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Article: L.C. Coates and P.S. Helliwell reply.

Coates, Laura C / Helliwell, Philip S

2016 Volume 43, Issue 9, Page(s) 1766

Language	English
Publishing date	2016-09
Publishing country	Canada
Document type	Journal Article
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
DOI	10.3899/jrheum.160727
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Zs.A 1168: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Book ; Online: Atlas of Psoriatic Arthritis

Mease, P. J. / Helliwell, P. S.

2008

Author's details	edited by P. J. Mease, P. S. Helliwell
Keywords	Dermatology ; Family medicine ; Rheumatology
Language	English
Publisher	Springer-Verlag London Limited
Publishing place	London
Document type	Book ; Online
HBZ-ID	TT050387270
ISBN	978-1-8462-8896-8 ; 978-1-8462-8897-5 ; 1-8462-8896-7 ; 1-8462-8897-5
DOI	10.1007/978-1-84628-897-5
Database	ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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Article ; Online: Estimating postoperative mortality in colorectal surgery- a systematic review of risk prediction models.

Dosis, Alexios / Helliwell, Jack / Syversen, Aron / Tiernan, Jim / Zhang, Zhiqiang / Jayne, David

International journal of colorectal disease

2023 Volume 38, Issue 1, Page(s) 155

Abstract: ... AUROC values between regression models (0.833 s.d. ± 0.52) and ML (0.846 s.d. ± 0.55), p = 0.539 ...

Abstract	Purpose: Risk prediction models are frequently used to support decision-making in colorectal surgery but can be inaccurate. Machine learning (ML) is becoming increasingly popular, and its application may increase predictive accuracy. We compared conventional risk prediction models for postoperative mortality (based on regression analysis) with ML models to determine the benefit of the latter approach. Methods: The study was registered in PROSPERO(CRD42022364753). Following the PRISMA guidelines, a systematic search of three databases (MEDLINE, EMBASE, WoS) was conducted (from 1/1/2000 to 29/09/2022). Studies were included if they reported the development of a risk model to estimate short-term postoperative mortality for patients undergoing colorectal surgery. Discrimination and calibration performance metrics were compared. Studies were evaluated against CHARMS and TRIPOD criteria. Results: 3,052 articles were screened, and 45 studies were included. The total sample size was 1,356,058 patients. Six studies used ML techniques for model development. Most studies (n = 42) reported the area under the receiver operating characteristic curve (AUROC) as a measure of discrimination. There was no significant difference in the mean AUROC values between regression models (0.833 s.d. ± 0.52) and ML (0.846 s.d. ± 0.55), p = 0.539. Calibration statistics, which measure the agreement between predicted estimates and observed outcomes, were less consistent. Risk of bias assessment found most concerns in the data handling and analysis domains of eligible studies. Conclusions: Our study showed comparable predictive performance between regression and ML methods in colorectal surgery. Integration of ML in colorectal risk prediction is promising but further refinement of the models is required to support routine clinical adoption.
MeSH term(s)	Humans ; Colorectal Surgery/adverse effects ; Digestive System Surgical Procedures ; Area Under Curve ; Calibration ; Databases, Factual
Language	English
Publishing date	2023-06-01
Publishing country	Germany
Document type	Systematic Review ; Journal Article ; Review
ZDB-ID	84975-3
ISSN	1432-1262 ; 0179-1958
ISSN (online)	1432-1262
ISSN	0179-1958
DOI	10.1007/s00384-023-04455-0
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Article ; Online: Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study.

Coates, Laura C / Gossec, Laure / Zimmermann, Miriam / Shawi, May / Rampakakis, Emmanouil / Shiff, Natalie J / Kollmeier, Alexa P / Xu, Xie L / Nash, Peter / Mease, Philip J / Helliwell, Philip S

RMD open

2024 Volume 10, Issue 1

Abstract: Objective: Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).: Methods: Post hoc analyses used data ... ...

Abstract	Objective: Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA). Methods: Post hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data. Results: 442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported. Conclusion: In biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets.
MeSH term(s)	Humans ; Arthritis, Psoriatic/drug therapy ; Psoriasis ; Joint Diseases ; Double-Blind Method ; Enthesopathy ; Inflammatory Bowel Diseases ; Uveitis ; Biological Products/therapeutic use ; Antibodies, Monoclonal, Humanized
Chemical Substances	guselkumab (089658A12D) ; Biological Products ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2024-03-26
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	2812592-7
ISSN	2056-5933 ; 2056-5933
ISSN (online)	2056-5933
ISSN	2056-5933
DOI	10.1136/rmdopen-2023-003977
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Article ; Online: Development and validation of a bi-lingual interactive tool to educate people about osteomalacia.

Walker, David / Robinson, Sandra / Helliwell, Philip / Adebajo, Ade

Musculoskeletal care

2020 Volume 18, Issue 3, Page(s) 265–270

Abstract: ... in these people, before and after the education, and increased from an average of 14 to 25 points (p < 0.05 ...

Abstract	Osteomalacia is a condition where bone mineralisation is impaired by lack of vitamin D. It more commonly affects darker skinned individuals in the UK, especially if they wear occlusive clothing. Lifestyle changes and Vitamin D supplementation are recommended for those people most at risk through these factors, but such advice is not commonly followed. This indicates an educational need for information on osteomalacia and its treatment. Using a previously developed Mind-Map on osteomalacia, a layered and interactive" PowerPoint" style presentation was developed, using hyperlinks. The "basic" layer was translated into Urdu and validated by Urdu speaking professionals. The translation was accurate and meaningful and the tool was well received by representatives of the community. The tool was used to educate a group of 10 community leaders from the Urdu community in Stourbridge, UK. Knowledge about osteomalacia was tested in these people, before and after the education, and increased from an average of 14 to 25 points (p < 0.05). Qualitative feedback gained was very positive. Conclusion: An interactive educational tool for Osteomalacia was developed and translated into Urdu. Use of the tool resulted in increased knowledge about osteomalacia.
MeSH term(s)	Humans ; Language ; Osteomalacia/etiology ; Patient Education as Topic
Language	English
Publishing date	2020-02-23
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2171452-6
ISSN	1557-0681 ; 1478-2189
ISSN (online)	1557-0681
ISSN	1478-2189
DOI	10.1002/msc.1459
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Article ; Online: Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: analysis of pooled data from two phase 3 studies.

Mease, Philip J / Orbai, Ana-Maria / FitzGerald, Oliver / Bedaiwi, Mohamed / Dona L Fleishaker / Mundayat, Rajiv / Young, Pamela / Helliwell, Philip S

Arthritis research & therapy

2023 Volume 25, Issue 1, Page(s) 153

Abstract: Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). This post hoc analysis assessed tofacitinib efficacy on enthesitis by baseline location and severity, and impact on disease activity and patient- ... ...

Abstract	Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). This post hoc analysis assessed tofacitinib efficacy on enthesitis by baseline location and severity, and impact on disease activity and patient-reported outcomes (PROs), in patients with PsA. Methods: Data were pooled from two phase 3 studies (NCT01877668/NCT01882439) in patients with PsA receiving tofacitinib 5 or 10 mg twice daily to month (M)6 or placebo to M3. Endpoints were: change from baseline in Leeds Enthesitis Index (LEI) or Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC); proportions of patients with enthesitis, relapsed enthesitis after resolution, de novo enthesitis, low disease activity (LDA) or remission (minimal disease activity/very low disease activity; Psoriatic Arthritis Disease Activity Score; Disease Activity Index for Psoriatic Arthritis, and Composite Psoriatic Disease Activity in Psoriatic Arthritis); and PROs (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] total and arthritis pain Visual Analog Scale scores). Descriptive statistics were generated by visit and treatment. Change from baseline in PROs was evaluated by multivariate linear regression. Results: Seven hundred ten patients from two studies were included: 479 had LEI > 0; 545 had SPARCC > 0; and 136 had LEI = 0 and SPARCC = 0 at baseline. At baseline, among patients with LEI > 0 or SPARCC > 0, mean LEI and SPARCC across treatments and enthesitis locations/severities ranged from 1.0-4.4 and 1.3-9.4, respectively. Across several baseline enthesitis locations/severities, changes from baseline in LEI and SPARCC up to M3 were greater with tofacitinib (-2.0-0.4 and -3.5-0.2) vs placebo (-‍0.9-‍0.4 and -1.5-1.1). Enthesitis at M6 was more common in patients with greater baseline enthesitis severity. At M6, ≤ 40% of patients with baseline LEI > 0 or SPARCC > 0 whose enthesitis had resolved by M1/M3 experienced a relapse, and < 14% of patients with baseline LEI = 0 and SPARCC = 0 had de novo enthesitis. LDA/remission rates generally increased with tofacitinib over time. Baseline LEI location was significantly associated with change from baseline in arthritis pain score, while baseline SPARCC severity was significantly associated with change from baseline in FACIT-F total and arthritis pain scores. Conclusion: Tofacitinib treatment resulted in improvements in enthesitis in patients with PsA, regardless of baseline location or severity. Trial registration: NCT01877668;NCT01882439.
MeSH term(s)	Humans ; Arthritis, Psoriatic/drug therapy ; Enthesopathy/drug therapy ; Pain ; Piperidines/therapeutic use ; Spondylarthritis
Chemical Substances	Piperidines ; tofacitinib (87LA6FU830)
Language	English
Publishing date	2023-08-22
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2107602-9
ISSN	1478-6362 ; 1478-6354
ISSN (online)	1478-6362
ISSN	1478-6354
DOI	10.1186/s13075-023-03108-5
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Article ; Online: Psoriasis flare with corticosteroid use in psoriatic arthritis.

Coates, L C / Helliwell, P S

The British journal of dermatology

2015 Volume 174, Issue 1, Page(s) 219–221

MeSH term(s)	Adult ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Arthritis, Psoriatic/drug therapy ; Drug Therapy, Combination ; Glucocorticoids/administration & dosage ; Glucocorticoids/adverse effects ; Humans ; Injections, Intra-Articular ; Injections, Intramuscular ; Methylprednisolone/administration & dosage ; Methylprednisolone/adverse effects ; Psoriasis/chemically induced
Chemical Substances	Antirheumatic Agents ; Glucocorticoids ; Methylprednisolone (X4W7ZR7023)
Language	English
Publishing date	2015-11-22
Publishing country	England
Document type	Letter ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	80076-4
ISSN	1365-2133 ; 0007-0963
ISSN (online)	1365-2133
ISSN	0007-0963
DOI	10.1111/bjd.14061
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Article ; Online: Multidomain Efficacy and Safety of Guselkumab Through 1 Year in Patients With Active Psoriatic Arthritis With and Without Prior Tumor Necrosis Factor Inhibitor Experience: Analysis of the Phase 3, Randomized, Placebo-Controlled DISCOVER-1 Study.

Ritchlin, Christopher T / Deodhar, Atul / Boehncke, Wolf-Henning / Soriano, Enrique R / Kollmeier, Alexa P / Xu, Xie L / Zazzetti, Federico / Shawi, May / Jiang, Yusang / Sheng, Shihong / Helliwell, Philip S

ACR open rheumatology

2023 Volume 5, Issue 3, Page(s) 149–164

Abstract: Objective: To evaluate efficacy and safety of the interleukin-23p19-subunit inhibitor, guselkumab, in DISCOVER-1 patients with active psoriatic arthritis (PsA) by prior use of tumor necrosis factor inhibitor (TNFi).: Methods: The phase 3, randomized, ...

Abstract	Objective: To evaluate efficacy and safety of the interleukin-23p19-subunit inhibitor, guselkumab, in DISCOVER-1 patients with active psoriatic arthritis (PsA) by prior use of tumor necrosis factor inhibitor (TNFi). Methods: The phase 3, randomized, placebo-controlled DISCOVER-1 study enrolled patients with active PsA (swollen joint count ≥3, tender joint count ≥3, and C-reactive protein level ≥ 0.3 mg/dl) despite standard therapies; approximately one-third could have received two or fewer prior TNFi. Patients were randomized to 100 mg of guselkumab every 4 weeks (Q4W); 100 mg of guselkumab at week 0, at week 4, and every 8 weeks (Q8W); or placebo with crossover to guselkumab Q4W at week 24. Efficacy end points of ≥20% and ≥50% improvement in individual American College of Rheumatology (ACR) criteria and achieving the minimal disease activity (MDA) components were summarized by prior TNFi status. Results: In DISCOVER-1, 118 (31%) patients previously received one or two TNFi. As previously reported, rates for acheiving ≥20% improvement in the composite ACR response at week 24 and week 52 were similar in TNFi-naive and TNFi-experienced patients randomized to guselkumab Q4W (76% and 68%, respectively) and Q8W (61% and 58%, respectively). Similar trends were observed for response rates of ≥20% and ≥50% improvement in individual ACR criteria and for achieving individual MDA components at week 24; TNFi-naive patients were more likely to achieve end points related to physical function and pain than TNFi-experienced patients. Overall, response rates were maintained or increased through week 52 regardless of prior TNFi use. Through week 60 in guselkumab-treated TNFi-naive and TNFi-experienced patients, 62% and 64%, respectively, reported one or more adverse events (AEs); 4% and 6% had serious AEs, respectively. Conclusion: Through 1 year, 100 mg of guselkumab Q4W and Q8W provided sustained improvements across multiple domains in both TNFi-naive and TNFi-experienced patients with active PsA.
Language	English
Publishing date	2023-02-10
Publishing country	United States
Document type	Journal Article
ISSN	2578-5745
ISSN (online)	2578-5745
DOI	10.1002/acr2.11523
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Article ; Online: Patient education about recovery after colorectal surgery: systematic scoping review.

Chapman, S J / Helliwell, J A / Lonsdale, M D S / Tiernan, J P / Jayne, D G

Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

2020 Volume 22, Issue 12, Page(s) 1842–1849

Abstract: Aim: Enhanced recovery after surgery (ERAS) protocols aim to optimize recovery through a series of evidence-based recommendations. A key component of ERAS is the provision of patient education. Whilst the recommendation for this is strong, the evidence ... ...

Abstract	Aim: Enhanced recovery after surgery (ERAS) protocols aim to optimize recovery through a series of evidence-based recommendations. A key component of ERAS is the provision of patient education. Whilst the recommendation for this is strong, the evidence to inform its format, timing and delivery is unclear. The aim of this review was to describe previous educational interventions used to improve recovery after colorectal surgery and to explore opportunities for future research. Methods: A systematic scoping review was performed. MEDLINE and Embase databases were searched between 1 January 1990 and 12 February 2020. Studies which described or assessed the effectiveness of a patient education or information resource to improve recovery after colorectal surgery were eligible. Outcomes of interest included the format, timing and delivery of interventions, as well as key features of intervention and study design. A narrative synthesis of data was produced through a process of charting and summarizing key results. Results: A total of 1298 papers were inspected, and 11 were eligible for inclusion. Five papers were reports of randomized controlled trials, and others reported a mix of non-randomized and qualitative studies. The design of educational interventions included audio-visual resources (n = 3), smartphone device applications (n = 3) and approaches to facilitate person-to-person counselling (n = 5). Most of the counselling interventions reported positive outcomes (mainly in length of hospital stay), whereas the other types reported mixed results. Patients and the public were seldom involved as collaborators in the design of interventions. Conclusions: Patient education is generally advantageous, but there is insufficient evidence to optimize its design and delivery in the setting of colorectal surgery.
MeSH term(s)	Colorectal Surgery ; Digestive System Surgical Procedures ; Enhanced Recovery After Surgery ; Humans ; Length of Stay ; Patient Education as Topic
Language	English
Publishing date	2020-09-24
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review
ZDB-ID	1440017-0
ISSN	1463-1318 ; 1462-8910
ISSN (online)	1463-1318
ISSN	1462-8910
DOI	10.1111/codi.15337
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Article ; Online: Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial.

Mease, Philip / Helliwell, Philip / Silwinska-Stanczyk, Paula / Miakisz, Malgorzata / Ostor, Andrew / Peeva, Elena / Vincent, Michael S / Sun, Qiankun / Sikirica, Vanja / Winnette, Randall / Qiu, Ruolun / Li, Gang / Feng, Gang / Beebe, Jean S / Martin, David A

Arthritis & rheumatology (Hoboken, N.J.)

2023 Volume 75, Issue 8, Page(s) 1370–1380

Abstract: ... 30 mg and 60 mg once daily groups had significantly greater ACR20 response rates (66.7% [P = 0.0197 ... and 74.6% [P = 0.0006], respectively), versus the placebo group (43.3%), and significantly higher ...

Abstract	Objective: Brepocitinib is a TYK2/JAK1 inhibitor in development for the treatment of several immunologic diseases. The efficacy and safety of oral brepocitinib were assessed in participants with moderately-to-severely active psoriatic arthritis (PsA) for up to 52 weeks. Methods: In this placebo-controlled, dose-ranging, phase IIb study, participants were randomized to receive 10 mg, 30 mg, or 60 mg of brepocitinib once daily or placebo, advancing to 30 mg or 60 mg of brepocitinib once daily at week 16. The primary endpoint was the response rate according to the American College of Rheumatology criteria for 20% improvement (ACR20) in disease activity at week 16. Secondary endpoints included response rates according to the ACR50/ACR70 response criteria, 75% and 90% improvement in the Psoriasis Area and Severity Index (PASI75/PASI90) score, and minimal disease activity (MDA) at weeks 16 and 52. Adverse events were monitored throughout the study. Results: Overall, 218 participants were randomized and treated. At week 16, the brepocitinib 30 mg and 60 mg once daily groups had significantly greater ACR20 response rates (66.7% [P = 0.0197] and 74.6% [P = 0.0006], respectively), versus the placebo group (43.3%), and significantly higher ACR50/ACR70, PASI75/PASI90, and MDA response rates. Response rates were maintained or improved through week 52. Adverse events were mostly mild/moderate; serious adverse events (15) in 12 participants (5.5%) included infections in 6 participants (2.8%) in the brepocitinib 30 mg and 60 mg once daily groups. No major adverse cardiovascular events or deaths occurred. Conclusion: Treatment with brepocitinib at dosages of 30 mg and 60 mg once daily was superior to placebo at reducing signs and symptoms of PsA. Brepocitinib was generally well tolerated throughout the 52-week study, with a safety profile consistent with those found in other brepocitinib clinical trials.
MeSH term(s)	Humans ; Antibodies, Monoclonal/therapeutic use ; Antirheumatic Agents/therapeutic use ; Arthritis, Psoriatic/drug therapy ; Double-Blind Method ; Immunologic Factors/therapeutic use ; Janus Kinase 1 ; Treatment Outcome ; TYK2 Kinase/therapeutic use
Chemical Substances	Antibodies, Monoclonal ; Antirheumatic Agents ; Immunologic Factors ; JAK1 protein, human (EC 2.7.10.2) ; Janus Kinase 1 (EC 2.7.10.2) ; TYK2 Kinase (EC 2.7.10.2) ; TYK2 protein, human (EC 2.7.10.2)
Language	English
Publishing date	2023-06-22
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.42519
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