Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis

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Abstract

Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who previously had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).

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Severe Psoriasis – Oral Therapy with a New Retinoid

T Fredriksson, U Pettersson (2004)

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Measuring clinical enthesitis in psoriatic arthritis: assessment of existing measures and development of an instrument specific to psoriatic arthritis.

P. Healy, P. Helliwell (2008)

To assess currently available tools for measurement of enthesitis and to develop a new instrument specifically for use in psoriatic arthritis (PsA). Twenty-eight patients with PsA underwent clinical assessment over a period of 6 months after change of disease-modifying therapy, usually to methotrexate. Measures of enthesitis included the Mander Enthesitis Index (MEI), the Maastricht Ankylosing Spondylitis Enthesitis Score, the Major index, and the Gladman index. Data from these assessments were used to develop a new enthesitis index, the Leeds Enthesitis Index (LEI). An iterative process of data reduction enabled derivation of the LEI index, which consisted of 6 sites: right and left Achilles insertions, medial femoral condyles, and lateral epicondyles of the humerus. All measures showed significant change from baseline but only the LEI and Gladman indices showed a large effect size. All indices demonstrated a floor effect (a score of 0 when the MEI is >0) but this was minimal for the LEI index. All indices correlated strongly with each other and other measures of disease activity. The LEI is a new enthesitis index designed for use in PsA. It shows good test characteristics that suggest it will be a robust and reliable assessment tool. We suggest that it be adopted for use in any randomized controlled trials and longitudinal observation cohorts involving patients with PsA.

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Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index.

Wai-Man R Wong, K Shojania, B Conner-Spady … (2009)

Enthesitis is a recommended core domain for assessment of ankylosing spondylitis (AS), but no measurement has yet been validated according to Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) criteria. The purpose of this study was to seek to validate an enthesitis index for patients with AS according to OMERACT criteria. An enthesitis index was validated in two AS patient cohorts: (1) a longitudinal cohort (n = 223) and (2) 22 patients from three Canadian sites participating in a 24-week randomised placebo-controlled trial of adalimumab in AS. Construct validity was evaluated by correlation analysis with the Bath AS Disease Activity Index (BASDAI), the Bath AS Functional Index (BASFI) and quality of life instruments. Reproducibility was assessed by intraclass correlation coefficient (ICC), and responsiveness was assessed by Guyatt's effect size and standardised response mean. The most frequently affected sites were the greater trochanter and supraspinatus insertion ( approximately 20%). Patients with enthesitis had significantly greater scores for the BASDAI, BASFI, patient global, AS-specific quality of life index (ASQOL) and the Short Form 36 (SF-36) General Health Survey (p<0.001). The enthesitis score contributed significantly to variance in the BASDAI and BASFI. Interobserver ICCs were 0.96 in the longitudinal cohort and 0.89 and 0.77 in the adalimumab clinical trial cohort (for status and change score, respectively). Significant differences in change scores were evident for all patients after 24 weeks of adalimumab treatment, (p = 0.04), this being more significant when a subset of the most commonly affected entheses were analysed (p = 0.01). AS patients with enthesitis constitute a more severe subset of disease, and the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index is feasible and reliable for measurement of this condition. Discrimination requires further study in larger trials.

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Author and article information

Journal

Title: New England Journal of Medicine

Abbreviated Title: N Engl J Med

Publisher: New England Journal of Medicine (NEJM/MMS)

ISSN (Print): 0028-4793

ISSN (Electronic): 1533-4406

Publication date Created: October 19 2017

Publication date (Print): October 19 2017

Volume: 377

Issue: 16

Pages: 1537-1550

Article

DOI: 10.1056/NEJMoa1615975

PubMed ID: 29045212

SO-VID: 082c2fb6-7b01-4411-80af-269c6faa097f

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Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis

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Most cited references 8

Severe Psoriasis – Oral Therapy with a New Retinoid

Measuring clinical enthesitis in psoriatic arthritis: assessment of existing measures and development of an instrument specific to psoriatic arthritis.

Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index.

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