Value of Literature Review to Inform Development and Use of Biologics in Juvenile Idiopathic Arthritis

Golhen, Klervi; Winskill, Carolyn; Yeh, Cynthia; Zhang, Nancy R.; Welzel, Tatjana; Pfister, Marc

doi:10.3389/fped.2022.909118

Cited by 5 publications

(4 citation statements)

References 42 publications

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“…Previous studies have shown a pattern of progression in TMJ deformities over time 30 . This difference can probably be explained by the fact that the children in the current study to a large extent received highly effective medication (bDMARDS) 31 , implicating low disease activity. Further, there are other possible explanations for TMJ deformities in children than JIA involvement.…”

Section: Discussionmentioning

confidence: 82%

Temporomandibular involvement in children and adolescents with juvenile idiopathic arthritis: a 2-year prospective cohort study

Collin,

Christidis,

Hagelberg

et al. 2024

Sci Rep

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This study aimed to clinically evaluate temporomandibular joint (TMJ) involvement in juvenile idiopathic arthritis (JIA) and the ability to identify and/or predict development of TMJ-deformities over time using cone beam computed tomography (CBCT). The predictive value of self-reported TMJ pain was also assessed. A prospective longitudinal cohort study comprising 54 children with JIA, 39 girls and 15 boys, was performed. All children had active disease at baseline, 50% with the subtype oligoarthritis. Repeated clinical orofacial and CBCT examinations were performed over a two-year period. At baseline, 39% had radiographic TMJ deformities (24% unilateral, 15% bilateral), at 2-year follow-up, 42% (p > 0.05). Both progressing and improving TMJ deformities were observed. An association was found between TMJ-deformities and self-reported TMJ pain at baseline (p = 0.01). Maximum unassisted mouth opening (MUO) was smaller for children with TMJ-deformities (p < 0.05). The prevalence of palpatory muscle pain was high (48–59%) but not predictive of development of TMJ-deformities. TMJ noises increased over time and crepitations were associated with TMJ-deformities (p < 0.05). In conclusion, in children with JIA, self-reported TMJ pain and dysfunction were common and predictive of TMJ deformities. TMJ deformities were associated with smaller MUO and palpatory TMJ pain as well as crepitations. Trial registration. ClinicalTrials.gov Protocol id: 2010/2089-31/2.

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Section: Discussionmentioning

confidence: 82%

Temporomandibular involvement in children and adolescents with juvenile idiopathic arthritis: a 2-year prospective cohort study

Collin,

Christidis,

Hagelberg

et al. 2024

Sci Rep

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“…The introduction of bDMARDs has markedly improved the efficacy of JIA treatment. 30 , 33 In addition, more patients can now avoid the safety concerns associated with conventional methotrexate and glucocorticoids, but there are still many issues to be examined regarding the short- and long-term safety of bDMARDs, including the risk of infection and potential risk of malignancy associated with their immunosuppressive effects. Future studies are needed to clarify these issues.…”

Section: Discussionmentioning

confidence: 99%

Biologic Disease-Modifying and Other Anti-Rheumatic Drugs Use in Patients with Moderate-to-Severe Juvenile Idiopathic Arthritis Based on a Japanese Nationwide Claims Database

Hata¹,

Hirata²,

Ota³

et al. 2022

TCRM

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Biologic disease-modifying anti-rheumatic drugs (bDMARDs) are highly effective and safe against juvenile idiopathic arthritis (JIA), which is classified into systemic JIA (sJIA) and the other JIA categories (non-sJIA) according to differences in clinical symptoms and pathophysiology. The purpose of the current study was to investigate trends in patterns of prescribing bDMARDs for moderate-to-severe JIA using a relatively large sample size in Japan. Patients and Methods:A descriptive epidemiological study based on a nationwide claims database in Japan was conducted from 2012 to 2018 using the "JMDC Claims Database" to explain annual changes based on the number of patients prescribed bDMARDs. Study drugs were identified based on the Anatomical Therapeutic Chemical codes, such as methotrexate, glucocorticoids, non-steroidal anti-inflammatory drugs, and bDMARDs. Results: From a database of 6,862,244 patients, the following exclusion criteria were applied: aged ≥16 years, without "M08" in their ICD-10 code as disease, and missing the information of prescription date in the database during the study period, resulting in a final number of 111 JIA patients. We found an increasing trend for adalimumab and tocilizumab and a decreasing trend for methotrexate. Differences in medication use between sJIA and non-sJIA patients were also evident, being consistent with national and international guidelines. Conclusion: Although the introduction of bDMARDs has markedly improved the efficacy of JIA therapy, there are still many shortand long-term safety issues to be examined, including the risk of infection and potential risk of associated malignancy. Future studies are needed to clarify these issues.

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“…An enhanced understanding of the efficacy-safety balance of existing and new biologics will facilitate decision-making in clinical practice as well as the development of new treatment options in children with psoriasis. Exploratory meta-analyses and model-based meta-analysis can utilize integrated data from clinical controlled studies strengthening the knowledge of a particular drug and its efficacy and safety relative to other treatment options in adults and children (78,79). Metaanalysis, especially model-based meta-analysis, facilitates the bridging of clinical outcomes data from adult and pediatric patients and can be a useful quantitative tool for enhancing key decisions such as dose selection and study design (Pediatric Investigation Plan, PIP), product positioning, and go/no-go decisions in pediatric drug development (80)(81)(82).…”

Section: Use and Development Of Biologics In Pediatric Psoriasismentioning

confidence: 99%

Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis

et al. 2022

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BackgroundPsoriasis is a chronic immune-mediated inflammatory skin disease affecting both adults and children. To better understand the efficacy-safety profile of biologics in children with moderate-to-severe psoriasis, this study aimed to analyze efficacy and safety data of randomized controlled trials (RCTs) performed in pediatric psoriasis and to compare efficacy outcomes in children with those in adults.MethodsRCTs investigating biologics in children with moderate-to-severe psoriasis were identified in a systematic literature review. PASI75/90 treatment responses at weeks 11/12 were analyzed comparing biologics with control arms. Serious adverse events (SAEs) were analyzed at the end of each study. Efficacy data from RCTs in adults with psoriasis were selected for the same biologics. Risk ratios (RR) of selected RCTs were pooled together in a statistical random effects model using the inverse variance method.ResultsFor children, there were 1 etanercept, 2 secukinumab, 1 ixekizumab and 1 ustekinumab placebo-controlled RCTs and 1 adalimumab RCT using methotrexate as reference arm at weeks 11/12. For adults, out of 263 RCTs, 7 adalimumab and 15 etanercept (TNF inhibitors) and 4 ixekizumab and 12 ustekinumab (IL-17 and IL-12/23 inhibitors) RCTs reported PASI75/90 efficacy responses at weeks 11/12. Regarding efficacy, all biologics showed improved PASI responses over control arms. RRs ranges were 2.02–7.45 in PASI75 and 4.10–14.50 in PASI90. The highest PASI75 responses were seen for ustekinumab 0.375 mg/kg (RR = 7.25, 95% CI 2.83–18.58) and ustekinumab 0.75 mg/kg (RR = 7.45, 95% CI 2.91–19.06) in the CADMUS study. The highest PASI90 response was seen for ixekizumab (RR = 14.50, 95% CI 4.82–43.58) in the IXORA-PEDS study. SAE incidences in pediatric and adult arms with biologics were 0 to 3% except for a pediatric arm with adalimumab 0.40 mg/kg (8%). For adults, pooled RR also showed improved PASI responses over placebo for all biologics, with highest PASI75 response observed for ixekizumab (pooled RR = 16.18, 95% CI 11.83–22.14).ConclusionBoth adults and children with psoriasis show superior efficacy with biologics compared to control arms after 3 months of treatment with SAE incidences in the low percentages. Additional longer-term clinical studies are warranted to fully understand the overall efficacy-safety profile of biologics in children with moderate-to-severe psoriasis.

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Value of Literature Review to Inform Development and Use of Biologics in Juvenile Idiopathic Arthritis

Cited by 5 publications

References 42 publications

Temporomandibular involvement in children and adolescents with juvenile idiopathic arthritis: a 2-year prospective cohort study

Temporomandibular involvement in children and adolescents with juvenile idiopathic arthritis: a 2-year prospective cohort study

Biologic Disease-Modifying and Other Anti-Rheumatic Drugs Use in Patients with Moderate-to-Severe Juvenile Idiopathic Arthritis Based on a Japanese Nationwide Claims Database

Understanding efficacy-safety balance of biologics in moderate-to-severe pediatric psoriasis

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