scholarly journals Trials and tribulations in managing a complex case of psoriatic arthritis—a success story in the real world

Author(s):  
Aneela Devarakonda ◽  
Ira Pande
2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Gareth T. Jones ◽  
Gary J. Macfarlane ◽  
Karen Forrest Keenan ◽  
Paul McNamee ◽  
Aileen R. Neilson ◽  
...  

Abstract Background Psoriatic arthritis (PsA) presents a unique clinical challenge. Affecting joints, skin, nails, and other organs, it is associated with various comorbidities and has a significant impact on quality of life, social participation and working life. While biologic and other targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have revolutionised therapy, questions remain about the long-term safety of these agents, and their effectiveness and cost-effectiveness in the real-world clinical setting. Methods/design The British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA) is a prospective registry of patients with PsA, recruited from across Great Britain, who are (a) commencing a bDMARD/tsDMARD; or (b) naïve to all bDMARDs/tsDMARDs. Ethical approval was given by the NHS West of Scotland Research Ethics Committee 3 (reference: 18/WS/0126). Clinical data are extracted from participants’ medical records, including symptom onset and diagnosis, joint, skin and nail symptoms, dactylitis and enthesitis. Physical measurements (height, weight and 66/68 joint counts) and a detailed drug history are taken. Participants are also asked to complete questionnaires comprising instruments relating to general health and quality of life, axial disease, sleep and fatigue, impact of disease, functional status, mental health, other symptoms, and occupational status. The study duration is 5 years in the first instance, and all participants are followed up annually until the end of the study. Participants commencing a bDMARD/tsDMARD are also followed up three and six months after the start of therapy. Disease activity, including C-reactive protein, is assessed at each visit; and participants from some centres are invited to donate blood and urine samples for the creation of a biobank. Discussion Complementing data from randomised trials, results from this study will contribute to the evidence base underpinning the clinical management of psoriatic arthritis. Various analyses will determine the effectiveness and safety of bDMARDs/tsDMARDs in the real-world, will examine the clinical and biological predictors of treatment response, and will provide real-world data on the cost-effectiveness of these therapies, as well as providing informative data important to patients such as quality of life and occupational outcomes. Trial registration The full study protocol is registered on the Open Science Framework (https://osf.io/jzs8n).


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Karl Gaffney ◽  
Nicola Gullick ◽  
Uta Kiltz ◽  
Petros Sfikakis ◽  
Athina Theodoridou ◽  
...  

Abstract Background/Aims  SERENA is an ongoing, non-interventional study involving ∼400 European sites with an observation period of ≤ 5 years to evaluate retention, effectiveness, safety/tolerability and quality of life with secukinumab (SEC) in patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS) in the real world. We present effectiveness and safety data through 1 year in the 577 PsA and 507 AS patients enrolled, of which 533 PsA and 461 AS patients comprised the target study population (fulfilling all eligibility criteria). Methods  Patients (aged ≥18 years) with active PsA or AS who were treated for at least 16 weeks with SEC were enrolled. Effectiveness assessments included 78 tender joint count/76 swollen joint count, PGA, total pain (VAS, 0-100 mm), presence of enthesitis/dactylitis and PASI75/90/100 in patients with PsA, and BASDAI, PtGA, C-reactive protein, ASDAS and total spinal pain in patients with AS. Results  Mean disease duration from diagnosis to enrolment was 8.6 and 9.8 years for PsA and AS patients. Patients received SEC for a mean duration of 1 year prior to enrolment (range: 0.90-1.00). In total, 64.7% (N = 533) of PsA and 60.7% (N = 461) of AS patients received other biologic drugs prior to SEC treatment, with 59.7% and 52.7% of PsA and AS patients receiving at least two different biologic drugs. Most patients pre-treated with biologics discontinued biologic treatment due to lack of efficacy (88.0% PsA; 86.8% AS). Retention rates for SEC after 1 year were 85.9% and 86.5% in PsA and AS patients. Responses across all effectiveness assessments in both cohorts were maintained or improved after 1 year of observation (Table 1). No new or unexpected safety signals were reported. P186 Table 1:Effectiveness outcomes in patients with PsA or AS at enrolment and Year 1Characteristic, mean±SD (M), unless otherwise specifiedPsA (N = 533)PsA (N = 533)AS (N = 461)AS (N = 461)EnrolmentYear 1EnrolmentYear 1Total pain (VAS 0-100 mm)31.80±24.28a (432)30.77±24.57a (322)34.68±24.23b (350)34.16±24.49b (228)Presence of tender or swollen joint, n/M (%)280/520 (53.8%)158/373 (42.4%)--Tender joint count, mean [min-max] (m)6.5 [0-68] (203)6.8 [0-78] (140)--Swollen joint count, mean [min-max] (m)3.3 [0-38] (203)2.8 [0-23] (140)--Presence of dactylitis, n/M (%)33/516 (6.4%)13/370 (3.5%)--Enthesitis index0.4±1.0c (276)c0.3±0.9c (243)c0.7±1.70d (246)0.6±1.7d (170)HAQ-DI0.83±0.70 (398)0.83±0.72 (268)--BASDAI--3.20±2.28 (436)3.24±2.36 (270)ASDAS-CRP--2.25±0.94 (229)2.27±0.97 (173)hsCRP, mg/L--8.53±13.42 (285)8.10±14.72 (218)PtGA (NRS) (VAS 0-10 cm)--4.18±2.32 (366)4.07±2.37 (246)aTotal pain;bTotal back pain;cLeeds enthesitis index;dMaastricht Ankylosing Spondylitis Enthesitis Score. AS, ankylosing spondylitis; ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score-C-reactive protein; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; HAQ-DI, Health Assessment Questionnaire Disability Index; hsCRP, high sensitivity C-reactive protein; m, number of patients with detailed assessments of tender or swollen joints; M, number of patients with evaluation; n, number of patients with a positive response; N, number of patients in the study population; NRS, numeric rating scale; PsA, psoriatic arthritis; PtGA, Patient’s Global Assessment; SD, standard deviation; VAS, visual analogue scale. Conclusion  Patients in SERENA had long-standing disease with more than half previously treated with biologics, most of whom had discontinued treatment due to lack of efficacy. SEC showed sustained effectiveness, a high retention rate and favourable safety profile in PsA and AS patients in the real world over 1 year of observation. Incomplete data due to lack of rigorous monitoring (an intrinsic weakness of observational studies) must be considered when interpreting real-world findings. Disclosure  K. Gaffney: Grants/research support; Research grants, consultancy fees and/or speaker fees from AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB. N. Gullick: Grants/research support; Research support, consultancy fees and/or speakers fees from AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB. U. Kiltz: Grants/research support; Research grants, support and/or consultancy fees from AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche and UCB. P. Sfikakis: Grants/research support; Research grants, support and consultancy fees from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis and Pfizer. A. Theodoridou: Honoraria; Consultancy fees from UCB, Amgen, Novartis. J. Brandt-Jürgens: Honoraria; Consultancy fees and speaker honoraria from AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen and Medac. E. Lespessailles: Honoraria; Received speaker and consultant fees from Amgen, Expanscience, Lilly and MSD, and research grants from AbbVie, Amgen, Lilly, MSD and UCB. C. Perella: Other; Novartis employee. E. Pournara: Shareholder/stock ownership; Novartis shareholder. Other; Novartis employee. B. Schulz: Other; Novartis employee. J. Veit: Other; Novartis employee.


Author(s):  
Kim Wervers ◽  
Hannah den Braanker ◽  
Jolanda Luime ◽  
Ilja Tchetverikov ◽  
Andreas Gerards ◽  
...  

2010 ◽  
Vol 20 (3) ◽  
pp. 100-105 ◽  
Author(s):  
Anne K. Bothe

This article presents some streamlined and intentionally oversimplified ideas about educating future communication disorders professionals to use some of the most basic principles of evidence-based practice. Working from a popular five-step approach, modifications are suggested that may make the ideas more accessible, and therefore more useful, for university faculty, other supervisors, and future professionals in speech-language pathology, audiology, and related fields.


2006 ◽  
Vol 40 (7) ◽  
pp. 47
Author(s):  
LEE SAVIO BEERS
Keyword(s):  

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