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3 studies confirm the value of etanercept therapy in treating juvenile idiopathic arthritis
June 12, 2009Three new studies have individually shown the anti-TNF (tumour necrosis factor) therapy etanercept to be effective, with a good safety profile, in children under four years of age with juvenile idiopathic arthritis (JIA), and associated with improved Health-Related Quality of Life (HRQoL) in a substantial proportion of children with JIA. The data are being presented at the Paediatric Rheumatology European Society Congress (PReS) 2009, a joint congress with the 2009 Congress of the European League Against Rheumatism (EULAR) in Copenhagen, Denmark.
The first study, conducted in Italy, showed entanercept to be effective, with a good safety profile, in children under four years of age (an as yet unlicensed patient population for the treatment). Thirty-three patients under four years of age with unresponsive JIA (24 female, 9 male) were treated with etanercept for an average of 23 months. After the first 6 months of treatment, 82% achieved the ACR Pedi 30* response and 48% achieved the ACR Pedi 70* response. There was a low rate of mild adverse events, whilst one patient temporarily suspended treatment following hospitalisation for an infection.
The second study, conducted in The Netherlands, from the Arthritis and Biological in Children (ABC) project, observed impressive improvements in the Health-Related Quality of Life (HRQoL) of 53 patients with previously refractory (unresponsive) JIA in seven Dutch centres during entanercept use of at least 27 months. These comprised both disease-specific improvements (inflamed joints, functional impairment, erythrocyte sedimentation rate (ESR), a laboratory marker of inflammation) (p<0.001) and all generic HRQoL outcomes impaired by JIA (including pain, movement and dexterity) (p<0.05).
The third study, also from The Netherlands ABC-project, showed that a substantial 57% of non-responders to etanercept at three months (12 patients from 21 non-responders of a total of 179 JIA patients; average age of 5.8 years) who continued with the treatment eventually responded. The researchers in this study thereby suggest extending the use of etanercept in non-responding patients beyond the commonly recommended three-month therapy window to achieve higher response rates in JIA patients.
* The American College of Rheumatology (ACR) pediatric criteria assess patient response to a treatment. An ACR Pedi 30 response represents a >30% improvement in JIA signs and symptoms, such as the number of swollen joints with loss of motion, assessment of pain and level of disability. ACR Pedi 50 represents a >50% improvement, and ACR Pedi 70 represents a >70% improvement.
Further details on the three studies are outlined below:
1. Safety and efficacy of etanercept in a cohort of juvenile idiopathic arthritis (JIA) patients under four years of age. (OP-0137)
Thirty-three patients with unresponsive JIA under four years of age in a single centre were treated with etanercept for a mean of 23 months (range 6-86), with all receiving other concurrent drug treatments. Efficacy (using ACR Pediatric 30, 50 and 70 criteria for improvement) and safety end points were recorded at each hospital visit.
The ACR Pedi 30 response was reached by 82% (27) after 6 months and 85% (28) at the last observation. The ACR Pedi 50 response was reached by 76% (25) at 6 months and 85% (28) at the last follow-up, and the ACR Pedi 70 response was reached by 48% and 73% respectively.
Four patients (12%) developed mild adverse events: including one case of cytomegalovirus infection and three varicella zoster virus (VZV) infections. One patient experienced a serious adverse event and was hospitalised for a necrotising fasciitis during VZV infection. No cases of tuberculosis, opportunistic infections or malignancies were reported.
2. Major improvements in health-related quality of life during the use of etanercept in patients with refractory juvenile idiopathic arthritis. (THU0426)
In 53 JIA patients, who previously did not respond to other second-line drugs, data were collected to evaluate HRQoL during treatment with etanercept. HRQoL was measured by the Childhood Health Assessment Questionnaire (CHAQ), Child Health Questionnaire (CHQ) and Health Utilities Index mark 3 (HUI3) before start and after 3, 15 and 27 months. At the same time-points, information on JIA disease activity variables were also collected, including; physician's global assessment through the Visual Analogue Scale (VAS), number of active and limited joints and erythrocyte sedimentation rate. Linear mixed models were used to assess outcomes over time.
Significant improvements in HRQoL were seen during the 27 month study period. The disease specific CHAQ, including the VAS pain and VAS well-being scores showed a significant improvement on all domains (p<0.001). The generic health-profile measure CHQ improved on all the health concepts (p<0.05) except 'family cohesion', which is known to be unaffected by JIA.1 The generic preference-based HUI3 showed significant improvement (p<0.05) on the more specific areas of 'pain', 'ambulatory', and 'dexterity'. In accordance, disease activity variables improved significantly over time (p<0.001).
Dr Femke H.M. Prince of the Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands, said: "JIA, the most common cause of chronic arthritis in children, frequently results in physical disabilities and chronic pain influencing daily life. The results for the Arthritis and Biologicals in Children project show impressive improvement on all domains of Health-Related Quality of Life impaired by JIA during treatment with etanercept. This indicates that these previously severely ill children, as well as their families, gain great benefits from this treatment. The results of our studies add to the bank of research on the role of etanercept in treating JIA patients of all subtypes who previously have not responded to other second-line drugs."
3. Delayed clinical response in patients with juvenile idiopathic arthritis treated with etanercept. (FRI0478)
From 179 JIA patients in the ABC-register, with a minimal follow-up of 15 months, the clinical response was assessed using the American College of Rheumatology Paediatric 30 variables. Of the 34 patients who initially failed to meet these response criteria, 21 continued etanercept therapy and 12 patients reached a delayed response at 15 months of treatment. Overall, 7% of the 179 patients were delayed responders after 3 months of treatment and this was most likely in those with the oligoarticular, arthritis psoriatica and enthesitis related arthritis subtypes.
Dr Marieke H. Otten of the Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands, said: 'Biological agents are one of the last therapeutic options for JIA and have shown to be highly effective in refractory patients. Previous studies on etanercept have shown rapid improvements, but the optimal duration to evaluate effectiveness is still unknown. This study shows a delayed clinical response in a substantial proportion of the patients treated with etanercept. We advise, especially in patients with a partial response, to continue treatment to at least six months.'
European League Against Rheumatism
The third study, also from The Netherlands ABC-project, showed that a substantial 57% of non-responders to etanercept at three months (12 patients from 21 non-responders of a total of 179 JIA patients; average age of 5.8 years) who continued with the treatment eventually responded. The researchers in this study thereby suggest extending the use of etanercept in non-responding patients beyond the commonly recommended three-month therapy window to achieve higher response rates in JIA patients.
* The American College of Rheumatology (ACR) pediatric criteria assess patient response to a treatment. An ACR Pedi 30 response represents a >30% improvement in JIA signs and symptoms, such as the number of swollen joints with loss of motion, assessment of pain and level of disability. ACR Pedi 50 represents a >50% improvement, and ACR Pedi 70 represents a >70% improvement.
Further details on the three studies are outlined below:
1. Safety and efficacy of etanercept in a cohort of juvenile idiopathic arthritis (JIA) patients under four years of age. (OP-0137)
Thirty-three patients with unresponsive JIA under four years of age in a single centre were treated with etanercept for a mean of 23 months (range 6-86), with all receiving other concurrent drug treatments. Efficacy (using ACR Pediatric 30, 50 and 70 criteria for improvement) and safety end points were recorded at each hospital visit.
The ACR Pedi 30 response was reached by 82% (27) after 6 months and 85% (28) at the last observation. The ACR Pedi 50 response was reached by 76% (25) at 6 months and 85% (28) at the last follow-up, and the ACR Pedi 70 response was reached by 48% and 73% respectively.
Four patients (12%) developed mild adverse events: including one case of cytomegalovirus infection and three varicella zoster virus (VZV) infections. One patient experienced a serious adverse event and was hospitalised for a necrotising fasciitis during VZV infection. No cases of tuberculosis, opportunistic infections or malignancies were reported.
2. Major improvements in health-related quality of life during the use of etanercept in patients with refractory juvenile idiopathic arthritis. (THU0426)
In 53 JIA patients, who previously did not respond to other second-line drugs, data were collected to evaluate HRQoL during treatment with etanercept. HRQoL was measured by the Childhood Health Assessment Questionnaire (CHAQ), Child Health Questionnaire (CHQ) and Health Utilities Index mark 3 (HUI3) before start and after 3, 15 and 27 months. At the same time-points, information on JIA disease activity variables were also collected, including; physician's global assessment through the Visual Analogue Scale (VAS), number of active and limited joints and erythrocyte sedimentation rate. Linear mixed models were used to assess outcomes over time.
Significant improvements in HRQoL were seen during the 27 month study period. The disease specific CHAQ, including the VAS pain and VAS well-being scores showed a significant improvement on all domains (p<0.001). The generic health-profile measure CHQ improved on all the health concepts (p<0.05) except 'family cohesion', which is known to be unaffected by JIA.1 The generic preference-based HUI3 showed significant improvement (p<0.05) on the more specific areas of 'pain', 'ambulatory', and 'dexterity'. In accordance, disease activity variables improved significantly over time (p<0.001).
Dr Femke H.M. Prince of the Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands, said: "JIA, the most common cause of chronic arthritis in children, frequently results in physical disabilities and chronic pain influencing daily life. The results for the Arthritis and Biologicals in Children project show impressive improvement on all domains of Health-Related Quality of Life impaired by JIA during treatment with etanercept. This indicates that these previously severely ill children, as well as their families, gain great benefits from this treatment. The results of our studies add to the bank of research on the role of etanercept in treating JIA patients of all subtypes who previously have not responded to other second-line drugs."
3. Delayed clinical response in patients with juvenile idiopathic arthritis treated with etanercept. (FRI0478)
From 179 JIA patients in the ABC-register, with a minimal follow-up of 15 months, the clinical response was assessed using the American College of Rheumatology Paediatric 30 variables. Of the 34 patients who initially failed to meet these response criteria, 21 continued etanercept therapy and 12 patients reached a delayed response at 15 months of treatment. Overall, 7% of the 179 patients were delayed responders after 3 months of treatment and this was most likely in those with the oligoarticular, arthritis psoriatica and enthesitis related arthritis subtypes.
Dr Marieke H. Otten of the Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands, said: 'Biological agents are one of the last therapeutic options for JIA and have shown to be highly effective in refractory patients. Previous studies on etanercept have shown rapid improvements, but the optimal duration to evaluate effectiveness is still unknown. This study shows a delayed clinical response in a substantial proportion of the patients treated with etanercept. We advise, especially in patients with a partial response, to continue treatment to at least six months.'
European League Against Rheumatism
Juvenile Idiopathic Arthritis Current Events and Juvenile Idiopathic Arthritis News RSSGene expression findings a step toward better classification and treatment of juvenile arthritis
Scientists have discovered gene expression differences that could lead to better ways to classify, predict outcome, and treat juvenile idiopathic arthritis (JIA).
Early treatment of systemic onset JIA with anakinra restores the IL-18 response
First line treatment with anakinra (an interleukin-1 (IL-1) receptor antagonist), results in a 'good' clinical response (ACRp90) in patients newly diagnosed with systemic onset juvenile idiopathic arthritis (SoJIA), and restores the deficient IL-18 response of natural killer (NK) cells.
Subclinical markers predict relapse in juvenile idiopathic arthritis post methotrexate withdrawal
Elevated levels of the inflammatory biomarkers Myeloid Related Protein (MRP) 8/14 predict an increased risk of relapse following withdrawal of methotrexate (MTX) therapy in children with juvenile idiopathic arthritis (JIA) who have achieved inactive disease status.
Pediatric researchers find possible 'master switch' gene in juvenile arthritis
Researchers have found that a gene region known to play a role in some varieties of adult rheumatoid arthritis is also present in all types of childhood arthritis. The researchers say the responsible gene may be a "master switch" that helps turn on the debilitating disease.
Early life infections increase the risk of rheumatoid arthritis and juvenile idiopathic arthritis
Infections during the first year of life are a marker of increased risk of developing specific types of arthritis later in life.
NICE gives backing for the use of advanced biological therapies to treat severe psoriasis
The UK National Institute for Health and Clinical Excellence (NICE) has today issued guidance for the use of the targeted biological therapies, Enbrel® (etanercept) and Raptiva® (efalizumab), to treat adult patients with severe plaque psoriasis.
Tocilizumab study offers new hope for children with arthritis
A new study has confirmed significant improvements after treatment with tocilizumab amongst children with systemic juvenile idiopathic arthritis (sJIA), who do not tolerate or have an inadequate response to conventional therapies.
Identification of role for proteins in children's muscle disease could open up new treatment options
A study presented by Mrs. Elisabeth Elst today shows for the first time that a protein—heat shock protein 60 (HSP60) — that is present in chronic inflammations, triggers a response by T-cells (a type of white blood cells that plays a part in the body's own immune response) in children with juvenile dermatomyositis (JDM).
Childhood arthritis raises risk of broken bones
Childhood arthritis increases the risk of fractures, particularly during adolescence, according to a large study of British patient records.
Study provides guidelines for treatment of juvenile idiopathic arthritis
A study published by the Cleveland Clinic and The Hospital for Sick Children (SickKids) provides the medical community for the first time with specific guidelines for treating juvenile idiopathic arthritis (JIA), previously known as juvenile rheumatoid arthritis (JRA), a condition that affects approximately one in every 1,000 children.
More Juvenile Idiopathic Arthritis Current Events and Juvenile Idiopathic Arthritis News Articles
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JIA patients thrive, if they can find a specialist.(MUSCULOSKELETAL DISORDERS)(juvenile idiopathic arthritis): An article from: Family Practice News by Betsy Bates (Author) This digital document is an article from Family Practice News, published by International Medical News Group on May 1, 2009. The length of the article is 1069 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available immediately after purchase. You can view it with any web browser. Citation Details Title: JIA patients thrive, if they can find a specialist.(MUSCULOSKELETAL DISORDERS)(juvenile idiopathic arthritis) Author: Betsy Bates Publication: Family Practice News (Magazine/Journal) Date: May 1, 2009 Publisher: International Medical News Group Volume: 39 Issue: 9 Page: 29(1) Distributed by Gale, a part of Cengage... | |
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Juvenile Idiopathic Arthritis It may come as a surprise to hear that children can suffer from arthritis... but researchers estimate 1 in 1000 children in the United States and around the world are affected by this disease. Juvenile Idiopathic Arthritis, formerly known as Juvenile Rheumatoid Arthritis, is the most common form of arthritis affecting children. It is a disease involving the immune system, which can cause painful inflammation in the joints. Other areas of the body, especially the eyes may also show signs of the disease. There are several different forms of JIA, and each has its own treatment method. The good news is treatments are more advanced and abundant for JIA patients now, compared to a decade ago. This product is manufactured on demand using DVD-R recordable media. Amazon.com's standard return... |
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Step-up drug therapy can curb systemic JIA.(Clinical Rounds)(juvenile idiopathic arthritis): An article from: Pediatric News by Betsy Bates (Author) This digital document is an article from Pediatric News, published by International Medical News Group on March 1, 2005. The length of the article is 608 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser. Citation Details Title: Step-up drug therapy can curb systemic JIA.(Clinical Rounds)(juvenile idiopathic arthritis) Author: Betsy Bates Publication: Pediatric News (Magazine/Journal) Date: March 1, 2005 Publisher: International Medical News Group Volume: 39 Issue: 3 Page: 28(1) Distributed by Thomson... | |
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Arthritis in Children and Adolescents: Juvenile Idiopathic Arthritis (Szer, Arthritis in Children and Adolescents) by Ilona Szer (Editor), Yukiko Kimura (Editor), Pete Malleson (Editor), Taunton Southwood (Editor) The only textbook of childhood arthritis available in the world, this book employs a unique approach to the recognition and treatment of these complex and chronic conditions. First, the book is divided into three sections emphasizing the logical sequence of events that occur after the child who might have Juvenile Idiopathic Arthritis (JIA) first presents to the doctor with a musculoskeletal complaint; the reader is first taught the extensive differential diagnosis of arthritis using simple but extensive algorithms and detailed discussions of each condition; more than 200 conditions are discussed. This is followed by a discussion of all types of JIA, using a revised classification system created by the International League Against Arthritis. The introduction of the new classification... |
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Trunk and center of mass movements during gait in children with juvenile idiopathic arthritis [An article from: Human Movement Science] by E. Brostrom (Author), M. Ortqvist (Author), Y. Haglund-Akerlind (Author), Hag (Author) This digital document is a journal article from Human Movement Science, published by Elsevier in 2007. The article is delivered in HTML format and is available in your Amazon.com Media Library immediately after purchase. You can view it with any web browser. Description: Motion of the body center of mass (CoM) can often indicate the overall effect of the strategy of forward progression used. In the present study, focus is placed on trunk movements in the sagittal, coronal, and transverse/rotation plane, as well as placement of the CoM, during gait in children with juvenile idiopathic arthritis (JIA). Seventeen children with JIA, all with polyarticular lower extremity involvement were examined before and approximately two weeks after treatment with intra-articular... |
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Data back etanercept's safety, efficacy for children with JIA.(Musculoskelatal Disorders)(juvenile idiopathic arthritis)(Clinical report): An article from: Family Practice News by Nancy Walsh (Author) This digital document is an article from Family Practice News, published by Thomson Gale on September 15, 2006. The length of the article is 427 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser. Citation Details Title: Data back etanercept's safety, efficacy for children with JIA.(Musculoskelatal Disorders)(juvenile idiopathic arthritis)(Clinical report) Author: Nancy Walsh Publication: Family Practice News (Magazine/Journal) Date: September 15, 2006 Publisher: Thomson Gale Volume: 36 Issue: 18 Page: 44(1) Article Type: Clinical report Distributed by Thomson... | |
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Surgery eases joint discomfort in juvenile idiopathic arthritis patients.(Musculoskeletal Disorders): An article from: Family Practice News by Damian McNamara (Author) This digital document is an article from Family Practice News, published by Thomson Gale on August 1, 2007. The length of the article is 573 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser. Citation Details Title: Surgery eases joint discomfort in juvenile idiopathic arthritis patients.(Musculoskeletal Disorders) Author: Damian McNamara Publication: Family Practice News (Magazine/Journal) Date: August 1, 2007 Publisher: Thomson Gale Volume: 37 Issue: 15 Page: 35(1) Distributed by Thomson... | |
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Etanercept for juvenile idiopathic arthritis is safe in long term.(Across Specialties): An article from: Skin & Allergy News by Nancy Walsh (Author) This digital document is an article from Skin & Allergy News, published by Thomson Gale on September 1, 2007. The length of the article is 602 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser. Citation Details Title: Etanercept for juvenile idiopathic arthritis is safe in long term.(Across Specialties) Author: Nancy Walsh Publication: Skin & Allergy News (Magazine/Journal) Date: September 1, 2007 Publisher: Thomson Gale Volume: 38 Issue: 9 Page: 50(1) Distributed by Thomson... |
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