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SAN DIEGO – Rheumatoid arthritis patients who switched from conventional immediate-release prednisone to delayed-release prednisone taken at bedtime experienced a mean reduction of more than 60 minutes in daily morning stiffness that was maintained throughout a 9-month open-label study.
This reduction from a mean baseline of 143.5 minutes of daily morning stiffness during 3 months on a mean 6.8 mg/day of immediate-release prednisone to a similar dose of proprietary delayed-release prednisone (Rayos) constitutes a clinically meaningful benefit. It was accompanied by improvements in other important patient-reported outcomes, Dr. Allan Gibofsky observed at the annual meeting of the American College of Rheumatology.
He presented an analysis of the 9-month open-label phase of the CAPRA-1 (Circadian Administration of Prednisone in Rheumatoid Arthritis-1) study, which also featured a previously reported double-blind phase. The open-label phase involved 207 patients with baseline moderate-to-severe active RA on a stable regimen of disease-modifying antirheumatic drug (DMARD) therapy. After 3 months on immediate-release prednisone during the double-blind phase of CAPRI-1, 110 study participants were switched to delayed-release prednisone; the other 97 had been on delayed-release prednisone during the double-blind phase and continued taking it at about 10 p.m. during the open-label phase.
Levels of the inflammatory cytokine interleukin-6 (IL-6) were measured at the start and conclusion of the 9-month open-label study. The 107 patients who switched from immediate- to delayed-release prednisone showed a median 53% drop in IL-6 levels from a baseline of 1,055 IU/L, reported Dr. Gibofsky, professor of medicine and public health at Cornell University and a rheumatologist at the Hospital for Special Surgery, both in New York.
Self-reported pain scores on a 0-100 visual analog scale dropped from a baseline of 44 by a mean 6.1 points after the switch to delayed-release prednisone and remained stable thereafter. In addition, patient-reported global assessment improved significantly at 3 and 6 months despite 3 months of previous double-blind therapy with immediate-release prednisone.
Delayed-release prednisone is approved as an anti-inflammatory or immunosuppressive agent for a wide array of dermatologic, respiratory, GI, renal, and rheumatologic disorders, including RA. The underlying rationale for this form of chronotherapy is that it permits timed delivery of prednisone during the early morning hours in accord with the circadian pattern of inflammatory cytokine levels.
CAPRI-1 was funded by Horizon Pharma, which markets Rayos. Dr. Gibofsky is a consultant to the company.
SAN DIEGO – Rheumatoid arthritis patients who switched from conventional immediate-release prednisone to delayed-release prednisone taken at bedtime experienced a mean reduction of more than 60 minutes in daily morning stiffness that was maintained throughout a 9-month open-label study.
This reduction from a mean baseline of 143.5 minutes of daily morning stiffness during 3 months on a mean 6.8 mg/day of immediate-release prednisone to a similar dose of proprietary delayed-release prednisone (Rayos) constitutes a clinically meaningful benefit. It was accompanied by improvements in other important patient-reported outcomes, Dr. Allan Gibofsky observed at the annual meeting of the American College of Rheumatology.
He presented an analysis of the 9-month open-label phase of the CAPRA-1 (Circadian Administration of Prednisone in Rheumatoid Arthritis-1) study, which also featured a previously reported double-blind phase. The open-label phase involved 207 patients with baseline moderate-to-severe active RA on a stable regimen of disease-modifying antirheumatic drug (DMARD) therapy. After 3 months on immediate-release prednisone during the double-blind phase of CAPRI-1, 110 study participants were switched to delayed-release prednisone; the other 97 had been on delayed-release prednisone during the double-blind phase and continued taking it at about 10 p.m. during the open-label phase.
Levels of the inflammatory cytokine interleukin-6 (IL-6) were measured at the start and conclusion of the 9-month open-label study. The 107 patients who switched from immediate- to delayed-release prednisone showed a median 53% drop in IL-6 levels from a baseline of 1,055 IU/L, reported Dr. Gibofsky, professor of medicine and public health at Cornell University and a rheumatologist at the Hospital for Special Surgery, both in New York.
Self-reported pain scores on a 0-100 visual analog scale dropped from a baseline of 44 by a mean 6.1 points after the switch to delayed-release prednisone and remained stable thereafter. In addition, patient-reported global assessment improved significantly at 3 and 6 months despite 3 months of previous double-blind therapy with immediate-release prednisone.
Delayed-release prednisone is approved as an anti-inflammatory or immunosuppressive agent for a wide array of dermatologic, respiratory, GI, renal, and rheumatologic disorders, including RA. The underlying rationale for this form of chronotherapy is that it permits timed delivery of prednisone during the early morning hours in accord with the circadian pattern of inflammatory cytokine levels.
CAPRI-1 was funded by Horizon Pharma, which markets Rayos. Dr. Gibofsky is a consultant to the company.
SAN DIEGO – Rheumatoid arthritis patients who switched from conventional immediate-release prednisone to delayed-release prednisone taken at bedtime experienced a mean reduction of more than 60 minutes in daily morning stiffness that was maintained throughout a 9-month open-label study.
This reduction from a mean baseline of 143.5 minutes of daily morning stiffness during 3 months on a mean 6.8 mg/day of immediate-release prednisone to a similar dose of proprietary delayed-release prednisone (Rayos) constitutes a clinically meaningful benefit. It was accompanied by improvements in other important patient-reported outcomes, Dr. Allan Gibofsky observed at the annual meeting of the American College of Rheumatology.
He presented an analysis of the 9-month open-label phase of the CAPRA-1 (Circadian Administration of Prednisone in Rheumatoid Arthritis-1) study, which also featured a previously reported double-blind phase. The open-label phase involved 207 patients with baseline moderate-to-severe active RA on a stable regimen of disease-modifying antirheumatic drug (DMARD) therapy. After 3 months on immediate-release prednisone during the double-blind phase of CAPRI-1, 110 study participants were switched to delayed-release prednisone; the other 97 had been on delayed-release prednisone during the double-blind phase and continued taking it at about 10 p.m. during the open-label phase.
Levels of the inflammatory cytokine interleukin-6 (IL-6) were measured at the start and conclusion of the 9-month open-label study. The 107 patients who switched from immediate- to delayed-release prednisone showed a median 53% drop in IL-6 levels from a baseline of 1,055 IU/L, reported Dr. Gibofsky, professor of medicine and public health at Cornell University and a rheumatologist at the Hospital for Special Surgery, both in New York.
Self-reported pain scores on a 0-100 visual analog scale dropped from a baseline of 44 by a mean 6.1 points after the switch to delayed-release prednisone and remained stable thereafter. In addition, patient-reported global assessment improved significantly at 3 and 6 months despite 3 months of previous double-blind therapy with immediate-release prednisone.
Delayed-release prednisone is approved as an anti-inflammatory or immunosuppressive agent for a wide array of dermatologic, respiratory, GI, renal, and rheumatologic disorders, including RA. The underlying rationale for this form of chronotherapy is that it permits timed delivery of prednisone during the early morning hours in accord with the circadian pattern of inflammatory cytokine levels.
CAPRI-1 was funded by Horizon Pharma, which markets Rayos. Dr. Gibofsky is a consultant to the company.
AT THE ACR ANNUAL MEETING
Major finding: Patients with moderate to severe active rheumatoid arthritis on stable disease-modifying antirheumatic drug therapy experienced a greater than 60-minute reduction in daily morning stiffness from a baseline of 143.5 minutes when they were switched from immediate- to delayed-release prednisone.
Data source: This was an analysis of the 207 RA patients who participated in the 9-month open-label phase of the prospective CAPRA-1 study.
Disclosures: The study was funded by Horizon Pharma, which markets immediate-release prednisone. Dr. Gibofsky is a consultant to the company.