Psoriatic Arthritis

Moll, J. M. H.

doi:10.1093/rheumatology/23.4.241

Cited by 66 publications

(81 citation statements)

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“…Patients considered eligible for the study had to be Ն18 years of age, to have symptomatic PsA (according to the Moll and Wright criteria [25]) for Ն6 months before screening, and to have discontinued treatment with immunosuppressants other than MTX for an adequate washout period (washout duration Ն14 days for topical therapy, Ն28 days for nonbiologic systemic therapy and phototherapy, Ն56 days for etanercept, Ն84 days for adalimumab, efalizumab, or infliximab, and Ն168 days for alefacept). Participants were also required to have active PsA, defined as Ն3 swollen joints and Ն3 tender joints, at the time of screening and baseline, and to have tested negative for serum rheumatoid factor.…”

Section: Methodsmentioning

confidence: 99%

Oral apremilast in the treatment of active psoriatic arthritis: Results of a multicenter, randomized, double‐blind, placebo‐controlled study

Schett¹,

Wollenhaupt²,

Papp³

et al. 2012

Arthritis & Rheumatism

187

100

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Objective. To evaluate the efficacy and safety of apremilast, a novel, orally available small molecule that specifically targets phosphodiesterase 4, in the treatment of active psoriatic arthritis (PsA).Methods. This phase II, multicenter, randomized, double-blind, placebo-controlled study included the following: a 12-week treatment phase, with patients receiving placebo, apremilast 20 mg twice per day, or apremilast 40 mg once per day; a 12-week treatment-extension phase, with patients in the placebo group re-randomized to receive apremilast; and a 4-week observational phase after treatment cessation. The primary end point was the proportion of patients achieving the American College of Rheumatology criteria for 20% improvement (ACR20) at week 12. Safety assessments included adverse events (AEs), physical examinations, vital signs, laboratory parameters, and electrocardiograms.Results. Of the 204 patients with PsA who were randomized to a treatment group, 165 completed the treatment phase. At the end of the treatment phase (week 12), 43.5% of patients receiving apremilast 20 mg twice per day (P < 0.001) and 35.8% of those receiving 40 mg once per day (P ‫؍‬ 0.002) achieved an ACR20 response, compared with 11.8% of those receiving placebo. At the end of the treatment-extension phase (week 24), >40% of patients in each group (patients receiving apremilast 20 mg twice per day, patients receiving apremilast 40 mg once per day, and patients in the placebo group re-randomized to receive apremilast) achieved the ACR20 level of improvement. Most patients in the treatment phase (84.3%) and treatmentextension phase (68.3%) reported >1 AE. Diarrhea, headache, nausea, fatigue, and nasopharyngitis were reported most frequently; most events were mild or moderate. No clinically relevant laboratory or electrocardiographic abnormalities were reported.Conclusion. Treatment with apremilast at a dosage of 20 mg twice per day or 40 mg once per day demonstrated efficacy in comparison with placebo and was generally well tolerated in patients with active PsA. The balance of efficacy, tolerability, and safety supports further study of apremilast in PsA.Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that is present in up to 30% of individuals ClinicalTrials.gov identifier: NCT00456092. This is protocol PSA-001 from the Celgene Corporation, Summit, NJ.

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Section: Methodsmentioning

confidence: 99%

Oral apremilast in the treatment of active psoriatic arthritis: Results of a multicenter, randomized, double‐blind, placebo‐controlled study

Schett¹,

Wollenhaupt²,

Papp³

et al. 2012

Arthritis & Rheumatism

187

100

View full text Add to dashboard Cite

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“…Adults at least 18 years of age were eligible to enroll in the study if the following criteria were met: Patients must have had active PsA (Moll and Wright criteria 11 ), defined by ≥ 3 tender or painful joints and ≥ 3 swollen joints despite standard PsA therapy. Patients must have had an unsatisfactory response or intolerance to therapy for PsA as defined by individual provincial requirements or private insurance requirements for the reimbursement of biologic TNF inhibitors (generally ≥ 3 or ≥ 5 tender or swollen joints despite therapy, depending on the province).…”

Section: Methodsmentioning

confidence: 99%

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

Gladman

Sampalis²,

Illouz³

et al. 2010

J Rheumatol

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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.

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“…During this period, a rheumatologist determined the final diagnosis in each subject, with classification in accordance with the accepted American College of Rheumatology (ACR) 1987 criteria for RA (9) or accepted criteria for other rheumatic diseases (10)(11)(12).…”

Section: Figurementioning

confidence: 99%

Bone edema on magnetic resonance imaging is an independent predictor of rheumatoid arthritis development in patients with early undifferentiated arthritis

Duer-Jensen¹,

Hørslev‐Petersen²,

Hetland³

et al. 2011

Arthritis & Rheumatism

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Objective. To study magnetic resonance imaging (MRI) as a tool for early diagnosis of rheumatoid arthritis (RA) in patients with early undifferentiated arthritis (UA).Methods. Patients (n ‫؍‬ 116) without a specific rheumatologic diagnosis, but with >2 tender joints and/or >2 swollen joints among the metacarpophalangeal, proximal interphalangeal, wrist, or metatarsophalangeal (MTP) joints for >6 weeks but <24 months, underwent clinical, biochemical, conventional radiographic, and MRI examinations and were followed up for >12 months for the final diagnosis of RA or non-RA. Based on univariate analyses, clinical, biochemical, and imaging parameters were selected for inclusion as explanatory variables in multiple logistic regression analysis, with development of RA as the dependent variable. A prediction model was developed, and its performance was tested and compared with that of a previous model developed by van der Helm-van Mil et al (the vdHvM model).Results. Of the 116 patients with early UA, 27 (23.3%) developed RA. When the prediction model was applied, which included as explanatory variables presence of hand arthritis, positivity for rheumatoid factor (RF), morning stiffness lasting >1 hour, and the Outcome Measures in Rheumatology Clinical Trials MRI summary score for bone edema in the MTP and wrist joints, the outcome of RA or non-RA was correctly identified in 82% of the patients (sensitivity 81%, specificity 82%). Another cutoff value for the prediction index in the model would allow a higher specificity (98%) and higher accuracy (83%), but lower sensitivity (36%). With the vdHvM model, RA/non-RA was predicted in 60.2% of the population.Conclusion. MRI evidence of bone edema in the MTP and wrist joints is an independent predictor of future RA in patients with early UA. A prediction model that includes the variables clinical hand arthritis, morning stiffness, positivity for RF, and bone edema on MRI in the MTP and wrist joints correctly identified the development or lack of development of RA in 82% of patients.The approach to treatment of rheumatoid arthritis (RA) has changed markedly during the last decades.

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Psoriatic Arthritis

Cited by 66 publications

References 0 publications

Oral apremilast in the treatment of active psoriatic arthritis: Results of a multicenter, randomized, double‐blind, placebo‐controlled study

Oral apremilast in the treatment of active psoriatic arthritis: Results of a multicenter, randomized, double‐blind, placebo‐controlled study

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

Bone edema on magnetic resonance imaging is an independent predictor of rheumatoid arthritis development in patients with early undifferentiated arthritis

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