ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2742

How Are Enthesitis, Dactylitis and Nail Involvement Measured and Reported in Recent Clinical Trials of Psoriatic Arthritis (PsA)? a Systematic Literature Review

Sofia Ramiro1, Josef Smolen2, RBM Landewé3, Désirée van der Heijde4 and Laure Gossec5, 1Leiden University Medical Center, Leiden, Netherlands, 2Internal Medicine III, Div. of Rheumatology, Medical University of Vienna, Vienna, Austria, 3Department of Rheumatology, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 4Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 5Paris 06 University and AP-HP, Hôpital Pitié Salpêtrière, Paris, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Tuesday, November 15, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Enthesitis, dactylitis and nail involvement are part of the core set of domains to be reported in trials of PsA. However, no specific instruments for these domains are recommended in the core set and cutoffs for reporting (ie how to report state or improvement) are also unclear. We aimed to obtain an overview of the instruments and the respective cutoffs used to report state or improvement, for enthesitis, dactylitis and nail involvement in recent randomised controlled trials (RCTs) in PsA.

Methods: A systematic literature review of RCTs on any pharmacological intervention in patients with PsA was conducted, by searching Medline, Embase and Cochrane datasets for the period 2010-2015 (1). Only published papers and only results of the placebo-controlled phases were analysed. The presence and type of all outcome measures reflecting enthesitis, dactylitis and nail involvement were collected. Cutoffs used for each measure (either as state or change, absolute or relative) were also collected. Analyses were descriptive.

Results: Of 2,278 articles screened, 14 trials met the inclusion criteria: 4 (29%) reported on non-biologic drugs (included targeted synthetic DMARDs, 1 trial), 5 (36%) on anti-TNF, 4 (29%) on other biologic modes of action and there was one strategy trial. The trials included a total of 4,744 patients. Five of the trials (36%) did not report any outcome on any of the 3 domains of interest (Table). Enthesitis and dactylitis outcomes were reported in the remaining 9 trials (64%), while nail involvement was only reported in 3 trials (21%). These three outcomes have been measured in several different ways, none of which having been used in more than 3 trials (21%), and the majority of them was actually employed in only 1 (7%) or 2 (14%) trials (table). Table – Outcome measures used in 14 recent trials in PsA

Extra-articular manifestation

Outcome measure

Level of measurement

N (%)

Any

No extra-articular manifestation reported

5 (36%)

Enthesitis

Absolute change in enthesitis score

Change (mean) in Leeds enthesitis index

2 (14%)

Change (mean) in MASES

1 (7%)

Change (median) in tenderness at entheses (comprising the MASES, LEI and tenderness at the plantar fascia)

1 (7%)

Relative change (%) in enthesitis score

% change in MASES

2 (14%)

Proportion of patients with enthesitis

2 (14%)

Proportion of patients with change

% of patients with improvement in ≥1 tendon/ligament

1 (7%)

Resolution of enthesitis

MASES=0

1 (7%)

Enthesitis score=0 (range 0-4)

2 (14%)

Dactylitis

Absolute change in dactylitis score

Change (mean) in Dactylitis severity score (0-20)

2 (14%)

Change (median) in Leeds dactylitis index

1 (7%)

Change (mean) in Leeds dactylitis index

1 (7%)

Relative change (%) in dactylitis score

% change in a 0-60 score

3 (21%)

Proportion of patients with dactylitis

2 (14%)

Resolution of dactylitis

Dactylitis score=0 (range 0-20)

3 (21%)

Nail involvement

Absolute change in score of nail involvement

Change (mean) in modified Nail Psoriasis Severity Index

2 (14%)

Change (median) in modified Nail Psoriasis Severity Index

1 (7%)

Conclusion: There is substantial heterogeneity in the measurement of enthesitis, dactylitis and nail involvement in recent clinical trials of PsA. This heterogeneity relates to both the instruments used and the evaluation and interpretation of the results. Harmonization of measures to be used in trials and possibly also practive is desirable to allow for optimal assessment and better comparability of the efficacy of interventions. References (1) Ramiro et al, Ann Rheum Dis 2015

Disclosure: S. Ramiro, None; J. Smolen, Amgen, Abbvie, Astra-Zeneca, Astro, BMS, Celgene, Glaxo, ILTOO, Janssen, Merck-Serono, MSD, Novartis-Sandoz, Pfizer, Roche-Chugai, Samsung, UCB, 5; R. Landewé, Abbott, Amgen, Centocor, Novartis, Pfizer, Rhoche, Schering-Plough, UCB, Wyeth., 2,Robert Landewé is director of Rheumatology Consultancy BV, which is a registered company under Dutch law., 4,Abbott/AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Celgene, Janssen (formerly Centocor), Galapagos, Glaxo-Smith-Kline, Novartis, Novo-Nordisk, Merck, Pfizer, Rhoche, Schering-Plough, TiGenix, UCB, Wyeth., 5,Abbott/AbbVie, Amgen, Bristol Myers Squibb, Janssen (formerly Centocor), Merck, Pfizer, Rhoche, Schering-Plough, UCB, Wyeth., 9; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, Bristol- Myers Squibb, Boeringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5,Director: Imaging Rheumatology bv, 4; L. Gossec, Abbvie, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5.

To cite this abstract in AMA style:

Ramiro S, Smolen J, Landewé R, van der Heijde D, Gossec L. How Are Enthesitis, Dactylitis and Nail Involvement Measured and Reported in Recent Clinical Trials of Psoriatic Arthritis (PsA)? a Systematic Literature Review [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/how-are-enthesitis-dactylitis-and-nail-involvement-measured-and-reported-in-recent-clinical-trials-of-psoriatic-arthritis-psa-a-systematic-literature-review/. Accessed .

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