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  • 1
    In: Rheumatology, Oxford University Press (OUP), Vol. 60, No. Supplement_1 ( 2021-04-25)
    Abstract: Background/Aims  The objective of this analysis was to describe the upadacitinib (UPA) response rates of patients with psoriatic arthritis (PsA) enrolled in the SELECT-PsA-1 and SELECT-PsA-2 randomised controlled trials according to modified Psoriatic Arthritis Response Criteria (PsARC). The UK National Institute for Health and Care Excellence recommends assessing PsA treatment responses using PsARC (advanced therapy-specific time points: after weeks [W] 12, 16 or 24). Methods  PsARC responses were assessed from W2 through W24 post-initiation for patients enrolled in SELECT-PsA-1 (upadacitinib 15 mg once-daily [UPA-15mg], placebo and adalimumab 40 mg every other week [ADA] treatment arms) and SELECT-PsA-2 (UPA-15mg and placebo treatment arms). PsARC responses were derived from tender joint count 68 (TJC), swollen joint count 66 (SJC), patient global self-assessment (PtGA) and physician global assessment (PGA) and analysed using non-responder imputation. Results  UPA-15mg PsARC response rates increased progressively from W2 through to W12 in SELECT-PsA-1 (78.3%) and SELECT-PsA-2 (70.6%; see Table). Despite relatively high placebo response rates, UPA-15mg response rates were statistically significantly higher than placebo at all assessments between W2 and W24 in SELECT-PsA-1 and SELECT-PsA-2 and were statistically significantly higher than ADA from W20 (SELECT-PsA-1; see Table). Baseline characteristics (including sex, PsA duration, body mass index, tobacco use, body surface area ≥3%, enthesitis and dactylitis) were generally balanced between W24 PsARC responders and non-responders in each SELECT-PsA-1 and SELECT-PsA-2 treatment arm. Differences in PsARC response rates at W24 for UPA-15mg versus placebo (pooled SELECT-PsA-1 and SELECT-PsA-2 data) and versus ADA (SELECT-PsA-1) were similar in patients stratified by baseline characteristics and in patients receiving UPA-15mg monotherapy versus combination therapy. By W12, UPA-15mg response rates for individual PsARC components (SJC and TJC: ≥30% improvement; PtGA and PGA: ≥20% improvement) ranged between 77.6%-89.5% in SELECT-PsA-1 and between 70.1%-82.5% in SELECT-PsA-2. Conclusion  PsARC responses greater than placebo were seen as early as W2, with stable response rates from W12 in both SELECT-PsA-1 and SELECT-PsA-2. Statistically significantly higher response rates versus ADA were observed by W20. Differences in W24 PsARC responses versus placebo and versus ADA were generally consistent across baseline characteristics and UPA-15mg mono/combination therapy. P174 Table 1:Modified PsARC response rates at W2 to W24 in SELECT-PsA-1 and SELECT-PsA-2 trialsStudy and week of assessmentTreatment armResponse rate % (95% CI)Response rate difference % (95% CI) UPA-placeboResponse rate difference % (95% CI) UPA-ADASELECT-PsA-1W2Placebo (n = 423)27.2 (22.9-31.4)14.8 (8.5-21.1)*−2.3 (−9.0-4.3)ADA (n = 429)44.3 (39.6-49.0)UPA-15mg (n = 429)42.0 (37.3-46.6)W12Placebo (n = 423)54.6 (49.9-59.4)23.7 (17.6-29.9)*2.8 (−2.8-8.4)ADA (n = 429)75.5 (71.5-79.6)UPA-15mg (n = 429)78.3 (74.4-82.2)W16Placebo (n = 423)55.1 (50.3-59.8)24.4 (18.3-30.5)*1.9 (−3.6-7.4)ADA (n = 429)77.6 (73.7-81.6)UPA-15mg (n = 429)79.5 (75.7-83.3)W20Placebo (n = 423)62.4 (57.8-67.0)21.3 (15.5-27.1)*6.3 (1.0-11.6)*ADA (n = 429)77.4 (73.4-81.3)UPA-15mg (n = 429)83.7 (80.2-87.2)W24Placebo (n = 423)59.3 (54.7-64.0)24.3 (18.5-30.2)*7.0 (1.7-12.3)*ADA (n = 429)76.7 (72.7-80.7)UPA-15mg (n = 429)83.7 (80.2-87.2)SELECT-PsA-2W2Placebo (n = 212)25.5 (19.6-31.3)22.4 (13.5-31.3)*-UPA-15mg (n = 211)47.9 (41.1-54.6)W12Placebo (n = 212)36.3 (29.8-42.8)34.3 (25.4-43.2)*-UPA-15mg (n = 211)70.6 (64.5-76.8)W16Placebo (n = 212)34.4 (28.0-40.8)31.4 (22.4-40.5)*-UPA-15mg (n = 211)65.9 (59.5-72.3)W20Placebo (n = 212)41.5 (34.9-48.1)28.6 (19.6-37.7)*-UPA-15mg (n = 211)70.1 (64.0-76.3)W24Placebo (n = 212)36.3 (29.8-42.8)31.9 (22.9-40.9)*-UPA-15mg (n = 211)68.2 (62.0-74.5)SELECT-PsA-1: randomised controlled trial assessing the safety and efficacy of UPA versus placebo versus ADA in patients with PsA and prior inadequate response or intolerance to ≥ 1 non-biologic disease-modifying antirheumatic drug (DMARD).SELECT-PsA2: randomised controlled trial assessing the safety and efficacy of UPA versus placebo in patients with PsA and prior inadequate response or intolerance to ≥ 1 biologic DMARD.95% confidence intervals (95% CI) for response rates calculated based on normal approximation to the binomial distribution.95% CI for response rate difference based on normal approximation.*Statistically significant at 0.05 level; nominal p values constructed using Cochran-Mantel-Haenszel test adjusting for current disease-modifying antirheumatic drug use (yes/no). Disclosure  L.C. Coates: Consultancies; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. Honoraria; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. Member of speakers’ bureau; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. Grants/research support; AbbVie, Amgen, Boehringer-Ingelheim, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sun Pharma, and UCB. T. Garrood: Consultancies; AbbVie, Pfizer and Gilead. Honoraria; AbbVie, Pfizer and Gilead. Grants/research support; AbbVie, Pfizer and Gilead. N. Gullick: Consultancies; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis and UCB. Member of speakers’ bureau; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis and UCB. Grants/research support; AbbVie, Celgene, Eli Lilly, Izana, Janssen, Novartis and UCB. P. Helliwell: Consultancies; Eli Lilly. Other; fees for educational services from Pfizer, Novartis and Janssen. T. Kent: Corporate appointments; Employee of AbbVie. Shareholder/stock ownership; may own AbbVie stocks. J. Marks: Honoraria; AbbVie, Gilead, Novartis, Pfizer and UCB for participation in advisory boards and to support educational activities unrelated to the publication. W. Tillett: Consultancies; Lilly, Pfizer, AbbVie, Celgene, UCB, and Novartis. Honoraria; Lilly, Pfizer, AbbVie, Celgene, UCB, and Novartis. Member of speakers’ bureau; AbbVie, Janssen and Celgene. Grants/research support; Lilly, Pfizer, AbbVie, Celgene, UCB, and Novartis. D. Kaur-Papadakis: Corporate appointments; Employee of AbbVie. Shareholder/stock ownership; may own AbbVie stocks. H. Tahir: Consultancies; Fees for consultation or participation in advisory boards from AbbVie, Novartis, Pfizer, UCB, Eli-Lilly and Janssen. Other; Education Grants from Novartis and Pfizer. S. van Haaren: Corporate appointments; Employee of AbbVie. Shareholder/stock ownership; may own AbbVie stocks. I. McInnes: Honoraria; Bristol-Myers Squibb, Celgene, Eli Lilly and Company, AbbVie, Gilead, Janssen, Novartis, Pfizer, and UCB. Grants/research support; Bristol-Myers Squibb, Celgene, Eli Lilly and Company, AbbVie, Gilead, Janssen, Novartis, Pfizer, and UCB.
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 2
    In: Rheumatology, Oxford University Press (OUP), Vol. 62, No. 1 ( 2022-12-23), p. e1-e3
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 1464822-2
    detail.hit.zdb_id: 1474143-X
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  • 3
    In: The Lancet, Elsevier BV, Vol. 403, No. 10429 ( 2024-03), p. 838-849
    Type of Medium: Online Resource
    ISSN: 0140-6736
    RVK:
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
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  • 4
    Online Resource
    Online Resource
    Elsevier BV ; 2006
    In:  Trends in Immunology Vol. 27, No. 7 ( 2006-7), p. 299-302
    In: Trends in Immunology, Elsevier BV, Vol. 27, No. 7 ( 2006-7), p. 299-302
    Type of Medium: Online Resource
    ISSN: 1471-4906
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2006
    detail.hit.zdb_id: 2036831-8
    SSG: 12
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  • 5
    In: Rheumatology, Oxford University Press (OUP), Vol. 58, No. Supplement_3 ( 2019-04-01)
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
    detail.hit.zdb_id: 1464822-2
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  • 6
    In: Rheumatology, Oxford University Press (OUP), Vol. 59, No. Supplement_2 ( 2020-04-01)
    Abstract: Power Doppler ultrasound (PDUS) is superior to clinical examination in detecting synovitis in patients with rheumatoid arthritis (RA). Although dynamic and cheap it is impractical to scan large numbers of joints in routine clinical settings. MRI, whilst sensitive for synovitis, is expensive and routine use is limited to targeted joints. Bone scintigraphy produces whole body images but due to lower specificity is not routinely used. 99mTc-maraciclatide (Serac Healthcare) is a radio-labelled tracer which binds with high affinity to integrin αvβ3 (αvβ3), a cell-adhesion molecule up-regulated on neoangiogenic blood vessels. It therefore has the potential to image synovial inflammation at the whole-body level. We previously showed in a pilot study that uptake was seen in the inflamed joints of 5 RA patients and that this correlated with PDUS. This study explores correlation with PDUS in a larger group of patients with varied disease activities. Methods 50 patients with RA, fulfilling ACR 2010 classification criteria, were recruited. Patients underwent an ultrasound scan of 40 joints with grey scale (GS) and PD quantification. Each joint was scored on a scale of 0-3 for GS and PD with a total score calculated for each patient. Within 3 hours of the ultrasound, patients were injected with 740 MBq of 99mTc-maraciclatide. Using a gamma camera, whole body planar views and dedicated hand and foot views were taken 2 hours after injection. Acquisition time was 20 minutes for whole body, and 20 minutes for hand and foot views. 99mTc-maraciclatide images were scored as positive or negative uptake for each joint (binary score). A quantitative score was also calculated for each joint where there was uptake with this corrected for background muscle uptake. Total binary and quantitative scores per patient were calculated. Ultrasound and 99mTc-maraciclatide scores were tested for correlation with Pearson’s correlation coefficient (r) and the coefficient of determination (r2). Results Strong correlation was seen when total PDUS was compared to binary scores (r = 0.92, r2=0.85) and quantitative scores (r = 0.85, r2=0.72). p was & lt;0.0005 for all results. 99mTc-maraciclatide uptake was also seen in inflamed tendons/tendon sheaths. The imaging procedure was well-tolerated. Conclusion 99mTc-maraciclatide uptake was highly correlated with PDUS highlighting its potential as an alternative imaging modality. 99mTc-based planar imaging has the unique capacity to image the whole body and hence the total synovial inflammatory load in a quick acquisition. The imaging equipment to perform these scans is already widely available in radiology departments. Interpretation of scans is also much simpler compared to US/MRI. It could therefore have a role in key decision-making points in pathways for diagnosis, treatment failure, and remission prior to dose tapering. Disclosures L. Attipoe None. T. Garrood Grants/research support; Serac Healthcare. M. Opena None. C. Blanco-Gil None. S. Subesinghe None. S. Norton None. M. Rosser Other; Serac Healthcare Ltd. G. Cook None. A. Cope Grants/research support; AP received funding for research from BMS.
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 1464822-2
    detail.hit.zdb_id: 1474143-X
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  • 7
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2018
    In:  Rheumatology Vol. 57, No. suppl_3 ( 2018-04-01)
    In: Rheumatology, Oxford University Press (OUP), Vol. 57, No. suppl_3 ( 2018-04-01)
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
    detail.hit.zdb_id: 1464822-2
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  • 8
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2020
    In:  Rheumatology Vol. 59, No. Supplement_2 ( 2020-04-01)
    In: Rheumatology, Oxford University Press (OUP), Vol. 59, No. Supplement_2 ( 2020-04-01)
    Abstract: Patients with rheumatoid arthritis are generally seen at arbitrary intervals in secondary care. Patients with active disease may not always be seen at the most appropriate time and those with low disease activity may be seen more frequently than necessary. The NHS Long Term Plan expects outpatient appointments to be reduced by up to a third, with digital transformation a key enabler. The remote capture of patient-reported outcome measures (PROMs) has the potential to facilitate more flexible and responsive outpatient services. Methods This project aimed to design a digital remote monitoring platform to test the hypothesis that PROMs can be used to proactively monitor and trigger consultations when patients need them most. The Rheumatoid Arthritis Impact of Disease (RAID) questionnaire, a validated multidimensional PROM, was used. Waiting room testing with patients informed the design of an acceptable mobile device format of the RAID. Recruitment criteria and acceptable cut-offs for defining flare were agreed by the rheumatology multidisciplinary team. Patients in low disease activity or remission (DAS & lt;3.2) were invited to the service via SMS. All patients were informed regarding the governance of handling patient data and an opt-out option was offered. Patients were sent an automated monthly SMS with a PROM link and weekly reminder SMS if required. They also had the option to send in SMS messages at other times or add free text comments. Patients submitting a RAID score of ≥ 4 received a SMS with a link to the rheumatology advice service advising a remote consultation. The SMS-based service went live in January 2019 and all incoming communication was monitored on a daily basis. Results 104 RA patients are currently using the remote monitoring service with 10.3% (13/117) opting-out. 847 monthly PROMs have been sent via SMS. The PROM completion rate has been 68.9% (range 59.0-85.1%). 120 RAID (21.8%) scored 2-≤4 indicating low disease activity and 136 RAID (24.7%) ≤ 2 indicating disease remission. 480 SMS have been sent manually to patients who have engaged in two-way communication or returned a RAID score ≥4. 44 telephone advice appointments were triggered through the remote monitoring service by patients in disease flare. 80% (35/44) of remote consultation were considered to have to have averted a face to face consultation with the remaining 20% providing advice alone. Interviews have been conducted with PROM ‘non-completers’ to learn and inform further service design. Conclusion This project has demonstrated how a user-centred design approach to utilising technology can support access to rheumatology care when patients need it most, such as disease flare. The identification of patients self-reporting low disease activity using multidimensional PROMs may enable more efficient utilisation of clinical capacity through patient-initiated appointment deferment and lead to improved patient-centred care. Disclosures M.J. Martin: Honoraria; Novartis, Abbvie. Grants/research support; National Ankylosing Spondylitis Society. N. Ng None. L. Blackler None. T. Garrood None.
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 1464822-2
    detail.hit.zdb_id: 1474143-X
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  • 9
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2022
    In:  Rheumatology Vol. 61, No. Supplement_1 ( 2022-04-23)
    In: Rheumatology, Oxford University Press (OUP), Vol. 61, No. Supplement_1 ( 2022-04-23)
    Abstract: Depression and anxiety are more common in patients with rheumatic diseases and have been associated with higher levels of fatigue, pain and levels of physical disability. Although this has been described in distinct rheumatic conditions, the burden of psychological morbidity across the diseases presenting to rheumatology outpatients is not as well known. The prevalence of anxiety and depression in the UK was reported to be 5.9% and 3.3% respectively. Here, we report rates of depression and anxiety in a cross-section of new patients referred to rheumatology outpatients. Methods All new patients referred to a rheumatology outpatient clinic in London, UK for a 10-week period in February to May 2019 received a digital pre-appointment questionnaire which included Patient Health Questionnaire (PHQ8) and Generalised Anxiety Disorder Questionnaire (GAD7) questionnaire for detecting depression and anxiety respectively. A retrospective analysis was performed to assess the prevalence of significant depression and/or anxiety in various rheumatic diseases, defined as PHQ8 or GAD7 ≥ 10, signifying at least moderate depression or anxiety respectively. Results 464 patients completed the questionnaire, 338 female (73%), with a mean ± SD age of 44.3 ± 13.6 years. 41.2% of patients screened positive for depression and 26.5% for anxiety, with 24.4% screening positive for both. Of the patients screening positive for anxiety, 91.9% were also depressed. The four most prevalent conditions were rheumatoid arthritis (RA, 8.6%), osteoarthritis (OA, 15.3%), psoriatic arthritis (PsA, 8.4%) and fibromyalgia (FM, 24.4%). The prevalence of at least moderate depression and/or anxiety in RA, OA, PsA and FM was 22.5%, 35.2%, 46.1% and 77% respectively. Logistic regression determined odds ratios relative to RA for significant depression and/or anxiety as follows: OA 1.89 (95% CI 0.76-4.67), PsA 2.75 (1.02-7.41), FM 11.80 (4.91-28.36). Conclusion The burden of psychological illness is high across the population of patients presenting to rheumatology outpatients. Our findings show significant prevalence of psychological illness at first presentation. Early identification of psychological distress is important as it can predict adverse long-term outcomes in patients with rheumatic conditions. These results justify an integrated approach between rheumatology and mental health services. Disclosure N. Arumalla: None. R. Littlewood: None. W. Chen: None. T. Garrood: None.
    Type of Medium: Online Resource
    ISSN: 1462-0324 , 1462-0332
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 1464822-2
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  • 10
    In: Annals of Internal Medicine, American College of Physicians
    Type of Medium: Online Resource
    ISSN: 0003-4819 , 1539-3704
    RVK:
    Language: English
    Publisher: American College of Physicians
    Publication Date: 2024
    detail.hit.zdb_id: 2003473-8
    detail.hit.zdb_id: 336-0
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