Modified-release prednisone: in patients with rheumatoid arthritis

Area of Science:

• Rheumatology
• Pharmacology
• Clinical Trials

Background:

• Prednisone is a common treatment for rheumatoid arthritis (RA).
• Low-dose glucocorticoids improve RA symptoms and slow radiographic progression when combined with DMARDs.
• A modified-release (MR) prednisone formulation was developed for evening administration to target circadian inflammatory patterns.

Purpose of the Study:

• To evaluate the efficacy and tolerability of evening-administered, low-dose modified-release (MR) prednisone in adult patients with rheumatoid arthritis (RA).
• To compare the efficacy of MR prednisone against placebo and immediate-release (IR) prednisone for managing RA symptoms.

Main Methods:

• Two 12-week randomized trials (CAPRA-1 and CAPRA-2) were conducted in RA patients on stable DMARD therapy.
• CAPRA-2 assessed the proportion of patients achieving ≥20% improvement by ACR criteria.
• CAPRA-1 compared the reduction in morning stiffness duration between evening MR prednisone and morning IR prednisone.

Main Results:

• MR prednisone demonstrated a statistically significant improvement in ACR criteria compared to placebo (48% vs. 29%, p < 0.002).
• Evening MR prednisone significantly reduced morning stiffness duration more than morning IR prednisone (22.7% vs. 0.4%, p = 0.045).
• Improvements were maintained for 9-12 months, with a favorable safety profile similar to placebo or IR prednisone.

Conclusions:

• Evening-administered, low-dose MR prednisone is an effective and well-tolerated treatment for rheumatoid arthritis.
• This formulation offers significant benefits in reducing disease signs, symptoms, and morning stiffness.
• MR prednisone represents a potentially cost-effective addition to DMARD therapy for RA management.