Responses to Adalimumab in Patients with Active Psoriatic Arthritis Who Have Not Adequately Responded to Prior Therapy: Effectiveness and Safety Results From an Open-label Study

Abstract

Objective.To evaluate the effectiveness and safety of adalimumab in patients with active psoriatic arthritis (PsA) and an inadequate response to prior therapy.Methods.Patients were treated with subcutaneous injections of adalimumab 40 mg every other week in addition to their standard antirheumatic therapies in a 12-week, open-label study. Effectiveness evaluations at Week 12 included American College of Rheumatology (ACR) and Psoriasis Area and Severity Index (PASI) response rates, Psoriatic Arthritis Response Criteria (PsARC), active dactylitis, enthesitis, and target lesion assessment. Physical function was evaluated using the Health Assessment Questionnaire Disability Index (HAQ-DI).Results.A total of 127 patients were enrolled. At Week 12, patients achieved ACR20, ACR50, and ACR70 response rates of 78.0%, 55.9%, and 21.3%, respectively. PASI50 and PASI75 response rates were 64.7% and 47.1%. A PsARC response was experienced by 70.1% of patients. Between baseline and Week 12, clinically and statistically significant reductions occurred in the mean total plaque score of the target lesion as well as in the percentages of patients with active dactylitis and enthesitis. A mean improvement in HAQ-DI was also observed (−0.44; p < 0.001). Three serious adverse events were reported, but none was considered related to adalimumab therapy.Conclusion.Adalimumab-treated patients achieved significant improvements in both skin and joint manifestations of PsA, as well as in physical function. Adalimumab was well tolerated and had a safety profile similar to that observed in other clinical trials of adalimumab for the treatment of PsA. ClinicalTrials.gov identifier: NCT00427362.

Comprehensive Treatment of Dactylitis in Psoriatic Arthritis

“…Some studies used a simple count of dactylitic digits (based on clinician opinion), while others graded the severity 0-3 or 1-4, and all 20 digits were Because of the large variability in study designs and outcome measures, and poor availability of primary data, a metaanalysis could not be performed. Significant improvement (p < 0.05) in dactylitis compared to placebo was observed with the use of certolizumab in the RAPID-PsA trial 4 and with ustekinumab in the PSUMMIT1 trial 6 ; in Phase II studies, with the use of golimumab in the GO-REVEAL trials 8,9 ; with infliximab in the IMPACT1 21 and IMPACT2 22 trials; with a combination of infliximab plus methotrexate compared to methotrexate alone in an open-label study 11 ; and with the use of adalimumab in prior treatment failures in other open-label studies 7,15 .…”

“…Only randomized, double-blind placebo-controlled (RCT) or open-label trials of PsA in which dactylitis was assessed as a separate outcome measure were identified. Thus, 74 articles (English-language reports only) were identified, and 29 articles were selected for full review [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]25,26,27,28,29,30,31 .…”

Promoting patient‐centred care in psoriatic arthritis: a multidisciplinary European perspective on improving the patient experience

“…As treatment with a DMARD can lead to the improvement of QoL,47 the positive effects of early treatment may extend beyond the clinical outcomes.…”

Enthesitis in Psoriatic Disease

“…A Canadian open-label study to evaluate the safety and effectiveness of adalimumab when added to inadequate therapy for the treatment of PsA (ACCLAIM) enrolled 127 PsA patients who received 40 mg adalimumab every other week, in addition to pre-existing PsA treatment, for 12 weeks [73]. A decrease in the proportion of patients with enthesitis was observed during the study: tenderness of the Achilles tendon reduced from 30% of patients to 14% (p = 0.004), and tenderness of the plantar fascia from 24 to 11% (p = 0.008).…”