Magazin
2006-06-22
Basel, Switzerland and Amsterdam (ots/PRNewswire) -
- First RA Drug to Achieve These Results in Patients With anInadequate Response to Currently Available Treatments
New data presented at the EULAR meeting (European League AgainstRheumatism) show for the first time that MabThera (rituximab), aunique B cell targeted therapy, is able to significantly inhibitstructural damage of joints caused by rheumatoid arthritis (RA). Thestudy was conducted in patients who had an inadequate response to oneor more TNF inhibitors and they received either MabThera plusmethotrexate (MTX) or MTX alone. X-ray evidence at 56 weeks showedthat the progression of bone erosions and progression of narrowing ofjoint spaces in patients in the MabThera group were reduced by morethan 50 % compared to patients receiving MTX alone (erosion scores of0.59 and 1.32 respectively; joint space narrowing scores of 0.41 and0.99 respectively).
Damage to the structure of the joints ultimately causesdestruction of the joints and contributes to joint deformity and lossof mobility. Patients' ability to work and perform every day taskssuch as getting dressed, walking and eating can be severely hampered.
Presenting the results, Professor Keystone, RheumatologyDepartment at the University of Toronto, Canada, said: "This is thefirst evidence demonstrating that MabThera can inhibit structuraljoint damage in patients with an inadequate response to one or moreTNF inhibitors. Preventing structural damage is a critical outcome intreating rheumatoid arthritis. These X-ray data confirm MabThera asan effective and innovative therapy for patients with rheumatoidarthritis and highlight the value of targeting B cells."
Repeat treatment courses
Additional new data presented at EULAR demonstrate that repeatcourses of MabThera in RA patients, 6 to 12 months after the initialcourse, provide continued improvement of symptoms across all clinicalmeasures. Each treatment course consists of two infusions of 1000mggiven two weeks apart. The challenging goal of treatment in RA isremission and, following a second course of MabThera in patients withan inadequate response to one or more TNF inhibitors, the number ofpatients achieving remission doubled from 6 % following an initialcourse to 13 % following a second course. A similar trend was seenfor those achieving the hard-to-reach goal of a 70 % improvement insymptoms (ACR70), with responses increasing from 12 % following aninitial course to 21 % following a second course.
Patient perspectives
Importantly, data presented at EULAR show improvements in clinicalscores are reflected in patient reported outcomes.
"While it is important to a physician to address a disease from aclinical perspective, what matters most to the patient is whetherthey are able to function normally and how well they feel. Forexample, the impact of fatigue is often underestimated, but this issomething which really impacts patients' lives. MabThera hasdemonstrated continuous improvements in physical and mental healthaspects with repeated courses of therapy", said Professor Tak,Director, Division of Clinical Immunology and Rheumatology at theAcademic Medical Centre/University of Amsterdam, The Netherlands.
Editors notes:
Approval Status
On 2 June 2006 MabThera received a recommendation for approvalfrom the Committee for Medicinal Products for Human Use (CHMP) forthe treatment of rheumatoid arthritis (RA) in Europe. MabThera, incombination with methotrexate, has been recommended for the treatmentof adult patients with severe active rheumatoid arthritis who havehad an inadequate response or intolerance to other disease-modifyinganti-rheumatic drugs (DMARDs). On 28 February 2006, after priorityreview, Genentech and Biogen Idec received US approval for Rituxan(R)(rituximab in the US) for the treatment of adult patients withmoderately to severely active RA in combination with methotrexate forreducing signs and symptoms in those RA patients who have had aninadequate response to one or more tumour necrosis factor (TNF)antagonist therapies.
About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy ofMabThera in RA) is a multi-centre, randomized, double-blind,placebo-controlled Phase III study. In this trial, patients whoreceived a single course of only two infusions of MabThera with astable dose of methotrexate (MTX) displayed a statisticallysignificant improvement in symptoms measured at 24 weeks, compared tothose receiving placebo and MTX. Patients receiving additionalcourses did so between 6 and 12 months after the initial course.Consistent with previous findings, analysis of the REFLEX 56-weekdata did not reveal any unexpected safety signals. The companiescontinue to monitor the long-term safety of rituximab in all clinicaltrials.
A further phase III development programme for MabThera therapy inpatients with rheumatoid arthritis who have had an inadequateresponse to disease modifying anti-rheumatic drugs (DMARDs) isongoing.
Long term safety and repeated courses
Further new data of a pooled analysis presented at EULAR confirmedthe safety profile of rituximab identified in the original randomisedclinical trials. The analysis included all RA patients treated withMabThera during clinical development which amounted to over 1,600patient years with some patients being followed for over 3 years,many of whom had received multiple courses of treatment. Thisanalysis did not reveal any unexpected safety signals.
About MabThera in rheumatoid arthritis
MabThera selectively targets a subset of B cells that expressCD20, leaving stem, pro-B and plasma cells unaffected. This subset ofB cells plays a key role in the autoimmune process of RA and MabTheraaims to interrupt this process by inhibiting a series of reactionsinflaming the synovia and leading to cartilage loss and bone erosionthat is characteristic of the disease. More than 1,000 patients withRA have been treated with MabThera in clinical trials to date. Acomprehensive Phase III clinical development programme is alsocurrently underway to further investigate the potential clinicalbenefit of MabThera in earlier RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2005,sales by the Pharmaceuticals Division totalled 27.3 billion Swissfrancs, and the Diagnostics Division posted sales of 8.2 billionSwiss francs. Roche employs roughly 70,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).
All trademarks used or mentioned in this release are legallyprotected.
For further information:
- About EULAR: www.eular.org
- British Society for Rheumatology: www.rheumatology.org.uk
- American College of Rheumatology: www.rheumatology.org
- About Genentech: www.gene.com
- About BiogenIdec: www.biogenidec.com.
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Media Relations Contacts: Phone: +41-61-688-88-88, e-mail: basel.mediaoffice@roche.com, Baschi Dürr, Alexander Klauser, Daniel Piller (Head Roche Group Media Office), Katja Prowald (Head R&D Communications), Martina Rupp
New Evidence Shows MabThera Inhibits Joint Damage in Patients With Rheumatoid Arthritis
- First RA Drug to Achieve These Results in Patients With anInadequate Response to Currently Available Treatments
New data presented at the EULAR meeting (European League AgainstRheumatism) show for the first time that MabThera (rituximab), aunique B cell targeted therapy, is able to significantly inhibitstructural damage of joints caused by rheumatoid arthritis (RA). Thestudy was conducted in patients who had an inadequate response to oneor more TNF inhibitors and they received either MabThera plusmethotrexate (MTX) or MTX alone. X-ray evidence at 56 weeks showedthat the progression of bone erosions and progression of narrowing ofjoint spaces in patients in the MabThera group were reduced by morethan 50 % compared to patients receiving MTX alone (erosion scores of0.59 and 1.32 respectively; joint space narrowing scores of 0.41 and0.99 respectively).
Damage to the structure of the joints ultimately causesdestruction of the joints and contributes to joint deformity and lossof mobility. Patients' ability to work and perform every day taskssuch as getting dressed, walking and eating can be severely hampered.
Presenting the results, Professor Keystone, RheumatologyDepartment at the University of Toronto, Canada, said: "This is thefirst evidence demonstrating that MabThera can inhibit structuraljoint damage in patients with an inadequate response to one or moreTNF inhibitors. Preventing structural damage is a critical outcome intreating rheumatoid arthritis. These X-ray data confirm MabThera asan effective and innovative therapy for patients with rheumatoidarthritis and highlight the value of targeting B cells."
Repeat treatment courses
Additional new data presented at EULAR demonstrate that repeatcourses of MabThera in RA patients, 6 to 12 months after the initialcourse, provide continued improvement of symptoms across all clinicalmeasures. Each treatment course consists of two infusions of 1000mggiven two weeks apart. The challenging goal of treatment in RA isremission and, following a second course of MabThera in patients withan inadequate response to one or more TNF inhibitors, the number ofpatients achieving remission doubled from 6 % following an initialcourse to 13 % following a second course. A similar trend was seenfor those achieving the hard-to-reach goal of a 70 % improvement insymptoms (ACR70), with responses increasing from 12 % following aninitial course to 21 % following a second course.
Patient perspectives
Importantly, data presented at EULAR show improvements in clinicalscores are reflected in patient reported outcomes.
"While it is important to a physician to address a disease from aclinical perspective, what matters most to the patient is whetherthey are able to function normally and how well they feel. Forexample, the impact of fatigue is often underestimated, but this issomething which really impacts patients' lives. MabThera hasdemonstrated continuous improvements in physical and mental healthaspects with repeated courses of therapy", said Professor Tak,Director, Division of Clinical Immunology and Rheumatology at theAcademic Medical Centre/University of Amsterdam, The Netherlands.
Editors notes:
Approval Status
On 2 June 2006 MabThera received a recommendation for approvalfrom the Committee for Medicinal Products for Human Use (CHMP) forthe treatment of rheumatoid arthritis (RA) in Europe. MabThera, incombination with methotrexate, has been recommended for the treatmentof adult patients with severe active rheumatoid arthritis who havehad an inadequate response or intolerance to other disease-modifyinganti-rheumatic drugs (DMARDs). On 28 February 2006, after priorityreview, Genentech and Biogen Idec received US approval for Rituxan(R)(rituximab in the US) for the treatment of adult patients withmoderately to severely active RA in combination with methotrexate forreducing signs and symptoms in those RA patients who have had aninadequate response to one or more tumour necrosis factor (TNF)antagonist therapies.
About the REFLEX study
The REFLEX study (Randomised Evaluation oF Long-term Efficacy ofMabThera in RA) is a multi-centre, randomized, double-blind,placebo-controlled Phase III study. In this trial, patients whoreceived a single course of only two infusions of MabThera with astable dose of methotrexate (MTX) displayed a statisticallysignificant improvement in symptoms measured at 24 weeks, compared tothose receiving placebo and MTX. Patients receiving additionalcourses did so between 6 and 12 months after the initial course.Consistent with previous findings, analysis of the REFLEX 56-weekdata did not reveal any unexpected safety signals. The companiescontinue to monitor the long-term safety of rituximab in all clinicaltrials.
A further phase III development programme for MabThera therapy inpatients with rheumatoid arthritis who have had an inadequateresponse to disease modifying anti-rheumatic drugs (DMARDs) isongoing.
Long term safety and repeated courses
Further new data of a pooled analysis presented at EULAR confirmedthe safety profile of rituximab identified in the original randomisedclinical trials. The analysis included all RA patients treated withMabThera during clinical development which amounted to over 1,600patient years with some patients being followed for over 3 years,many of whom had received multiple courses of treatment. Thisanalysis did not reveal any unexpected safety signals.
About MabThera in rheumatoid arthritis
MabThera selectively targets a subset of B cells that expressCD20, leaving stem, pro-B and plasma cells unaffected. This subset ofB cells plays a key role in the autoimmune process of RA and MabTheraaims to interrupt this process by inhibiting a series of reactionsinflaming the synovia and leading to cartilage loss and bone erosionthat is characteristic of the disease. More than 1,000 patients withRA have been treated with MabThera in clinical trials to date. Acomprehensive Phase III clinical development programme is alsocurrently underway to further investigate the potential clinicalbenefit of MabThera in earlier RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2005,sales by the Pharmaceuticals Division totalled 27.3 billion Swissfrancs, and the Diagnostics Division posted sales of 8.2 billionSwiss francs. Roche employs roughly 70,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).
All trademarks used or mentioned in this release are legallyprotected.
For further information:
- About EULAR: www.eular.org
- British Society for Rheumatology: www.rheumatology.org.uk
- American College of Rheumatology: www.rheumatology.org
- About Genentech: www.gene.com
- About BiogenIdec: www.biogenidec.com.
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:Media Relations Contacts: Phone: +41-61-688-88-88, e-mail: basel.mediaoffice@roche.com, Baschi Dürr, Alexander Klauser, Daniel Piller (Head Roche Group Media Office), Katja Prowald (Head R&D Communications), Martina Rupp
Roche Pharmaceuticals
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