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An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound (INTERCEPT)

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Secukinumab 300 mg

Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Subclinical enthesitis, secukinumab, subclinical psoriatic arthritis, Plaque psoriasis, AIN457

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of chronic plaque-type psoriasis confirmed through physical examination by a dermatologist, with at least six months of clinical history prior to the baseline visit
Moderate to severe plaque psoriasis at baseline as defined as:
≥ 10 % Body Surface Area (BSA) involvement, or
≥ 3% to <10% Body Surface Area with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent

Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies

Presence of sonographic enthesitis at screening, in at least one enthesis, defined by the presence of at least abnormal thickening and hypoechogenicity of the tendon insertion, with or without presence of Doppler signal (Grade 0-3), or by the presence of grade ≥ 2 Doppler signal, independent of gray scale abnormalities

Exclusion Criteria:

Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints
Exposure to any IL-17 or IL-23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within twelve months prior to screening, or exposure to any inhibitors of TNF-ɑ and IL12/23 within six months prior to screening
Previous exposure to non-biologic systemic therapy for psoriasis, including methotrexate, PDE-4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half-lives (whichever is longer) prior to screening
A degree of obesity that impedes proper ultrasound examination of entheses and joints
Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g., erythrodermic, generalized or localized pustular psoriasis, or new onset guttate psoriasis)

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Secukinumab 300mg

Placebo

Arm Description

Randomized in a 2:1 ratio to secukinumab or placebo

Outcomes

Primary Outcome Measures

Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score

Twelve (12) entheses (bilateral AT, LE, PP, DP, PA, QT) will be scored in terms of inflammatory and morphological components according to the OMERACT enthesitis composite semi-quantitative scale (0 to 3). The lowest OMERACT score a participant can have at baseline is 2 (based on Inclusion Criterion number 6, which requires at least 2 points in the B-mode or the Doppler mode in at least one enthesis). The highest OMERACT score expected at baseline will be 72, assuming that each of the 12 entheses assessed shows a maximum of 3 points in the gray scale score, and a maximum of 3 points in the Doppler score. The largest change expected from baseline to Week 16 is -60 points (improvement). This assumes that the presence of structural changes (calcifications, enthesophytes and erosions) may add a maximum of 12 points to the score, and it may not be modifiable with study treatment during the study period.

Secondary Outcome Measures

Change from Baseline in the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) ultrasound enthesitis score

Sixteen (16) entheses (bilateral AT, LE, PP, DP, PA, QT, SS, TT) will be scored in terms of inflammatory components according with the GRAPPA ultrasound enthesitis score. The lowest GRAPPA score a participant may have at baseline is 2 (based on Inclusion Criterion number 6, which requires at least 2 points in the B-mode or the Doppler mode in at least 1 enthesis). The highest GRAPPA score expected at baseline is 248, assuming the maximum score that could be assigned to each enthesis. The largest change expected from baseline to Week 16 is -136 points (improvement). This value assumes that the presence of structural changes (calcifications, enthesophytes, and erosions) may add a maximum of 136 points to the score, and it may not be modifiable with study treatment during the study period.

Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis

Joints examined by the PsASon13 unilateral ultrasound composite score: Small finger joints: MCP2, MCP5, H-PIP1, H-PIP2, H-PIP3; Distal interphalangeal finger joints: H-DIP3; Small joints of feet: MTP1, MTP5, F-PIP1; Distal interphalangeal joints of feet: F-DIP2, F-DIP3; Large joints: wrist and knee. Lowest score a participant may have at baseline is 0. Highest score a participant may have at baseline is 184 (5 small finger joints, each ranging from 0 to 18; 1 distal interphalangeal finger joint, each ranging from 0 to 16; 3 small joints of feet, each ranging from 0 to 12; 2 distal interphalangeal joints of feet, each ranging from 0 to 12; 1 wrist ranging from 0 to 12; and 1 knee ranging from 0 to 6). Largest change expected from baseline to Week 16 is -118 points (improvement). This assumes that the presence of structural changes (erosions and osteophytes) may add a maximum of 66 points to the score and it may not be modifiable with study treatment during the study period.

Number of participants who achieve complete resolution of enthesitis based on OMERACT criteria (yes, no)

Proportion of participants experiencing complete resolution of their enthesitis based on Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) score

Number of participants who achieve Psoriasis Area and Severity Index 90 (PASI 90) (yes, no)

Psoriasis Area Severity Index 90 Scores range from 0 to 72. A score of more than 10 generally translates to "moderate-to-severe". Usually, the higher your PASI score, the lower the quality of life. A PASI 90 is at least a 90% improvement (reduction) in PASI score.

Number of participants who achieve Psoriasis Area and Severity Index 100 (PASI 100) (yes, no)

Psoriasis Area Severity Index 100 Scores range from 0 to 72. A score of more than 10 generally translates to "moderate-to-severe". Usually, the higher your PASI score, the lower the quality of life. A PASI 100 is a complete clearing of psoriasis (PASI score = 0).

Number of participants who achieve Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 (yes, no)

The IGA mod 2011 scale is a visual assessment that consists of a score ranging from 0 (clear) to 4 (severe). Skin rated a 4 is bright red in color with marked plaque elevation and is dominated by thick, non-tenacious scale. For a treatment to be considered successful, the affected area must receive a score of 0 or 1 and experience a two-point improvement from Baseline.

Change from Baseline in Body Surface Area (BSA)

The total percentage of body surface area affected by psoriasis

Change from Baseline in Dermatology Life Quality Index (DLQI) score

A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.

Number of participants who achieve Dermatology Life Quality Index (DLQI) score of 0 or 1 (yes, no)

A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.

Change from Baseline in HAQ-DI score

Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).

Number of participants who achieve HAQ-DI change from baseline ≤ -0.35 (yes, no)

Full Information

NCT ID

NCT04488185

First Posted

June 26, 2020

Last Updated

March 28, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04488185

Brief Title

An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

Acronym

INTERCEPT

Official Title

An Exploratory, Randomized, Double-blind, Parallel-group, Multicenter Study to Compare Secukinumab 300 mg With Placebo After 16 Weeks of Treatment in Adults With Moderate to Severe Plaque Psoriasis and Subclinical Enthesitis Measured by Musculoskeletal Ultrasound

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Withdrawn

Why Stopped

low recruitment

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

March 24, 2021 (Actual)

Study Completion Date

March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of subclinical enthesitis in psoriasis patients. This study will be the first randomized trial of a biologic therapy versus placebo in participants with plaque psoriasis and subclinical psoriatic arthritis, using musculoskeletal ultrasound.

Detailed Description

The primary objective of this study is to estimate the difference in effect between secukinumab 300 mg s.c. and placebo, based on change from baseline to Week 16 in the OMERACT ultrasound enthesitis score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis, Subclinical enthesitis, secukinumab, subclinical psoriatic arthritis, Plaque psoriasis, AIN457

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab 300mg

Arm Type

Experimental

Arm Description

Randomized in a 2:1 ratio to secukinumab or placebo

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Randomized in a 2:1 ratio to secukinumab or placebo

Intervention Type

Biological

Intervention Name(s)

Secukinumab 300 mg

Other Intervention Name(s)

AIN457

Intervention Description

Secukinumab 300 mg administered s.c. (2 single-use prefilled syringes of 150 mg/mL), on Days 1, 8, 15, 22, 29, 57, 85.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo administered s.c. (2 single-use prefilled 1 mL syringes) on Days 1, 8, 15, 22, 29, 57, 85.

Primary Outcome Measure Information:

Title

Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) ultrasound enthesitis score

Description

Time Frame

Baseline and Week 16

Secondary Outcome Measure Information:

Title

Change from Baseline in the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) ultrasound enthesitis score

Description

Time Frame

Baseline and Week 16

Title

Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis

Description

Time Frame

Baseline and Week 16

Title

Number of participants who achieve complete resolution of enthesitis based on OMERACT criteria (yes, no)

Description

Proportion of participants experiencing complete resolution of their enthesitis based on Change from Baseline in the Outcome Measures in Rheumatology (OMERACT) score

Time Frame

Baseline and Week 16

Title

Number of participants who achieve Psoriasis Area and Severity Index 90 (PASI 90) (yes, no)

Description

Time Frame

Baseline and Week 16

Title

Number of participants who achieve Psoriasis Area and Severity Index 100 (PASI 100) (yes, no)

Description

Time Frame

Baseline and Week 16

Title

Number of participants who achieve Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1 (yes, no)

Description

Time Frame

Baseline and Week 16

Title

Change from Baseline in Body Surface Area (BSA)

Description

The total percentage of body surface area affected by psoriasis

Time Frame

Baseline and Week 16

Title

Change from Baseline in Dermatology Life Quality Index (DLQI) score

Description

A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.

Time Frame

Baseline and Week 16

Title

Number of participants who achieve Dermatology Life Quality Index (DLQI) score of 0 or 1 (yes, no)

Description

A 10-item measure to assess health-related quality of life in adults with skin diseases. Scores range from 0-30 with a higher score being less quality of life.

Time Frame

Baseline and Week 16

Title

Change from Baseline in HAQ-DI score

Description

Time Frame

Baseline and Week 16

Title

Number of participants who achieve HAQ-DI change from baseline ≤ -0.35 (yes, no)

Description

Time Frame

Baseline and Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of chronic plaque-type psoriasis confirmed through physical examination by a dermatologist, with at least six months of clinical history prior to the baseline visit Moderate to severe plaque psoriasis at baseline as defined as: ≥ 10 % Body Surface Area (BSA) involvement, or ≥ 3% to <10% Body Surface Area with involvement of special regions (nails, scalp, or intertriginous skin), or with a history of psoriatic arthritis in a parent Candidate for systemic therapy, defined as having psoriasis inadequately controlled by current topical and/or systemic treatment(s) (including topical corticosteroids), phototherapy, or previous systemic therapies Presence of sonographic enthesitis at screening, in at least one enthesis, defined by the presence of at least abnormal thickening and hypoechogenicity of the tendon insertion, with or without presence of Doppler signal (Grade 0-3), or by the presence of grade ≥ 2 Doppler signal, independent of gray scale abnormalities Exclusion Criteria: Diagnosis of PsA as per CASPAR confirmed by a rheumatologist (including the presence of inflammatory pain in entheses or joints), and any other known rheumatological disease affecting the assessed joints Exposure to any IL-17 or IL-23(p19) inhibitor for the treatment of psoriasis (approved or investigational) within twelve months prior to screening, or exposure to any inhibitors of TNF-ɑ and IL12/23 within six months prior to screening Previous exposure to non-biologic systemic therapy for psoriasis, including methotrexate, PDE-4 inhibitors, or systemic corticosteroids within 12 weeks or 5 half-lives (whichever is longer) prior to screening A degree of obesity that impedes proper ultrasound examination of entheses and joints Forms of diagnosed psoriasis other than chronic plaque psoriasis (e.g., erythrodermic, generalized or localized pustular psoriasis, or new onset guttate psoriasis) Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

27932277

Citation

Acquitter M, Misery L, Saraux A, Bressollette L, Jousse-Joulin S. Detection of subclinical ultrasound enthesopathy and nail disease in patients at risk of psoriatic arthritis. Joint Bone Spine. 2017 Dec;84(6):703-707. doi: 10.1016/j.jbspin.2016.10.005. Epub 2016 Dec 5.

Results Reference

background

PubMed Identifier

23945732

Citation

Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013 Oct;149(10):1180-5. doi: 10.1001/jamadermatol.2013.5264. Erratum In: JAMA Dermatol. 2014 Jan;150(1):103. JAMA Dermatol. 2014 Mar;150(3):337.

Results Reference

background

PubMed Identifier

18795920

Citation

Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.

Results Reference

background

PubMed Identifier

17216680

Citation

Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9.

Results Reference

background

PubMed Identifier

12933510

Citation

Chen M, Kianifard F. A nonparametric procedure associated with a clinically meaningful efficacy measure. Biostatistics. 2000 Sep;1(3):293-8. doi: 10.1093/biostatistics/1.3.293.

Results Reference

background

PubMed Identifier

18485527

Citation

Doherty SD, Van Voorhees A, Lebwohl MG, Korman NJ, Young MS, Hsu S, National Psoriasis Foundation. National Psoriasis Foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents. J Am Acad Dermatol. 2008 Aug;59(2):209-17. doi: 10.1016/j.jaad.2008.03.023. Epub 2008 May 15.

Results Reference

background

PubMed Identifier

24794490

Citation

El Miedany Y, El Gaafary M, Youssef S, Ahmed I, Nasr A. Tailored approach to early psoriatic arthritis patients: clinical and ultrasonographic predictors for structural joint damage. Clin Rheumatol. 2015 Feb;34(2):307-13. doi: 10.1007/s10067-014-2630-2. Epub 2014 May 3.

Results Reference

background

PubMed Identifier

30756253

Citation

Elnady B, El Shaarawy NK, Dawoud NM, Elkhouly T, Desouky DE, ElShafey EN, El Husseiny MS, Rasker JJ. Subclinical synovitis and enthesitis in psoriasis patients and controls by ultrasonography in Saudi Arabia; incidence of psoriatic arthritis during two years. Clin Rheumatol. 2019 Jun;38(6):1627-1635. doi: 10.1007/s10067-019-04445-0. Epub 2019 Feb 12.

Results Reference

background

PubMed Identifier

26916344

Citation

Faustini F, Simon D, Oliveira I, Kleyer A, Haschka J, Englbrecht M, Cavalcante AR, Kraus S, Tabosa TP, Figueiredo C, Hueber AJ, Kocijan R, Cavallaro A, Schett G, Sticherling M, Rech J. Subclinical joint inflammation in patients with psoriasis without concomitant psoriatic arthritis: a cross-sectional and longitudinal analysis. Ann Rheum Dis. 2016 Dec;75(12):2068-2074. doi: 10.1136/annrheumdis-2015-208821. Epub 2016 Feb 25.

Results Reference

background

PubMed Identifier

26402388

Citation

Feldman SR, Zhao Y, Shi L, Tran MH. Economic and Comorbidity Burden Among Patients with Moderate-to-Severe Psoriasis. J Manag Care Spec Pharm. 2015 Oct;21(10):874-88. doi: 10.18553/jmcp.2015.21.10.874.

Results Reference

background

PubMed Identifier

25361855

Citation

Ficjan A, Husic R, Gretler J, Lackner A, Graninger WB, Gutierrez M, Duftner C, Hermann J, Dejaco C. Ultrasound composite scores for the assessment of inflammatory and structural pathologies in Psoriatic Arthritis (PsASon-Score). Arthritis Res Ther. 2014 Oct 31;16(5):476. doi: 10.1186/s13075-014-0476-2.

Results Reference

background

PubMed Identifier

8033378

Citation

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

Results Reference

background

PubMed Identifier

357213

Citation

Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.

Results Reference

background

PubMed Identifier

15708927

Citation

Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.

Results Reference

background

PubMed Identifier

15948985

Citation

Gottlieb AB, Griffiths CE, Ho VC, Lahfa M, Mrowietz U, Murrell DF, Ortonne JP, Todd G, Cherill R, Marks I, Emady-Azar S, Paul CF; Multi-Centre Investigator Group. Oral pimecrolimus in the treatment of moderate to severe chronic plaque-type psoriasis: a double-blind, multicentre, randomized, dose-finding trial. Br J Dermatol. 2005 Jun;152(6):1219-27. doi: 10.1111/j.1365-2133.2005.06661.x.

Results Reference

background

PubMed Identifier

20688358

Citation

Gutierrez M, Filippucci E, De Angelis R, Salaffi F, Filosa G, Ruta S, Bertolazzi C, Grassi W. Subclinical entheseal involvement in patients with psoriasis: an ultrasound study. Semin Arthritis Rheum. 2011 Apr;40(5):407-12. doi: 10.1016/j.semarthrit.2010.05.009. Epub 2010 Aug 5.

Results Reference

background

PubMed Identifier

30053825

Citation

Kampylafka E, d'Oliveira I, Linz C, Lerchen V, Stemmler F, Simon D, Englbrecht M, Sticherling M, Rech J, Kleyer A, Schett G, Hueber AJ. Resolution of synovitis and arrest of catabolic and anabolic bone changes in patients with psoriatic arthritis by IL-17A blockade with secukinumab: results from the prospective PSARTROS study. Arthritis Res Ther. 2018 Jul 27;20(1):153. doi: 10.1186/s13075-018-1653-5.

Results Reference

background

PubMed Identifier

18313491

Citation

King MT, Fayers PM. Making quality-of-life results more meaningful for clinicians. Lancet. 2008 Mar 1;371(9614):709-10. doi: 10.1016/S0140-6736(08)60324-4. No abstract available.

Results Reference

background

PubMed Identifier

18598104

Citation

Manuel O, Kumar D. QuantiFERON-TB Gold assay for the diagnosis of latent tuberculosis infection. Expert Rev Mol Diagn. 2008 May;8(3):247-56. doi: 10.1586/14737159.8.3.247.

Results Reference

background

PubMed Identifier

29204762

Citation

Mathew AJ, Bird P, Gupta A, George R, Danda D. Magnetic resonance imaging (MRI) of feet demonstrates subclinical inflammatory joint disease in cutaneous psoriasis patients without clinical arthritis. Clin Rheumatol. 2018 Feb;37(2):383-388. doi: 10.1007/s10067-017-3895-z. Epub 2017 Dec 4.

Results Reference

background

PubMed Identifier

21700682

Citation

Naredo E, Moller I, de Miguel E, Batlle-Gualda E, Acebes C, Brito E, Mayordomo L, Moragues C, Uson J, de Agustin JJ, Martinez A, Rejon E, Rodriguez A, Dauden E; Ultrasound School of the Spanish Society of Rheumatology and Spanish ECO-APs Group. High prevalence of ultrasonographic synovitis and enthesopathy in patients with psoriasis without psoriatic arthritis: a prospective case-control study. Rheumatology (Oxford). 2011 Oct;50(10):1838-48. doi: 10.1093/rheumatology/ker078. Epub 2011 Jun 23.

Results Reference

background

PubMed Identifier

30468001

Citation

Savage L, Goodfield M, Horton L, Watad A, Hensor E, Emery P, Wakefield R, Wittmann M, McGonagle D. Regression of Peripheral Subclinical Enthesopathy in Therapy-Naive Patients Treated With Ustekinumab for Moderate-to-Severe Chronic Plaque Psoriasis: A Fifty-Two-Week, Prospective, Open-Label Feasibility Study. Arthritis Rheumatol. 2019 Apr;71(4):626-631. doi: 10.1002/art.40778. Epub 2019 Mar 4.

Results Reference

background

PubMed Identifier

30742092

Citation

Scher JU, Ogdie A, Merola JF, Ritchlin C. Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition. Nat Rev Rheumatol. 2019 Mar;15(3):153-166. doi: 10.1038/s41584-019-0175-0.

Results Reference

background

PubMed Identifier

22134799

Citation

Tinazzi I, McGonagle D, Biasi D, Confente S, Caimmi C, Girolomoni G, Gisondi P. Preliminary evidence that subclinical enthesopathy may predict psoriatic arthritis in patients with psoriasis. J Rheumatol. 2011 Dec;38(12):2691-2. doi: 10.3899/jrheum.110505. No abstract available.

Results Reference

background

PubMed Identifier

26054432

Citation

Villani AP, Rouzaud M, Sevrain M, Barnetche T, Paul C, Richard MA, Beylot-Barry M, Misery L, Joly P, Le Maitre M, Aractingi S, Aubin F, Cantagrel A, Ortonne JP, Jullien D. Prevalence of undiagnosed psoriatic arthritis among psoriasis patients: Systematic review and meta-analysis. J Am Acad Dermatol. 2015 Aug;73(2):242-8. doi: 10.1016/j.jaad.2015.05.001. Epub 2015 Jun 6.

Results Reference

background

PubMed Identifier

14522626

Citation

Weisman S, Pollack CR, Gottschalk RW. Psoriasis disease severity measures: comparing efficacy of treatments for severe psoriasis. J Dermatolog Treat. 2003 Sep;14(3):158-65. doi: 10.1080/09546630310013360.

Results Reference

background

PubMed Identifier

31749987

Citation

Zabotti A, McGonagle DG, Giovannini I, Errichetti E, Zuliani F, Zanetti A, Tinazzi I, De Lucia O, Batticciotto A, Idolazzi L, Sakellariou G, Zandonella Callegher S, Sacco S, Quartuccio L, Iagnocco A, De Vita S. Transition phase towards psoriatic arthritis: clinical and ultrasonographic characterisation of psoriatic arthralgia. RMD Open. 2019 Oct 23;5(2):e001067. doi: 10.1136/rmdopen-2019-001067. eCollection 2019.

Results Reference

background

PubMed Identifier

25881759

Citation

Acquacalda E, Albert C, Montaudie H, Fontas E, Danre A, Roux CH, Breuil V, Lacour JP, Passeron T, Ziegler LE. Ultrasound study of entheses in psoriasis patients with or without musculoskeletal symptoms: A prospective study. Joint Bone Spine. 2015 Jul;82(4):267-71. doi: 10.1016/j.jbspin.2015.01.016. Epub 2015 Apr 13.

Results Reference

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An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

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