All authors have decided to the submission of the manuscript to Rheumatology. Funding None. Option of components and data not applicable. Declarations Ethics consent and authorization to participatenot applicable. Consent for applicable publicationnot. Contending interestsAll authors possess nothing at all to declare. Footnotes This article continues to be updated to rectify several values and in-text errors, full points can be purchased in the correction article. Publishers Note Springer Nature continues to be neutral in regards to to jurisdictional statements in published maps and institutional affiliations.. protection results and 16/35 offered pharmacokinetic data. The most frequent investigated remedies had been TNF inhibitors (60%), IL-1 inhibitors (17%) and IL-6 inhibitors (9%). No RCTs with released results had been determined for baricitinib, brodalumab, certolizumab pegol, guselkumab, risankizumab, rituximab, sarilumab, secukinumab, tildrakizumab, or upadacitinib. In individuals with juvenile idiopathic joint disease (JIA) 25/35 RCTs had been conducted. The rest of the 10 RCTs had been performed in non-JIA individuals including plaque psoriasis, Kawasaki Disease, systemic lupus erythematosus and noninfectious uveitis. In JIA-RCTs, the control arm was placebo as well as the concomitant remedies had been either methotrexate primarily, nonsteroidal anti-inflammatory medicines (NSAID) or corticosteroids. Non-JIA individuals received NSAID mostly. You can find ongoing tests abatacept looking into, adalimumab, baricitinib, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, risankizumab, secukinumab, tildrakizumab and tofacitinib. Conclusion Regardless of the FDA Modernization Work and support of main paediatric rheumatology systems, like the Pediatric Rheumatology Collaborative Research Group (PRCSG) as well as the Paediatric Rheumatology International Studies Company (PRINTO), which led to drug acceptance for PiRD signs, a couple of limited RCTs in PiRD sufferers. As therapy response is normally inspired by age-dependent adjustments, pharmacokinetic procedures and disease training course it’s important to consider developmental adjustments in bDMARDs/JAK inhibitor make use of in PiRD sufferers. As such it is advisable to collaborate and carry out worldwide RCTs to properly investigate and characterize efficiency, pharmacokinetics and basic safety of bDMARDs/JAK inhibitors in paediatric rheumatology. Supplementary Information The web version includes supplementary material offered by 10.1186/s12969-021-00514-4. interleukin, tumour necrosis aspect, Janus Kinase, juvenile idiopathic joint disease, connective tissues disease, polyarticular juvenile idiopathic joint disease, Kawasaki disease, systemic juvenile idiopathic joint disease, oligoarticular juvenile idiopathic joint disease, enthesitis-related juvenile idiopathic joint disease, psoriatic juvenile idiopathic joint disease, systemic lupus erythematosus Desk 3 Ongoing or recruiting research in paediatric sufferers with inflammatory rheumatic illnesses (July 2020) interleukin, tumour necrosis aspect, Janus Kinase, enthesitis-related juvenile idiopathic joint disease, juvenile idiopathic joint disease, oligoarticular juvenile idiopathic joint disease, psoriasis region and intensity index, Physician global evaluation, polyarticular juvenile idiopathic joint disease, systemic juvenile idiopathic joint disease, not really applicable registered under EudraCT 2017C003053-42 aAlso; signed up under EudraCT 2019C004141-32 bAlso, signed up under EudraCT 2019C001868-30 cAlso; signed up under EudraCT 2016C003761-26 dAlso; signed up under EudraCT 2017C004515-39 eAlso; signed up under EudraCT 2014C005663-32 fAlso; signed up under EudraCT 2019C000412-29 gAlso; signed up under EudraCT 2019C00119-10 hAlso; signed up under EudraCT 2017C004495-60 iAlso; jAlso signed up under EudraCT 2017C004518-24 Research characteristics Around two-thirds (25 out of 35) from the discovered RCTs had been executed in JIA sufferers and the rest of the ten RCTs had been performed in non-JIA sufferers, including KD, plaque psoriasis, SLE, and noninfectious uveitis (Desks?4 and?5). The mean/median age group of children signed up for the JIA RCTs ranged from 8?years to 15.3?years. On the other hand, the non-JIA sufferers contained in RCTs acquired a mean/median a long time differing between 2.2 and 15.2?years, with KD sufferers getting younger (range 2.2-3 3.7?years). In JIA RCTs, the control was placebo generally, as well as the concomitant history remedies had been either methotrexate generally, Corticosteroids or NSAID, whereas in non-JIA studies the control arm was an assortment of placebo or regular of care remedies and sufferers received mainly NSAID as history remedies (data not really proven for the control arm). The principal efficacy final result/endpoint in the JIA RCTs was generally ACR Pedi 30/improved ACR Pedi 30 or disease flare (Desk?4). Other equipment to measure the principal outcome had been count of joint parts with active joint disease, the evaluation of Spondyloarthritis International Culture 40% rating (ASAS 40), inactive disease, treatment failing and improvement of laser beam flare photometry (Desk?4). In non-JIA sufferers, efficacy final results/endpoints varied because of heterogeneous subgroups. The principal efficiency final result/endpoint of RCTs in KD was linked to fever generally, whereas for plaque psoriasis the Psoriasis Region and Intensity Index (PASI 75), or the Physician Global Evaluation (PGA) was utilized (Desk?5). The RCT handling SLE utilized the SLR response index (SRI 4), whereas the principal final result/endpoint in noninfectious uveitis was evaluated with uveitis disease activity using the Standardization of Uveitis Nomenclature (Sunlight) requirements, AC cells and vitreous haze. A lot of the JIA RCTs had been global research or executed in either European countries or america usually, with one research (NCT00144599) situated in Japan (data not really proven). The non-JIA RCTs occurred either in THE UNITED STATES, Europe or globally (data not shown). In particular, KD RCTs took place mainly in Asia or the United States. Details for JIA and non-JIA RCTs are shown in Furniture?4 and?5. All non-JIA studies were of a.JIA is one of the most commonly diagnosed PiRDs with a prevalence of 16/100,000 to 150/100,000 [3]. inhibitors (17%) and IL-6 inhibitors (9%). No RCTs with published results were recognized for baricitinib, brodalumab, certolizumab pegol, guselkumab, risankizumab, rituximab, sarilumab, secukinumab, tildrakizumab, or upadacitinib. In patients with juvenile idiopathic arthritis (JIA) 25/35 RCTs were conducted. The remaining 10 RCTs were performed in non-JIA patients including plaque psoriasis, Kawasaki Disease, systemic lupus erythematosus and non-infectious uveitis. In JIA-RCTs, the control arm was mainly placebo and the concomitant treatments were either methotrexate, non-steroidal anti-inflammatory drugs (NSAID) or corticosteroids. Non-JIA patients mostly received NSAID. You will find ongoing trials investigating abatacept, adalimumab, baricitinib, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, risankizumab, secukinumab, tofacitinib and tildrakizumab. Conclusion Despite the FDA Modernization Take action and support of major paediatric rheumatology networks, such as the Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Business (PRINTO), which resulted in drug approval for PiRD indications, you will find limited RCTs in PiRD patients. As therapy response is usually influenced by age-dependent changes, pharmacokinetic processes and disease course it is important to consider developmental changes in bDMARDs/JAK inhibitor use in PiRD patients. As such it is critical to collaborate and conduct international RCTs to appropriately investigate and characterize efficacy, security and pharmacokinetics of bDMARDs/JAK inhibitors in paediatric rheumatology. Supplementary Information The online version contains supplementary material available at 10.1186/s12969-021-00514-4. interleukin, tumour necrosis factor, Janus Kinase, juvenile idiopathic arthritis, connective tissue disease, polyarticular juvenile idiopathic arthritis, Kawasaki disease, systemic juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, enthesitis-related juvenile idiopathic arthritis, psoriatic juvenile idiopathic arthritis, systemic lupus erythematosus Table 3 Ongoing or recruiting studies in paediatric patients with inflammatory rheumatic diseases (July 2020) interleukin, tumour necrosis factor, Janus Kinase, enthesitis-related juvenile idiopathic arthritis, juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, psoriasis area and severity index, Physician global assessment, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, not applicable aAlso registered under EudraCT 2017C003053-42; bAlso registered under EudraCT 2019C004141-32, cAlso registered under EudraCT 2019C001868-30; dAlso registered under EudraCT 2016C003761-26; eAlso registered under EudraCT 2017C004515-39; fAlso registered under EudraCT 2014C005663-32; gAlso registered under EudraCT 2019C000412-29; hAlso registered under EudraCT 2019C00119-10; iAlso registered under EudraCT 2017C004495-60; jAlso registered under EudraCT 2017C004518-24 Study characteristics Approximately two-thirds (25 out of 35) of the recognized RCTs were conducted in JIA patients and the remaining ten RCTs were performed in non-JIA patients, including KD, plaque psoriasis, SLE, and non-infectious uveitis (Furniture?4 and?5). The mean/median age of children enrolled in the JIA RCTs ranged from 8?years to 15.3?years. In contrast, the non-JIA patients included in RCTs experienced a mean/median age range varying between 2.2 and 15.2?years, with KD patients being younger (range 2.2 to 3 3.7?years). In JIA RCTs, the control was mainly placebo, and the concomitant background treatments were usually either methotrexate, NSAID or corticosteroids, whereas in non-JIA trials the control arm was a mixture of placebo or standard of care treatments and patients received mostly NSAID as background treatments Anabasine (data not shown for the control arm). The primary efficacy outcome/endpoint in the JIA RCTs was mainly ACR Pedi 30/modified ACR Pedi 30 or disease flare (Table?4). Other instruments to assess the primary outcome were count of joints with active arthritis, the assessment of Spondyloarthritis International Society 40% score (ASAS 40), inactive disease,.For example, the FDA has approved rilonacept for the treatment of the Cryopyrin-associated periodic syndrome (CAPS) in adults and children aged 12?years and older, whereas EMA has not. in case of (i) observational or single arm study or (ii) sample size 5 patients. Study characteristics were extracted. Results Out of 608 screened references, 65 references were selected, reporting 35 unique RCTs. All 35 RCTs reported efficacy while 34/35 provided safety outcomes and 16/35 provided pharmacokinetic data. The most common investigated treatments were TNF inhibitors (60%), IL-1 inhibitors (17%) and IL-6 inhibitors (9%). No RCTs with published results were identified for baricitinib, brodalumab, certolizumab pegol, guselkumab, risankizumab, rituximab, sarilumab, secukinumab, tildrakizumab, or upadacitinib. In patients with juvenile idiopathic arthritis (JIA) 25/35 RCTs were conducted. The remaining 10 RCTs were performed in non-JIA patients including plaque psoriasis, Kawasaki Disease, systemic lupus erythematosus and non-infectious uveitis. In JIA-RCTs, the control arm was mainly placebo and the concomitant treatments were either methotrexate, non-steroidal anti-inflammatory drugs (NSAID) or corticosteroids. Non-JIA patients mostly received NSAID. There are ongoing trials investigating abatacept, adalimumab, baricitinib, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, risankizumab, secukinumab, tofacitinib and tildrakizumab. Conclusion Despite the FDA Modernization Act and support of major paediatric rheumatology networks, such as the Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organization (PRINTO), which resulted in drug approval for PiRD indications, there are limited RCTs in PiRD patients. As therapy response is influenced by age-dependent changes, pharmacokinetic processes and disease course it is important to consider developmental changes in bDMARDs/JAK inhibitor use in PiRD patients. As such it is critical to collaborate and conduct international RCTs to appropriately investigate and characterize efficacy, safety and pharmacokinetics of bDMARDs/JAK inhibitors in paediatric rheumatology. Supplementary Information The online version contains supplementary material available at 10.1186/s12969-021-00514-4. interleukin, tumour necrosis factor, Janus Kinase, juvenile idiopathic arthritis, connective tissue disease, polyarticular juvenile idiopathic arthritis, Kawasaki disease, systemic juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, enthesitis-related juvenile idiopathic arthritis, psoriatic juvenile idiopathic arthritis, systemic lupus erythematosus Table 3 Ongoing or recruiting studies in paediatric patients with inflammatory rheumatic diseases (July 2020) interleukin, tumour necrosis factor, Janus Kinase, enthesitis-related juvenile idiopathic arthritis, juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, psoriasis area and severity index, Physician global assessment, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, not applicable aAlso registered under EudraCT 2017C003053-42; bAlso authorized under EudraCT 2019C004141-32, cAlso authorized under EudraCT 2019C001868-30; dAlso authorized under EudraCT 2016C003761-26; eAlso authorized under EudraCT 2017C004515-39; fAlso authorized under EudraCT 2014C005663-32; gAlso authorized under EudraCT 2019C000412-29; hAlso authorized under EudraCT 2019C00119-10; iAlso authorized under EudraCT 2017C004495-60; jAlso authorized under EudraCT 2017C004518-24 Research characteristics Around two-thirds (25 out of 35) from the determined RCTs had been carried out in JIA individuals and the rest of the ten RCTs had been performed in non-JIA individuals, including KD, plaque psoriasis, SLE, and noninfectious uveitis (Dining tables?4 and?5). The mean/median age group of children signed up for the JIA RCTs ranged from 8?years Anabasine to 15.3?years. On the other hand, the non-JIA individuals contained in RCTs got a mean/median a long time differing between 2.2 and 15.2?years, with KD individuals getting younger (range 2.2-3 3.7?years). In JIA RCTs, the control was primarily placebo, as well as the concomitant history remedies had been generally either methotrexate, NSAID or corticosteroids, whereas in non-JIA tests the control arm was an assortment of placebo or regular of care remedies and individuals received mainly NSAID as history remedies (data not really demonstrated for the control arm). The principal efficacy result/endpoint in the JIA RCTs was primarily ACR Pedi 30/revised ACR Pedi 30 or disease flare (Desk?4). Other tools to measure the major outcome had been count of bones with active joint disease, the evaluation of Spondyloarthritis International Culture 40% rating (ASAS 40), inactive disease, treatment failing and improvement of laser beam flare photometry (Desk?4). In non-JIA individuals, efficacy results/endpoints varied because of heterogeneous subgroups. The principal efficacy result/endpoint of RCTs in KD was primarily linked to fever, whereas for plaque psoriasis the Psoriasis Region and Intensity Index (PASI 75), or the Physician Global Evaluation (PGA) was utilized (Desk?5). The RCT dealing with SLE utilized the SLR response index (SRI 4), whereas the principal result/endpoint in noninfectious uveitis was evaluated with uveitis disease activity using the Standardization of Uveitis Nomenclature (Sunlight) requirements, AC cells and vitreous.Additional instruments to measure the major outcome were count number of important joints with active joint disease, the assessment of Spondyloarthritis International Society 40% score (ASAS 40), inactive disease, treatment failing and improvement of laser beam flare photometry (Desk?4). offered pharmacokinetic data. The most frequent investigated remedies had been TNF inhibitors (60%), IL-1 inhibitors (17%) and IL-6 inhibitors (9%). No RCTs with released results had been determined for baricitinib, brodalumab, certolizumab pegol, guselkumab, risankizumab, rituximab, sarilumab, secukinumab, tildrakizumab, or upadacitinib. In individuals with juvenile idiopathic joint disease (JIA) 25/35 RCTs had been conducted. The rest of the 10 RCTs had been performed in non-JIA individuals including plaque psoriasis, Kawasaki Disease, systemic lupus erythematosus and noninfectious uveitis. In JIA-RCTs, the control arm was primarily placebo as well as the concomitant remedies had been either methotrexate, nonsteroidal anti-inflammatory medicines (NSAID) or corticosteroids. Non-JIA individuals mainly received NSAID. You can find ongoing trials looking into abatacept, adalimumab, baricitinib, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, risankizumab, secukinumab, tofacitinib and tildrakizumab. Summary Regardless of the FDA Modernization Work and support of main paediatric rheumatology systems, like the Pediatric Rheumatology Collaborative Research Group (PRCSG) as well as the Paediatric Rheumatology International Tests Corporation (PRINTO), which led to drug authorization for PiRD signs, you can find limited RCTs in PiRD individuals. As therapy response can be affected by age-dependent adjustments, pharmacokinetic procedures and disease program it’s important to CACNLG consider developmental adjustments in bDMARDs/JAK inhibitor make use of in PiRD individuals. As such it is critical to collaborate and conduct international RCTs to appropriately investigate and characterize effectiveness, security and pharmacokinetics of bDMARDs/JAK inhibitors in paediatric rheumatology. Supplementary Info The online version contains supplementary material available at 10.1186/s12969-021-00514-4. interleukin, tumour necrosis element, Janus Kinase, juvenile idiopathic arthritis, connective cells disease, polyarticular juvenile idiopathic arthritis, Kawasaki disease, systemic juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, enthesitis-related juvenile idiopathic arthritis, psoriatic juvenile idiopathic arthritis, systemic lupus erythematosus Table 3 Ongoing or recruiting studies in paediatric individuals with inflammatory rheumatic diseases (July 2020) interleukin, tumour necrosis element, Janus Kinase, enthesitis-related juvenile idiopathic arthritis, juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, psoriasis area and severity index, Physician global assessment, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, not applicable aAlso authorized under EudraCT 2017C003053-42; bAlso authorized under EudraCT 2019C004141-32, cAlso authorized under EudraCT 2019C001868-30; dAlso authorized under EudraCT 2016C003761-26; eAlso authorized under EudraCT 2017C004515-39; fAlso authorized under EudraCT 2014C005663-32; gAlso authorized under EudraCT 2019C000412-29; hAlso authorized under EudraCT 2019C00119-10; iAlso authorized under EudraCT 2017C004495-60; jAlso authorized under EudraCT 2017C004518-24 Study characteristics Approximately two-thirds (25 out of 35) of the recognized RCTs were carried out in JIA individuals and the remaining ten RCTs were performed in non-JIA individuals, including KD, plaque psoriasis, SLE, and non-infectious uveitis (Furniture?4 and?5). The mean/median age of children enrolled in the JIA RCTs ranged from 8?years to 15.3?years. In contrast, the non-JIA individuals included in RCTs experienced a mean/median age range varying between 2.2 and 15.2?years, with KD individuals being younger (range 2.2 to 3 3.7?years). In JIA RCTs, the control was primarily placebo, and the concomitant background treatments were usually either methotrexate, NSAID or corticosteroids, whereas in non-JIA tests the control arm was a mixture of placebo or standard of care treatments and individuals received mostly NSAID as background treatments (data not demonstrated for the control arm). The primary efficacy end result/endpoint in the JIA RCTs was primarily ACR Pedi 30/altered ACR Pedi 30 or disease flare (Table?4). Other devices to assess the main outcome were count of bones with active arthritis, the assessment of Spondyloarthritis International Society 40% score (ASAS 40), inactive disease, treatment failure and improvement of laser flare photometry (Table?4). In non-JIA individuals, efficacy results/endpoints varied due to heterogeneous.This might explain why a majority of Anabasine RCTs were performed for etanercept. in case of (we) observational or solitary arm study or (ii) sample size 5 individuals. Study characteristics were extracted. Results Out of 608 screened recommendations, 65 references were selected, reporting 35 unique RCTs. All 35 RCTs reported effectiveness while 34/35 offered safety results and 16/35 offered pharmacokinetic data. The most common investigated treatments were TNF inhibitors (60%), IL-1 inhibitors (17%) and IL-6 inhibitors (9%). No RCTs with published results were recognized for baricitinib, brodalumab, certolizumab pegol, guselkumab, risankizumab, rituximab, sarilumab, secukinumab, tildrakizumab, or upadacitinib. In individuals with juvenile idiopathic arthritis (JIA) 25/35 RCTs were conducted. The remaining 10 RCTs were performed in non-JIA individuals including plaque psoriasis, Kawasaki Disease, systemic lupus erythematosus and non-infectious uveitis. In JIA-RCTs, the control arm was primarily placebo and the concomitant treatments were either methotrexate, non-steroidal anti-inflammatory medicines (NSAID) or corticosteroids. Non-JIA individuals mostly received NSAID. You will find ongoing trials investigating abatacept, adalimumab, baricitinib, brodalumab, certolizumab pegol, etanercept, guselkumab, infliximab, risankizumab, secukinumab, tofacitinib and tildrakizumab. Bottom line Regardless of the FDA Modernization Work and support of main paediatric rheumatology systems, like the Pediatric Rheumatology Collaborative Research Group (PRCSG) as well as the Paediatric Rheumatology International Studies Firm (PRINTO), which led to drug acceptance for PiRD signs, you can find limited RCTs in PiRD sufferers. As therapy response is certainly inspired by age-dependent adjustments, pharmacokinetic procedures and disease training course it’s important to consider developmental adjustments in bDMARDs/JAK inhibitor make use of in PiRD sufferers. As such it is advisable to collaborate and carry out worldwide RCTs to properly investigate and characterize efficiency, protection and pharmacokinetics of bDMARDs/JAK inhibitors in paediatric rheumatology. Supplementary Details The online edition contains supplementary materials offered by 10.1186/s12969-021-00514-4. interleukin, tumour necrosis aspect, Janus Kinase, juvenile idiopathic joint disease, connective tissues disease, polyarticular juvenile idiopathic joint disease, Kawasaki disease, systemic juvenile idiopathic joint disease, oligoarticular juvenile idiopathic joint disease, enthesitis-related juvenile idiopathic joint disease, psoriatic juvenile idiopathic joint disease, systemic lupus erythematosus Desk 3 Ongoing or recruiting research in paediatric sufferers with inflammatory rheumatic illnesses (July 2020) interleukin, tumour necrosis aspect, Janus Kinase, enthesitis-related juvenile idiopathic joint disease, juvenile idiopathic joint disease, oligoarticular juvenile idiopathic joint disease, psoriasis region and intensity index, Physician global evaluation, polyarticular juvenile idiopathic joint disease, systemic juvenile idiopathic joint disease, not really applicable aAlso signed up under EudraCT 2017C003053-42; bAlso signed up under EudraCT 2019C004141-32, cAlso signed up under EudraCT 2019C001868-30; dAlso signed up under EudraCT 2016C003761-26; eAlso signed up under EudraCT 2017C004515-39; fAlso signed up under EudraCT 2014C005663-32; gAlso signed up under EudraCT 2019C000412-29; hAlso signed up under EudraCT 2019C00119-10; iAlso signed up under EudraCT 2017C004495-60; jAlso signed up under EudraCT 2017C004518-24 Research characteristics Around two-thirds (25 out of 35) from the determined RCTs had been executed in JIA sufferers and the rest of the ten RCTs had been performed in non-JIA sufferers, including KD, plaque psoriasis, SLE, and noninfectious uveitis (Dining tables?4 and?5). The mean/median age group of children signed up for the JIA RCTs ranged from 8?years to 15.3?years. On the other hand, the non-JIA sufferers contained in RCTs got a mean/median a long time differing between 2.2 and 15.2?years, with KD sufferers getting younger (range 2.2-3 3.7?years). In JIA RCTs, the control was generally placebo, as well as the concomitant history remedies had been generally either methotrexate, NSAID or corticosteroids, whereas in non-JIA studies the control arm was an assortment of placebo or regular of care remedies and sufferers received mainly NSAID as history remedies (data not really proven for the control arm). The principal efficacy result/endpoint in the JIA RCTs was generally ACR Pedi 30/customized ACR Pedi 30 or disease flare (Desk?4). Other musical instruments to measure the major outcome had been count of joint parts with active joint disease, the evaluation of Spondyloarthritis International Culture 40% score (ASAS 40), inactive disease, treatment failure and improvement of laser flare photometry (Table?4). In non-JIA patients, efficacy outcomes/endpoints varied due to heterogeneous subgroups. The primary efficacy outcome/endpoint of RCTs in KD was mainly related to fever, whereas for plaque psoriasis the Psoriasis Area and Severity Index (PASI 75), or the Physician Global Assessment (PGA) was used (Table?5). The RCT addressing SLE used the SLR response index (SRI 4), whereas the primary outcome/endpoint in non-infectious uveitis was assessed with uveitis disease activity using the Standardization of Uveitis Nomenclature (SUN) criteria, AC cells and vitreous haze. The majority of the JIA RCTs were global studies or otherwise conducted in either Europe or the United States, with one study (NCT00144599) located in Japan (data not shown). The non-JIA RCTs took place either in North America, Europe or globally (data not shown). In particular, KD RCTs took place mainly in Asia or the United States. Details for JIA and non-JIA RCTs are shown in Tables?4.