A148: A Multi‐Center, Double‐Blind, Randomized‐Withdrawal Trial of Subcutaneous Golimumab in Pediatric Patients With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy: Week 48 Results

Brunner, Hermine I.; Ruperto, N; Tzaribachev, Nikolay; Horneff, Gerd; Wouters, C; Panavienė, Violeta; Часнык, В. Г.; Abud‐Mendoza, Carlos; Cuttica, Rubén; Reiff, A.; Maldonado-Velázquez, M.; Rubio-Pérez, Nadina; Alexeeva, Е.I.; Joos, Rik; Keltsev, Vladimir; Nasonov, E.; Kingsbury, Daniel J.; Bandeira, Márcia; Silverman, E.K.; Weller‐Heinemann, Frank; Royen‐Kerkhof, Annet van; Mendelsohn, Alan M.; Kim, Lilianne; Lovell, DJ; Martini, Alberto

doi:10.1002/art.38569

Cited by 21 publications

(10 citation statements)

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“…A clinical trial on a second recombinant human TNF inhibitor, golimumab [123], in 173 children with active arthritis despite MTX therapy for at least 3 months showed a rapid response to the medication after 16 weeks of open-label treatment, resulting in achievement of an American College of Rheumatology (ACR) Pediatric 30 response and the state of inactive disease in 87.3% and 36.1% of the patients, respectively. However, no differences in flare rates between golimumab and placebo arms were seen from week 16 to 48 among responders to golimumab in the open-label phase, and the primary endpoint of the trial was not met.…”

Section: Diagnosismentioning

confidence: 99%

Juvenile Idiopathic Arthritis: Diagnosis and Treatment

et al. 2016

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Juvenile idiopathic arthritis is a broad term that describes a clinically heterogeneous group of arthritides of unknown cause, which begin before 16 years of age. This term encompasses several disease categories, each of which has distinct presentation, clinical manifestations, and, presumably, genetic background and etiopathogenesis. Although none of the available drugs has curative potential, prognosis has greatly improved as a result of substantial progresses in disease management. The most important new development has been the introduction of the biologic medications, which constitute a valuable treatment option for patients who are resistant to conventional antirheumatic agents. Further insights into the disease pathogenesis and treatment will be provided by the continuous advances in understanding of the mechanisms related to the immune response and inflammatory process, and by the development of new drugs that are capable of selectively inhibiting single molecules or pathways.

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Section: Diagnosismentioning

confidence: 99%

Juvenile Idiopathic Arthritis: Diagnosis and Treatment

et al. 2016

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“…A multicenter, open-label study of certolizumab pegol is underway in children with severe polyarticular-course JIA 147. Similarly, a randomized, double-blind study is ongoing for golimumab treatment in polyarticular JIA with results at 48 weeks not reaching its primary endpoint; however, improvements were noted on an imaging substudy 148,149…”

Section: Current and Emerging Treatment Optionsmentioning

confidence: 99%

Polyarticular juvenile idiopathic arthritis – epidemiology and management approaches

Oberle

Harris

Verbsky

2014

CLEP

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Juvenile idiopathic arthritis (JIA) is a group of disorders characterized by arthritis persisting for at least 6 weeks with onset before the age of 16 years. Within this cluster of conditions, the polyarticular form (involving more than four joints within the first 6 months) is further divided based on the presence of rheumatoid factor. Children with polyarticular JIA pose unique diagnostic and therapeutic challenges compared to children with involvement of fewer joints. Polyarticular JIA patients tend to have a more refractory course and therefore are at increased risk for joint damage, resulting in poorer functional outcomes and decreased quality of life. Although the ability to treat this disorder continues to improve, especially with the advent of biologic agents, there is still much about the epidemiology and pathogenesis of polyarticular JIA that is unknown. The epidemiology of polyarticular JIA varies worldwide with a vast difference in reported cases between different global regions as well as within individual countries. Several genetic risk loci have been identified conferring increased susceptibility to JIA, many within the human leukocyte antigen region. Beyond the genome, environmental factors also seem to contribute to the etiology of polyarticular JIA. This review article will focus on the epidemiology and current treatments of polyarticular JIA and briefly discuss genetic and environmental influences on the pathogenesis of JIA as well as new and emerging therapies.

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“…For example, the GO-KIDS study used randomized withdrawal design to evaluate golimumab in polyarticular JIA [21, 22]. At week 16, 87% achieved an ACR Ped-30 response; however, the primary endpoint (proportion of responders without flare) was not met because there were no significant differences in flare rates between the placebo group and golimumab group during the blinded portion of the trial [22].…”

Section: Study Design In Jia and Lessons Learnedmentioning

confidence: 99%

“…At week 16, 87% achieved an ACR Ped-30 response; however, the primary endpoint (proportion of responders without flare) was not met because there were no significant differences in flare rates between the placebo group and golimumab group during the blinded portion of the trial [22]. The high response rate in the placebo group may have limited detection of a treatment difference [4, 22]. Pre-specified subgroup analysis showed that participants with a CRP ≥1 mg/dL had significantly higher flare rates on methotrexate and placebo, compared to golimumab and methotrexate (87% vs 40%, p= 0.0068) [4].…”

Section: Study Design In Jia and Lessons Learnedmentioning

confidence: 99%

Clinical Trial Design in Juvenile Idiopathic Arthritis

et al. 2017

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Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the impact of developmental changes in trial design. Advances within pediatric rheumatology combined with the need to comply with legislative requirements have driven new approaches to performing pediatric clinical trials such as utilization of large research networks, incorporation of patient and family stakeholders in the planning and implementation of clinical trials, and the development of novel trial designs. The expansion of available biological therapeutics that now includes biosimilar drugs highlights the important and difficult balance of providing new and cost effective drugs to children while ensuring safety in a vulnerable population. Future advances in JIA clinical trials will likely be the application of precision medicine based on biologic, rather than phenotypic, classification of JIA, with improved understanding of pediatric clinical pharmacology. Clinical trial simulations and comparative effectiveness studies are important supplements to traditional clinical trials, permitting efficient studies and results that are more generalizable.

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A148: A Multi‐Center, Double‐Blind, Randomized‐Withdrawal Trial of Subcutaneous Golimumab in Pediatric Patients With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy: Week 48 Results

Cited by 21 publications

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Juvenile Idiopathic Arthritis: Diagnosis and Treatment

Juvenile Idiopathic Arthritis: Diagnosis and Treatment

Polyarticular juvenile idiopathic arthritis – epidemiology and management approaches

Clinical Trial Design in Juvenile Idiopathic Arthritis

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A148: A Multi‐Center, Double‐Blind, Randomized‐Withdrawal Trial of Subcutaneous Golimumab in Pediatric Patients With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy: Week 48 Results

Cited by 21 publications

References 0 publications

Juvenile Idiopathic Arthritis: Diagnosis and Treatment

Juvenile Idiopathic Arthritis: Diagnosis and Treatment

Polyarticular juvenile idiopathic arthritis &ndash; epidemiology and management approaches

Clinical Trial Design in Juvenile Idiopathic Arthritis

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Polyarticular juvenile idiopathic arthritis – epidemiology and management approaches