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Celecoxib (Celebrex) Meets Primary Goals in Juvenile Rheumatoid Arthritis Study
Results have been announced from a phase IV clinical trial in which the primary objective was to measure blood pressure (hypertension) in pediatric patients with juvenile rheumatoid arthritis (JRA; also known as juvenile idiopathic arthritis) taking celecoxib (Celebrex, Pfizer) capsules or naproxen.
The study showed that there was virtually no difference in changes to systolic blood pressure (SBP, the primary endpoint) and diastolic blood pressure (DBP, the secondary endpoint) between the celecoxib and naproxen treatment groups. The safety profiles in both groups were also similar.
It is well-known that both selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to new-onset hypertension or worsening of underlying hypertension in adults, but little is known about the effect of NSAID therapy on blood pressure in children.
The purpose of the study was to determine the effect of treatment with celecoxib or naproxen on blood pressure in patients aged 2 to 17 years with JRA. Since 2006, Celebrex (celecoxib) has been approved by the FDA for relief of the signs and symptoms of JRA in pediatric patients 2 years of age and older.
The 6-week study was a randomized, double-blind, active-controlled trial conducted to evaluate the effects of celecoxib (50 mg or 100 mg twice daily, based on the patient’s weight) or naproxen (7.5 mg/kg twice daily; maximum dosage: 500 mg twice daily) on blood pressure in pediatric patients with JRA.
A total of 201 patients were included in the study. All of the patients were diagnosed with JRA, including patients with disease types where few joints were affected (oligoarticular JRA) and where many joints were affected (polyarticular JRA). Children with systemic-onset disease — a form characterized by high fevers and rash — were included only if they still had arthritis but no longer had systemic features, such as fever.
The primary endpoint analysis for the change in SBP from baseline to week 6 showed a 90% confidence that the true difference of the change from baseline in SBP between the celecoxib and naproxen groups was between –0.56 and +2.76, with 0 (no difference) being a possibility. Similar results were observed for DBP, where the 95% confidence interval was between –1.69 and +1.33.
JRA is a chronic, long-term disease that results in joint pain and swelling. It is the most common form of arthritis in children. According to the Centers for Disease Control and Prevention (CDC), the prevalence of JRA ranges from 11,700 to 69,000 children under the age of 18 years in the U.S.
Source: Pfizer; April 25, 2013.