Daniel H Solomon, Kelli D Allen, Patricia Katz, Amr H Sawalha, Ed Yelin
{"title":"ChatGPT, et al … Artificial Intelligence, Authorship, and Medical Publishing.","authors":"Daniel H Solomon, Kelli D Allen, Patricia Katz, Amr H Sawalha, Ed Yelin","doi":"10.1002/acr2.11538","DOIUrl":"https://doi.org/10.1002/acr2.11538","url":null,"abstract":"If you have not yet heard of ChatGPT, you will! This artificial intelligence (AI)-based chatbot is making waves in medicine, education, academic publishing, and more widely. If you are a clinician and dismissed the idea that AI-powered care is part of our future, think again. AI-powered chatbots like ChatGPT are being put to the test on clinical scenarios and board examinations and fare pretty well (1). GPT, generative pretrained transformer, describes the next generation in AI-powered chatbots that not only construct full sentences on topic but now synthesize information from many fields, from many sources, and with tremendous nuance. We tried ChatGPT recently, asking it to create a patient-facing educational brochure on medications for gout. Almost instantaneously, ChatGPT spit out a brochure that was accurate, written at the correct reading level, and appropriate in its supportive tone. It is useful to explain a bit more about this type of AI. ChatGPT is just one of several large language model (LLM) interfaces for AI; many vendors are working on other interfaces that will have very similar capabilities. You might already be familiar with narrower forms of AI, which focus on one task, although you may not think of these applications as AI. These tasks might be as narrow as correcting grammar, detecting plagiarism, proof-reading insurance forms, interpreting radiology imaging, or telling us the weather. However, with the advent of LLM interfaces, AI has become a co-author on scientific papers (2). Can an LLM AI tool really co-author a scientific paper? At this stage, no one doubts that these tools can generate useful text that might accurately synthesize previously collected or original data. But authorship raises other questions about accountability. If the methods that LLM AI tools use to generate text are not transparent (they probably will never be), then who is accountable? One pillar of authorship according to the International Committee of Medical Journal Editors requires that authors agree “to be accountable for all aspects of the work...” (3). At this stage, it is not clear that LLM AI tools can be held accountable, so the American College of Rheumatology (ACR) journal editors and the ACR Committee on Journal Publications have agreed that co-authorship is not appropriate for these tools (see new Author Instructions; https://onlinelibrary.wiley.com/page/ journal/25785745/homepage/guide-to-authors). Another potential issue is that LLM AI tools are trained on existing literature that may be inaccurate and biased. Thus, we also have concerns that unintended biases may be magnified through these tools, often in ways that are not apparent. We acknowledge that there will likely be many instances when such tools will be used to perform analyses or to contribute to a scientific project. Narrow AI tools are currently widely used in imaging analyses (4). Such contributions should be reported by referring to the specific versions of the tools used","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 6","pages":"288-289"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9639844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amr H Sawalha, Daniel H Solomon, Kelli D Allen, Patricia Katz, Ed Yelin
{"title":"Immediate Open Access: The Good, the Bad, and the Impact on Academic Society Publishing.","authors":"Amr H Sawalha, Daniel H Solomon, Kelli D Allen, Patricia Katz, Ed Yelin","doi":"10.1002/acr2.11547","DOIUrl":"https://doi.org/10.1002/acr2.11547","url":null,"abstract":"","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 6","pages":"308-309"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10267799/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9634547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ACR Open RheumatologyPub Date : 2023-06-01Epub Date: 2023-05-01DOI: 10.1002/acr2.11546
Shilpa Venkatachalam, Kelly Gavigan, Shubhasree Banerjee, Jennifer Gordon, Lisa Emrich, Hope Sullivan, Ashira Blazer, Brittany Banbury, Kimberly N Weaver, Laura Stradford, Vandana Dronadula, Angela Degrassi, Peter A Merkel, Dianne G Shaw, Kalen Larsen, Jeffrey R Curtis, Robert N McBurney, Michael D Kappelman, Michael D George, W Benjamin Nowell
{"title":"Engaging Multistakeholder Perspectives to Identify Patient-Centered Research Priorities Regarding Vaccine Uptake Among Adults With Autoimmune Conditions.","authors":"Shilpa Venkatachalam, Kelly Gavigan, Shubhasree Banerjee, Jennifer Gordon, Lisa Emrich, Hope Sullivan, Ashira Blazer, Brittany Banbury, Kimberly N Weaver, Laura Stradford, Vandana Dronadula, Angela Degrassi, Peter A Merkel, Dianne G Shaw, Kalen Larsen, Jeffrey R Curtis, Robert N McBurney, Michael D Kappelman, Michael D George, W Benjamin Nowell","doi":"10.1002/acr2.11546","DOIUrl":"10.1002/acr2.11546","url":null,"abstract":"<p><strong>Objective: </strong>The study objective was to prioritize topics for future patient-centered research to increase uptake of common vaccines, such as for pneumococcal pneumonia, influenza, herpes zoster, human papillomavirus, and severe acute respiratory syndrome coronavirus 2, among adults living with autoimmune conditions.</p><p><strong>Methods: </strong>A steering committee (SC) was formed that included clinicians, patients, patient advocates, and researchers associated with rheumatic diseases (psoriatic arthritis, rheumatoid arthritis, vasculitis), inflammatory bowel disease, and multiple sclerosis. Through a scoping review and discussions, SC members identified research topics regarding vaccine uptake and/or hesitancy for prioritization. A larger multistakeholder alliance that included patients and patient advocates, clinicians, researchers, policy makers, regulators, and vaccine manufacturers conducted a modified Delphi exercise online with three rating rounds and one ranking round. Frequency analysis and comparisons across stakeholder groups were conducted. A weighted ranking score was generated for each item in the ranking round for final prioritization.</p><p><strong>Results: </strong>Through the Delphi process, 33 research topics were identified, of which 13 topics were rated as critical by more than 70% of all stakeholders (n = 31). The two highest ranked critical topics per the full stakeholder group were \"How well a vaccine works for adults with autoimmune conditions\" and \"How beliefs about vaccine safety affect vaccine uptake.\"</p><p><strong>Conclusion: </strong>A multistakeholder group identified key topics as critically important priorities for future research to decrease vaccine hesitancy and improve uptake of vaccines for adults with autoimmune conditions.</p>","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 6","pages":"290-297"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d5/c1/ACR2-5-290.PMC10267803.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9900888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Namrata Singh, Petros Grivas, Una E Makris, Maria E Suarez-Almazor, Ann M O'Hare, Jennifer L Barton
{"title":"Use of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: Supporting Shared Decision-Making Between Patients With Cancer and Clinicians.","authors":"Namrata Singh, Petros Grivas, Una E Makris, Maria E Suarez-Almazor, Ann M O'Hare, Jennifer L Barton","doi":"10.1002/acr2.11552","DOIUrl":"https://doi.org/10.1002/acr2.11552","url":null,"abstract":")","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 6","pages":"305-307"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/74/58/ACR2-5-305.PMC10267802.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9634537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bénédicte Delcoigne, AnnaCarin Horne, Johan Reutfors, Johan Askling
{"title":"Risk of Psychiatric Disorders in Juvenile Idiopathic Arthritis: Population- and Sibling-Controlled Cohort and Cross-Sectional Analyses.","authors":"Bénédicte Delcoigne, AnnaCarin Horne, Johan Reutfors, Johan Askling","doi":"10.1002/acr2.11549","DOIUrl":"https://doi.org/10.1002/acr2.11549","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to examine the incidence and accumulated burden of psychiatric disorders in juvenile idiopathic arthritis (JIA) relative to the general population (GP) and to their same-sex siblings.</p><p><strong>Methods: </strong>We performed an observational register-based study from July 1, 2006, to December 31, 2020, with three different study population contrasts: 1) patients with incident JIA versus five age- and sex-matched GP individuals (cohort), 2) patients with incident JIA versus full same-sex siblings (cohort), and 3) patients with prevalent JIA at age 18 versus matched GP individuals (cross-sectional). We investigated six groups of psychiatric disorders defined via International Classification of Diseases, Tenth Revision codes: mood and anxiety, suicidal behavior, eating, sleeping, substance use, psychotic, plus an overall combined outcome (ie, at least one of the six). Incidences rates were compared through Cox regression (contrasts 1 and 2) and logistic regression (contrast 3), all adjusted for demographics, comorbidities, and proxies for socioeconomic status.</p><p><strong>Results: </strong>During 25,141 person-years of follow-up of 4939 incident patients with JIA, the incidence of the overall combined outcome was 20.1 per 1000 person-years in patients with JIA versus 13.1 per 1000 person-years in the GP (adjusted hazard ratio [HR] = 1.49 [95% confidence interval: 1.35-1.65]). The three most elevated HRs were obtained for sleeping disorder (1.91 [1.41-2.59]), suicidal behavior (1.60 [1.23-2.07]), and mood and anxiety disorders (1.46 [1.30-1.64]). The comparison of patients with JIA (n = 1815) with their siblings (n = 2050) for the overall combined outcome resulted in a nonstatistically significant HR (1.16 [0.82-1.64]). By age 18, patients with JIA were more likely to have been diagnosed with any psychiatric disorder (adjusted odds ratio = 1.37 [1.25-1.50]).</p><p><strong>Conclusion: </strong>There is an increased burden of psychiatric morbidity in JIA, which holds both individual and familial components.</p>","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 5","pages":"277-284"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/98/64/ACR2-5-277.PMC10184008.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9476143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ACR Open RheumatologyPub Date : 2023-05-01Epub Date: 2023-03-25DOI: 10.1002/acr2.11539
Alyssa Howren, J Antonio Avina-Zubieta, Joseph H Puyat, Deborah Da Costa, Hui Xie, Eileen Davidson, Nevena Rebić, Louise Gastonguay, Hallie Dau, Mary A De Vera
{"title":"Impact of Loneliness and Social Isolation on Mental Health Outcomes Among Individuals With Rheumatic Diseases During the COVID-19 Pandemic.","authors":"Alyssa Howren, J Antonio Avina-Zubieta, Joseph H Puyat, Deborah Da Costa, Hui Xie, Eileen Davidson, Nevena Rebić, Louise Gastonguay, Hallie Dau, Mary A De Vera","doi":"10.1002/acr2.11539","DOIUrl":"10.1002/acr2.11539","url":null,"abstract":"<p><strong>Objective: </strong>The study objective was to assess mental and social health outcomes for individuals with rheumatic disease during the COVID-19 pandemic and evaluate the relationship of loneliness and social isolation with depression and anxiety.</p><p><strong>Methods: </strong>We administered an international cross-sectional online survey to individuals with rheumatic disease(s) (≥18 years) between April 2020 and September 2020, with a follow-up survey from December 2020 to February 2021. We used questionnaires to evaluate loneliness (3-item UCLA Loneliness Scale [UCLA-3]), social isolation (Lubben Social Network Scale [LSNS-6]), depression (Patient Health Questionnaire [PHQ-9]), and anxiety (Generalized Anxiety Disorder 7-item [GAD-7] Scale). We used multivariable linear regression models to evaluate the cross-sectional associations of loneliness and social isolation with depression and anxiety at baseline.</p><p><strong>Results: </strong>Seven hundred eighteen individuals (91.4% women, mean age: 45.4 ± 14.2 years) participated in the baseline survey, and 344 completed the follow-up survey. Overall, 51.1% of participants experienced loneliness (UCLA-3 score ≥6) and 30.3% experienced social isolation (LSNS-6 score <12) at baseline. Depression (PHQ-9 score ≥10) and anxiety (GAD-7 score ≥10) were experienced by 42.8% and 34.0% of participants at baseline, respectively. Multivariable models showed that experiencing both loneliness and social isolation, in comparison to experiencing neither, was significantly associated with an average 7.27 higher depression score (ß = 7.27; 95% confidence interval [CI]: 6.08-8.47) and 5.14 higher anxiety score (ß = 5.14; 95% CI: 4.00-6.28).</p><p><strong>Conclusion: </strong>Aside from showing substantial experience of loneliness and social isolation during the COVID-19 pandemic, our survey showed significant associations with depression and anxiety. Patient supports to address social health have potential implications for also supporting mental health.</p>","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 5","pages":"243-250"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/72/09/ACR2-5-243.PMC10184014.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9474527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Images Clinical: Acro-osteolysis: a complication of systemic sclerosis or rheumatoid arthritis?","authors":"Hammad Ali, William N Roberts","doi":"10.1002/acr2.11541","DOIUrl":"https://doi.org/10.1002/acr2.11541","url":null,"abstract":"","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 5","pages":"251"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/61/37/ACR2-5-251.PMC10184007.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9843928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ACR Open RheumatologyPub Date : 2023-05-01Epub Date: 2023-03-29DOI: 10.1002/acr2.11536
BrianJ Andonian, Leanna M Ross, Alyssa M Zidek, Liezl B Fos, Lucy W Piner, Johanna L Johnson, Kelsey B Belski, Julie D Counts, Carl F Pieper, Ilene C Siegler, Connie W Bales, Kathryn N Porter Starr, William E Kraus, Kim M Huffman
{"title":"Remotely Supervised Weight Loss and Exercise Training to Improve Rheumatoid Arthritis Cardiovascular Risk: Rationale and Design of the Supervised Weight Loss Plus Exercise Training-Rheumatoid Arthritis Trial.","authors":"BrianJ Andonian, Leanna M Ross, Alyssa M Zidek, Liezl B Fos, Lucy W Piner, Johanna L Johnson, Kelsey B Belski, Julie D Counts, Carl F Pieper, Ilene C Siegler, Connie W Bales, Kathryn N Porter Starr, William E Kraus, Kim M Huffman","doi":"10.1002/acr2.11536","DOIUrl":"10.1002/acr2.11536","url":null,"abstract":"<p><p>Patients with rheumatoid arthritis (RA) remain at an increased risk for cardiovascular disease (CVD) and mortality. RA CVD results from a combination of traditional risk factors and RA-related systemic inflammation. One hypothetical means of improving overall RA CVD risk is through reduction of excess body weight and increased physical activity. Together, weight loss and physical activity can improve traditional cardiometabolic health through fat mass loss, while also improving skeletal muscle health. Additionally, disease-related CVD risk may improve as both fat mass loss and exercise reduce systemic inflammation. To explore this hypothesis, 26 older persons with RA and overweight/obesity will be randomized to 16 weeks of a usual care control arm or to a remotely Supervised Weight Loss Plus Exercise Training (SWET) program. A caloric restriction diet (targeting 7% weight loss) will occur via a dietitian-led intervention, with weekly weigh-ins and group support sessions. Exercise training will consist of both aerobic training (150 minutes/week moderate-to-vigorous exercise) and resistance training (twice weekly). The SWET remote program will be delivered via a combination of video conference, the study YouTube channel, and study mobile applications. The primary cardiometabolic outcome is the metabolic syndrome Z score, calculated from blood pressure, waist circumference, high-density lipoprotein cholesterol, triglycerides, and glucose. RA-specific CVD risk will be assessed with measures of systemic inflammation, disease activity, patient-reported outcomes, and immune cell function. The SWET-RA trial will be the first to assess whether a remotely supervised, combined lifestyle intervention improves cardiometabolic health in an at-risk population of older individuals with RA and overweight/obesity.</p>","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 5","pages":"252-263"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b1/b1/ACR2-5-252.PMC10184018.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9474535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marina Magrey, Jessica A Walsh, Sandra Flierl, Richard A Howard, Renato C Calheiros, David Wei, Muhammad A Khan
{"title":"The International Map of Axial Spondyloarthritis Survey: A US Patient Perspective on Diagnosis and Burden of Disease.","authors":"Marina Magrey, Jessica A Walsh, Sandra Flierl, Richard A Howard, Renato C Calheiros, David Wei, Muhammad A Khan","doi":"10.1002/acr2.11543","DOIUrl":"https://doi.org/10.1002/acr2.11543","url":null,"abstract":"<p><strong>Objective: </strong>Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that causes inflammation in the axial skeleton, resulting in structural damage and disability. We aimed to understand the effect of axSpA on work activity, day-to-day function, mental health, relationships, and quality of life and to examine barriers to early diagnosis.</p><p><strong>Methods: </strong>A 30-minute quantitative US version of the International Map of Axial Spondyloarthritis survey was administered online to US patients aged 18 years and older with a diagnosis of axSpA who were under the care of a health care provider from July 22 to November 10, 2021. This analysis describes demographics, clinical characteristics, journey to axSpA diagnosis, and disease burden.</p><p><strong>Results: </strong>We surveyed 228 US patients with axSpA. Patients had a mean diagnostic delay of 8.8 years, with a greater delay in women versus men (11.2 vs. 5.2 years), and 64.5% reported being misdiagnosed before receiving an axSpA diagnosis. Most patients (78.9%) had active disease (Bath Ankylosing Spondylitis Disease Activity Index score ≥4), reported psychological distress (57.0%; General Health Questionnaire 12 score ≥3), and experienced a high degree of impairment (81.6%; Assessment of Spondyloarthritis International Society Health Index score ≥6). Overall, 47% of patients had a medium or high limitation in activities of daily living, and 46% were not employed at survey completion.</p><p><strong>Conclusion: </strong>The majority of US patients with axSpA had active disease, reported psychological distress, and reported impaired function. US patients experienced a substantial delay in time to diagnosis of axSpA that was twice as long in women versus men.</p>","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 5","pages":"264-276"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/12/79/ACR2-5-264.PMC10184009.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9528406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dennis McGonagle, Iain B McInnes, Atul Deodhar, Georg Schett, May Shawi, Soumya D Chakravarty, Alexa P Kollmeier, Xie L Xu, Shihong Sheng, Stephen Xu, Christopher T Ritchlin, Proton Rahman, Phillip J Mease
{"title":"Guselkumab, a Selective Interleukin-23 p19 Subunit Inhibitor, Resolves Dactylitis in Patients With Active Psoriatic Arthritis: Pooled Results Through Week 52 From Two Phase 3 Studies.","authors":"Dennis McGonagle, Iain B McInnes, Atul Deodhar, Georg Schett, May Shawi, Soumya D Chakravarty, Alexa P Kollmeier, Xie L Xu, Shihong Sheng, Stephen Xu, Christopher T Ritchlin, Proton Rahman, Phillip J Mease","doi":"10.1002/acr2.11537","DOIUrl":"https://doi.org/10.1002/acr2.11537","url":null,"abstract":"<p><strong>Objective: </strong>Previous analyses of pooled DISCOVER-1 and DISCOVER-2 data through Week 24 showed significantly higher rates of dactylitis resolution in patients treated with guselkumab compared with placebo. Here, we investigate associations between dactylitis resolution and other outcomes through 1 year.</p><p><strong>Methods: </strong>Patients were randomized 1:1:1 to receive subcutaneous injections of guselkumab 100 mg at Week 0, Week 4, and then every 4 or 8 weeks, or placebo with crossover to guselkumab at Week 24. Independent assessors determined dactylitis severity score (DSS; 0-3/digit; total = 0-60). Dactylitis resolution (DSS = 0) (prespecified) and at least 20%, at least 50%, and at least 70% DSS improvement from baseline (post hoc) were determined through Week 52 (nonresponder imputation for treatment failure through Week 24 and for missing data through Week 52). ACR50, tender/swollen joints, low disease activity (LDA) as assessed by composite indices, and radiographic progression (DISCOVER-2 only) were assessed in patients with dactylitis versus without dactylitis resolution at Week 24 and Week 52.</p><p><strong>Results: </strong>Patients with dactylitis at baseline (473 of 1118) had more severe joint and skin disease than those without dactylitis (645 of 1118). At Week 52, approximately 75% of guselkumab-randomized patients with dactylitis at baseline had complete resolution; approximately 80% had at least 70% DSS improvement. Through Week 52, new-onset dactylitis (DSS ≥1) was uncommon among patients with a DSS of 0 at baseline. Guselkumab-randomized patients with dactylitis resolution were more likely to achieve ACR50, at least 50% reduction in tender and swollen joints, and LDA at Week 24 and Week 52 than those without resolution. At Week 52, patients with dactylitis resolution had numerically less radiographic progression from baseline (DISCOVER-2).</p><p><strong>Conclusion: </strong>Through 1 year, approximately 75% of guselkumab-randomized patients had complete resolution of dactylitis; patients exhibiting resolution were more likely to achieve other important clinical outcomes. Given the high burden of dactylitis, resolution may be associated with better long-term patient outcomes.</p>","PeriodicalId":7084,"journal":{"name":"ACR Open Rheumatology","volume":"5 4","pages":"227-240"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e7/31/ACR2-5-227.PMC10100698.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9298750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}