) | 1 (2.4) | 6 (7.1) |
Influenza | 3 (7.1) | 1 (2.4) | 4 (4.8) |
Leukopenia | 3 (7.1) | 1 (2.4) | 4 (4.8) |
Pyrexia | 3 (7.1) | 1 (2.4) | 4 (4.8) |
AEs of interest | |||
Hypersensitivity (SMQ) | 3 (7.1) | 1 (2.4) | 4 (4.8) |
Neutropenia (NMQ) | 3 (7.1) | 2 (4.8) | 5 (6.0) |
Diarrhea hemorrhagic (PT)d | 0 | 1 (2.4) | 1 (1.2) |
Suicide/self-injury (SMQ)e | 1 (2.4) | 0 | 1 (1.2) |
Candida infection (HLT) | 1 (2.4) | 1 (2.4) | 2 (2.4) |
Vulvovaginal candidiasis (PT) | 0 | 1 (2.4) | 1 (1.2) |
Injection site reactionsf | 1 (2.4) | 2 (4.8) | 3 (3.6) |