KU-55933 Despite this finding our study

Despite this finding, our study demonstrated an efficacy in treating PsA comparable to that of previous studies mainly conducted in Europe and North America. At Week 12, PsARC response achievement was 75%, which was very similar to that reported in an open-label, uncontrolled trial of adalimumab in patients with PsA with moderate to severe psoriasis (Table 5). That significant alleviation of joint pain and swelling, as well as of functional disability, resulted KU-55933 from our adalimumab dosage regimen was also indicated by examination of the DLQI evaluations and the patient and physician global assessments.
Analysis of PASI score trajectory shows that when adalimumab treatment began, four patients (33%) exhibited initial aggravation, seven patients (58%) had gradual improvement, and one patient (8%) had persistent disease progression (Table 1). All of the patients who exhibited initial aggravation had received at least one systemic treatment before the trial, compared to 71% (5 in 7) of those who gradually improved. In KU-55933 to the usual protocol of a minimum washout time of 2 weeks before adalimumab administration is begun, our protocol was to start adalimumab treatment immediately after discontinuation of the previous treatment. One patient was noted as having progression of PASI throughout the study, whereas his symptoms of psoriatic arthritis were found to gradually improve. This might imply that the response of psoriasis to adalimumab is not completely parallel with the response of psoriatic arthritis.
During the course of our study, systemic medication in addition to adalimumab was prescribed and administered to two patients, namely a regimen of MTX. Among others treated with adalimumab only, mean reduction rate of PASI was 54.6%, which was higher than that (35.9%) in the total population. Two previous randomized controlled studies in which concomitant use of DMARDs was excluded also showed a high rate of PASI 75 achievement. In ACCLAIM trial (A Canadian open-label study to evaluate the safety and effectiveness of adaLimumab when Added to Inadequate therapy for the treatment of psoriatic arthritis), an open-label study, concomitant use of DMARDs was allowed at stable, prestudy dosages throughout the course. Response for patients with active PsA, as measured by percentages achieved in the Psoriatic Arthritis Joint Activity Index, showed no difference between groups treated with and without concomitant DMARDs.
ANA has been reported to be associated with loss of response to anti-TNF-α therapy. Pink et al found that patients on anti-TNF therapy commonly developed ANA and anti-double–stranded DNA antibodies, which appears to be related to anti-TNF treatment failure. In our study, there were 11 patients with undetectable ANA titer and one with positive titer (1:640) at baseline. Two of the patients who had undetectable baseline ANA tested weakly positive (1:40) for ANA antibodies at Week 12. Their disease activity responsiveness to adalimumab was no different from the others. The single patient who had elevated baseline ANA continued to test at the same positive level during the 12 weeks of treatment and yet this patient exhibited fair improvement with respect to both psoriasis and PsA. None of our patients developed the lupus-like syndrome that has been reported in a few cases. In our study, ANA was neither associated with responsiveness, nor did it influence the manifestation of adverse side effects.
Unlike previously published studies, we did not design inclusion and exclusion criteria in this retrospective study. Not only did the small number of patients and short follow-up period make doing so unfeasible, but most of our patients would not have fulfilled the strict criteria in which patients selected for randomized controlled trials must fit. They had severe disease with mean PASI of 24.6 initially, and their response in terms of joint manifestations to previous systemic treatment had been poor. Randomized controlled trials also require a minimum washout period of 2 weeks for nonbiological systemic therapies, which would not have been possible in many of our patients due to the severity of their disease. The concomitant use of topical agents and additional DMARDs during the study are potential confounding factors that need to be analyzed further.