Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis
AbstractIntroductionIxekizumab, a humanized interleukin-17A antibody, has shown efficacy in ankylosing spondylitis (AS), with a greater proportion of ixekizumab-treated patients achieving an ASAS40 (Assessment of Spondyloarthritis International Society 40) endpoint compared to placebo. An ASAS40 response is a high standard that is not routinely used in clinical practice. The goals of this study were (a) to measure improvement in ixekizumab-treated patients in the four ASAS treatment response domains and in other patient-reported outcomes, and (b) to determine how the ASAS response was associated with changes in spinal pain...
Source: Rheumatology and Therapy - June 28, 2019 Category: Rheumatology Source Type: research

Real-Life Tolerability and Effectiveness of Adalimumab Biosimilar in Rheumatoid Arthritis: ASPIRE Registry Data
AbstractIntroductionThe TNF- α blocker adalimumab is a well-proven therapy for rheumatoid arthritis (RA). A biosimilar adalimumab (ZRC-3197; Exemptia™), a ‘fingerprint match’ to reference adalimumab, has been approved for prescription in India since 2014. Here, we report on the effectiveness and tolerability of this bi osimilar adalimumab (bADA) from the Adalimumab Biosimilar Patient Registry [ASPIRE; ISRCTN16838474], which contains data from real-life RA patients from India.MethodsASPIRE is a post-marketing, observational registry that evaluates real-world experience across multiple ...
Source: Rheumatology and Therapy - June 28, 2019 Category: Rheumatology Source Type: research

Patterns of Prednisone Use in Patients with Rheumatoid Arthritis Initiating Treatment with Tocilizumab in Routine US Clinical Practice
ConclusionsIn this real-world analysis, many patients initiating TCZ monotherapy or combination therapy were able to discontinue or decrease their prednisone dose over 12  months. Similar changes in prednisone dose were observed over 6 months.Trial RegistrationClinicalTrials.gov identifier, NCT01402661.FundingCorrona, LLC and Genentech, Inc.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - June 25, 2019 Category: Rheumatology Source Type: research

Efficacy and Safety of Subcutaneous Secukinumab 150  mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study
ConclusionThe secukinumab 150  mg or 150 mg no-load regimen demonstrated significant and sustained improvements in the signs and symptoms of psoriatic arthritis through 104 weeks; the loading regimen was associated with numerically higher and earlier responses for some high-hurdle end points. Improved efficacy was observed up on dose escalation from 150 to 300 mg. The safety profile was consistent with previous reports.Trial RegistrationClinicalTrials.gov identifier, NCT02294227.FundingNovartis Pharma AG, Basel, Switzerland. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - June 21, 2019 Category: Rheumatology Source Type: research

Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial
AbstractIntroductionTo explore the relationship of pain and fatigue with daily activity and work productivity in rheumatoid arthritis (RA) patients from the baricitinib clinical trial, RA-BEAM.MethodsIn RA-BEAM, a double-blind phase 3 study, patients were randomized 3:3:2 to placebo (n = 488), baricitinib 4 mg once daily (n = 487), or adalimumab 40 mg biweekly (n = 330) with background methotrexate. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) measured fatigue and the pain visual analog scale (0–100 mm) assessed pain. Work Producti...
Source: Rheumatology and Therapy - June 21, 2019 Category: Rheumatology Source Type: research

A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire
AbstractIntroductionThe Work Productivity and Activity Impairment Specific Health Problem Questionnaire (WPAI:SHP) is used to assess the impact of an intervention on work productivity in patients with psoriatic arthritis (PsA). Unfortunately, studies reporting changes or improvements in domains of WPAI:SHP by patients with PsA have a limited threshold of meaning due to the absence of published minimal clinically important differences (MCIDs). Our objective was to determine the MCIDs for improvement in WPAI:SHP in patients with active PsA.MethodsMCIDs for WPAI:SHP domains (presenteeism, work productivity loss, and activity ...
Source: Rheumatology and Therapy - June 1, 2019 Category: Rheumatology Source Type: research

Disease Activity and Patient-Reported Health Measures in Relation to Cytokine Levels in Ankylosing Spondylitis
ConclusionsA large proportion of AS not on biologics have active disease far into the disease course. This impacts negatively on quality of life, work ability, and spinal mobility. Serum cytokine levels are poor markers for these central disease features in AS management.FundingAbbott Norway AS and Arthritis Foundation of Western Australia. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - May 30, 2019 Category: Rheumatology Source Type: research

Insight into the Quality of Life of Patients with Ankylosing Spondylitis: Real-World Data from a US-Based Life Impact Survey
ConclusionAS negatively impacted all QOL domains analyzed. The incorporation of subjective measures of disease into disease evaluation should be considered.FundingNovartis Pharmaceuticals Corporation and UCB, Inc.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - May 20, 2019 Category: Rheumatology Source Type: research

Psoriatic Arthritis: What is Happening at the Joint?
AbstractPsoriatic arthritis (PsA) is a heterogeneous and inflammatory disease with diverse clinical manifestations, including psoriasis, nail psoriasis, peripheral joint disease, axial joint disease, enthesitis, and dactylitis. Typically, this varied clinical presentation complicates the clinician ’s ability to distinguish PsA from other forms of arthritis. In the synovium of individuals with PsA, upregulation of the genes WNT3A, BMPR2, and TGFBR1 results in bone erosion and new bone formation, a pattern unique to the disease. Additionally, genes associated with angiogenesis and vascularization such as VEGF and TGFB1...
Source: Rheumatology and Therapy - May 17, 2019 Category: Rheumatology Source Type: research

Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs
ConclusionsADA titers were low and persistent ADAs and NAbs occurred relatively infrequently in both sarilumab dose groups. ADA did not meaningfully impact the safety or efficacy of either dose of sarilumab over 24  weeks.Trial RegistrationClinicalTrials.gov, identifier NCT02121210.FundingSanofi Genzyme and Regeneron Pharmaceuticals, Inc.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - May 14, 2019 Category: Rheumatology Source Type: research

Economic Burden of Switching to Different Biologic Therapies Among Tumor Necrosis Factor Inhibitor-Experienced Patients with Psoriatic Arthritis
This study compared the healthcare resource use (HRU), expenditures, and time to discontinuation among TNFi-experienced patients with PsA who switched to different biologic therapies in the United States (US).MethodsAdults with PsA who discontinued an initial TNFi (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) and switched to another TNFi or a non-TNFi (ustekinumab or secukinumab) were identified in the Symphony Health Solutions database [Quarter (Q)1 2010 –Q2 2017]. Eligible patients had claims data activity for ≥ 12 months before (baseline) and after (study period) the ...
Source: Rheumatology and Therapy - May 4, 2019 Category: Rheumatology Source Type: research

Shared Decision-Making and Patient Satisfaction in Japanese Rheumatoid Arthritis Patients: A New “Preference Fit” Framework for Treatment Assessment
ConclusionThe association between depression and a low treatment preference fit suggests that depression may pose challenges to SDM and that doctors in Japan are less attuned to the SDM preferences of depressed patients.FundingJanssen Pharmaceutical KK. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - May 2, 2019 Category: Rheumatology Source Type: research

Real-World Patient Experience on the Path to Diagnosis of Ankylosing Spondylitis
We describe the journey to diagnosis of ankylosing spondylitis (AS) from the patient perspective and examine differences in this journey by sex.MethodsUS adults aged ≥ 18 years with a self-reported AS diagnosis were recruited online through CreakyJoints, a patient support community, and ArthritisPower, a patient research registry. Respondents completed a web-based survey on sociodemographics, disease burden, and diagnosis history. Results were stratified by sex and time to diagnosis using two-samplet tests andχ2 tests, respectively, to observe differences across the groups;P 
Source: Rheumatology and Therapy - April 30, 2019 Category: Rheumatology Source Type: research

How Health Information Technologies and Artificial Intelligence May Help Rheumatologists in Routine Practice
(Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - April 26, 2019 Category: Rheumatology Source Type: research

Decreased Injection Site Pain Associated with Phosphate-Free Etanercept Formulation in Rheumatoid Arthritis or Psoriatic Arthritis Patients: A Randomized Controlled Trial
ConclusionsThe new phosphate-free formulation of etanercept had statistically significantly lower mean pain scores than the prior formulation, with largest pain reductions observed among patients who reported highest pain with the prior formulation.Trial RegistrationClinicalTrials.gov: NCT02986139.FundingAmgen Inc, Thousand Oaks, CA USA. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 27, 2019 Category: Rheumatology Source Type: research

Use of Pre-Infusion Serum Uric Acid Levels as a Biomarker for Infusion Reaction Risk in Patients on Pegloticase
ConclusionsA pre-infusion sUA level functions as a highly accurate biomarker for identification of patients who are at risk of IRs while on pegloticase therapy. Stopping pegloticase in patients who have a rise in pre-infusion uric acid levels to above 6  mg/dl while on therapy would result in most IRs being avoided.FundingHorizon Pharma. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 14, 2019 Category: Rheumatology Source Type: research

Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry
ConclusionsImprovements in clinical disease activity were seen in anti-CCP+ abatacept and TNFi initiators. TNFi-experienced anti-CCP+ patients with RA had more improvement in disease activity with abatacept versus TNFis, whereas outcomes were similar between treatments in the overall population and in biologic-na ïve patients.Trial RegistrationClinicalTrials.gov identifier: NCT01625650.FundingThis study is sponsored by Corrona, LLC and funded by Bristol-Myers Squibb. Bristol-Myers Squibb funded the publication of this manuscript. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 13, 2019 Category: Rheumatology Source Type: research

Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies
ConclusionIn routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified.FundingF. Hoffmann-La Roche. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 11, 2019 Category: Rheumatology Source Type: research

Persistence, Discontinuation, and Switching Patterns of Newly Initiated TNF Inhibitor Therapy in Ankylosing Spondylitis Patients in the United States
ConclusionsThis study suggests that approximately 67% of male AS patients and 77% of female AS patients newly initiating a TNFi do not remain on the index therapy 2  year post initiation.FundingEli Lilly and Company. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - March 5, 2019 Category: Rheumatology Source Type: research

Moving the Needle: Improving the Care of the Gout Patient
AbstractGout is a the most common inflammatory arthritis in the United States. It is a significant cause of morbidity, disability, lost work days, and high healthcare utilization due to intermittent attacks, chronic inflammation, and joint damage. Despite our understanding of the prelude and pathophysiology of gout, hyperuricemia, it is still poorly misunderstood by patients and poorly managed by healthcare providers. Several parallel treatment paradigms have been developed by professional societies around the world based on the understanding of how hyperuricemia occurs, gout epidemiology, expert opinion, and clinical tria...
Source: Rheumatology and Therapy - March 2, 2019 Category: Rheumatology Source Type: research

Assessing Disease Activity in Psoriatic Arthritis: A Literature Review
AbstractPsoriatic arthritis (PsA) is a multifaceted disease, with a high impact on patients ’ psychological and physical well-being. There is increasing recognition that assessment of both clinical aspects of disease and patient identified concerns, such as fatigue, work disability, and treatment satisfaction need to be addressed. Only then can we fully understand disease burden and make well-informed treatment decisions aimed at improving patients’ lives. In recent years, there has been much progress in the development of unidimensional and composite measures of disease activity, as well as questionnaires capt...
Source: Rheumatology and Therapy - February 28, 2019 Category: Rheumatology Source Type: research

Nurse and Patient Perceptions and Preferences for Subcutaneous Autoinjectors for Inflammatory Joint or Bowel Disease: Findings from a European Survey
AbstractIntroductionImraldi ™ is a biosimilar of the anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab and was recently approved in Europe for the treatment of various inflammatory conditions. Imraldi is administered via an autoinjector device that features distinct design attributes compared with other biologi c TNF inhibitor autoinjectors, such as the Humira (adalimumab) Pen® and Enbrel® (etanercept) MyClic® Pen were developed by the relevant pharmaceutical companies. The aim of this study was to evaluate patients’ and nurses’ preferences for the Imraldi versus Humira or Enbrel...
Source: Rheumatology and Therapy - February 21, 2019 Category: Rheumatology Source Type: research

A Review on the Effect of Tumor Necrosis Factor Inhibitors on Structural Progression in Early Axial Spondyloarthritis Using Magnetic Resonance Imaging
ConclusionsIn conclusion, treatment with TNF α inhibitors reduces MRI-evident inflammatory lesions in the SIJ and spine of patients with early axSpA for up to 4 years. There is less evidence of benefits on structural lesions. Additional studies are required to determine whether TNFα-inhibitor therapy can limit or delay radiological progress ion in patients with early axSpA.FundingPfizer. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - February 20, 2019 Category: Rheumatology Source Type: research

Non-Radiographic Axial Spondyloarthritis (nr-axSpA): Advances in Classification, Imaging and Therapy
AbstractNon-radiographic axial spondyloarthritis (nr-axSpA) is a recently described form of axial inflammatory arthritis that has not caused substantial erosive damage to the sacroiliac joints. Nr-axSpA is associated with significant impairment in quality of life and, in a proportion of patients, it can evolve into ankylosing spondylitis (AS, also termed radiographic axSpA). The identification in the clinic of nr-axSpA has been made possible by advances in magnetic resonance imaging (MRI). Classification criteria for nr-axSpA have been proposed but there remains discussion in the international community regarding this. Stu...
Source: Rheumatology and Therapy - February 20, 2019 Category: Rheumatology Source Type: research

Reassessing the Safety Profile of Lesinurad in Combination with Xanthine Oxidase Inhibitor Therapy
We examined these risks for each treatment group and the risks stratified by estimated glomerular filtration rate (eGFR).ResultsOverall, the relative risk for sCri was>  1.0 with the 400 mg/day dose of lesinurad and higher with the 200 mg/day dose, but it was
Source: Rheumatology and Therapy - February 14, 2019 Category: Rheumatology Source Type: research

Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study
ConclusionsRepeat administration of TA –ER using a flexible dosing schedule timed to patient response was well tolerated, with no radiographic evidence of cartilage impact. Both injections resulted in similar improvements in OA symptoms across a broad spectrum of disease severity reflective of that seen in clinical practice.Trial Registration InformationClinicalTrials.gov identifier: NCT03046446.FundingFlexion Therapeutics, Inc.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - February 11, 2019 Category: Rheumatology Source Type: research

An Assessment of Hand Erosive Osteoarthritis: Correlation of Radiographic Severity with Clinical, Functional and Laboratory Findings
ConclusionThe present study showed that EOA is characterised by a significant correlation between radiographic involvement and some clinical characteristics of the disease. However, an impairment of joint function was mainly associated to radiological proximal IP joint involvement, but not with other symptoms such as pain. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - February 6, 2019 Category: Rheumatology Source Type: research

Adverse Events in Giant Cell Arteritis and Rheumatoid Arthritis Patient Populations: Analyses of Tocilizumab Clinical Trials and Claims Data
ConclusionHigher IRs of AESI were observed in patients with GCA versus those with RA in both TCZ-na ïve and -treated cohorts. Differences in underlying disease, age, and glucocorticoid use may influence AESI incidence, irrespective of intervention.FundingThis study was funded by F. Hoffmann-La Roche Ltd and Genentech, Inc. Article processing charges were funded by F. Hoffmann-La Roche Ltd.Plain Language SummaryPlain language summary is available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - February 1, 2019 Category: Rheumatology Source Type: research

Tocilizumab Effectiveness After Switching from Intravenous to Subcutaneous Route in Patients with Rheumatoid Arthritis: The RoSwitch Study
ConclusionsThe RoSwitch study showed the maintenance of effectiveness at 6  months in RA patients switching from intravenous (IV) to subcutaneous (SC) tocilizumab.FundingRoche SAS and Chugai Pharma France. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - January 10, 2019 Category: Rheumatology Source Type: research

Characteristics of Patients with Psoriatic Arthritis Receiving Secukinumab and Reasons for Initiation: A US Retrospective Medical Chart Review
ConclusionsAt the time of the chart review, most patients with PsA who initiated secukinumab were biologic experienced, although one-quarter received secukinumab as first-line biologic therapy. Efficacy/effectiveness of secukinumab and failure of other biologics were the most common reasons for initiating secukinumab.FundingNovartis Pharmaceuticals Corporation, East Hanover, NJ.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - January 5, 2019 Category: Rheumatology Source Type: research

A Summary of 2018 and What Lies Ahead for Rheumatology and Therapy in 2019
(Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - January 5, 2019 Category: Rheumatology Source Type: research

Patient Perspective on the Burden of Skin and Joint Symptoms of Psoriatic Arthritis: Results of a Multi-National Patient Survey
ConclusionsIn this study, both skin and joint symptoms had a broad, meaningful impact on patient QoL, work productivity, daily activities, and emotional well-being. These data highlighted the unique and significant impact of PsA among patients with PsO.FundingEli Lilly and Company. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - January 4, 2019 Category: Rheumatology Source Type: research

A Review for Physician Assistants and Nurse Practitioners on the Considerations for Diagnosing and Treating Psoriatic Arthritis
AbstractPsoriatic arthritis (PsA) is a clinically heterogeneous form of progressive inflammatory arthritis that affects up to 30% of patients with psoriasis. The rapid rate of progression associated with PsA makes early-disease diagnosis and treatment crucial to patients ’ quality of life and long-term health. With the aim of providing clinical guidance to physician assistants and nurse practitioners, this article gives an overview of the different PsA clinical domains, including peripheral arthritis, axial disease, enthesitis, dactylitis, skin disease, and nail d ystrophy, which should be considered as part of diagn...
Source: Rheumatology and Therapy - December 20, 2018 Category: Rheumatology Source Type: research

Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study
The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA).MethodsWe conducted a randomized, open-label, parallel group study comparing AI to pre-filled syringe (PFS). Adult patients with RA (ACR/EULAR 2010) receiving MTX (orally or by injection) for at least 3  months were allocated to AI or PFS for 6 months and then were allocated to AI for 6 further months. Two co-primary endpoints were defined at M6: percentage of patients with compliance at least 80%; change in functional...
Source: Rheumatology and Therapy - December 13, 2018 Category: Rheumatology Source Type: research

Risk Associated with Cumulative Oral Glucocorticoid Use in Patients with Giant Cell Arteritis in Real-World Databases from the USA and UK
The objective of this analysis was to determine the glucocorticoid exposure and risk of glucocorticoid-related adverse events (AEs) in real-world patients with GCA.MethodsData from the Truven Healthcare MarketScan® database (from January 1, 2000, to June 30, 2015) and the Clinical Practice Research Datalink (CPRD; from January 1, 1995, to August 31, 2013) were used to retrospectively analyze patients aged  ≥ 50 years with GCA in the USA and UK, respectively. Outcomes included oral glucocorticoid use (cumulative prednisone-equivalent exposure), glucocorticoid-related AEs and the association of AE r...
Source: Rheumatology and Therapy - November 23, 2018 Category: Rheumatology Source Type: research

Treatment Patterns of Newly Diagnosed Rheumatoid Arthritis Patients from a Commercially Insured Population
AbstractIntroductionTo describe treatment patterns in newly diagnosed rheumatoid arthritis (RA) patients in a large, nationally representative managed-care database.MethodsNewly diagnosed RA patients were identified from 07/01/2006 –08/31/2014. Patients had ≥ 1 RA diagnosis by a rheumatologist, or ≥ 2 non-rheumatologist RA diagnoses ≥ 30 days apart, or RA diagnosis followed by a disease-modifying antirheumatic drug (DMARD) prescription fill within 1 year. Patients were ≥ 18 years old at index (earliest date fulfillin g diagnostic criteria) and had ≥ 6 and 12 months of pre- and post-index health plan en...
Source: Rheumatology and Therapy - November 23, 2018 Category: Rheumatology Source Type: research

Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses
AbstractIntroductionHere we examine the relationship between achieving different levels of disease activity with tofacitinib (an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis), long-term structural progression, and patient-reported physical function.MethodsThis was a post hoc analysis of two 24-month, phase III randomized controlled trials in methotrexate (MTX)-na ïve (ORAL Start [NCT01039688]) or MTX-inadequate responder (IR) patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10 mg twice daily as either monotherapy or with background MTX. The modified total Sharp score (mTSS) a...
Source: Rheumatology and Therapy - November 23, 2018 Category: Rheumatology Source Type: research

Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies
ConclusionsIn a pooled analysis of csDMARD-IR/TNFi-na ïve and TNFi-IR patients, tofacitinib was superior to placebo at month 3 across four PsA domains: peripheral arthritis, psoriasis, enthesitis and dactylitis.Trial RegistrationOPAL Broaden (NCT01877668); OPAL Beyond (NCT01882439).FundingPfizer Inc. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - November 9, 2018 Category: Rheumatology Source Type: research

Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study
ConclusionsPatients initiating tocilizumab in routine practice had comparable effectiveness and safety outcomes regardless of whether they received tocilizumab as monotherapy or as combination therapy with csDMARDs.Trial RegistrationClinicalTrials.gov identifier, NCT01613378FundingF. Hoffmann-La Roche (Roche) Canada. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - October 28, 2018 Category: Rheumatology Source Type: research

Safety and Efficacy of Baricitinib in Patients Receiving Conventional Synthetic Disease-Modifying Antirheumatic Drugs or Corticosteroids
ConclusionsBaricitinib was efficacious regardless of concomitant use of csDMARDs or corticosteroids; the incidence of adverse events was similar across all groups of patients.FundingEli Lilly and Company and Incyte Corporation. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - October 24, 2018 Category: Rheumatology Source Type: research

Tumor Necrosis Factor Inhibitor Discontinuation in Patients with Ankylosing Spondylitis: An Observational Study From the US-Based Corrona Registry
This study compared demographic and clinical characteristics of patients with AS who discontinued vs. continued a TNFi by their second follow-up visit in the US-based Corrona Psoriatic Arthritis and Spondyloarthritis (PsA/SpA) Registry.MethodsAll patients aged  ≥ 18 years with AS enrolled in the Corrona PsA/SpA Registry between April 2013 and January 2015 who were receiving or had initiated a TNFi (index therapy) at the time of registry enrollment (baseline) and had ≥ 2 follow-up visits were included. Patient demographics, clinical characteri stics, and patient-reported outcome scores...
Source: Rheumatology and Therapy - October 23, 2018 Category: Rheumatology Source Type: research

Real-world Comparative Effectiveness of Tocilizumab Monotherapy vs. Tumor Necrosis Factor Inhibitors with Methotrexate in Patients with Rheumatoid Arthritis
ConclusionsIn this real-world population of US patients with RA who had prior TNFi exposure, there was no evidence of a difference in the effectiveness of TCZ monotherapy compared with that of TNFi  + MTX, regardless of MTX dose, at 6 months for improving RA disease activity.FundingCorrona, LLC.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - October 6, 2018 Category: Rheumatology Source Type: research

Clinical and Immunological Features of Anti-centromere Antibody-Positive Primary Sj ögren’s Syndrome
AbstractIntroductionAnti-centromere antibody (ACA)-positive Sj ögren’s syndrome (SS) is considered a subtype of SS. ACA-positive SS patients display several features, such as Raynaud’s phenomenon, sclerodactyly, and extraglandular dysfunction. However, information on the features of ACA-positive SS is insufficient and the clinical significance of ACA in SS has not been fully established. The aim of this study was to clarify the features of ACA-positive SS.MethodsAll patients with primary SS who visited our hospital were enrolled. Clinical information and immunological tests were collected and statistically...
Source: Rheumatology and Therapy - September 25, 2018 Category: Rheumatology Source Type: research

Local Effects Following Single and Repeat Intra-Articular Injections of Triamcinolone Acetonide Extended-Release: Results from Three Nonclinical Toxicity Studies in Dogs
ConclusionsThese findings suggest that the effects of IA injections of TA –ER on cartilage are predominantly transient, and comparable to those observed with TAcs in the normal canine knee joint. These mild effects in the normal joint differ from the beneficial effects observed with TA–ER and other corticosteroids in disease models. The synovial FBR to PLGA microspher es was focal and transient.FundingFlexion Therapeutics, Inc.Plain Language SummaryPlain language summary available for this article. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - September 10, 2018 Category: Rheumatology Source Type: research

Efficacy and Safety of Secukinumab 150  mg with and Without Loading Regimen in Ankylosing Spondylitis: 104-week Results from MEASURE 4 Study
ConclusionsSecukinumab 150  mg, with or without loading regimen, provided rapid and sustained decreases in the signs and symptoms of patients with AS, but the differences were not statistically significant at week 16 due to higher than expected placebo responses. The responses and safety profile were consistent with previous phase 3 studies and sustained through 2 years.Trial registrationClinicalTrials.gov identifier, NCT02159053.FundingNovartis Pharma AG, Basel, Switzerland. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - August 18, 2018 Category: Rheumatology Source Type: research

Healthcare Utilization and Direct Costs in Patients with Ankylosing Spondylitis Using a Large US Administrative Claims Database
This study assessed both all-cause and AS-specific healthcare utilization and direct costs in US patients with AS using administrative claims data.MethodsAdults aged ≥ 18 years enrolled in the MarketScan® Commercial and Medicare databases with ≥ 1 inpatient or ≥ 2 non-rule-out outpatient diagnoses of AS between January 1, 2013, and December 31, 2013, were included. Patients had continuous enrollment with medical and pharmacy benefits for ≥ 12 months before and after the index date (first diagnosis). Non-AS controls were match ed up to 5:1 to patients with AS on age, geo...
Source: Rheumatology and Therapy - August 18, 2018 Category: Rheumatology Source Type: research

Efficacy and Safety of Secukinumab 150  mg with and Without Loading Regimen in Ankylosing Spondylitis: 104-week Results from MEASURE 4 Study
ConclusionsSecukinumab 150  mg, with or without loading regimen, provided rapid and sustained decreases in the signs and symptoms of patients with AS, but the differences were not statistically significant at week 16 due to higher than expected placebo responses. The responses and safety profile were consistent with previous phase 3 studies and sustained through 2 years.Trial registrationClinicalTrials.gov identifier, NCT02159053.FundingNovartis Pharma AG, Basel, Switzerland. (Source: Rheumatology and Therapy)
Source: Rheumatology and Therapy - August 18, 2018 Category: Rheumatology Source Type: research

Healthcare Utilization and Direct Costs in Patients with Ankylosing Spondylitis Using a Large US Administrative Claims Database
This study assessed both all-cause and AS-specific healthcare utilization and direct costs in US patients with AS using administrative claims data.MethodsAdults aged ≥ 18 years enrolled in the MarketScan® Commercial and Medicare databases with ≥ 1 inpatient or ≥ 2 non-rule-out outpatient diagnoses of AS between January 1, 2013, and December 31, 2013, were included. Patients had continuous enrollment with medical and pharmacy benefits for ≥ 12 months before and after the index date (first diagnosis). Non-AS controls were match ed up to 5:1 to patients with AS on age, geo...
Source: Rheumatology and Therapy - August 18, 2018 Category: Rheumatology Source Type: research