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Full-Text Articles in Rheumatology

Patient-Reported Outcomes Data In Patients With Psoriatic Arthritis From A Randomised Trial Of Etanercept And Methotrexate As Monotherapy Or In Combination., Vibeke Strand, Philip Mease, Ervant J Maksabedian Hernandez, Bradley S Stolshek, Lyrica X H Liu, David H Collier, Gregory Kricorian, Joseph F Merola Jan 2021

Patient-Reported Outcomes Data In Patients With Psoriatic Arthritis From A Randomised Trial Of Etanercept And Methotrexate As Monotherapy Or In Combination., Vibeke Strand, Philip Mease, Ervant J Maksabedian Hernandez, Bradley S Stolshek, Lyrica X H Liu, David H Collier, Gregory Kricorian, Joseph F Merola

Articles, Abstracts, and Reports

OBJECTIVES: We examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA.

METHODS: Efficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and …


Long-Term Safety And Tolerability Of Apremilast Versus Placebo In Psoriatic Arthritis: A Pooled Safety Analysis Of Three Phase Iii, Randomized, Controlled Trials., Philip Mease, Dafna D Gladman, Juan J Gomez-Reino, Stephen Hall, Arthur Kavanaugh, Eric Lespessailles, Georg Schett, Maria Paris, Nikolay Delev, Lichen Teng, Jürgen Wollenhaupt Jul 2020

Long-Term Safety And Tolerability Of Apremilast Versus Placebo In Psoriatic Arthritis: A Pooled Safety Analysis Of Three Phase Iii, Randomized, Controlled Trials., Philip Mease, Dafna D Gladman, Juan J Gomez-Reino, Stephen Hall, Arthur Kavanaugh, Eric Lespessailles, Georg Schett, Maria Paris, Nikolay Delev, Lichen Teng, Jürgen Wollenhaupt

Articles, Abstracts, and Reports

OBJECTIVE: Psoriatic arthritis (PsA) requires long-term treatment, yet safety concerns and monitoring requirements make maintenance a challenge. This analysis of pooled Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) 1, 2, and 3 data describes 3-year apremilast safety and tolerability in PsA.

METHODS: Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily. Placebo patients were re-randomized to apremilast 30 mg twice daily or 20 mg twice daily at week 16 (early escape) or 24. Double-blind treatment continued to week 52; patients could continue apremilast during an open-label, long-term treatment …


Assessing The Effect Of Interventions For Axial Spondyloarthritis According To The Endorsed Asas/Omeract Core Outcome Set: A Meta-Research Study Of Trials Included In Cochrane Reviews., Rikke A Andreasen, Lars E Kristensen, Xenofon Baraliakos, Vibeke Strand, Philip Mease, Maarten De Wit, Torkell Ellingsen, Inger Marie J Hansen, Jamie Kirkham, George A Wells, Peter Tugwell, Lara Maxwell, Maarten Boers, Kenneth Egstrup, Robin Christensen Jul 2020

Assessing The Effect Of Interventions For Axial Spondyloarthritis According To The Endorsed Asas/Omeract Core Outcome Set: A Meta-Research Study Of Trials Included In Cochrane Reviews., Rikke A Andreasen, Lars E Kristensen, Xenofon Baraliakos, Vibeke Strand, Philip Mease, Maarten De Wit, Torkell Ellingsen, Inger Marie J Hansen, Jamie Kirkham, George A Wells, Peter Tugwell, Lara Maxwell, Maarten Boers, Kenneth Egstrup, Robin Christensen

Articles, Abstracts, and Reports

The Assessment of SpondyloArthritis international Society (ASAS) has defined core sets for (i) symptom-modifying anti-rheumatic drugs (SM-ARD), (ii) clinical record keeping, and (iii) disease-controlling anti-rheumatic therapy (DC-ART). These include the following domains for all three core sets: "physical function," "pain," "spinal mobility," "spinal stiffness," and "patient's global assessment" (PGA). The core set for clinical record keeping further includes the domains "peripheral joints/entheses" and "acute phase reactants," and the core set for DC-ART further includes the domains "fatigue" and "spine radiographs/hip radiographs." The Outcome Measures in Rheumatology (OMERACT) endorsed the core sets in 1998.Using empirical evidence from axSpA trials, we investigated …


Characterization Of Patients With Axial Spondyloarthritis By Enthesitis Presence: Data From The Corrona Psoriatic Arthritis/Spondyloarthritis Registry., Philip Mease, Mei Liu, Sabrina Rebello, Winnie Hua, Robert R Mclean, Esther Yi, Yujin Park, Alexis Ogdie Jul 2020

Characterization Of Patients With Axial Spondyloarthritis By Enthesitis Presence: Data From The Corrona Psoriatic Arthritis/Spondyloarthritis Registry., Philip Mease, Mei Liu, Sabrina Rebello, Winnie Hua, Robert R Mclean, Esther Yi, Yujin Park, Alexis Ogdie

Articles, Abstracts, and Reports

OBJECTIVE: To compare the characteristics of patients with axial spondyloarthritis (axSpA) who had enthesitis versus those without enthesitis.

METHODS: This study included adult patients with axSpA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry (March 2013 to August 2018). Enthesitis was assessed at enrollment via the Spondyloarthritis Research Consortium of Canada Enthesitis Index. Characteristics were compared between patients with and without enthesitis using t tests or Wilcoxon rank-sum tests for continuous variables and χ

RESULTS: Of 477 patients with axSpA, 121 (25.4%) had enthesitis (mean, 3.9 sites) at enrollment. Higher proportions of patients with enthesitis were female and had nonradiographic axSpA …


Secukinumab Provides Sustained Low Rates Of Radiographic Progression In Psoriatic Arthritis: 52-Week Results From A Phase 3 Study, Future 5., Désirée Van Der Heijde, Philip Mease, Robert B M Landewé, Proton Rahman, Hasan Tahir, Atul Singhal, Elke Boettcher, Sandra Navarra, Xuan Zhu, Gregory Ligozio, Aimee Readie, Shephard Mpofu, Luminita Pricop Jun 2020

Secukinumab Provides Sustained Low Rates Of Radiographic Progression In Psoriatic Arthritis: 52-Week Results From A Phase 3 Study, Future 5., Désirée Van Der Heijde, Philip Mease, Robert B M Landewé, Proton Rahman, Hasan Tahir, Atul Singhal, Elke Boettcher, Sandra Navarra, Xuan Zhu, Gregory Ligozio, Aimee Readie, Shephard Mpofu, Luminita Pricop

Articles, Abstracts, and Reports

OBJECTIVE: To evaluate the effect of secukinumab on radiographic progression through 52 weeks in patients with PsA from the FUTURE 5 study.

METHODS: Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response), were randomized to s.c. secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load regimens or placebo at baseline, at weeks 1, 2 and 3 and every 4 weeks starting at week 4. Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers). Statistical analysis used a linear mixed-effects model (random …


Inhibition Of Radiographic Progression Across Levels Of Composite Index-Defined Disease Activity In Patients With Active Psoriatic Arthritis Treated With Intravenous Golimumab: Results From A Phase-3, Double-Blind, Placebo-Controlled Trial., Philip Mease, M Elaine Husni, Shelly Kafka, Soumya D Chakravarty, Diane D Harrison, Kim Hung Lo, Stephen Xu, Elizabeth C Hsia, Arthur Kavanaugh Mar 2020

Inhibition Of Radiographic Progression Across Levels Of Composite Index-Defined Disease Activity In Patients With Active Psoriatic Arthritis Treated With Intravenous Golimumab: Results From A Phase-3, Double-Blind, Placebo-Controlled Trial., Philip Mease, M Elaine Husni, Shelly Kafka, Soumya D Chakravarty, Diane D Harrison, Kim Hung Lo, Stephen Xu, Elizabeth C Hsia, Arthur Kavanaugh

Articles, Abstracts, and Reports

BACKGROUND: In the GO-VIBRANT trial of intravenous golimumab in psoriatic arthritis (PsA), golimumab significantly inhibited radiographic progression. In post hoc analyses, we evaluated changes in total PsA-modified Sharp/van der Heijde scores (SHS) across levels of composite index-defined disease activity following treatment.

METHODS: In this phase-3, double-blind, placebo-controlled trial, 480 bio-naïve patients with active PsA randomly received intravenous golimumab 2 mg/kg (N = 241; week 0, week 4, every 8 weeks [q8w]) or placebo (N = 239; week 0, week 4, week 12, week 20) followed by golimumab (week 24, week 28, q8w) through week 52. Week 24 and week 52 …


Preface To The Psoriatic Arthritis Supplement., Philip Mease Mar 2020

Preface To The Psoriatic Arthritis Supplement., Philip Mease

Articles, Abstracts, and Reports

No abstract provided.


Enthesitis In Psoriatic Arthritis (Part 3): Clinical Assessment And Management., Philip Mease Mar 2020

Enthesitis In Psoriatic Arthritis (Part 3): Clinical Assessment And Management., Philip Mease

Articles, Abstracts, and Reports

Enthesitis is a common clinical feature of PsA, which is characterized by inflammation at the site of insertion of tendons, ligaments and joint capsule fibres into bone. Enthesitis is relatively unique to the spondyloarthritides, setting this group of diseases apart from other rheumatological conditions. The pathophysiological underpinnings of this clinical domain, and the imaging assessment of it, are described in accompanying articles in this supplement. The focus of this article is on the assessment of enthesitis by physical examination, the impact of enthesitis on function and quality of life, the impact of concomitant FM on clinical assessment, and the evidence …


A Head-To-Head Comparison Of The Efficacy And Safety Of Ixekizumab And Adalimumab In Biological-Naïve Patients With Active Psoriatic Arthritis: 24-Week Results Of A Randomised, Open-Label, Blinded-Assessor Trial., Philip Mease, Josef S Smolen, Frank Behrens, Peter Nash, Soyi Liu Leage, Lingnan Li, Hasan Tahir, Melinda Gooderham, Eswar Krishnan, Hong Liu-Seifert, Paul Emery, Sreekumar G Pillai, Philip S Helliwell Jan 2020

A Head-To-Head Comparison Of The Efficacy And Safety Of Ixekizumab And Adalimumab In Biological-Naïve Patients With Active Psoriatic Arthritis: 24-Week Results Of A Randomised, Open-Label, Blinded-Assessor Trial., Philip Mease, Josef S Smolen, Frank Behrens, Peter Nash, Soyi Liu Leage, Lingnan Li, Hasan Tahir, Melinda Gooderham, Eswar Krishnan, Hong Liu-Seifert, Paul Emery, Sreekumar G Pillai, Philip S Helliwell

Articles, Abstracts, and Reports

OBJECTIVES: To compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).

METHODS: Patients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the …


Secukinumab Provides Sustained Improvements In The Signs And Symptoms Of Psoriatic Arthritis: Final 5-Year Results From The Phase 3 Future 1 Study., Philip Mease, Arthur Kavanaugh, Andreas Reimold, Hasan Tahir, Juergen Rech, Stephen Hall, Piet Geusens, Pascale Pellet, Eumorphia Maria Delicha, Luminita Pricop, Shephard Mpofu Jan 2020

Secukinumab Provides Sustained Improvements In The Signs And Symptoms Of Psoriatic Arthritis: Final 5-Year Results From The Phase 3 Future 1 Study., Philip Mease, Arthur Kavanaugh, Andreas Reimold, Hasan Tahir, Juergen Rech, Stephen Hall, Piet Geusens, Pascale Pellet, Eumorphia Maria Delicha, Luminita Pricop, Shephard Mpofu

Articles, Abstracts, and Reports

OBJECTIVE: To report the 5-year efficacy and safety of secukinumab in the treatment of patients with psoriatic arthritis (PsA) in the FUTURE 1 study (NCT01392326).

METHODS: Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab entered a 3-year extension phase. Results are presented for key efficacy endpoints for the secukinumab 150-mg group (n = 236), including patients who escalated from 150 to 300 mg (approved doses) starting at week 156. Safety is reported for all patients (n = 587) who received 1 dose or more of study treatment.

RESULTS: Overall, 81.8%% (193 of 236) of patients in the secukinumab …


Unmet Need In Rheumatology: Reports From The Targeted Therapies Meeting 2019., Kevin L Winthrop, Michael E Weinblatt, Joan Bathon, Gerd R Burmester, Philip Mease, Leslie Crofford, Vivian Bykerk, Maxime Dougados, James Todd Rosenbaum, Xavier Mariette, Joachim Sieper, Fritz Melchers, Bruce N Cronstein, Ferry C Breedveld, Joachim Kalden, Josef S Smolen, Daniel Furst Jan 2020

Unmet Need In Rheumatology: Reports From The Targeted Therapies Meeting 2019., Kevin L Winthrop, Michael E Weinblatt, Joan Bathon, Gerd R Burmester, Philip Mease, Leslie Crofford, Vivian Bykerk, Maxime Dougados, James Todd Rosenbaum, Xavier Mariette, Joachim Sieper, Fritz Melchers, Bruce N Cronstein, Ferry C Breedveld, Joachim Kalden, Josef S Smolen, Daniel Furst

Articles, Abstracts, and Reports

OBJECTIVES: To detail the greatest areas of unmet scientific and clinical needs in rheumatology.

METHODS: The 21st annual international Advances in Targeted Therapies meeting brought together more than 100 leading basic scientists and clinical researchers in rheumatology, immunology, epidemiology, molecular biology and other specialties. During the meeting, breakout sessions were convened, consisting of 5 disease-specific groups with 20-30 experts assigned to each group based on expertise. Specific groups included: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. In each group, experts were asked to identify unmet clinical and translational research needs in general …


Secukinumab Efficacy On Resolution Of Enthesitis In Psoriatic Arthritis: Pooled Analysis Of Two Phase 3 Studies., Laura C Coates, Johan K Wallman, Dennis Mcgonagle, Georg A Schett, Iain B Mcinnes, Philip Mease, Lawrence Rasouliyan, Erhard Quebe-Fehling, Darren L Asquith, Andreas E R Fasth, Luminita Pricop, Corine Gaillez Dec 2019

Secukinumab Efficacy On Resolution Of Enthesitis In Psoriatic Arthritis: Pooled Analysis Of Two Phase 3 Studies., Laura C Coates, Johan K Wallman, Dennis Mcgonagle, Georg A Schett, Iain B Mcinnes, Philip Mease, Lawrence Rasouliyan, Erhard Quebe-Fehling, Darren L Asquith, Andreas E R Fasth, Luminita Pricop, Corine Gaillez

Articles, Abstracts, and Reports

BACKGROUND: Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies.

METHOD: Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3-6) to full resolution (FR), stable (similar or reduction …


Secukinumab Efficacy On Resolution Of Enthesitis In Psoriatic Arthritis: Pooled Analysis Of Two Phase 3 Studies., Laura C Coates, Johan K Wallman, Dennis Mcgonagle, Georg A Schett, Iain B Mcinnes, Philip Mease, Lawrence Rasouliyan, Erhard Quebe-Fehling, Darren L Asquith, Andreas E R Fasth, Luminita Pricop, Corine Gaillez Dec 2019

Secukinumab Efficacy On Resolution Of Enthesitis In Psoriatic Arthritis: Pooled Analysis Of Two Phase 3 Studies., Laura C Coates, Johan K Wallman, Dennis Mcgonagle, Georg A Schett, Iain B Mcinnes, Philip Mease, Lawrence Rasouliyan, Erhard Quebe-Fehling, Darren L Asquith, Andreas E R Fasth, Luminita Pricop, Corine Gaillez

Articles, Abstracts, and Reports

BACKGROUND: Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies.

METHOD: Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3-6) to full resolution (FR), stable (similar or reduction …


Assessing Physical Activity And Sleep In Axial Spondyloarthritis: Measuring The Gap., Atul Deodhar, Lianne S Gensler, Marina Magrey, Jessica A Walsh, Adam Winseck, Daniel Grant, Philip Mease Dec 2019

Assessing Physical Activity And Sleep In Axial Spondyloarthritis: Measuring The Gap., Atul Deodhar, Lianne S Gensler, Marina Magrey, Jessica A Walsh, Adam Winseck, Daniel Grant, Philip Mease

Articles, Abstracts, and Reports

Patients with axial spondyloarthritis (axSpA) frequently report pain, stiffness, fatigue, and sleep problems, which may lead to impaired physical activity. The majority of reported-on measures evaluating physical activity and sleep disturbance in axSpA are self-reported questionnaires, which can be impacted by patient recall (reporting bias). One objective measure, polysomnography, has been employed to evaluate sleep in patients with axSpA; however, it is an intrusive measure and cannot be used over the long term. More convenient objective measures are therefore needed to allow for the long-term assessment of both sleep and physical activity in patients' daily lives. Wearable technology that utilizes …


Consumer Prices For Surgical Management Of Ankle Arthritis: Limited Availability And Wide Variability., Niall A Smyth, Brody J Dawkins, Joshua P Goldstein, Jonathan R Kaplan, Lew C Schon, Amiethab A Aiyer Jul 2019

Consumer Prices For Surgical Management Of Ankle Arthritis: Limited Availability And Wide Variability., Niall A Smyth, Brody J Dawkins, Joshua P Goldstein, Jonathan R Kaplan, Lew C Schon, Amiethab A Aiyer

Articles, Abstracts, and Reports

Background: Healthcare costs for the surgical management of ankle arthritis continue to rise. Patients are generally unaware of the prices of the services they use. Understanding the costs associated with surgical management of ankle arthritis is an important facet of patient care. The purposes of this study were to (1) determine the access to the surgical cost of total ankle arthroplasty (TAAs) and ankle arthrodesis and (2) the variability of the price between the two procedures.

Methods: Fifty foot and ankle centers (25 academic, 25 private) that perform TAAs and ankle arthrodeses were contacted using a standardized patient script. The …


Long-Term Experience With Apremilast In Patients With Psoriatic Arthritis: 5-Year Results From A Palace 1-3 Pooled Analysis., Arthur Kavanaugh, Dafna D Gladman, Christopher J Edwards, Georg Schett, Benoit Guerette, Nikolay Delev, Lichen Teng, Maria Paris, Philip Mease May 2019

Long-Term Experience With Apremilast In Patients With Psoriatic Arthritis: 5-Year Results From A Palace 1-3 Pooled Analysis., Arthur Kavanaugh, Dafna D Gladman, Christopher J Edwards, Georg Schett, Benoit Guerette, Nikolay Delev, Lichen Teng, Maria Paris, Philip Mease

Articles, Abstracts, and Reports

BACKGROUND: The efficacy and safety of apremilast were assessed in patients with psoriatic arthritis (PsA) in three phase III clinical trials with similar designs (PALACE 1, 2, and 3).

METHODS: Following a 24-week, randomized (1:1:1 to apremilast 30 mg twice daily, 20 mg twice daily, or placebo), double-blind phase and a 28-week blinded active treatment phase, patients could receive apremilast in open-label extension studies for an additional 4 years. Eligible adult patients had active PsA for ≥ 6 months and three or more swollen joints and three or more tender joints despite prior treatment with disease-modifying anti-rheumatic drugs.

RESULTS: A …


Long-Term Safety Of Secukinumab In Patients With Moderate-To-Severe Plaque Psoriasis, Psoriatic Arthritis, And Ankylosing Spondylitis: Integrated Pooled Clinical Trial And Post-Marketing Surveillance Data., A Deodhar, Philip Mease, I B Mcinnes, X Baraliakos, K Reich, A Blauvelt, C Leonardi, B Porter, A Das Gupta, A Widmer, L Pricop, T Fox May 2019

Long-Term Safety Of Secukinumab In Patients With Moderate-To-Severe Plaque Psoriasis, Psoriatic Arthritis, And Ankylosing Spondylitis: Integrated Pooled Clinical Trial And Post-Marketing Surveillance Data., A Deodhar, Philip Mease, I B Mcinnes, X Baraliakos, K Reich, A Blauvelt, C Leonardi, B Porter, A Das Gupta, A Widmer, L Pricop, T Fox

Articles, Abstracts, and Reports

BACKGROUND: Secukinumab, a fully human immunoglobulin G1-kappa monoclonal antibody that directly inhibits interleukin (IL)-17A, has been shown to have robust efficacy in the treatment of moderate-to-severe psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) demonstrating a rapid onset of action and sustained long-term clinical responses with a consistently favorable safety profile in multiple Phase 2 and 3 trials. Here, we report longer-term pooled safety and tolerability data for secukinumab across three indications (up to 5 years of treatment in PsO and PsA; up to 4 years in AS).

METHODS: The integrated clinical trial safety dataset included data pooled from …


Tofacitinib Or Adalimumab Versus Placebo: Patient-Reported Outcomes From Opal Broaden-A Phase Iii Study Of Active Psoriatic Arthritis In Patients With An Inadequate Response To Conventional Synthetic Disease-Modifying Antirheumatic Drugs., Vibeke Strand, Kurt De Vlam, Jose A Covarrubias-Cobos, Philip Mease, Dafna D Gladman, Daniela Graham, Cunshan Wang, Joseph C Cappelleri, Thijs Hendrikx, Ming-Ann Hsu Jan 2019

Tofacitinib Or Adalimumab Versus Placebo: Patient-Reported Outcomes From Opal Broaden-A Phase Iii Study Of Active Psoriatic Arthritis In Patients With An Inadequate Response To Conventional Synthetic Disease-Modifying Antirheumatic Drugs., Vibeke Strand, Kurt De Vlam, Jose A Covarrubias-Cobos, Philip Mease, Dafna D Gladman, Daniela Graham, Cunshan Wang, Joseph C Cappelleri, Thijs Hendrikx, Ming-Ann Hsu

Articles, Abstracts, and Reports

Objectives: Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and tumour necrosis factor inhibitor-naïve in a 12-month, phase III randomised controlled trial (OPAL Broaden [NCT01877668]).

Methods: Patients (N=422) received tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg subcutaneously every 2 weeks or placebo advancing to tofacitinib 5 mg or 10 mg twice daily at month 3. Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences (MCID); and …


Predicting Adherence To Therapy In Rheumatoid Arthritis, Psoriatic Arthritis Or Ankylosing Spondylitis: A Large Cross-Sectional Study., Josef S Smolen, Dafna Gladman, H Patrick Mcneil, Philip J Mease, Joachim Sieper, Maja Hojnik, Pascal Nurwakagari, John Weinman Jan 2019

Predicting Adherence To Therapy In Rheumatoid Arthritis, Psoriatic Arthritis Or Ankylosing Spondylitis: A Large Cross-Sectional Study., Josef S Smolen, Dafna Gladman, H Patrick Mcneil, Philip J Mease, Joachim Sieper, Maja Hojnik, Pascal Nurwakagari, John Weinman

Articles, Abstracts, and Reports

Objective: This analysis explored the association of treatment adherence with beliefs about medication, patient demographic and disease characteristics and medication types in rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) to develop adherence prediction models.

Methods: The population was a subset from ALIGN, a multicountry, cross-sectional, self-administered survey study in adult patients (n=7328) with six immune-mediated inflammatory diseases who were routinely receiving systemic therapy. Instruments included Beliefs about Medicines Questionnaire (BMQ) and 4-item Morisky Medication Adherence Scale (MMAS-4

Results: A total of 3390 rheumatological patients were analysed (RA, n=1943; PsA, n=635; AS, n=812). Based on the strongest significant …


Measurement Properties Of The Minimal Disease Activity Criteria For Psoriatic Arthritis., Laura C Coates, Vibeke Strand, Hilary Wilson, Dennis Revicki, Brad Stolshek, Ahmed Samad, James B Chung, Dafna Gladman, Philip Mease Jan 2019

Measurement Properties Of The Minimal Disease Activity Criteria For Psoriatic Arthritis., Laura C Coates, Vibeke Strand, Hilary Wilson, Dennis Revicki, Brad Stolshek, Ahmed Samad, James B Chung, Dafna Gladman, Philip Mease

Articles, Abstracts, and Reports

Objective: To comprehensively assess evidence on the measurement properties of the minimal disease activity (MDA) criteria, a composite measure of the state of disease activity in psoriatic arthritis (PsA).

Methods: A targeted literature review was conducted to identify studies that informed the validity and/or ability of the MDA to detect change among patients known to have experienced a change in clinical status. The search was conducted using MEDLINE and Embase databases (published as of October 2017). Pertinent articles provided by investigators and identified from select conference proceedings were also evaluated.

Results: A total of 20 publications met the inclusion criteria. …


Effect Of Tofacitinib On Patient-Reported Outcomes In Patients With Active Psoriatic Arthritis And An Inadequate Response To Tumour Necrosis Factor Inhibitors In The Phase Iii, Randomised Controlled Trial: Opal Beyond., Vibeke Strand, Kurt De Vlam, Jose A Covarrubias-Cobos, Philip Mease, Dafna D Gladman, Linda Chen, Elizabeth Kudlacz, Joseph Wu, Joseph C Cappelleri, Thijs Hendrikx, Ming-Ann Hsu Jan 2019

Effect Of Tofacitinib On Patient-Reported Outcomes In Patients With Active Psoriatic Arthritis And An Inadequate Response To Tumour Necrosis Factor Inhibitors In The Phase Iii, Randomised Controlled Trial: Opal Beyond., Vibeke Strand, Kurt De Vlam, Jose A Covarrubias-Cobos, Philip Mease, Dafna D Gladman, Linda Chen, Elizabeth Kudlacz, Joseph Wu, Joseph C Cappelleri, Thijs Hendrikx, Ming-Ann Hsu

Articles, Abstracts, and Reports

Objectives: Tofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). Patient-reported outcomes (PROs) were evaluated in patients with PsA with inadequate responses to tumour necrosis factor inhibitors (TNFi-IR) in a 6-month, phase III randomised controlled trial (OPAL Beyond [NCT01882439]).

Methods: Patients (N=394) received tofacitinib 5 or 10 mg twice daily or placebo (advancing to tofacitinib 5 or 10 mg twice daily at month 3). Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences and scores ≥normative values were determined in Patient Global Assessment of disease activity (PtGA), Pain, Patient …


Participation In An Innovative Patient Support Program Reduces Prescription Abandonment For Adalimumab-Treated Patients In A Commercial Population., Diana Brixner, Manish Mittal, David T Rubin, Philip Mease, Harry H Liu, Matthew Davis, Arijit Ganguli, A Mark Fendrick Jan 2019

Participation In An Innovative Patient Support Program Reduces Prescription Abandonment For Adalimumab-Treated Patients In A Commercial Population., Diana Brixner, Manish Mittal, David T Rubin, Philip Mease, Harry H Liu, Matthew Davis, Arijit Ganguli, A Mark Fendrick

Articles, Abstracts, and Reports

Purpose: Nonadherence to indicated therapy reduces treatment effectiveness and may increase cost of care. HUMIRA Complete, a Patient Support Program (PSP), aims to reduce nonadherence in patients prescribed adalimumab (ADA). The objective of this study was to assess the relationship between participation in the PSP and prescription abandonment rates among ADA-treated patients.

Patients and methods: This longitudinal study using patient-level data from AbbVie's PSP linked with medical and pharmacy claims data included patients ≥18 years with an ADA-approved indication, ≥1 pharmacy claim for ADA, and available data ≥3 months before and ≥6 months after the index date (defined as the …


Understanding The Association Between Skin Involvement And Joint Activity In Patients With Psoriatic Arthritis: Experience From The Corrona Registry., Philip Mease, Carol J Etzel, William J Huster, Talia M Muram, April W Armstrong, Jeffrey R Lisse, Sabrina Rebello, Rhiannon Dodge, Mwangi James Murage, Jeffrey D Greenberg, William N Malatestinic Jan 2019

Understanding The Association Between Skin Involvement And Joint Activity In Patients With Psoriatic Arthritis: Experience From The Corrona Registry., Philip Mease, Carol J Etzel, William J Huster, Talia M Muram, April W Armstrong, Jeffrey R Lisse, Sabrina Rebello, Rhiannon Dodge, Mwangi James Murage, Jeffrey D Greenberg, William N Malatestinic

Articles, Abstracts, and Reports

Objective: To compare the characteristics of patients with psoriatic arthritis among patient groups stratified by degree of skin and joint involvement, and to evaluate the relationship between skin severity and joint activity.

Methods: Body surface area (BSA) and Clinical Disease Activity Index (CDAI) at enrolment were analysed. Patient characteristics were stratified by skin severity and joint activity. Baseline patient characteristics, clinical and disease characteristics and patient-reported outcomes were compared. The strength of the relationship of skin severity and joint activity was evaluated using methods for categorical variables (χ

Results: 1542 adult patients in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry enrolled between …


Body Mass Index And Treatment Response To Subcutaneous Abatacept In Patients With Psoriatic Arthritis: A, Iain B Mcinnes, Gianfranco Ferraccioli, Maria-Antonietta D'Agostino, Manuela Le Bars, Subhashis Banerjee, Harris A Ahmad, Yedid Elbez, Philip Mease Jan 2019

Body Mass Index And Treatment Response To Subcutaneous Abatacept In Patients With Psoriatic Arthritis: A, Iain B Mcinnes, Gianfranco Ferraccioli, Maria-Antonietta D'Agostino, Manuela Le Bars, Subhashis Banerjee, Harris A Ahmad, Yedid Elbez, Philip Mease

Articles, Abstracts, and Reports

Objective: This

Methods: In ASTRAEA, patients with active PsA were randomised (1:1) to receive blinded weekly SC abatacept 125 mg or placebo for 24 weeks. Treatment response at week 24 was assessed by the proportions of patients achieving American College of Rheumatology 20% improvement response, Disease Activity Score in 28 joints (DAS28 (C reactive protein (CRP))) ≤3.6 and

Results: Of 212/213 and 210/211 patients with baseline BMI data in the abatacept and placebo groups, respectively, 15% and 19% were underweight/normal, 36% and 27% were overweight, and 49% and 54% were obese. After adjusting for baseline characteristics, there were no significant …


Discontinuation And Switching Patterns Of Tumour Necrosis Factor Inhibitors (Tnfis) In Tnfi-Naive And Tnfi-Experienced Patients With Psoriatic Arthritis: An Observational Study From The Us-Based Corrona Registry., Philip Mease, Chitra Karki, Mei Liu, Youfu Li, Bernice Gershenson, Hua Feng, Peter Hur, Jeffrey D Greenberg Jan 2019

Discontinuation And Switching Patterns Of Tumour Necrosis Factor Inhibitors (Tnfis) In Tnfi-Naive And Tnfi-Experienced Patients With Psoriatic Arthritis: An Observational Study From The Us-Based Corrona Registry., Philip Mease, Chitra Karki, Mei Liu, Youfu Li, Bernice Gershenson, Hua Feng, Peter Hur, Jeffrey D Greenberg

Articles, Abstracts, and Reports

Objective: To examine patterns of tumour necrosis factor inhibitor (TNFi) use in TNFi-naive and TNFi-experienced patients with psoriatic arthritis (PsA) in the USA.

Methods: All patients aged ≥18 years with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry who initiated a TNFi (index therapy) between March 2013 and January 2017 and had ≥1 follow-up visit were included. Times to and rates of discontinuation/switch of the index TNFi were compared between TNFi-naive and TNFi-experienced cohorts. Patient demographics and disease characteristics at the time of TNFi initiation (baseline) were compared between cohorts and between patients who continued versus discontinued their index TNFi …


Correction: Secukinumab In The Treatment Of Psoriatic Arthritis: Efficacy And Safety Results Through 3 Years From The Year 1 Extension Of The Randomised Phase Iii Future 1 Trial., Philip Mease, A Kavanaugh, A Reimold Sep 2018

Correction: Secukinumab In The Treatment Of Psoriatic Arthritis: Efficacy And Safety Results Through 3 Years From The Year 1 Extension Of The Randomised Phase Iii Future 1 Trial., Philip Mease, A Kavanaugh, A Reimold

Articles, Abstracts, and Reports

No abstract provided.


Comparative Effectiveness Of Secukinumab And Etanercept In Biologic-Naïve Patients With Psoriatic Arthritis Assessed By Matching-Adjusted Indirect Comparison., Philip Mease, Ernest Choy, Peter Nash, Chrysostomos Kalyvas, Matthias Hunger, Luminita Pricop, Kunal K Gandhi, Steffen M Jugl, Howard Thom Jul 2018

Comparative Effectiveness Of Secukinumab And Etanercept In Biologic-Naïve Patients With Psoriatic Arthritis Assessed By Matching-Adjusted Indirect Comparison., Philip Mease, Ernest Choy, Peter Nash, Chrysostomos Kalyvas, Matthias Hunger, Luminita Pricop, Kunal K Gandhi, Steffen M Jugl, Howard Thom

Articles, Abstracts, and Reports

OBJECTIVE: Matching-adjusted indirect comparison (MAIC) can be used to assess the comparative effectiveness of two treatments indirectly using data from randomized placebo-controlled trials. This MAIC assessed the comparative effectiveness of secukinumab (an anti-interleukin-17A) and etanercept (a tumor necrosis factor inhibitor) in a target population of biologic-naïve patients with psoriatic arthritis (PsA).

METHODS: Individual patient data pooled from FUTURE 2 (NCT01752634), FUTURE 3 (NCT01989468), and FUTURE 5 (NCT02404350) (secukinumab: 150 mg, n=458 and 300 mg, n=461) were matched to data from the population in the NCT00317499 trial (etanercept 25 mg, n=101) using MAIC methodology, by adjusting for clinical and demographic baseline …


Secukinumab Versus Adalimumab For Psoriatic Arthritis: Comparative Effectiveness Up To 48 Weeks Using A Matching-Adjusted Indirect Comparison., Peter Nash, Iain B Mcinnes, Philip Mease, Howard Thom, Matthias Hunger, Andreas Karabis, Kunal Gandhi, Shephard Mpofu, Steffen M Jugl Jun 2018

Secukinumab Versus Adalimumab For Psoriatic Arthritis: Comparative Effectiveness Up To 48 Weeks Using A Matching-Adjusted Indirect Comparison., Peter Nash, Iain B Mcinnes, Philip Mease, Howard Thom, Matthias Hunger, Andreas Karabis, Kunal Gandhi, Shephard Mpofu, Steffen M Jugl

Articles, Abstracts, and Reports

INTRODUCTION: Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations.

METHODS: Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N = 299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs. placebo; N = 313). Logistic regression determined adjustment weights for age, body weight, sex, race, methotrexate use, psoriasis affecting ≥ 3% of body surface area, Psoriasis Area and Severity Index score, Health Assessment Questionnaire Disability Index …


Secukinumab Improves Active Psoriatic Arthritis Symptoms And Inhibits Radiographic Progression: Primary Results From The Randomised, Double-Blind, Phase Iii Future 5 Study., Philip Mease, Désirée Van Der Heijde, Robert Landewé, Shephard Mpofu, Proton Rahman, Hasan Tahir, Atul Singhal, Elke Boettcher, Sandra Navarra, Karin Meiser, Aimee Readie, Luminita Pricop, Ken Abrams Jun 2018

Secukinumab Improves Active Psoriatic Arthritis Symptoms And Inhibits Radiographic Progression: Primary Results From The Randomised, Double-Blind, Phase Iii Future 5 Study., Philip Mease, Désirée Van Der Heijde, Robert Landewé, Shephard Mpofu, Proton Rahman, Hasan Tahir, Atul Singhal, Elke Boettcher, Sandra Navarra, Karin Meiser, Aimee Readie, Luminita Pricop, Ken Abrams

Articles, Abstracts, and Reports

OBJECTIVES: To evaluate the effect of subcutaneous (s.c.) secukinumab, an interleukin-17A inhibitor, on clinical signs and symptoms and radiographic progression in patients with psoriatic arthritis (PsA).

METHODS: Adults (n=996) with active PsA were randomised 2:2:2:3 to s.c. secukinumab 300 mg or 150 mg with loading dose (LD), 150 mg without LD or placebo. All groups received secukinumab or placebo at baseline, weeks 1, 2 and 3 and then every 4 weeks from week 4. The primary endpoint was the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response at week 16.

RESULTS: Significantly more patients achieved an …


Baseline Patient Characteristics Associated With Response To Biologic Therapy In Patients With Psoriatic Arthritis Enrolled In The Corrona Psoriatic Arthritis/Spondyloarthritis Registry., Philip Mease, Chitra Karki, Mei Liu, Arthur Kavanaugh, Christopher T Ritchlin, Doquyen Hoa Huynh, Jacqueline B Palmer, Jeffrey D Greenberg Jan 2018

Baseline Patient Characteristics Associated With Response To Biologic Therapy In Patients With Psoriatic Arthritis Enrolled In The Corrona Psoriatic Arthritis/Spondyloarthritis Registry., Philip Mease, Chitra Karki, Mei Liu, Arthur Kavanaugh, Christopher T Ritchlin, Doquyen Hoa Huynh, Jacqueline B Palmer, Jeffrey D Greenberg

Articles, Abstracts, and Reports

Objectives: To compare baseline characteristics between patients with psoriatic arthritis (PsA) who achieved and did not achieve minimal disease activity (MDA) with biologic therapy in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis Registry.

Methods: Patients with PsA aged ≥18 years enrolled between March 2013 and March 2016 who were receiving biologics at enrolment (baseline), not in MDA and had ≥2 follow-up visits were included. Patients were classified as those who remained on their index biologic and achieved MDA at the second follow-up visit (MDA achievers (MDA-A)) and those who did not (MDA non-achievers (MDA-NA)). Demographics, clinical characteristics, patient-reported outcomes and medication history …