Secukinumab (Cosentyx) was found effective in reducing the occurrence of flares in children diagnosed with juvenile idiopathic arthritis in a recent two-year phase 3 clinical trial study. The study participants were children two to 18 years of age diagnosed with a type of juvenile idiopathic diagnosis (60% with enthesitis-related arthritis and 40% with juvenile psoriatic arthritis).
During the first 12 weeks of the study, all participants were treated with secukinumab (the doses ranged from 75mg to 150mg depending on body weight). At the 12-week mark, study participants were placed in two randomized groups: the treatment group continued treatment with secukinumab in doses of 75mg or 150mg every 4 weeks, and the placebo group received an inactive substance (sugar pill). To measure disease activity and improvement, the ACR 30/50/70/90/100 response criteria and ACR’s criteria for inactive disease were used. The findings are shown below and demonstrate that patients who remained on secukinumab were less likely to have a disease flare and showed a significantly higher level of improvement in disease activity than the group that stopped taking secukinumab.
| Criteria for Measuring disease Improvement | Week 12
All Participants were treated with Secukinumab |
Week 104
(Secukinumab group) |
Week 104
(Placebo group) |
| ACR 30 [1] (Improvement of 30%) | 90.4% | 89.2% | 64.9% |
| ACR 50 [2]
(Improvement of 50%) |
86.7% | 78.4% | 62.2% |
| ACR 70 [3]
(Improvement of 70%) |
69.9% | 67.6% | 43.2% |
| ACR 90 [4]
(Improvement of 90%) |
39.8% | 51.4% | 40.5% |
| ACR 100 [5]
(Improvement of 100%) |
25.3% | 43.2% | 37.8% |
| Inactive disease [6] | 36.1% | 47.2% | 37.8% |
Furthermore, the secukinumab treatment group had a higher constant rate of inactive disease, and lower rate of adverse side effects reported than the placebo group (91.7% vs. 92.1%). The most common side effects included gastrointestinal complaints, minor infections, and headaches. Diarrhea was also reported, though it can be associated with inflammatory bowel disease, a symptom that can be reactivated when taking an IL-17 inhibitor treatment. Nonetheless, the adverse events resolved on their own.
The study concluded that in children and adolescents with enthesitis-related arthritis and juvenile psoriatic arthritis, treatment with secukinumab proved to significantly reduce flares vs. the placebo group with continued improvement of signs and symptoms of disease, and that the medication is a promising choice for treatment.
[1] The ACR Response Criteria (ACR 30)– is a composite measure defined as both improvement of 30% in the number of tender and number of swollen joints, and a 30% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
[2] The ACR Response Criteria (ACR 50)– is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
[3] The ACR Response Criteria (ACR 70)– is a composite measure defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
[4] The ACR Response Criteria (ACR 90)– is a composite measure defined as both improvement of 90% in the number of tender and number of swollen joints, and a 90% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
[5] The ACR Response Criteria (ACR 100)– is a composite measure defined as both improvement of 100% in the number of tender and number of swollen joints, and a 100% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
[6] The criteria for inactive disease include the following: no active arthritis; no fever, no rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal erythrocyte sedimentation rate or C-reactive protein level; and a physician’s global assessment of disease activity indicating clinical disease quiescence.
References:
Walsh, N. (2021, June 07). Secukinumab Shows Promise for Kids With Arthritis. Retrieved from Secukinumab Shows Promise for Kids With Arthritis | MedPage Today.
Ruperto N, Foeldvari I, Alexeeva E on behalf of PRCSG and PRINTO investigative sites, et al
LB0004 Efficacy and Safety of Secukinumab in Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-Blind, Placebo-Controlled, Treatment Withdrawal, Phase 3 Study (Junipera) Annals of the Rheumatic Diseases 2021;80:201-202.
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