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ObjectiveTo describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials.MethodsData were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient’s Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 (tofacitinib and placebo) in the AS population.ResultsOverall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12.ConclusionTofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.

Background:Pain is a debilitating symptom of ankylosing spondylitis (AS) and negatively impacts patient (pt) lives. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor engineered for increased selectivity for JAK1 over JAK2, JAK3, and tyrosine kinase 2, 1 showed significant efficacy vs placebo (PBO) in the randomized phase 2/3 SELECT-AXIS 1 study in active AS.2Objectives:To evaluate the efficacy of UPA on multiple pain assessments through 64 weeks (wks).Methods:SELECT-AXIS 1 (NCT03178487) enrolled adults with active AS, who had an inadequate response, intolerance or contraindications to ≥2 NSAIDs, were biologic DMARD naive and met the modified New-York Criteria. Pts were randomized 1:1 to UPA 15 mg once daily (QD, n=93) or PBO (n=94) for 14 wks (Period 1), followed by open-label UPA 15 mg QD during 90-wk extension (Period 2); reported here are data through wk 64. Pain endpoints included the proportion of pts achieving ≥30%/≥50%/≥70% reduction in Pt’s Global Assessment (PGA) of pain on a 0–10 numeric rating scale (NRS), minimal clinically important difference (MCID, defined as ≥1 point reduction or ≥15% reduction from baseline [BL]) in PGA of pain, and much better improvement (MBI, defined as ≥2 point reduction and ≥33% reduction from BL) in PGA of pain. In addition, mean change from baseline in PGA of pain, BASDAI questions 2 (neck/back/hip pain) and 3 (peripheral pain/swelling), and pt’s assessment of back pain and nocturnal back pain NRS scores (NRS 0–10) were assessed. Non-responder imputation (binary endpoints) and mixed-effects model for repeated measurements (continuous endpoints) were used for missing data/dropouts in Period 1; as-observed analysis was used for Period 2.Results:A significantly higher proportion of pts receiving UPA vs PBO achieved reductions in all PGA of pain assessments as early as wk 2 that was sustained at all time points in Period 1; the only exception was ≥70% reduction in PGA of pain that was significant at wk 4 and sustained thereafter (Figure 1). For ≥30%/≥50%/≥70% reduction and MBI, the response rate increased over time with UPA; the difference for UPA vs PBO also continued to increase over time for ≥50% and ≥70% reduction endpoints. For MCID, an increase from BL to wk 2 was observed and plateaued thereafter. The mean change from BL in PGA of pain, BASDAI Q2, back pain, and nocturnal back pain NRS scores were significantly greater for UPA vs PBO at all time points in Period 1; BASDAI Q3 was significant at wk 8 and 14 (Figure 1). The effect of UPA on pain reduction was sustained through wk 64. PBO pts who switched to open-label UPA at wk 14 generally reached the same level of pain reduction as those initially randomized to UPA (Figure 1).Conclusion:In pts with active AS and an inadequate response/contraindication to NSAIDs, a greater proportion of patients treated with UPA achieved rapid, significant, and clinically meaningful reductions in pain vs PBO through 14 wks across multiple pain assessments. The reductions in pain were sustained over time, and pts who switched from PBO to UPA reached the same level of improvement as the continuous UPA group.References:[1]Parmentier JM, et al. BMC Rheumatology. 2018;2(23).[2]van der Heijde D, et al. Lancet. 2019;394(10214):2108-2117.Acknowledgements:AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by M Hovenden and J Matsuura of ICON plc and was funded by AbbVie.Disclosure of Interests:Atul Deodhar Speakers bureau: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Consultant of: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Grant/research support from: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Xenofon Baraliakos Consultant of: Novartis, Pfizer AbbVie, Eli Lilly, UCB Pharma, Galapagos Janssen, Celgene and Amgen, Grant/research support from: Novartis, Pfizer AbbVie, Eli Lilly, UCB Pharma, Galapagos Janssen, Celgene and Amgen, Iain McInnes Consultant of: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Kurt de Vlam Speakers bureau: Celgene Eli Lilly, Galapagos, Novartis, and UCB, Consultant of: Celgene, Eli Lilly, Galapagos, Novartis, and UCB, Grant/research support from: Celgene and Galapagos, Louis Bessette Speakers bureau: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, and Sanofi, Consultant of: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, Gilead, Grant/research support from: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, and Gilead, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Christopher Saffore Shareholder of: AbbVie, Employee of: AbbVie, Tianming Gao Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie, Andrew Ostor Consultant of: AbbVie, BMS, Roche, Janssen, Lilly, Novartis, Pfizer, UCB, Gilead, and Paradigm

Background:Pain is a dominant symptom of psoriatic arthritis (PsA), and pain reduction is a priority for patients (pts) that is often assessed in clinical trials. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor engineered for increased selectivity for JAK1 over JAK2, JAK3, and tyrosine kinase2, has demonstrated safety and efficacy in pts with active PsA in the SELECT-PsA 1 and 2 studies.1,2Objectives:The objective of this analysis was to compare the efficacy of UPA vs placebo (PBO) and adalimumab (ADA) on pain using different assessments through 24 weeks (wks).Methods:The SELECT-PsA program enrolled adult pts with active PsA with prior inadequate response (IR) or intolerance to ≥1 non-biologic DMARD (SELECT-PsA 1; NCT03104400) or prior IR or intolerance to ≥1 biologic DMARD (SELECT-PsA 2; NCT03104374). Concomitant background therapy with ≤2 non-biologic DMARDs was allowed but not required. Pts were randomized to UPA 15 mg or UPA 30 mg once daily (QD) or PBO (both studies), or ADA 40 mg every other week (EOW; SELECT-PsA 1 only). Pain was assessed as proportion of pts achieving ≥30%, ≥50%, or ≥70% reduction from baseline (BL) in Pt’s global assessment (PGA) of pain numeric rating scale (NRS) score (0–10), proportion of pts achieving minimal clinically important difference (MCID) in pain (defined as ≥1 point reduction or 15% reduction from BL on a 0–10 NRS)3,4 and change from baseline in pain NRS (0–10) at all time points. In addition, change from BL in BASDAI questions 2 (spinal pain) and 3 (joint pain/swelling) and 36-Item Short Form Survey (SF-36) questions 7 (bodily pain) and 8 (pain interference) at weeks 12 and 24 were assessed. Non-responder imputation was used for binary endpoints and mixed-effects model for repeated measurements for continuous endpoints. The statistical significance defined as PResults:In both studies, a significantly higher proportion of pts receiving UPA 15 mg QD and UPA 30 mg QD vs PBO achieved improvements in most pain endpoints as early as wk 2, and improvements were generally either sustained or increased through wk 24 (nominal P<0.05). A significant improvement with UPA vs PBO was also observed for change from BL in PGA of pain NRS scores over time, as well as in BASDAI spinal pain and joint pain/swelling and SF-36 bodily pain and pain interference at weeks 12 and 24. In SELECT-PsA 1 significantly higher proportions of pts receiving UPA 30 mg QD vs ADA 40 mg EOW achieved improvements in most pain assessments as early as wk 2 which were sustained through wk 24; improvements in several assessments were also significantly greater with UPA 15 mg QD vs ADA 40 mg EOW at wk 24 (nominal P Data will be presented).Conclusion:In pts with active PsA who had inadequate response to non-biologic or biologic DMARDs, a greater proportion of pts treated with UPA vs PBO achieved rapid, significant, and clinically meaningful reductions in pain across multiple pain assessments. The reductions in pain were sustained over 24 wks.References:[1]McInnes I. et al. Ann Rheum Dis. 2020;79(Suppl 1):12-13.[2]Genovese M.C. et al. Ann Rheum Dis. 2020;79(Suppl 1):139.[3]Dworkin, R.H. et al. J Pain. 2008;9(2):105-121.[4]Salaffi F. et al. Eur J Pain. 2004;8:283–291.Acknowledgements:AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by M Hovenden and J Matsuura of ICON plc (North Wales, PA) and was funded by AbbVie.Disclosure of Interests:Iain McInnes Consultant of: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, William Tillett Speakers bureau: AbbVie, Amgen, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, and UCB, Philip J Mease Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Leo, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Leo, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Leo, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, Kurt de Vlam Speakers bureau: Celgene Eli Lilly, Galapagos, Novartis, and UCB, Consultant of: Celgene, Eli Lilly, Galapagos, Novartis, and UCB, Grant/research support from: Celgene and Galapagos, Louis Bessette Speakers bureau: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, and Sanofi, Consultant of: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, Gilead, Grant/research support from: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Sanofi, and Gilead, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Patrick Zueger Shareholder of: AbbVie, Employee of: AbbVie, Dai Feng Shareholder of: AbbVie, Employee of: AbbVie, Koji Kato Shareholder of: AbbVie, Employee of: AbbVie, Andrew Ostor Consultant of: AbbVie, BMS, Roche, Janssen, Lilly, Novartis, Pfizer, UCB, Gilead, and Paradigm.

Background Intimate partner violence can have a devastating impact on victims’ psychological and physical health and ability to maintain and preserve interpersonal relationships. The aim of the current study is to empirically test the effectiveness of Strong Through Every Mile (STEM), a 10-week structured running (exercise) program designed to increase psychological, social, and physical well-being among survivors of intimate partner violence. To the authors’ knowledge, STEM is the only community-based structured running program designed to improve the quality of life of survivors of intimate partner violence. This paper will describe the STEM program and present the theoretical basis of the program and the program evaluation design. Methods The current study will utilize an interdisciplinary lens to evaluate a community-based intervention aimed at decreasing the negative effects of intimate partner violence on women’s lives. The study will use a mixed method approach (qualitative and quantitative), including a pre- and post-test evaluation of the STEM running program. Primary data will be collected using paper and pencil surveys which assess women’s psychological, social, and physical well-being prior to participation in the program and following the completion of the program. Qualitative data from focus groups will also be collected and allow for a more rich understanding of the changes that women experience over the course of the program and specific mechanisms underlying these changes. Discussion The current study will employ an interdisciplinary lens to examine the extent to which a structured exercise program, specifically running, impacts the psychological, social and physical well-being of women survivors of intimate partner violence. Findings of this study can influence the development and implementation of similar programs for survivors of intimate partner violence and other types of trauma by identifying mechanisms central in achieving positive outcomes for participants.

Background Pain is a core domain of psoriatic arthritis (PsA).1 Rapid, sustained pain reduction is a priority for patients (pts) and physicians when choosing treatment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. Objectives This post hoc analysis aimed to estimate time to clinically meaningful pain improvement with tofacitinib. Methods Data were analysed from 2 Phase 3 studies of tofacitinib in pts with active PsA and an inadequate response to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) (OPAL Broaden; NCT01877668; 12-month study), or to ≥1 tumour necrosis factor inhibitor (OPAL Beyond; NCT01882439; 6-month study). Pts treated with tofacitinib 5 mg twice daily (BID) and placebo (PBO) advanced to tofacitinib 5 mg BID at Month 3 (PBO-tofacitinib), in combination with csDMARDs, were included in this analysis. Current arthritis pain severity was reported by pts using a 100 mm visual analogue scale, where higher scores indicated greater severity of pain. Pain improvement was defined as the first post-baseline improvement of ≥30% (meaningful change), ≥50% (substantial change) or ≥70% relative to baseline.2 Time-to-event analyses were performed using a Kaplan-Meier (KM) method on pooled data. Descriptive analyses of the rate of improvements by study were performed. Results Overall, 354 pts were available for analysis. Rates of pain improvement over time with tofacitinib 5 mg BID were approximately the same in both studies (Figure). By Month 1, ≥40% of pts experienced ≥30% pain improvement, and by Month 2, approximately 55% of pts experienced ≥30% pain improvement (Figure). KM analyses showed that pts receiving tofacitinib 5 mg BID achieved improvements in pain severity of 30–70% significantly faster compared with pts in the PBO-tofacitinib group (Table). The median time to ≥30% pain improvement was 55 days in the tofacitinib 5 mg BID group and 106 days in the PBO-tofacitinib group (pts switched to tofacitinib 5 mg BID at Month 3; p=0.0132). Similar trends between treatment groups were observed across other pain improvement thresholds. Conclusion In pts with active PsA, faster, clinically meaningful pain improvements were reported in pts receiving tofacitinib 5 mg BID vs pts receiving PBO who switched to tofacitinib 5 mg BID at Month 3. After switch from PBO to active treatment, pain improvement was observed in line with pts receiving active treatment from Day 0. To achieve pain improvement at greater thresholds, longer duration of active treatment was required. References [1] Orbai aM, et al. Ann Rheum Dis2017;76:673-80. [2] Dworkin RH, et al. J Pain2008;9:105-21. Acknowledgement This study was sponsored by Pfizer inc. Medical writing support was provided by Karleen Nicholson, PhD, on behalf of CMC Connect, a division of McCann Health Medical Communications Ltd, Macclesfield, UK, and was funded by Pfizer inc. Disclosure of interests Alexis Ogdie Grant/research support from: (To my university) Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Consultant for: abbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly and Company, Novartis, Pfizer, and Takeda, Consultant for: abbVie, amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer inc, Takeda, Consultant for: abbvie, amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Consultant for: abbvie, amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Kurt de Vlam Consultant for: Pfizer inc, Consultant for: Johnson & Johnson, andrew G Bushmakin Shareholder of: Pfizer inc, Employee of: Pfizer inc, Joseph C Cappelleri Shareholder of: Pfizer inc, Employee of: Pfizer inc, Philip J Mease Grant/research support from: abbVie, amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: abbVie, amgen, BMS, Galapagos, Gilead Sciences, inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: abbVie, amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, Roy Fleischmann Grant/research support from: abbVie, amgen, astraZeneca, Bristol-Myers Squibb, Celtrion, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer inc, Sanofi-Aventis, UCB, Consultant for: abbVie, amgen, astraZeneca, Bristol-Myers Squibb, Celtrion, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer inc, Sanofi-Aventis, UCB, Peter C. Taylor Grant/research support from: Celgene, Galapagos, Eli Lilly, UCB, Consultant for: abbVie, Galapagos, Gilead, Eli Lilly, Pfizer inc, Valderilio F azevedo Grant/research support from: abbVie, GSK, Janssen, Merck Serono, Novartis, Pfizer inc, UCB, Consultant for: abbVie, GSK, Janssen, Merck Serono, Novartis, Pfizer inc, UCB, Lara Fallon Shareholder of: Pfizer inc, Employee of: Pfizer inc, anna Maniccia Shareholder of: Pfizer inc, Employee of: Pfizer inc, John Woolcott Shareholder of: Pfizer inc, Employee of: Pfizer inc

Background:Assessment of SpondyloArthritis international Society (ASAS) response criteria and AS Disease Activity Score (ASDAS) are both commonly used, rigorous composite indices consisting of components with relevance to patients. Clinically meaningful thresholds for these measures have been defined to reflect partial remission (PR), inactive disease (ID), and low disease activity (LDA).Objectives:To study the association of ASAS PR and ordinal ASDAS disease categories (including ASDAS ID, which is the most stringent category of this composite score) in upadacitinib (UPA)-treated patients with AS.Methods:In the SELECT-AXIS 1 (NCT03178487) study, biologic DMARD naïve-patients (pts; ≥18 y) with active AS and intolerance/contraindication or inadequate response to ≥2 NSAIDs were randomized 1:1 to UPA 15 mg once daily (QD) or placebo (PBO).1 At wk 14, pts entered an open-label extension (OLE) of UPA 15 mg QD; pts randomized to PBO were switched to UPA. This post hoc analysis assessed the responsiveness of individual ASAS and ASDAS core components among pts who achieved ASAS PR. The association of ASAS PR with achievement of ASDAS ID (ASDAS Results:At wk 14, for the continuous UPA group, 16 pts (19%) achieved ASAS PR. At wk 32, following 18 wks of UPA exposure for the PBO-to-UPA group, 28 pts (33%) achieved ASAS PR. Among both groups (continuous UPA and PBO-to-UPA), improvements were seen across all core components (Figure 1). Of the 44 total pts who achieved ASAS PR, 91% achieved either ASDAS ID or LDA. The majority of patients who achieved ASAS PR achieved ASDAS ID in the continuous UPA and PBO-to-UPA groups: 11/16 (69%) and 16/28 (57%), respectively. For the continuous UPA group, the remaining 5 pts who achieved ASAS PR also achieved ASDAS LDA (Table 1). ASAS PR was associated with ASDAS categories in the following manner: the highest rate of ASAS PR was achieved for ASDAS ID followed by ASDAS LDA followed by ASDAS HDA/VHDA. The cutoff of 1.3 (the upper threshold for ASDAS ID) was a better discrimination threshold for ASAS PR than the cutoff of 2.1 (the upper threshold for ASDAS LDA).Conclusion:Nineteen percent of pts receiving UPA from BL achieved ASAS PR after 14 wks of treatment, with similar results seen in pts who were originally randomized to PBO and switched to UPA at wk 14. A consistent improvement was seen across all core components of ASAS among those who achieved ASAS PR with UPA treatment. The achievement of ASAS PR was most closely associated with the achievement of ASDAS ID, providing further clarity on the reduction of disease activity in AS pts treated with UPA.References:[1]van der Heijde, et al. Lancet. 2019;394(10214):2108-2117.Table 1.Association Between ASAS PR and ASDAS Clinical Thresholds (ID/LDA/HDA or VHDA)ASDAS ID(ASDAS LDA(1.3 to ASDAS HDA or VHDA(≥2.1)Continuous UPA Groupn=15n=31n=39 ASAS PR Responders (n=16)1150 ASAS PR Non-responders (n=69)42639PBO to UPA Groupn=25n=35n=25 ASAS PR Responders (n=28)1684 ASAS PR Non-responders (n=57)92721PP-value calculated from Cochran-Armitage trend test for association of ordinal categories.ASAS, Assessment of SpondyloArthritis international Society response criteria; ASDAS, AS Disease Activity Score; HDA, high disease activity; ID, inactive disease; LDA, low disease activity; PBO, placebo; PR, partial remission; UPA, upadacitinib; VHDA, very high disease activity.Acknowledgements:AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by J Urbanik of AbbVie and M Hovenden and J Matsuura of Complete Publication Solutions, LLC (funded by AbbVie).Disclosure of Interests:Atul Deodhar Speakers bureau: Novartis and Pfizer, Consultant of: Novartis, Pfizer, AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Galapagos, Janssen, Boehringer Ingelheim and Celgene, Amgen., Grant/research support from: AbbVie, Eli Lilly, UCB Pharma, GlaxoSmithKline, Andrew Ostor Consultant of: AbbVie, BMS, Roche, Janssen, Lilly, Novartis, Pfizer, UCB, Gilead, and Paradigm, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Fabiana Ganz Shareholder of: AbbVie, Employee of: AbbVie, Tianming Gao Shareholder of: AbbVie, Employee of: AbbVie, Alvina Chu Shareholder of: AbbVie, Employee of: AbbVie, Denis Poddubnyy Speakers bureau: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Gilead, GSK, Lilly, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Lilly, MSD, Novartis, and Pfizer

Background:While some risk factors for severe COVID have been identified for patients with rheumatic diseases,1 few studies have investigated whether outcomes differ based on the type of rheumatoid arthritis (RA) treatment. Most existing reports have been limited to individual centers or voluntary reporting registries.2,3Objectives:To compare the occurrence of hospitalizations following COVID-19 diagnosis among patients with RA treated with various classes of DMARDs.Methods:A cohort of patients with confirmed COVID-19 (ICD10 diagnosis code or positive PCR or antigen test result) were identified within a large US electronic health record (EHR) dataset (Optum, Inc.) during the time period Feb 1, 2020 through Oct 14, 2020. From these, we identified RA patients (ICD10 RA diagnosis code) with treatment (most recent of JAK inhibitor [JAKi], biologic [bDMARD] or conventional synthetic [csDMARD] only) within the 12 months prior to COVID-19 diagnosis (i.e., index). The primary outcome was any hospitalization on or within 30 days after COVID-19 diagnosis. Multivariable logistic regression models compared users of JAKi’s to non-TNFi bDMARDs and csDMARDs (separately), as well as users of TNFi’s to non-TNFi bDMARDS and csDMARDs (separately), and were adjusted for age, gender, index month and baseline corticosteroid use. Sensitivity analyses included restriction of prevalent treatment use to within 180 days prior to COVID-19 diagnosis and restriction of csDMARDs to a group without hydroxychloroquine or chloroquine.Results:The study included 910 RA patients on DMARD treatment who were diagnosed with COVID-19 (mean age ± SD: 61±15, 80% female, 62% white. Of those, 26% (n=240) were hospitalized on or within 30 days after COVID-19 diagnosis. The proportion of patients hospitalized was highest in non-TNFi bDMARD users (37/87; 43%), followed by csDMARDs users (161/581; 28%) and lowest in JAKi (13/68; 19%) and TNFi users (29/174; 17%). In multivariable-adjusted models, no differences in risk of hospitalization were found comparing JAKi users to csDMARD users (aOR=0.71; 95% CI 0.37-1.36) or TNFi users to csDMARD users (aOR=0.67; 95%CI 0.43-1.06). Compared to non-TNFi bDMARD users, JAKi use and TNFi use was associated with reduced risk of hospitalization (JAKi aOR=0.32; 95%CI 0.14-0.71; TNFi aOR=0.34; 95%CI 0.18-0.62). Age and corticosteroid use were positively associated with 30-day hospitalization in all models. Results of sensitivity analyses were consistent with the main findings.Conclusion:In this study, roughly a quarter of RA patients with recent DMARD treatment were hospitalized within 30 days after COVID diagnosis. Patients treated with JAKi and TNFi therapies experienced the lowest risk of hospitalization, with risk of hospitalization significantly lower than non-TNFi bDMARDs. However, recent therapy recorded in the EHR may not reflect exposure at time of COVID-19 diagnosis and small sample size per treatment may limit interpretation.References:[1]Hyrich KL, Machado PM. Nat Rev Rheumatol 2020;1-2. doi:10.1038/s41584-020-00562-2[2]Gianfrancesco MA, et al. Lancet Rheumatol 2020;2(5):e250-e253. doi:10.1016/S2665-9913(20)30095-3[3]Veenstra J, et al. J Am Acad Dermatol 2020;83(6):1696-1703.Acknowledgements:Jonathan Johnson of Optum, Inc. provided dataset guidance and conducted data analyses. AbbVie funded this study, contributed to its design, participated in data collection, analysis, and interpretation of the data, and in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship.Disclosure of Interests:Lani Wegrzyn Shareholder of: AbbVie, Employee of: AbbVie, Kevin Winthrop Consultant of: Pfizer, AbbVie, UCB, Eli Lilly & Company, Galapagos, GSK, Roche, Gilead, BMS, Regeneron, Sanofi, AstraZeneca, Novartis, Grant/research support from: BMS, Pfizer, Seoyoung Kim Grant/research support from: institutional research grants from Pfizer, AbbVie, Roche, BMS for unrelated studies, Yizhou Ye Shareholder of: AbbVie, Employee of: AbbVie, Carrie Huisingh Shareholder of: AbbVie, Employee of: AbbVie, Whitney Krueger Shareholder of: AbbVie, Employee of: AbbVie, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Ryan Kilpatrick Shareholder of: AbbVie, Employee of: AbbVie.

Background:Upadacitinib (UPA) has demonstrated efficacy in randomized controlled trials1-3; however, few data are available from patients with rheumatoid arthritis (RA) who have been treated with UPA in real-world clinical practice.Objectives:Describe the characteristics and 6-month outcomes in patients with RA initiating UPA in a real-world setting.Methods:We identified adults with RA enrolled in the Corrona RA Registry through October 31, 2020 who initiated UPA during or after August 2019 and had a follow-up visit 6 (±3) months after initiation of UPA. Descriptive statistics were used to summarize characteristics in all patients initiating UPA who had a 6-month follow-up visit. Outcomes (CDAI, modified HAQ-DI, pain, and fatigue) were described at the 6-month visit for all UPA initiators regardless of UPA use at 6 months and for the subset of patients who continued UPA through the 6-month visit. Patients who discontinued UPA before the 6-month visit were considered non-responders for dichotomous variables and were assigned the value at the time of discontinuation for continuous variables. Mean change from baseline in continuous variables was analyzed with one-sample t tests or one-sample Wilcoxon rank sum tests. Minimum clinically important difference (MCID) in HAQ-DI is defined as an improvement of 0.22 units or more. MCID in CDAI is an improvement of at least 2, 7, and 13 units for patients in low, moderate and severe disease at initiation, respectively. MCID for 100-point VAS is an improvement of ≥10 points. Percentages of patients achieving MCID thresholds were calculated.Results:We identified 181 patients who initiated UPA and had a 6-month follow-up visit. Mean±SD age was 58.6±12.1 years, 81% were female. Patients had RA for a mean of 11.5±9.8 years. At UPA initiation, 45% of patients were on monotherapy. Prior use of one or more TNFi and JAKi was 79% and 52%, respectively. Seventy-two percent of patients (n=130) initiated UPA as the third or higher line of therapy. Mean CDAI was 18.7±11.6 and mean HAQ-DI was 1.1±0.8 at initiation. Based on CDAI (n=155), 29%, 52%, and 15% of patients had high, moderate, and low disease activity, respectively; 4.5% were in remission at initiation. At 6 months (n=158), 22%, 39%, and 28% had high, moderate, and low disease activity, respectively; 11% were in remission. Among 138 initiators with valid CDAI measures at initiation and 6 months, mean change in CDAI was –4.8±11.8, P=MCID in CDAI, HAQ-DI, pain, and fatigue were achieved in 36–44% of UPA initiators. Improvements were similar, but larger in the subset of patients (n=122) who continued UPA through the 6-month visit (Table 1).Conclusion:Among patients in the Corrona RA Registry, UPA is frequently started in those who failed multiple previous therapies. UPA initiators responded to therapy in the first 6 months with improvements in several disease activity measures including CDAI and HAQ-DI, as well as patient-reported pain and fatigue.References:[1]Fleischmann R. Arthritis Rheumatol. 2019;71:1788–800.[2]Smolen JS. Lancet. 2019;393:2303–11.[3]Burmester GR. Lancet. 2018;382:2505–12.Outcomes at 6-month follow-upAll initiators(n=181)Subset remainingon UPA (n=122)nValueanValueaRemission (CDAI 15818 (11)10512 (11)Low (CDAI >=2.8 and 15844 (28)10538 (36)Moderate (CDAI >=10 and 15862 (39)10536 (34)High (CDAI >=22)15834 (22)10519 (18)Improvement in any CDAI category13854 (39)8940 (45)Maintenance of CDAI category13863 (46)10539 (44)Mean change in CDAI138–4.8±11.8*89–7.1±12.0* HAQ-DI154–0.1±0.5*101–0.2±0.5* Pain154–9.3±25.1*101–13.5±25.8* Fatigue153–7.6±27.3*100–12.5±27.5*MCID achievement in CDAI13857 (41)8943 (48) HAQ-DI15455 (36)10139 (39) Pain15468 (44)10153 (52) Fatigue15365 (42)10049 (49)aMean±SD or n (%).*PAcknowledgements:This study was sponsored by Corrona, LLC. Corrona has been supported through contracted subscriptions in the last 2 years by AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Crescendo, Eli Lilly and Company, Genentech, Gilead, GSK, Janssen, Merck, Momenta Pharmaceuticals, Novartis, Pfizer, Regeneron, Roche, Sun, UCB, and Valeant. The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. No honoraria or payments were made for authorship.Medical writing services were provided by Joann Hettasch of Fishawack Facilitate Ltd., part of Fishawack Health, and funded by AbbVie.Disclosure of Interests:Joel M Kremer Shareholder of: Corrona, Consultant of: AbbVie, Grant/research support from: AbbVie, Employee of: Corrona, Namita Tundia Shareholder of: AbbVie, Employee of: AbbVie, Robert McLean Employee of: Corrona, Taylor Blachley Employee of: Corrona, anna maniccia Shareholder of: AbbVie, Employee of: AbbVie, Dimitrios A Pappas Shareholder of: Corrona, Consultant of: AbbVie, Genentech, Novartis, Regeneron, and Roche Hellas, Employee of: Corrona

Background In order to better understand the perspectives of patients and physicians regarding the treatment and management of rheumatoid arthritis (RA), we present and compare results from a patient-based and a physician-based survey developed by the RA NarRAtive advisory panel. Methods The RA NarRAtive initiative is directed by a global advisory panel of 39 healthcare providers and patient organization leaders from 17 countries. A survey of patients self-reporting a diagnosis of RA and a physician-based survey, designed by the advisory panel, were fielded online by Harris Poll from September 2014 to April 2016, and from August 2015 to October 2015, respectively. Results We present findings from 1805 patients whose RA was primarily managed by a rheumatologist, and 1736 physicians managing patients with RA. Results confirmed that RA carries a substantial disease burden; half of the patients surveyed reported stopping participation in certain activities as a result of their disease. While 90% of physicians were satisfied with their communications with their patients regarding RA treatment, 61% of patients felt uncomfortable raising concerns or fears with their physician. Of the patients providing responses, 52% felt that improved dialogue/discussion would optimize their RA management, and 68% of physicians wished that they and their patients talked more about their RA goals and treatment. Overall, 88% of physicians agreed that patients involved in making treatment decisions tend to be more satisfied with their treatment experience. Conclusion The results of these surveys highlight the impact of RA on patients, and a discrepancy between patient and physician views on communication. Further research, focused on improving patient–physician dialogue, shared goal-setting, and treatment planning, is needed. Electronic supplementary material The online version of this article (10.1186/s12955-018-1035-3) contains supplementary material, which is available to authorized users.

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA), which has also been evaluated in other inflammatory rheumatic diseases (IRD) including ankylosing spondylitis (AS). Pain contributes substantial morbidity in patients (pts) with IRD and directly impacts treatment adherence, assessment of disease improvement and health-related quality of life. Objectives: To evaluate the effectiveness of tofacitinib in reducing pain in randomised controlled clinical trials in pts with RA, PsA and AS. Methods: Five pt populations treated with tofacitinib 5 mg twice daily (BID), 10 mg BID or placebo (PBO) were evaluated: [1] conventional synthetic disease-modifying antirheumatic drug (csDMARD)-inadequate response (IR) RA pts pooled from ORAL Scan (NCT00847613), ORAL Sync (NCT00856544) and ORAL Standard (NCT00853385), [2] tumour necrosis factor inhibitor (TNFi)-IR RA pts from ORAL Step (NCT00960440), [3] csDMARD-IR PsA pts from OPAL Broaden (NCT01877668), [4] TNFi-IR PsA pts from OPAL Beyond (NCT01882439) and [5] AS pts from a Phase 2 study (NCT01786668). Pain outcomes evaluated from baseline to Month (M)6 (Week [W]12 in the AS population) included Pt’s Assessment of Arthritis Pain (PAAP) (RA and PsA populations only), Short-Form Health Survey (SF)-36v2 Q7 (bodily pain in the past week), SF-36v2 Bodily Pain Domain (BP), EuroQol Five Dimensions Questionnaire Pain/Discomfort Domain (EQ-5D PD; all populations) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 (level of AS neck, back or hip pain) and Q3 (other pain) score (PsA and AS populations only; PsA pts had presence of spondylitis at screening and baseline BASDAI total score >0 in the full analysis set [FAS]). Data were analysed descriptively. Results: The csDMARD-IR RA, TNFi-IR RA, csDMARD-IR PsA, TNFi-IR PsA and AS populations comprised a total of 2066, 399, 316, 394 and 155 pts in the FAS, respectively. In each RA or PsA csDMARD-IR and TNFi-IR population treated with tofacitinib, mean PAAP at baseline (5 mg BID, range 55.7–65.7 mm; 10 mg BID, 54.4–60.1 mm) decreased as early as W2 (1st post-baseline assessment; 45.8–49.8 mm; 38.9–44.8 mm) and continued to decrease through M6 (30.9–34.4 mm; 28.2–36.7 mm); decreases were numerically greater vs PBO and the magnitude of change in RA and PsA populations was similar (Table). Improvements in SF-36v2 Q7 (Table), SF-36v2 BP (Table) and EQ-5D PD were observed in all 4 RA and PsA csDMARD-IR and TNFi-IR populations, and in BASDAI Q2 and Q3 in the csDMARD-IR PsA and TNFi-IR PsA populations. In the AS population, improvements from baseline in mean SF-36v2 Q7 (Table), SF-36v2 BP (Table), EQ-5D PD and BASDAI Q2 were reported at W12 and were numerically greater vs PBO. Conclusions: Treatment with tofacitinib is associated with a rapid improvement and sustained reduction of pain in pts with RA and PsA who are csDMARD-IR or TNFi-IR, and in pts with AS. Acknowledgements: Study sponsored by Pfizer Inc. Medical writing support was provided by P Scutt of CMC and funded by Pfizer Inc. Disclosure of Interest: A. Ogdie Grant/research support from: Novartis, Consultant for: Novartis, Pfizer Inc, Takeda, K. de Vlam Consultant for: Eli Lilly, Pfizer Inc, I. McInnes Grant/research support from: Celgene, Janssen, Novartis, Pfizer Inc, Roche, UCB, Consultant for: AbbVie, Celgene, Janssen, Novartis, Pfizer Inc, Roche, UCB, P. Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer Inc, Sun, UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer Inc, Sun, UCB, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer Inc, UCB, P. Baer Consultant for: AbbVie, Amgen, Janssen, Johnson and Johnson, Lilly, Novartis, Paladin, Pfizer Inc, Sanofi-Genzyme, Takeda, Speakers bureau: Amgen, Janssen, Lifelass, Pfizer Inc, T. Lukic Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, K. Kwok Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, C. Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, M.-A. Hsu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, A. Maniccia Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

We have developed an innovative lighting system prototype for a patient room application that integrates a multi-channel luminaire platform into indoor general area luminaires. This system is energy efficient, spectrally tunable, and supports the visual and nonvisual needs of occupants. We evaluated the performance of two separate multichannel platforms in different luminaire types, using a unique color-processing algorithm. The LED modeling and simulations enabled optimization of spectral power distributions, color, light output, and efficacy. This paper discusses the complicated results of SPDs developed for the patient room application, especially how they are effective for positively supporting the human visual and non-visual (circadian) systems. Additionally, application measurements demonstrate the large impact of the application space on the resulting SPD of a luminaire, calling into question the feasibility of using traditional field measurements to validate luminaire performance.

Objective Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. This post hoc analysis evaluated patients receiving tofacitinib monotherapy or combination therapy, as well as those who switched from monotherapy to combination therapy (mono→combo) or vice versa (combo→mono) in long-term extension (LTE) studies. Methods Data were pooled from open-label LTE studies (ORAL Sequel (NCT00413699; ongoing; data collected 14 January 2016) and NCT00661661) involving patients who participated in qualifying index studies. Efficacy outcomes included American College of Rheumatology 20/50/70 rates, change from baseline in Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28-4(ESR)), Clinical Disease Activity Index (CDAI) and Health Assessment Questionnaire-Disability Index and DAS28-4(ESR) and CDAI low disease activity and remission. Safety was evaluated over 96 months. Results Of the 4967 patients treated, 35.4% initiated tofacitinib monotherapy, 64.6% initiated combination therapy, 2.6% were mono→combo switchers and 7.1% were combo→mono switchers. Patients who switched multiple times were excluded. Of those who initiated monotherapy and combination therapy, 87.8% (1543/1757) and 82.0% (2631/3210), respectively, remained on the same regimen throughout the study; efficacy was maintained. Incidence rates (IRs) for serious adverse events with tofacitinib 5 mg and 10 mg twice daily, respectively, were 9.42 and 8.41 with monotherapy and 8.36 and 10.75 with combination therapy; IRs for discontinuations due to AEs were 7.13 and 6.06 with monotherapy and 7.82 and 8.06 with combination therapy (overlapping CIs). For mono→combo and combo→mono switchers, discontinuations due to AEs were experienced by 0.8% and 0.9%, respectively, within 30 days of switching. Conclusion Tofacitinib efficacy as monotherapy or combination therapy was maintained through month 48 and sustained to month 72, with minimal switching of treatment regimens. Safety was consistent over 96 months. Clinical trial registration NCT00413699 (Pre-results) and NCT00661661 (Results).

Rationale, aims and objectives Unprecedented national and state initiatives are underway to promote adoption and meaningful use of electronic health records (EHRs) with health information exchange (HIE). New York State leads the nation in state initiatives and is conducting ongoing surveillance of its investments. Lessons learned from studying states like New York can inform federal policies and will be essential to evaluate the effectiveness of these initiatives. We undertook this first in a series of planned surveys to assess EHR adoption and HIE activities by New York State hospitals. Methods Between May and December 2009, we surveyed all New York State hospitals to determine rates of EHR adoption, participation in HIE and implementation of functionalities associated with nine core meaningful use criteria. Results We received responses from 148 (72.2%) of 205 hospitals surveyed and found that 23 (15.5%) had adopted an EHR and 29 (23.2%) were participating in HIE. Two hospitals (1.4%) reported full implementation of the meaningful use functionalities surveyed. Public hospitals were ahead of private hospitals and notable regional differences were found. Discussion EHR adoption rates and participation in HIE are higher among New York hospitals than hospitals nationwide, suggesting that state initiatives funding community EHR implementation may influence these efforts by hospitals. However, overall rates of adoption and preparedness to meet meaningful use remain low. Direct support for hospitals, such as that provided through the national EHR Incentive Program, will likely be critical for rates of EHR adoption and HIE to significantly rise, even in advanced states.

(2001). The Effects of Changing Occupancy Sensor Time-out Setting on Energy Savings, Lamp Cycling and Maintenance Costs. Journal of the Illuminating Engineering Society: Vol. 30, No. 2, pp. 97-110.

(1999). Occupant Use of Manual Lighting Controls in Private Offices. Journal of the Illuminating Engineering Society: Vol. 28, No. 2, pp. 42-56.

Background Treatment options delivering sustained efficacy when given as monotherapy in RA are limited. 1 Tofacitinib is an oral JAK inhibitor for the treatment of RA. Tofacitinib monotherapy demonstrated efficacy in adult patients (pts) with RA in two Phase (P) 3 index studies (ORAL Solo 2 and ORAL Start 3 ). Objectives To present data through Month 84 for safety and Month 60 for efficacy for pts who stayed on tofacitinib monotherapy in long-term extension (LTE) studies. Methods Data were pooled from two tofacitinib LTE studies (NCT00413699 [ongoing; database unlocked as of Mar 2015 data cut-off] and NCT00661661 [completed; Apr 2014]). Pts from P 1/2/3 tofacitinib index studies received tofacitinib 5 or 10 mg twice daily (BID) as monotherapy or with background conventional synthetic DMARDs in LTE. For tofacitinib and permitted concomitant RA medications, dose adjustments were allowed for inadequate efficacy or for safety reasons. In this analysis, pts were assigned to tofacitinib 5 or 10 mg BID groups based on average total daily dose in LTE ( Results 1750 pts initiated LTE on tofacitinib monotherapy; 1552 (89%) stayed on monotherapy throughout LTE (495 on 5 mg BID; 1057 on 10 mg BID). For pts staying on monotherapy, mean (max) treatment duration was 1248 (2892) and 1011 (2377) days for 5 and 10 mg BID, respectively. Efficacy responses for tofacitinib monotherapy were stable through Month 60 (Table 1). In the 5 and 10 mg groups, 66% and 82% of pts, respectively, stayed on initial dose throughout LTE. The proportion of pts staying on steroids decreased from 56% to 40% and 41% to 35%, in the 5 and 10 mg groups respectively, from baseline to Month 60. Rates of discontinuation due to lack of efficacy and adverse events (AEs), and of serious infection and malignancy (excluding non-melanoma skin cancer) were low (Table 1). Conclusions In this analysis of pts receiving tofacitinib monotherapy in the LTE studies, nearly 90% of pts stayed on monotherapy, most did not have tofacitinib dose adjustments or add a DMARD and efficacy was sustained over 60 months, with low rates of discontinuation due to lack of efficacy or AEs. Safety was consistent with what has been reported previously. References Smolen JS et al. Ann Rheum Dis 2014; 73: 492–509. Fleischmann R et al. N Engl J Med 2012; 367: 495–507. Lee EB et al. N Engl J Med 2014; 370: 2377–2386. Acknowledgement Previously presented (Fleischmann R et al. Arthritis Rheumatol. 2015; 67 (S10): Abstr 1639) and reproduced with permission from Arthritis Rheumatol. This study was funded by Pfizer Inc. Editorial support was provided by S Johnson, PhD, of Complete Medical Communications and funded by Pfizer Inc. Disclosure of Interest R. Fleischmann Grant/research support from: Pfizer Inc, J. Wollenhaupt Consultant for: Pfizer Inc, Speakers bureau: Pfizer Inc, L. Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, A. Maniccia Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, K. Kwok Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, L. Takiya Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, R. van Vollenhoven Grant/research support from: Pfizer Inc, Consultant for: Pfizer Inc

Background Rheumatoid arthritis (RA) is a chronic, debilitating disease for which there is no cure. Objectives To identify and better understand the perspective of patients (pts) regarding pt/healthcare provider (HCP) interactions, RA treatment and RA management, based on results from a pt-based survey developed by the RA NarRAtive global advisory panel. Methods The RA NarRAtive initiative comprises an advisory panel of 39 RA experts (including rheumatologists and pt advocacy group leaders [many with RA themselves]) from 17 countries. A pt-based survey designed by the working group was fielded online across 13 countries between Sept 2014 and Jan 2015. Results are presented for all respondents who consented to the survey. Results Total of 3649 pts responded to the survey: mean age 52.8 yrs (SD ±15), 59% female. Median time since diagnosis of RA (pt-reported) was 7 yrs. Only 34% of pts (n=1251) described their current overall health as excellent/good. Respondents represented a wide spectrum of self-reported disease activity from mild (39%) to moderate to severe (30%) to severe (8%). Overall, 93% and 50% of pts were under the care of an HCP or rheumatologist/RA specialist, respectively. In total, 59% (2139) of pts were receiving prescribed RA medication, including pain relievers (70%), disease-modifying antirheumatic drugs (DMARDs) (38%), steroids/corticosteroids (32%), and biologic DMARDs (16%). Of these, 38% were not taking their medication as prescribed. Overall, 78% of pts currently taking RA medication were satisfied with their treatment regimen, however 70% desired fewer medications, 57% were worried their medications would fail and 56% wanted more medication choices. The number or dosing frequency of medications was the most frequently cited aspect that pts would most like to change with respect to their current prescribed medications (Figure). Almost half of pts under HCP care (48%) acknowledged that dialogue with the HCP would optimise management of their RA. However, 62% of respondents felt uncomfortable raising treatment/disease concerns to their HCP. Of those currently seeing an HCP to manage their RA, 34% strongly/somewhat agreed that if they ask too many questions, their HCP will consider them a difficult pt and this may affect the quality of care they receive. The current treatment goal for physicians is to achieve clinical remission or low disease activity.1 However, successful treatment was most commonly defined by pts as a reduction of pain and/or joint swelling/inflammation (81%) and improvements in quality of life (77%). Conclusions This pt-based survey highlights the importance of treatment conversations between pts and HCPs. Although many pts are satisfied with their RA treatment, non-adherence persists and many would like to discuss and/or change their currently prescribed treatment. Further understanding the responses from this survey will be important to facilitate communication between pts and HCPs, with the aim of improving treatment outcomes. References Smolen JS et al. Ann Rheum Dis 2015; 75: 3–15. Acknowledgement These surveys were funded by Pfizer Inc. Editorial support was provided by S Johnson, PhD, of Complete Medical Communications, and funded by Pfizer Inc. Disclosure of Interest C. Koehn Shareholder of: Arthritis Consumer Experts, Grant/research support from: Canadian Institutes of Health Research, Arthritis Research Canada, St. Paul9s Hospital, Employee of: Arthritis Consumer Experts, A. Dikranian Consultant for: Pfizer Inc, AbbVie, Speakers bureau: Pfizer Inc, AbbVie, A. Maniccia Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, E. Bananis Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

Background RA is a chronic, debilitating condition for which there is no cure. Objectives To identify and better understand the perspectives of both healthcare providers (HCPs) and patients (pts) regarding RA treatment and management, using data from an HCP- and a pt-based survey, developed by the RA NarRAtive global advisory panel. Methods The RA NarRAtive initiative comprises an advisory panel of 39 RA experts from 17 countries. An HCP-based (16 countries) and a pt-based survey (15 countries), designed by the working group, were fielded online between Aug-Oct 2015, and Sept 2014-Jan 2016, respectively. Results are presented from pts treated by a rheumatologist. All respondents are from the same 15 countries. Results 3987 pts responded (1653 were currently managed by a rheumatologist): mean age 51.5 years (yrs), 64% female, median time since diagnosis 7 yrs; respondents represented a wide spectrum of disease activity: moderate to severe (30%; 501) and severe (11%; 176). In the HCP survey, 90% of respondents were satisfied with their communications with pts but 68% acknowledged, “I wish my pts and I talked more about goals and treatment”. In the pt survey, 53% of pts acknowledged that dialogue with the HCP would optimise the management of their RA. 61% of all respondents felt uncomfortable raising concerns or fears to their HCP. 93% of HCP respondents discuss quality of life (QoL) issues with their pts including impact of RA on ability to work, participation in activities and lifestyle goals. 86% discuss treatment-related issues including adherence to therapy, medication preferences and whether pts seek treatment from other HCPs. The most common topics that pts report worrying about (and HCPs believe their pts worry about) are similar but these factors were ranked differently between pts and HCPs: the number one factor for pts is the impact on QoL; the number one factor for HCPs is prescription side effects. HCPs and pts have similar views on what they would most like to change about currently available RA medications, ie severity and number of side effects, cost and efficacy. HCPs highlighted disease remission as a treatment goal; while pts more frequently referred to symptom reduction. Overall, 88% of HCPs agreed that pts involved in making treatment decisions tend to be more satisfied with their treatment experience; 74% felt that pts who are not involved are less likely to adhere to treatment. Setting treatment goals with pts and agreement on the treatment plan are considered important by 78% and 79% of HCPs, respectively, as is being able to have an open dialogue (86%). Conclusions Differences between treatment goals set by pts and HCPs were reported, highlighting the importance of an open pt-HCP dialogue in the successful management of RA. These findings could help improve adherence and pt satisfaction with their disease management. Acknowledgement These surveys were funded by Pfizer Inc. Editorial support was provided by S Johnson of CMC and funded by Pfizer Inc. Disclosure of Interest A. Dikranian Consultant for: Pfizer Inc, AbbVie, Speakers bureau: Pfizer Inc, AbbVie, J. Galloway Consultant for: Pfizer Inc, J. Kekow: None declared, C. A. Zerbini Grant/research support from: Pfizer Inc, Amgen, Sanofi, Novartis, Merck, Eli Lilly, GSK,Celltrion, Consultant for: Pfizer Inc, Eli Lilly, Sanofi, M. de la Vega Consultant for: Pfizer Inc, G. Lee Consultant for: Pfizer Inc, AbbVie, A. Maniccia Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, E. Bananis Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, D. Ponce de Leon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, A. Gibofsky Shareholder of: AbbVie, Amgen, BMS, GSK, J&J, Pfizer Inc, Consultant for: AbbVie, Antares, Celgene, Horizon, Iroko, Medac, Novartis, Pfizer Inc, Relburn, Samumed, Speakers bureau: AbbVie, Amgen, Celgene, Pfizer Inc

BACKGROUND: Screen time, especially television viewing, is associated with risk of overweight and obesity in children. Although several interventions have been developed to reduce children's screen time, no systematic review of these interventions exists to date. OBJECTIVE: This is a systematic review and meta-analysis of interventions targeting a reduction in children's screen time. METHODS: Effect sizes and associated 95% confidence intervals (CIs) were calculated by using a random-effects model. Heterogeneity tests, moderator analyses, assessment of bias, and sensitivity analyses were conducted. Reliability was assessed with Cohen's κ. RESULTS: The systematic search identified 3002 documents; 33 were eligible for inclusion, and 29 were included in analyses. Most reported preintervention and postintervention data and were published in peer-reviewed journals. Although heterogeneity was present, no moderators were identified. Overall Hedges g (−0.144 [95% CI: −0.217 to −0.072]) and standard mean difference (SMD) (−0.148 [95% CI: −0.224 to −0.071]) indicated that interventions were linked with small but statistically significant reductions in screen time in children. The results were robust; the failsafe N was large, and the funnel plot and trim-and-fill methods identified few missing studies. CONCLUSIONS: Results show that interventions to reduce children's screen time have a small but statistically significant effect. As the evidence base expands, and the number of screen-time interventions increases, future research can expand on these findings by examining the clinical relevance and sustainability of effects, conducting a more thorough analysis of effect modifiers, and identifying critical components of effective interventions.

This article describes lessons learned by the University at Albany Center for Public Health Preparedness (UA-CPHP) in using three technologies to deliver preparedness training for public health professionals in New York State. These three technologies are: Audience response system (ARS, or the “clicker” system)—Purchased to improve engagement of all participants in heterogeneous training audiences, it also markedly reduces staff time while improving training evaluation (cost: $4,500). Satellite broadcast programs—UA-CPHP produced more than 50 broadcasts, which remain available as videostreams and/or podcasts. Viewership of archived programs sometimes surpasses that of the live event (cost estimate: $23,000 to $39,000). Interactive online courses—Seventeen courses have registered more than 44,000 learners worldwide. The Pandemic Influenza course alone has reached more than 16,000 registrants from all 50 U.S. states and at least 56 other countries (cost estimate: $30,000 to $65,000). UA-CPHP's experience as a preparedness training center has confirmed that contemporary technology can be employed to improve and increase the reach of these training efforts. An additional finding was that, quite unintentionally, the intensive use of distance-based educational modalities designed to reach public health practitioners in New York State has afforded UA-CPHP a substantial national and international audience as well, and at no additional cost.

The Energy Policy Act of 1992 (EPACT) requires that manufacturers stop manufacturing and distributing some very commonly used fluorescent and incandescent lamps after October 31, 1995. Consequentially, when end users are faced with replacing standard reflector (R) and parabolic aluminized reflector (PAR) lamps, their alternatives will be limited to those that comply with EPACT. Confusion is likely to occur when users try to understand how the available alternatives would perform compared with the original lamp. This paper discusses a research study that was conducted to evaluate manufacturer-recommended equivalents for 150 Watt PAR38 flood and spot lamps, and 75 Watt R30 flood and spot base case lamps. The photometric performance and visual beam distribution of 58 lamp types from seven manufacturers, a total of 211 lamps, were evaluated. The results indicate that halogen and krypton-filled equivalents performed as well as, or better than, the base case lamps. Compact fluorescent reflector lamps, however, did not perform as well. The evaluations identified seven categories of beam distributions that represent the beam distributions of the base case lamps and their equivalents. Most of the base case lamps had smooth beam distributions; however, many of the recommended replacements did not. >

Progesterone and 17 beta-estradiol peripheral plasma levels have been determined during labor and after 1, 3, 6, 12, 24, 48, 72, 96, 120 and 144 h from delivery in a group of 7 women, whose corpus luteum had been removed at delivery and in a corresponding control group with intact corpus luteum. In both groups the results indicate a progressive fall of progesterone and 17 beta-estradiol, that is evident until 144 h for progesterone and 72 h from 17 beta-estradiol. The analysis of the two groups with the Student's t test has shown significantly lower levels in the group of women, whose corpus luteum had been removed, at the 6th h (p less than 0.01), 12th h (p less than 0.02) and 24th h (p less than 0.05) for progesterone and at 3rd h (p less than 0.01) and 6th (p less than 0.01) for 17 beta-estradiol. The significant difference for progesterone appearing later than for 17 beta-estradiol could be due to the fact that progesterone is also dismissed by the adipose tissue, where it is stored. A further statistical elaboration of the results, carried out by calculating the regression line and the transfer function, confirmed the different pattern in time of progesterone and 17 beta-estradiol plasma levels after delivery in the two groups of patients considered.

Ovarian and peripheral plasma concentrations of oestrone (E1), oestradiol (E2), androstenedione (A), testosterone (T), progesterone (P) and 17 alpha-hydroxy-progesterone (17 alpha OH-P) were assayed in 20 healthy post-menopausal women undergoing hysterectomy because of uterine fibromatosis. Significant differences were found between the ovarian and peripheral levels of E1 (P less than 0.01), E2 (P less than 0.001), A (P less than 0.01), T (P less than 0.001) and P (P less than 0.001). Analysis of the possible relationships between peripheral and ovarian levels of the six steroids considered and the patients' clinical characteristics revealed a positive correlation in only three cases, viz. between body weight and peripheral levels of E1 and E2, between E1 and E2 peripheral levels and between body weight and the E1/A ratio. The ovarian-peripheral gradient was calculated for each patient and was considered significant only if the ovarian peripheral difference exceeded the sum of each concentration multiplied by twice the maximal coefficient of variation of the assays used (12%). This gradient was significant in 75% of patients for T, in 45% for A, in 35% for E2, in 25% for E1, in 35% for P and in 30% for 17 17 alpha OH-P. Our findings confirm that circulating oestrogens in post-menopausal women originate mainly from the peripheral conversion of ovarian and adrenal androgens and that the ovary still continues to produce androgens. They also provide evidence that the ovary, at least in some post-menopausal subjects, can be a potential source of oestrogens and progestogens.

Twenty-four evaluable patients with recurrent carcinoma of the cervix after previous pelvic irradiation were treated with cis-diamminedichloroplatinum II (cis-DDP). Of the 14 patients who received low-dose (1 mg/kg) weekly induction cis-DDP, 10 (71%) responded, 6 (43%) of which were complete responses. Four (40%) of the ten patients who received high-dose (100 mg/m2) monthly cis-DDP responded, two of which were complete responses. Maintenance of these responses by combination chemotherapy which includes cis-DDP remains a significant problem.

Ovarian and peripheral plasma levels of oestrone (E1), oestradiol (E2), androstenedione (A) and testosterone (T) were assayed in 58 post-menopausal women who underwent hysterectomy and oophorectomy (35 for endometrial carcinoma and 23 for benign gynaecological diseases). No significant difference between the two groups was seen when they were matched for percentage of ideal weight. However, significant differences were found between the ovarian and peripheral levels of the four steroids investigated. To facilitate analysis of the data, 40 of these women were classified into three groups (1, 2 and 3) according to degree of stromal hyperplasia of the ovary. Group 1 comprised those with atrophic ovaries, group 2 those with slight stromal hyperplasia and group 3 those with moderate or marked stromal hyperplasia. Ovarian levels of A and T were significantly higher than peripheral levels in all three groups, but the ovarian/peripheral oestrogen differences were significant only in groups 1 and 2. The ovarian steroid levels in group 3 were significantly higher than those in groups 1 and 2 in the cases of E1 (P less than 0.01), E2 (P less than 0.001) and A (P less than 0.001), but not in that of T. It was concluded that ovaries showing marked stromal hyperplasia can produce significant amounts not only of androgens but also of E2, and hence that any evaluation of the hormonal pattern in post-menopausal women must also take into account the microscopic characteristics of the ovary.