Rheumatology Commons^™

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 …

Classification And Outcome Measures For Psoriatic Arthritis., Ying Ying Leung, Alexis Ogdie, Ana-Maria Orbai, William Tillett, Laura C Coates, Vibeke Strand, Philip Mease, Dafna D Gladman

Articles, Abstracts, and Reports

Psoriatic arthritis (PsA) is an inflammatory arthritis with multiple manifestations: peripheral/axial arthritis, enthesitis, dactylitis, psoriasis, and nail involvement. From having an agreed upon classification criteria in 2006, the assessment of PsA has advanced from uncertainties to development and validation of numerous specific outcome measures. The Group for Research and Assessment of Psoriasis and Psoriatic arthritis (GRAPPA) has spearheaded the development of a core domain set and is now working on a core outcome measurement set to standardize outcome measures for PsA, that will provide guidance for use of instruments in randomized controlled trials (RCTs) and longitudinal observational studies (LOS). This …

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 …

Secukinumab Sustains Improvement In Signs And Symptoms Of Psoriatic Arthritis: 2 Year Results From The Phase 3 Future 2 Study., Iain B Mcinnes, Philip Mease, Christopher T Ritchlin, Proton Rahman, Alice B Gottlieb, Bruce Kirkham, Radhika Kajekar, Eumorphia-Maria Delicha, Luminita Pricop, Shephard Mpofu

Articles, Abstracts, and Reports

Objectives: To assess long-term efficacy, safety and tolerability of secukinumab up to 104 weeks in patients with active PsA.

Methods: Patients with PsA (n = 397) were randomized to s.c. secukinumab 300, 150 or 75 mg or placebo at baseline, weeks 1, 2, 3 and 4 and every 4 weeks thereafter. Placebo-treated patients were re-randomized to receive secukinumab 300 or 150 mg s.c. from week 16 (placebo non-responders) or week 24 (placebo responders). Exploratory endpoints at week 104 included 20, 50 and 70% improvement in ACR criteria (ACR20, 50, 70); 75 and 90% improvement in the Psoriasis Area Severity Index, …

Updating The Psoriatic Arthritis (Psa) Core Domain Set: A Report From The Psa Workshop At Omeract 2016., Ana-Maria Orbai, Maarten De Wit, Philip Mease, Kristina Callis Duffin, Musaab Elmamoun, William Tillett, Willemina Campbell, Oliver Fitzgerald, Dafna D Gladman, Niti Goel, Laure Gossec, Pil Hoejgaard, Ying Ying Leung, Chris Lindsay, Vibeke Strand, Désirée M Van Der Heijde, Bev Shea, Robin Christensen, Laura Coates, Lihi Eder, Neil Mchugh, Umut Kalyoncu, Ingrid Steinkoenig, Alexis Ogdie

Articles, Abstracts, and Reports

OBJECTIVE: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS).

METHODS: At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants.

RESULTS: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries …

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 …

Persistence Of Low Disease Activity After Tumour Necrosis Factor Inhibitor (Tnfi) Discontinuation In Patients With Psoriatic Arthritis., D H Huynh, T A Boyd, C J Etzel, V Cox, J Kremer, P Mease, A Kavanaugh

Articles, Abstracts, and Reports

OBJECTIVE: To determine the duration of clinical benefit among patients with psoriatic arthritis (PsA) discontinuing tumour necrosis factor inhibitor (TNFi) therapy while in low disease activity (LDA), and to identify patient characteristics associated with prolonged clinical benefit.

METHODS: We performed an observational cohort study assessing patients with PsA from the Consortium of Rheumatology Researchers of North America (CORRONA) registry who had discontinued TNFi after achieving LDA, defined as clinical disease activity index (CDAI) score ≤10 and physician's global assessment (PGA) of skin psoriasis ≤20/100. Kaplan-Meier method was used to estimate the duration of clinical benefit.

RESULTS: Of the 5945 patients …

Prediction And Benefits Of Minimal Disease Activity In Patients With Psoriatic Arthritis And Active Skin Disease In The Adept Trial., Philip Mease, Arthur Kavanaugh, Laura C Coates, Iain B Mcinnes, Maja Hojnik, Ying Zhang, Jaclyn K Anderson, Alexander P Dorr, Dafna D Gladman

Articles, Abstracts, and Reports

Objectives: To determine the proportion of patients with psoriatic arthritis in the Adalimumab Effectiveness in Psoriatic Arthritis trial achieving minimal disease activity (MDA) and its individual components at 1 or more visits over 144 weeks, identify baseline predictors of MDA achievement, and evaluate the association of MDA status with independent quality of life (QoL)-related patient-reported outcomes (PROs).

Methods: Univariate and multivariate analyses were used to identify the baseline characteristics that predicted achievement of MDA at individual time points (weeks 12 through 144) or sustained MDA (achievement of MDA at 2 consecutive time points 12 weeks apart). The association of independent …