Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .
Ankylosing spondylitis: what is the optimum duration of a clinical study? A one year versus a 6 weeks non-steroidal anti-inflammatory drug trial.
OBJECTIVE To consider the relevance of the duration of a clinical trial in ankylosing spondylitis : long-term ( i.e. 1 yr ) vs short-term ( i.e. 6 weeks ) assessment of a non-steroidal anti-inflammatory drug (NSAID)-placebo controlled study . METHODS The design was a prospect i ve , multicentre , double-blind , placebo-controlled study of 6 weeks duration with a 12 months double-blind extension . Study drugs were placebo ( n = 121 ) or active NSAID ( n = 352 ) . A decrease of at least 50 % in pain and /or global assessment and /or functional impairment during the study defined the response to treatment . The percentage of patients discontinuing the study drug over time ( life table analysis ) permitted the evaluation of both the efficacy and toxicity . RESULTS Among the 473 recruited patients , the percentage of responders was similar at 1 yr and week 6 with a highly statistically significant difference in favour of the active NSAID groups when compared to placebo ( at 1 yr , 17 % in the placebo group vs 37 , 50 and 43 % in the piroxicam 20 mg , meloxicam 15 mg and meloxicam 22.5 mg , respectively , for the patient 's overall assessment ) without any statistically significant difference between the three active groups . However , evaluation of the patients discontinuing the study drug during the 1 yr of the study permitted the detection of a statistically significant difference between the active NSAID groups . A lower percentage of patients taking meloxicam 22.5 mg had to discontinue the study drug when compared to either meloxicam 15 mg or piroxicam 20 mg ( 37 % vs 53 % and 53 % , respectively , P < 0.05 ) . By 52 weeks , drug-related upper gastrointestinal adverse events occurred in 13 , 32 , 20 and 18 % in the placebo , piroxicam 20 mg , meloxicam 15 mg and meloxicam 22.5 mg groups , respectively . Some of the adverse events occurred only after week 6 . CONCLUSION This study suggests that a 1 yr trial might be of optimum value compared to a 6 week assessment in order to define better the efficacy and tolerability of NSAIDs in ankylosing spondylitis
Good disease control , with therapeutic escalation to achieve low disease activity , was recommended .
OBJECTIVE To develop treatment recommendations for children with juvenile idiopathic arthritis manifesting as non-systemic polyarthritis , sacroiliitis , or enthesitis .