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What’s on tap for rheumatology in 2013? We asked some of our editorial advisory board members to weigh in with their expectations for this year. They highlighted trends in the practice and insurance environment, women’s health issues, patient-reported outcomes, the development of biosimilar drugs and small-molecule drugs for rheumatoid arthritis, and advances in lupus research as important subjects to follow.
Women’s Health Issues
Rheumatologists Dimitrios T. Boumpas of the University of Crete in Heraklion, Greece, and Daniel E. Furst of the University of California, Los Angeles, both pointed to 2013 as a year in which women’s health issues will gain more attention in rheumatology. They foresee more emphasis on rheumatologists taking an individualized approach to counseling women on reproductive issues based on their personal risk factors and history, as well as unique symptoms and signs they might have in some rheumatic diseases compared with men.
Patient-Reported Outcomes
Dr. Boumpas and Dr. Furst also predicted that patient-reported outcomes will make a further push into rheumatology clinical research and day-to-day clinical practice. The availability of patient-reported outcome tools from the National Institutes of Health’s PROMIS (Patient-Reported Outcomes Measurement Information System) toolbox should help to speed this for important constructs or traits such as physical function, global health assessment, and fatigue. Patients can fill out customized item banks for a variety of PROMIS measures on a tablet, laptop, personal computer, or possibly a smartphone while they are in a waiting room.
Changing Practice and Insurance Environment
Dr. Norman Gaylis, a rheumatologist in private practice in Aventura, Fla, cited numerous challenges to rheumatology practices in the coming year. He noted that "overhead creep in both private practice and academic settings" could result in an increase in staff, time, prior authorizations needed to perform treatment procedures, and the cost of health insurance for staff.
He foresees more rheumatology community practices being acquired by hospital corporations and institutions as the economic environment continues to make it difficult for small and solo practices to survive. The disconnect between the value of imaging, such as MRI, in rheumatology and its reimbursement level is a related issue that may get more attention in the coming year, Dr. Gaylis said.
Payers also might begin to replace coverage of infusion therapy with subcutaneous treatments and then ultimately oral biologics. We also might see rebates to payers begin to drive trends in rheumatoid arthritis treatment in a crowded therapeutic marketplace, he said.
Biosimilar Drugs
With the issuance of the first draft guidance on biosimilar product development last February, Dr. Gaylis said to expect that further announcements will be made to set the stage for Food and Drug Administration approval of biosimilar drugs.
As part of the Affordable Care Act, Congress created an abbreviated licensure pathway for biologic products that can be shown to be "highly similar" to an already-approved biologic drug. The Biologics Price Competition and Innovation Act, which lawmakers had been working on for years, was passed in 2010 as part of the ACA. It will make it possible for biosimilar manufacturers to bring their products to market with less clinical testing than is required of originator biopharmaceuticals and therefore at a significantly lower cost to consumers.
Under the new pathway, biosimilars must be shown to be highly similar to an already-approved product. The biosimilar may have minor differences in clinically inactive components, but there must be no clinically meaningful differences between the original and the biosimilar product in terms of safety, purity, and potency, according to the FDA.
New Drugs in the Pipeline
With the approval of tofacitinib (Xeljanz) for rheumatoid arthritis last November, Dr. Boumpas wondered whether other small molecules in the regulatory pathway will be approved. It will be interesting to see if further trials bear out the different clinical effects that three different Janus kinase (JAK) inhibitors in development have reported so far in phase II trials, he said. While tofacitinib blocks all four JAKs, its effects seem strongest on JAK3, and other JAK inhibitors in clinical development have specific JAK targets, such as Vertex Pharmaceuticals’ VX-509 (JAK3), Eli Lilly and Incyte’s baricitinib (JAK1 and JAK2), and Abbott and Galapagos’s GLPG0634 (JAK1).
Advances in Lupus Research
Lupus researcher and rheumatologist Joan T. Merrill of the Oklahoma Medical Research Foundation suggested that 2013 may see greater evolution of lupus clinical trials that involve integrating basic science into patient selection and dosing studies. "This is just now starting to happen more seriously, such as with Genentech’s phase II anti-interferon-alpha study and Amgen’s entire development program for lupus. These developments derive in part from the phase II analysis of the belimumab studies where autoantibodies became a probable surrogate for high B-lymphocyte stimulator levels. This will revolutionize medical care and bring diagnostic testing out of the initial diagnosis and vague prognostic category and more cleanly into the daily practice of optimizing treatments."
Dr. Merrill also said that the trend of certain patient advocacy groups playing a larger role in setting the research and practice agendas will continue to grow. The Lupus Foundation of America (LFA), for example, has mobilized companies to share data from placebo groups to improve clinical trial designs, created an online training site for clinical trialists worldwide, formed a Congressional Lupus Caucus, initiated a national ad campaign to educate about lupus, funded an international project to come up with a definition for lupus flare, funded the Systemic Lupus International Collaborating Clinics project to revise the classification criteria for lupus, and the list goes on – they have had a major impact on lupus. The LFA (and also some other organizations such as the Lupus Research Institute and Lupus Awareness and Research) also fund basic and clinical research in lupus.
"The LFA has done so many specific, innovative things to ‘bring down the barriers’ to treatment development in a complex and heterogenous disease where clinical trial design has been a tough nut to crack," said Dr. Merrill, noting that the foundation’s work "serves as a template for what can be done in other underserved rheumatic diseases."
Dr. Furst is the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. Dr. Boumpas is professor of medicine and director of internal medicine/rheumatology at the University of Crete, Heraklion, Greece, and is acting clinical director of the National Institute of Arthritis, Musculoskeletal, and Skin Diseases. Dr. Gaylis is in private practice in Aventura, Fla. Dr. Merrill is program chair of the clinical pharmacology research program at the Oklahoma Medical Research Foundation and is professor of medicine at the University of Oklahoma Health Sciences Center in Oklahoma City. All have financial relationships with numerous pharmaceutical companies that have products that are relevant to rheumatology.
What’s on tap for rheumatology in 2013? We asked some of our editorial advisory board members to weigh in with their expectations for this year. They highlighted trends in the practice and insurance environment, women’s health issues, patient-reported outcomes, the development of biosimilar drugs and small-molecule drugs for rheumatoid arthritis, and advances in lupus research as important subjects to follow.
Women’s Health Issues
Rheumatologists Dimitrios T. Boumpas of the University of Crete in Heraklion, Greece, and Daniel E. Furst of the University of California, Los Angeles, both pointed to 2013 as a year in which women’s health issues will gain more attention in rheumatology. They foresee more emphasis on rheumatologists taking an individualized approach to counseling women on reproductive issues based on their personal risk factors and history, as well as unique symptoms and signs they might have in some rheumatic diseases compared with men.
Patient-Reported Outcomes
Dr. Boumpas and Dr. Furst also predicted that patient-reported outcomes will make a further push into rheumatology clinical research and day-to-day clinical practice. The availability of patient-reported outcome tools from the National Institutes of Health’s PROMIS (Patient-Reported Outcomes Measurement Information System) toolbox should help to speed this for important constructs or traits such as physical function, global health assessment, and fatigue. Patients can fill out customized item banks for a variety of PROMIS measures on a tablet, laptop, personal computer, or possibly a smartphone while they are in a waiting room.
Changing Practice and Insurance Environment
Dr. Norman Gaylis, a rheumatologist in private practice in Aventura, Fla, cited numerous challenges to rheumatology practices in the coming year. He noted that "overhead creep in both private practice and academic settings" could result in an increase in staff, time, prior authorizations needed to perform treatment procedures, and the cost of health insurance for staff.
He foresees more rheumatology community practices being acquired by hospital corporations and institutions as the economic environment continues to make it difficult for small and solo practices to survive. The disconnect between the value of imaging, such as MRI, in rheumatology and its reimbursement level is a related issue that may get more attention in the coming year, Dr. Gaylis said.
Payers also might begin to replace coverage of infusion therapy with subcutaneous treatments and then ultimately oral biologics. We also might see rebates to payers begin to drive trends in rheumatoid arthritis treatment in a crowded therapeutic marketplace, he said.
Biosimilar Drugs
With the issuance of the first draft guidance on biosimilar product development last February, Dr. Gaylis said to expect that further announcements will be made to set the stage for Food and Drug Administration approval of biosimilar drugs.
As part of the Affordable Care Act, Congress created an abbreviated licensure pathway for biologic products that can be shown to be "highly similar" to an already-approved biologic drug. The Biologics Price Competition and Innovation Act, which lawmakers had been working on for years, was passed in 2010 as part of the ACA. It will make it possible for biosimilar manufacturers to bring their products to market with less clinical testing than is required of originator biopharmaceuticals and therefore at a significantly lower cost to consumers.
Under the new pathway, biosimilars must be shown to be highly similar to an already-approved product. The biosimilar may have minor differences in clinically inactive components, but there must be no clinically meaningful differences between the original and the biosimilar product in terms of safety, purity, and potency, according to the FDA.
New Drugs in the Pipeline
With the approval of tofacitinib (Xeljanz) for rheumatoid arthritis last November, Dr. Boumpas wondered whether other small molecules in the regulatory pathway will be approved. It will be interesting to see if further trials bear out the different clinical effects that three different Janus kinase (JAK) inhibitors in development have reported so far in phase II trials, he said. While tofacitinib blocks all four JAKs, its effects seem strongest on JAK3, and other JAK inhibitors in clinical development have specific JAK targets, such as Vertex Pharmaceuticals’ VX-509 (JAK3), Eli Lilly and Incyte’s baricitinib (JAK1 and JAK2), and Abbott and Galapagos’s GLPG0634 (JAK1).
Advances in Lupus Research
Lupus researcher and rheumatologist Joan T. Merrill of the Oklahoma Medical Research Foundation suggested that 2013 may see greater evolution of lupus clinical trials that involve integrating basic science into patient selection and dosing studies. "This is just now starting to happen more seriously, such as with Genentech’s phase II anti-interferon-alpha study and Amgen’s entire development program for lupus. These developments derive in part from the phase II analysis of the belimumab studies where autoantibodies became a probable surrogate for high B-lymphocyte stimulator levels. This will revolutionize medical care and bring diagnostic testing out of the initial diagnosis and vague prognostic category and more cleanly into the daily practice of optimizing treatments."
Dr. Merrill also said that the trend of certain patient advocacy groups playing a larger role in setting the research and practice agendas will continue to grow. The Lupus Foundation of America (LFA), for example, has mobilized companies to share data from placebo groups to improve clinical trial designs, created an online training site for clinical trialists worldwide, formed a Congressional Lupus Caucus, initiated a national ad campaign to educate about lupus, funded an international project to come up with a definition for lupus flare, funded the Systemic Lupus International Collaborating Clinics project to revise the classification criteria for lupus, and the list goes on – they have had a major impact on lupus. The LFA (and also some other organizations such as the Lupus Research Institute and Lupus Awareness and Research) also fund basic and clinical research in lupus.
"The LFA has done so many specific, innovative things to ‘bring down the barriers’ to treatment development in a complex and heterogenous disease where clinical trial design has been a tough nut to crack," said Dr. Merrill, noting that the foundation’s work "serves as a template for what can be done in other underserved rheumatic diseases."
Dr. Furst is the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. Dr. Boumpas is professor of medicine and director of internal medicine/rheumatology at the University of Crete, Heraklion, Greece, and is acting clinical director of the National Institute of Arthritis, Musculoskeletal, and Skin Diseases. Dr. Gaylis is in private practice in Aventura, Fla. Dr. Merrill is program chair of the clinical pharmacology research program at the Oklahoma Medical Research Foundation and is professor of medicine at the University of Oklahoma Health Sciences Center in Oklahoma City. All have financial relationships with numerous pharmaceutical companies that have products that are relevant to rheumatology.
What’s on tap for rheumatology in 2013? We asked some of our editorial advisory board members to weigh in with their expectations for this year. They highlighted trends in the practice and insurance environment, women’s health issues, patient-reported outcomes, the development of biosimilar drugs and small-molecule drugs for rheumatoid arthritis, and advances in lupus research as important subjects to follow.
Women’s Health Issues
Rheumatologists Dimitrios T. Boumpas of the University of Crete in Heraklion, Greece, and Daniel E. Furst of the University of California, Los Angeles, both pointed to 2013 as a year in which women’s health issues will gain more attention in rheumatology. They foresee more emphasis on rheumatologists taking an individualized approach to counseling women on reproductive issues based on their personal risk factors and history, as well as unique symptoms and signs they might have in some rheumatic diseases compared with men.
Patient-Reported Outcomes
Dr. Boumpas and Dr. Furst also predicted that patient-reported outcomes will make a further push into rheumatology clinical research and day-to-day clinical practice. The availability of patient-reported outcome tools from the National Institutes of Health’s PROMIS (Patient-Reported Outcomes Measurement Information System) toolbox should help to speed this for important constructs or traits such as physical function, global health assessment, and fatigue. Patients can fill out customized item banks for a variety of PROMIS measures on a tablet, laptop, personal computer, or possibly a smartphone while they are in a waiting room.
Changing Practice and Insurance Environment
Dr. Norman Gaylis, a rheumatologist in private practice in Aventura, Fla, cited numerous challenges to rheumatology practices in the coming year. He noted that "overhead creep in both private practice and academic settings" could result in an increase in staff, time, prior authorizations needed to perform treatment procedures, and the cost of health insurance for staff.
He foresees more rheumatology community practices being acquired by hospital corporations and institutions as the economic environment continues to make it difficult for small and solo practices to survive. The disconnect between the value of imaging, such as MRI, in rheumatology and its reimbursement level is a related issue that may get more attention in the coming year, Dr. Gaylis said.
Payers also might begin to replace coverage of infusion therapy with subcutaneous treatments and then ultimately oral biologics. We also might see rebates to payers begin to drive trends in rheumatoid arthritis treatment in a crowded therapeutic marketplace, he said.
Biosimilar Drugs
With the issuance of the first draft guidance on biosimilar product development last February, Dr. Gaylis said to expect that further announcements will be made to set the stage for Food and Drug Administration approval of biosimilar drugs.
As part of the Affordable Care Act, Congress created an abbreviated licensure pathway for biologic products that can be shown to be "highly similar" to an already-approved biologic drug. The Biologics Price Competition and Innovation Act, which lawmakers had been working on for years, was passed in 2010 as part of the ACA. It will make it possible for biosimilar manufacturers to bring their products to market with less clinical testing than is required of originator biopharmaceuticals and therefore at a significantly lower cost to consumers.
Under the new pathway, biosimilars must be shown to be highly similar to an already-approved product. The biosimilar may have minor differences in clinically inactive components, but there must be no clinically meaningful differences between the original and the biosimilar product in terms of safety, purity, and potency, according to the FDA.
New Drugs in the Pipeline
With the approval of tofacitinib (Xeljanz) for rheumatoid arthritis last November, Dr. Boumpas wondered whether other small molecules in the regulatory pathway will be approved. It will be interesting to see if further trials bear out the different clinical effects that three different Janus kinase (JAK) inhibitors in development have reported so far in phase II trials, he said. While tofacitinib blocks all four JAKs, its effects seem strongest on JAK3, and other JAK inhibitors in clinical development have specific JAK targets, such as Vertex Pharmaceuticals’ VX-509 (JAK3), Eli Lilly and Incyte’s baricitinib (JAK1 and JAK2), and Abbott and Galapagos’s GLPG0634 (JAK1).
Advances in Lupus Research
Lupus researcher and rheumatologist Joan T. Merrill of the Oklahoma Medical Research Foundation suggested that 2013 may see greater evolution of lupus clinical trials that involve integrating basic science into patient selection and dosing studies. "This is just now starting to happen more seriously, such as with Genentech’s phase II anti-interferon-alpha study and Amgen’s entire development program for lupus. These developments derive in part from the phase II analysis of the belimumab studies where autoantibodies became a probable surrogate for high B-lymphocyte stimulator levels. This will revolutionize medical care and bring diagnostic testing out of the initial diagnosis and vague prognostic category and more cleanly into the daily practice of optimizing treatments."
Dr. Merrill also said that the trend of certain patient advocacy groups playing a larger role in setting the research and practice agendas will continue to grow. The Lupus Foundation of America (LFA), for example, has mobilized companies to share data from placebo groups to improve clinical trial designs, created an online training site for clinical trialists worldwide, formed a Congressional Lupus Caucus, initiated a national ad campaign to educate about lupus, funded an international project to come up with a definition for lupus flare, funded the Systemic Lupus International Collaborating Clinics project to revise the classification criteria for lupus, and the list goes on – they have had a major impact on lupus. The LFA (and also some other organizations such as the Lupus Research Institute and Lupus Awareness and Research) also fund basic and clinical research in lupus.
"The LFA has done so many specific, innovative things to ‘bring down the barriers’ to treatment development in a complex and heterogenous disease where clinical trial design has been a tough nut to crack," said Dr. Merrill, noting that the foundation’s work "serves as a template for what can be done in other underserved rheumatic diseases."
Dr. Furst is the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. Dr. Boumpas is professor of medicine and director of internal medicine/rheumatology at the University of Crete, Heraklion, Greece, and is acting clinical director of the National Institute of Arthritis, Musculoskeletal, and Skin Diseases. Dr. Gaylis is in private practice in Aventura, Fla. Dr. Merrill is program chair of the clinical pharmacology research program at the Oklahoma Medical Research Foundation and is professor of medicine at the University of Oklahoma Health Sciences Center in Oklahoma City. All have financial relationships with numerous pharmaceutical companies that have products that are relevant to rheumatology.
