Medicine and Health Sciences Commons^™

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 …

Salvage Of Failed Femoral Neck Fracture Fixation With Conversion Total Hip Arthroplasty Using The Direct Anterior Approach., Andrew G Yun, Marilena Qutami, Kory B Dylan Pasko

Articles, Abstracts, and Reports

Purpose: Failed femoral neck fracture (FNF) fixation with

Materials and Methods: Medical records for 42 patients with a prior history of FNF fixation who underwent conversion THA with hardware removal between 2009 and 2019 were retrospectively reviewed. Surgery was performed by a single surgeon at a single institution. All patients underwent hardware removal followed by direct anterior approach (DAA) THA using two separate incisions. Clinical outcomes, radiographic findings, and perioperative morbidity and mortality are reported.

Results: Clinically, there were no postoperative dislocations, periprosthetic fractures, or infections at follow-up. After a mean follow-up of 4 years, the mean hip disability and …

Conversion From Knee Arthrodesis Back To Arthroplasty: A Particular Challenge In Combination With Fungal Periprosthetic Joint Infection., Sven Frieler, Emre Yilmaz, Ryan Goodmanson, Yannik Hanusrichter, Thomas A Schildhauer, Hinnerk Baecker

Articles, Abstracts, and Reports

A 58-year-old female treated at an outside facility with knee arthrodesis due to persistent periprosthetic joint infection fulfilled all prerequisites for a conversion back to arthroplasty, as part of a 2-stage revision. Owing to the detection of Candida parapsilosis, the treatment concept was converted to a three-stage procedure. A scheduled spacer exchange with additional amphotericin B-loaded polymethylmethacrylate was conducted as an intermediate revision before reimplantation. Conversion in the setting of fungal periprosthetic joint infection presents a challenge, and successful treatment hinges on the use of proper antifungal and antimicrobial protocols, advanced surgical techniques, and a multidisciplinary team approach. At …

Third-Generation Medium Cross-Linked Polyethylene Demonstrates Very Low Wear In Total Hip Arthroplasty., Omid Jalali, Travis S Scudday, Marie-Claire Fickenscher, Steven L Barnett, Robert S Gorab

Articles, Abstracts, and Reports

Background: Cross-linked polyethylene (XLPE) liners have shown lower wear rates than conventional polyethylene liners in total hip arthroplasty. The primary aim of our study was to report our most recent analysis of wear rates and clinical outcomes of a third-generation XLPE liner. Secondary aims were to investigate the rate of adverse events related to mechanical failure or oxidation of this liner.

Methods: A series of 266 total hip arthroplasties using a specific XLPE liner were retrospectively reviewed. Radiographs were examined to determine linear and volumetric wear rates and presence of osteolysis. Clinical outcomes, revision rates, mechanical failures, and risk factors …

Management Of Failed Uka To Tka: Conventional Versus Robotic-Assisted Conversion Technique., Andrew G Yun, Marilena Qutami, Mary Chang-Hwa Chen, Kory B Dylan Pasko

Articles, Abstracts, and Reports

BACKGROUND: Failure of unicompartmental knee arthroplasty (UKA) is a distressing and technically challenging complication. Conventional conversion techniques (CCT) with rods and jigs have produced varying results. A robotic-assisted conversion technique (RCT) is an unexplored, though possibly advantageous, alternative. We compare our reconstructive outcomes between conventional and robotic methods in the management of failed UKA.

METHODS: Thirty-four patients with a failed UKA were retrospectively reviewed. Patients underwent conversion total knee arthroplasty (TKA) with either a CCT or RCT. Seventeen patients were included in each group. All procedures were done by a single surgeon at a single institution, with a mean time …

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 …

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

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 …

Medial Femoral Condyle Vascularized Bone Graft For Treatment Of Midshaft Clavicle Recalcitrant Nonunion With Use Of The Transverse Cervical Artery As An Anastomosis., Christopher M Belyea, Jefferson L Lansford, Joseph B Golden, Emily H Shin, Rey D L Gumboc

Articles, Abstracts, and Reports

Vascularized medial femoral condyle bone grafts have been reported to be a reliable treatment for recalcitrant bony nonunions of the extremities. Although clavicle fracture nonunions are rare after treatment with open reduction internal fixation, symptomatic nonunions can be a challenge. The medial femoral condyle vascularized bone graft has been described as a treatment option for clavicle nonunions with the thoracoacromial trunk as the recipient anastomosis site. This case illustrates how the transverse cervical artery and accompanying veins can be used as an anastomosis when the thoracoacromial trunk is inaccessible because of previous surgical- and infection-related scaring. At the final follow-up, …

Assessing Structural Damage Progression In Psoriatic Arthritis And Its Role As An Outcome In Research., Désirée Van Der Heijde, Dafna D Gladman, Arthur Kavanaugh, Philip Mease

Articles, Abstracts, and Reports

Psoriatic arthritis (PsA) is an immune-mediated, clinically heterogeneous disease characterized by arthritis, enthesitis, dactylitis, spondylitis, and psoriasis of the skin and nails. Persistent articular inflammation in patients with PsA can lead to structural damage, which can result in reduced physical function and quality of life. Structural damage can occur rapidly, and irreversible joint damage may be observed if patients are not treated promptly and appropriately. Therefore, evaluating therapeutic agents for their ability to inhibit structural progression has become increasingly important, with radiographic progression becoming a key efficacy outcome in clinical trials in PsA. Here, we review how structural damage and …

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 …

Modified Two-Stage Exchange For Periprosthetic Joint Infection In Uka., Andrew G Yun, Marilena Qutami, Kory B Dylan Pasko

Articles, Abstracts, and Reports

Periprosthetic joint infection (PJI) is a rare complication following unicompartmental knee arthroplasty (UKA), and current management guidelines are still evolving. This report presents a novel surgical technique of resection arthroplasty with an articulated hemispacer as part of a 2-stage exchange protocol. A 66-year-old man developed a culture-negative PJI four months after a medial UKA. Rather than conventional full resection arthroplasty, the patient underwent partial resection with preservation of the lateral and patellofemoral compartments to maintain vascularized bone stock. An articulating hemispacer fashioned from the old implants after sterilization was reimplanted medially to preserve function during the course of antibiotic treatment. …

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 …

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 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

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

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 …

Big Spine Data Put To Good Use: The Nhs Sets An Example., Jens R Chapman, Jeffrey C Wang, Karsten Wiechert

Articles, Abstracts, and Reports

No abstract provided.

Three Pillars Of Expectation Management In Spine Surgery: Trust, Communication, And Patient Education., Karsten Wiechert, Jeffrey C Wang, Jens R Chapman

Articles, Abstracts, and Reports

No abstract provided.

Comparison Of Asymmetric Reaming Versus A Posteriorly Augmented Component For Posterior Glenoid Wear And Retroversion: A Radiographic Study., Jia-Wei Kevin Ko, Usman Ali Syed, Jonathan D Barlow, Scott Paxton, Bryan J Loeffler, Ocean Thakar, Grant Jamgochian, Joseph A Abboud, Charles L Getz, Gerald R Williams

Articles, Abstracts, and Reports

Background: Managing posterior glenoid wear and retroversion remains a challenge in shoulder arthroplasty. Correcting glenoid version through asymmetric reaming (AR) with placement of a standard glenoid component and the use of posteriorly augmented glenoid (PAG) components are two methods used to address this problem. Our objective is to report the radiographic outcomes of patients with posterior glenoid wear and/or retroversion treated with either approach.

Methods: Patients with posterior glenoid wear and a minimum of 15 degrees of retroversion, treated with AR and standard glenoid component or with a PAG component (3 mm, 5 mm, or 7 mm posterior augmentation), were …

Global Spinal Deformity From The Upper Cervical Perspective. What Is "Abnormal" In The Upper Cervical Spine?, Peter G Passias, Haddy Alas, Renaud Lafage, Bassel G Diebo, Irene Chern, Christopher P Ames, Paul Park, Khoi D Than, Alan H Daniels, D Kojo Hamilton, Douglas C Burton, Robert A Hart, Shay Bess, Breton G Line, Eric O Klineberg, Christopher I Shaffrey, Justin S Smith, Frank J Schwab, Virginie Lafage

Articles, Abstracts, and Reports

Hypothesis: Reciprocal changes in the upper cervical spine correlate with adult TL deformity modifiers.

Design: This was a retrospective review.

Introduction: The upper cervical spine has remarkable adaptability to wide ranges of thoracolumbar (TL) deformity.

Methods: Patients >18 years with adult spinal deformity (ASD) and complete radiographic data at baseline (BL) and 1 year were identified. Patients were grouped into component types of the Roussouly classification system (Type 1: Pelvic incidence [PI]

Results: A total of 343 ASD patients were analyzed. When grouped by BL Schwab and Roussouly, Group

Conclusions: Our study suggests that upper cervical alignment remains relatively stable …

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 …

The Impact Of Osteotomy Grade And Location On Regional And Global Alignment Following Cervical Deformity Surgery., Peter G Passias, Samantha R Horn, Tina Raman, Avery E Brown, Virginie Lafage, Renaud Lafage, Justin S Smith, Cole A Bortz, Frank A Segreto, Katherine E Pierce, Haddy Alas, Breton G Line, Bassel G Diebo, Alan H Daniels, Han Jo Kim, Alex Soroceanu, Gregory M Mundis, Themistocles S Protopsaltis, Eric O Klineberg, Douglas C Burton, Robert A Hart, Frank J Schwab, Shay Bess, Christopher I Shaffrey, Christopher P Ames

Articles, Abstracts, and Reports

Introduction: Correction of cervical deformity (CD) often involves different types of osteotomies to address sagittal malalignment. This study assessed the relationship between osteotomy grade and vertebral level on alignment and clinical outcomes.

Methods: Retrospective review of a multi-center prospectively collected CD database. CD was defined as at least one of the following: C2-C7 Cobb >10°, cervical lordosis (CL) >10°, C2-C7 sagittal vertical axis (cSVA) >4 cm, and chin-brow vertical angle > 25°. Patients were evaluated for level and type of cervical osteotomy.

Results: 86 CD patients were included (61.4 ± 10.6 years, 66.3% female, body mass index 29.1 kg/m

Conclusions: CD …

Ossification Of The Mamillo-Accessory Ligament: A Review Of The Literature And Clinical Considerations., Graham Dupont, Emre Yilmaz, Joe Iwanaga, Rod J Oskouian, R Shane Tubbs

Articles, Abstracts, and Reports

Ossification of the mamillo-accessory ligament (MAL) is a misunderstood phenomenon; however, many have posited that it can result in nerve entrapment of the medial branch of the dorsal ramus causing zygapophyseal joint related low back pain. The MAL has been studied anatomically by few, yet the data indicate possible associations between ossification of this ligament and spondylosis. It has been proposed that mechanical stress upon the lumbar spine may also lead to progressive ossification of the MAL into a bony foramen.

Limited Morbidity And Possible Radiographic Benefit Of C2, Peter G Passias, Cole A Bortz, Frank Segreto, Samantha Horn, Katherine E Pierce, Haddy Alas, Avery E Brown, Renaud Lafage, Virginie Lafage, Justin S Smith, Breton Line, Robert Eastlack, Daniel M Sciubba, Eric O Klineberg, Alexandra Soroceanu, Douglas C Burton, Frank J Schwab, Shay Bess, Christopher I Shaffrey, Christopher P Ames

Articles, Abstracts, and Reports

Background: The study aims to evaluate differences in alignment and clinical outcomes between surgical cervical deformity (CD) patients with a subaxial upper-most instrumented vertebra (UIV) and patients with a UIV at C2. Use of CD-corrective instrumentation in the subaxial cervical spine is considered risky due to narrow subaxial pedicles and vertebral artery anatomy. While C2 fixation provides increased stability, the literature lacks guidelines indicating extension of CD-corrective fusion from the subaxial spine to C2.

Methods: Included: operative CD patients with baseline (BL) and 1-year postop (1Y) radiographic data, cervical UIV ≥ C2. Patients were grouped by UIV: C2 or subaxial …

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

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 …

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 …

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 …