Suggestions(2)
Exact(2)
Patients were to be withdrawn from the study if they did not show adequate response to study treatment at Week 16 (less than 20% reduction in tender joint count [TJC] and/or swollen joint count [SJC] compared with study entry).
Specific data to guide such dose escalation are not well elaborated yet, since in clinical trials a dose increase from 4 to 8 mg was usually done only after 16 weeks and only in patients failing to achieve 20% reduction in tender and swollen joint counts, a quite minimalistic requirement given the baseline disease activity and length of time.
Similar(58)
Anti-TNF treatment is associated with substantial sustained reductions in tender and swollen peripheral joint counts [ 70, 71], although longer-term outcome data on subsequent need for surgery are awaited.
After four infusions of infliximab, patients experienced reductions in mean tender joint counts (57%), mean swollen joint counts (66%), ESR (20%), and mean daily prednisone requirement (38%) (Table 2) [ 17].
At the highest dosage tried in Phase II trials, patients experienced a 61% average reduction in swollen and tender joints; patients receiving a placebo got only a 25% reduction.
In the majority, the treatment target was a reduction in swollen and tender joint counts.
At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose.
Some studies implemented treatment targets before escalating therapy: in ankylosing spondylitis, most trials used a decrease in Bath Ankylosing Spondylitis Disease Activity Index; in psoriatic arthritis, protocols primarily considered a reduction in swollen and tender joints; in psoriasis, the Modified Psoriasis Severity Score and the Psoriasis Area and Severity Index were used.
At week 16, patients who did not have a ≥20 % reduction in swollen and tender joint counts were re-randomized equally to receive either apremilast dose if they were initially randomized to placebo, or they remained on their initial apremilast dose.
The primary efficacy endpoint was the reduction in the number of tender points at 12 months with respect to baseline.
With regard to the primary efficacy outcome, the study showed a reduction in the number of tender points (pairs) in the r-hGH group compared to the control group, at 12-month evaluation (p = 0.0001).
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