SAN DIEGO, CA—Patients with rheumatoid arthritis (RA) on stable DMARD therapy, who have not adequately responded to immediate-release (IR) prednisone with respect to morning stiffness, showed a statistically significant and clinically meaningful improvement in this symptom when switched to delayed-release (DR) prednisone, according to analysis data presented at the 2013 ACR/ARHP Annual Meeting.
An important therapeutic target in rheumatoid arthritis is the nocturnal inflammatory cytokines that cause morning stiffness. DR prednisone administered at bedtime produces significant absolute and relative reduction in morning symptoms. A significant reduction in inflammatory cytokines is also observed when DR prednisone is administered.
Rieke Alten, MD, from Schlosspark-Klinik, Charité University Medicine, Berlin, Germany, and colleagues analyzed 9 months of patient-reported data from the CAPRA I trial to evaluate the reduction of symptoms that impact patients’ quality of life. Patients in this trial were switched from IR prednisone to DR prednisone after 3 months of previous therapy. Diary entries were completed at least 7 days prior to each of the 3 month visits including waking time, stiffness (Yes or No), time of resolution, and intensity of pain (VAS) during the day.
Patients with RA previously randomized to IR prednisone (N=110) were switched to DR prednisone open-label and evaluated at 3, 6, and 9 months to measure median absolute (paired t-test) and relative changes (Wilcoxon Rank Sum Test) in pain, patient’s global, and morning stiffness as the primary outcome.
Study analyses showed there was a statistically significant and clinically meaningful reduction in morning stiffness during the first 3 months after the switch (mean absolute change -6.1, P=0.002). This response was maintained over the entire 9-month study period.
In addition, absolute reduction in morning stiffness was approximately 50min from 143.5min and there was a >40% relative reduction in morning stiffness at each visit. IL-6 levels were reduced concomitantly by the same amount. Dr. Allen added, “The mean reduction in morning stiffness was over 60 minutes at each of the three visits.”