Rheumatology Commons^™

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 …

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 …

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. …

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.

Outcomes Of Shoulder Arthroplasty Performed For Postinfectious Arthritis., Eric M. Padegimas, Thema A. Nicholson, Stephen Silva, Matthew L. Ramsey, Gerald R. Williams, Mark D. Lazarus, Surena Namdari

Rothman Institute Papers

Background: The purpose of this study was to evaluate the functional outcomes, infection rate, and complications associated with shoulder arthroplasty for sequelae of prior septic arthritis.

Methods: This is a retrospective cohort study of 17 patients who underwent shoulder arthroplasty for sequelae of septic arthritis. Patients were analyzed for patient-reported outcomes, complications, and reoperations.

Results: The 17 patients in this cohort were an average age of 65.4 ± 12.2 years old, were 58.8% male, and had an average body mass index of 27.9 ± 4.1 kg/m

Conclusions: Shoulder arthroplasty after septic arthritis had inconsistent functional outcomes and high complication rates …

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 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 …

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 …

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 …

4-Year Results From The Rapid-Psa Phase 3 Randomised Placebo-Controlled Trial Of Certolizumab Pegol In Psoriatic Arthritis., Désirée Van Der Heijde, Atul Deodhar, Oliver Fitzgerald, Roy Fleischmann, Dafna Gladman, Alice B Gottlieb, Bengt Hoepken, Lars Bauer, Oscar Irvin-Sellers, Majed Khraishi, Luke Peterson, Anthony Turkiewicz, Jürgen Wollenhaupt, Philip Mease

Articles, Abstracts, and Reports

Objective: To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years' certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA).

Methods: RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) …

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 J Mease, Arthur Kavanaugh, Andreas Reimold, Hasan Tahir, Jürgen Rech, Stephen Hall, Piet Geusens, Pascale Pellet, Evie Maria Delicha, Shephard Mpofu, Luminita Pricop

Articles, Abstracts, and Reports

Objective: To assess the long-term (3 year) efficacy and safety of secukinumab in patients with active psoriatic arthritis (PsA) in the extension phase of the FUTURE 1 study (NCT01892436).

Methods: Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab 150 or 75 mg entered a 3-year extension phase. Results are presented for key efficacy and safety endpoints at week 156.

Results: In total, 460 patients entered the extension study; 308 patients originally randomised to secukinumab were assessed for efficacy. Sustained improvements in all efficacy endpoints were achieved with secukinumab through week 156. Overall, 76.8%/54.9% (secukinumab 150 mg) and 65.2%/39.0% …

Therapeutic Benefit Of Apremilast On Enthesitis And Dactylitis In Patients With Psoriatic Arthritis: A Pooled Analysis Of The Palace 1-3 Studies., Dafna D Gladman, Arthur Kavanaugh, Juan J Gómez-Reino, Jürgen Wollenhaupt, Maurizio Cutolo, Georg Schett, Eric Lespessailles, Benoit Guerette, Nikolay Delev, Lichen Teng, Christopher J Edwards, Charles A Birbara, Philip J Mease

Articles, Abstracts, and Reports

Objective: The Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) clinical trial programme findings demonstrated that apremilast, an oral phosphodiesterase 4 inhibitor, is effective for treating psoriatic arthritis (PsA). Enthesitis and dactylitis are difficult-to-treat features of PsA leading to disability and affecting quality of life. PALACE 1, 2 and 3 data were pooled to assess the efficacy of apremilast on enthesitis and dactylitis outcomes in patients with these conditions at baseline.

Methods: Patients with enthesitis (n=945) or dactylitis (n=633) at baseline were analysed after receiving double-blind treatment with placebo, apremilast 30 mg two times per day or apremilast 20 mg …

Sustained Efficacy, Safety And Patient-Reported Outcomes Of Certolizumab Pegol In Axial Spondyloarthritis: 4-Year Outcomes From Rapid-Axspa., Désirée Van Der Heijde, Maxime Dougados, Robert Landewé, Joachim Sieper, Walter P Maksymowych, Martin Rudwaleit, Filip Van Den Bosch, Jürgen Braun, Philip Mease, Alan J Kivitz, Jessica Walsh, Owen Davies, Lars Bauer, Bengt Hoepken, Luke Peterson, Atul Deodhar

Articles, Abstracts, and Reports

Objective: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.

Methods: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further …

Efficacy And Safety Of Abatacept, A T-Cell Modulator, In A Randomised, Double-Blind, Placebo-Controlled, Phase Iii Study In Psoriatic Arthritis., Philip Mease, Alice B Gottlieb, Désirée Van Der Heijde, Oliver Fitzgerald, Alyssa Johnsen, Marleen Nys, Subhashis Banerjee, Dafna D Gladman

Articles, Abstracts, and Reports

OBJECTIVES: To assess the efficacy and safety of abatacept, a selective T-cell costimulation modulator, in a phase III study in psoriatic arthritis (PsA).

METHODS: This study randomised patients (1:1) with active PsA (~60% with prior exposure to a tumour necrosis factor inhibitor) to blinded weekly subcutaneous abatacept 125 mg (n=213) or placebo (n=211) for 24 weeks, followed by open-label subcutaneous abatacept. Patients without ≥20% improvement in joint counts at week 16 were switched to open-label abatacept. The primary end point was the proportion of patients with ≥20% improvement in the American College of Rheumatology (ACR20) criteria at week 24.

RESULTS: …

Defining Outcome Measures For Psoriatic Arthritis: A Report From The Grappa-Omeract Working Group., Alexis Ogdie, Maarten De Wit, Kristina Callis Duffin, Willemina Campbell, Jeffrey Chau, Laura C Coates, Lihi Eder, Musaab Elmamoun, Oliver Fitzgerald, Dafna D Gladman, Niti Goel, Jana James, Umut Kalyoncu, John Latella, Chris Lindsay, Philip Mease, Denis O'Sullivan, Ingrid Steinkoenig, Vibeke Strand, William Tillett, Ana-Maria Orbai

Articles, Abstracts, and Reports

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group recently published the updated 2016 psoriatic arthritis (PsA) core domain set, a set of disease features that should be measured in all clinical trials. At the GRAPPA annual meeting in July 2016, the PsA working group presented the updated PsA core domain set endorsed by 90% of participants at OMERACT in May 2016 and drafted a roadmap for the development of the PsA core outcome measurement set. In this manuscript, we review the development process of the …

The Feasibility Of Implementing The Ichom Standard Set For Hip And Knee Osteoarthritis: A Mixed-Methods Evaluation In Public And Private Hospital Settings., Ilana N Ackerman, Bernarda Cavka, Jacob Lippa, Andrew Bucknill

Articles, Abstracts, and Reports

Background: There is growing international momentum for standardising patient outcome assessment and using patient-reported outcome measures (PROMs) to capture outcomes that matter to patients. The International Consortium for Health Outcomes Measurement (ICHOM) Standard Sets were developed to capture the outcomes of care for costly conditions including osteoarthritis. This study evaluated the feasibility of implementing the ICHOM Standard Set for Hip and Knee Osteoarthritis in 'real world' public and private hospital settings.

Methods: A mixed-methods design was used to capture comprehensive data on patient outcomes, implementation costs, and the implementation experiences of patients, clinicians and administrative staff. The ICHOM Standard Set …

The Role Of Occupational Therapy In Primary Care, Priti Patel

Occupational Therapy Doctorate Capstone Projects

The Capstone Project is focused on communicating, influencing and educating other health care professionals regarding the role of occupational therapy in the future model of primary care delivery initiated by the adoption of the Affordable Care Act and the Triple Aim Initiative. Currently, primary care, the largest health care platform in United States, is not inclusive of occupational therapy services. Occupational therapists have the scope, knowledge and understanding to be part of the redesigned team model of primary care. Educating those currently working in primary care about adding occupational therapy services can have a significant impact on the profession of …