70 results on '"Adebajo, A."'
Search Results
2. Potential for biosimilars in rheumatology in Africa
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Abu-Zaid, Mohamed Hassan, primary, Adebajo, Adewale, additional, and El Miedany, Yasser, additional
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- 2023
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3. Multimorbidity: small steps in the right direction
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Adebajo, Adewale O, primary
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- 2023
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4. Patients and healthcare professionals in priority setting partnerships: two very different sides of the same coin
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Adebajo, Adewale, primary
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- 2022
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5. OP0191 CONCEPTUALISING PATIENT AND PUBLIC INVOLVEMENT IN MUSCULOSKELETAL GUIDELINES IMPLEMENTATION: THE ALLIANCE FRAMEWORK
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Babatunde, O., primary, Dawson, S., additional, Adebajo, A., additional, and Dziedzic, K., additional
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- 2022
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6. Patients and healthcare professionals in priority setting partnerships: two very different sides of the same coin
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Adewale, Adebajo
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Health Personnel ,Humans ,General Medicine ,Delivery of Health Care - Published
- 2022
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7. COVID-19 and the practice of rheumatology in Africa: big changes to services from the shockwave of a pandemic
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Adewale Adebajo, Dalia M. E. El Mikkawy, Doaa Mosad, Asgar Ali Kalla, Akpabio Akanimo Akpabio, Yasser El Miedany, Yassmin Taha, Hakeem Olaosebikan, Imad Ghozlani, Samy Slimani, Nermeen A Fouad, Dzifa Dey, Wafa Hamdi, Omondi Oyoo, Angela Migowa, Rachid Bahiri, Richard Oluyinka Akintayo, Kawther Ben Abdelghani, Mohammed Tikly, Rasha A. Abdel-Magied, Abubakar Yerima, Djohra Hadef, M. H. Abu-Zaid, and Olufemi Adelowo
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0301 basic medicine ,medicine.medical_specialty ,Scope of practice ,Exacerbation ,Immunology ,MEDLINE ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Rheumatic Diseases ,Epidemiology ,Health care ,Pandemic ,medicine ,Humans ,Immunology and Allergy ,Pandemics ,030203 arthritis & rheumatology ,business.industry ,SARS-CoV-2 ,Health services research ,COVID-19 ,030104 developmental biology ,Family medicine ,business ,Hydroxychloroquine - Abstract
The onset of the COVID-19 pandemic has led to far-reaching changes in the delivery of healthcare services across Africa. A number of drugs used in the management of rheumatic diseases have been touted to have roles to play in the treatment and/or exacerbation of COVID-19 symptoms and this has resulted in significant changes in the practice of rheumatology. The global rheumatology community has risen to this challenge by demonstrating collaborative partnership, resulting in the establishment of the global rheumatology registry to collect data on rheumatic patients infected with COVID-19.1 In view of the study by Gianfrancesco et al ,2 an online survey consisting of 40 practice and experience questions ((online supplementary file 1) and (online supplementary file 2)) was created by the COVID-19 African Rheumatology Study Group which was formed through the network of the African League of Associations for Rheumatology (AFLAR). The aim of the study was to identify the changes in rheumatology practice and patient behaviour, as well as to highlight key concerns of rheumatologists across Africa resulting from the ongoing COVID-19 pandemic.### Supplementary data [annrheumdis-2020-218273supp001.pdf] ### Supplementary data [annrheumdis-2020-218273supp002.pdf] A total of 554 completed responses were received from 20 African countries. There were 431 (77.8%) responses from Northern Africa, 43 (7.8%) from West Africa, 6 (1%) from Central Africa, 20 (3.6%) from East Africa and 54 (9.8%) from Southern Africa. The scope of practice was adult only in 296 (53.4%), paediatric only in 15 (2.7%) and both in 243 (43.9%). A total of 288 (52.9%) of the respondents practised in academic institutions, while 162 (29.2%) practised primarily in a private setting. Forty-four (7.9%) were using hydroxychloroquine (HCQ) more than before, 19 (3.4%) admitted to have prescribed HCQ to prevent severe COVID-19 disease, 92 (16.6%) …
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- 2020
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8. OP0191 CONCEPTUALISING PATIENT AND PUBLIC INVOLVEMENT IN MUSCULOSKELETAL GUIDELINES IMPLEMENTATION: THE ALLIANCE FRAMEWORK
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O. Babatunde, S. Dawson, A. Adebajo, and K. Dziedzic
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Rheumatology ,Immunology ,Immunology and Allergy ,General Biochemistry, Genetics and Molecular Biology - Abstract
BackgroundPatient and Public Involvement (PPI), have supported high quality Rheumatology research which have now been successfully curated into widely endorsed evidence-based recommendations and guidelines. However, uptake and applicability of guidelines is less than optimal, significant variation exist in care, and health and socio-economic burdens attributed to rheumatic conditions continues to rise, suggesting an implementation challenge.ObjectivesWe conducted a rapid review to investigate the role of PPI in guideline implementation.MethodsA comprehensive search for relevant literature was undertaken (three databases - Medline, Embase, Cinahl, and two large repositories -WHO, G-IN). A priori eligibility criteria and systematic review-based methods were used to identify primary studies with explicit reference to PPI involvement in a rheumatic/musculoskeletal - MSK guideline implementation activity. Extracted data from included studies was interrogated for details regarding activities, contexts, outcomes, and impact of PPI in guidelines implementation and further discussed in review project meetings. Findings were brought together in a narrative synthesis. Recommendations for future research and practice, and a conceptual framework for PPI in Rheumatic and MSK guidelines implementation were co-developed with a public contributor.ResultsTen papers were included, only 1 from the global south. A prevalence of consultative PPI activities in guidelines dissemination (e.g., language translations, patient versions) was found. Few studies explicitly report high-level PPI engagement in relation to care pathway adjustments, care commissioning, institutional operations and policy with a view to MSK guideline implementation. Training, development, and practice of PPI in MSK guideline implementations were not evidenced to have spread much beyond Europe and are also not well reported in literature nor rightly accrued as PPI activities in guideline implementation. The alliance framework (Figure 1) highlighting an iterative process of “creative thinking/co-production” and “strategic doing” helps to conceptualise PPI in MSK guideline implementation. The framework guides knowledge translation from guidelines to real world practice and aims to drive quality improvement for MSK care with patients, for patients, across and within care settings globally.Figure 1.The Alliance framework for conceptualising Patient and Public Involvement in Rheumatic and Musculoskeletal guidelines implementation.ConclusionDespite success of PPI in rheumatology/MSK research, oversight or ineffective PPI in guideline implementation may hamper translation of novel advances in MSK care into real world practice and patient benefit. The Alliance framework prioritises effective PPI in MSK guideline implementation design, delivery, and evaluation, ideally applied in parallel with the development of evidence-based guidance recommendations. It highlights continuous application of innovative thinking, dynamic, and impactful collaborations for bridging the evidence-practice gap and improving quality of care for MSK patients globally through novel partnerships.Disclosure of InterestsNone declared
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- 2022
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9. COVID-19 and the practice of rheumatology in Africa: big changes to services from the shockwave of a pandemic
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Akintayo, Richard Oluyinka, primary, Akpabio, Akpabio, additional, Kalla, Asgar, additional, Dey, Dzifa, additional, Migowa, Angela, additional, Olaosebikan, Hakeem, additional, Bahiri, Rachid, additional, El Miedany, Yasser, additional, Hadef, Djohra, additional, Hamdi, Wafa, additional, Oyoo, Omondi, additional, Slimani, Samy, additional, Yerima, Abubakar, additional, Taha, Yassmin, additional, Adebajo, Adewale, additional, Adelowo, Olufemi, additional, Tikly, Mohammed, additional, Ghozlani, Imad, additional, Abdelghani, Kawther Ben, additional, Fouad, Nermeen Ahmed, additional, Mosad, Doaa, additional, El Mikkawy, Dalia, additional, Abu-Zaid, Mohamed Hassan, additional, and Abdel-Magied, Rasha A, additional
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- 2020
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10. Asymptomatic lymphogranuloma venereum among Nigerian men who have sex with men
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Afoke Kokogho, Zahra Parker, Trevor A Crowell, Senate Amusu, Julie A Ake, Charlotte A. Gaydos, Sylvia Adebajo, Stefan Baral, Manhattan E Charurat, Rebecca G. Nowak, Andrew Ivo, Justin Hardick, Sunday Odeyemi, and Kara Lombardi
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Adult ,Male ,0301 basic medicine ,Serotype ,Proctocolitis ,medicine.medical_specialty ,Adolescent ,Nigeria ,Chlamydia trachomatis ,HIV Infections ,Dermatology ,Real-Time Polymerase Chain Reaction ,urologic and male genital diseases ,medicine.disease_cause ,Asymptomatic ,Article ,Men who have sex with men ,Cohort Studies ,Gonorrhea ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Prevalence ,medicine ,Humans ,Mass Screening ,030212 general & internal medicine ,Homosexuality, Male ,Asymptomatic Infections ,Coinfection ,Transmission (medicine) ,business.industry ,Lymphogranuloma venereum ,Rectum ,medicine.disease ,030112 virology ,female genital diseases and pregnancy complications ,Rectal Diseases ,Infectious Diseases ,Lymphogranuloma Venereum ,Cohort ,medicine.symptom ,business - Abstract
ObjectivesRecent outbreaks of anorectal lymphogranuloma venereum (LGV) among men who have sex with men (MSM) have been characterised by proctocolitis requiring extended antibiotic treatment compared with infections caused by other serovars of Chlamydia trachomatis (CT). We describe the prevalence and clinical features of LGV among Nigerian MSM diagnosed with anorectal CT.MethodsMSM were recruited for this observational cohort in Lagos, Nigeria, using respondent-driven sampling and screened for HIV and bacterial STIs every three months for up to 18 months. Nucleic acid amplification tests for CT were performed on rectal swab specimens. Prevalent and incident cases of anorectal CT underwent additional testing to identify LGV using novel real-time PCR assays specific for the L-serovars of CT.ResultsFrom April 2014 to July 2016, 420 MSM underwent testing for rectal STIs, of whom 66 (15.7%) had prevalent anorectal CT. Among those without prevalent disease, 68 developed incident infections during 208 person-years of follow-up. Of 134 prevalent and incident cases of anorectal CT, 7 (5.2%) were identified as LGV. None of the seven participants with LGV reported any symptoms. Two of the participants with LGV were simultaneously coinfected with rectal gonorrhoea. HIV coinfection was common among participants with both LGV (n=5, 71%) and non-LGV (n=98, 77%) serovars of CT (P=0.66).ConclusionsAnorectal LGV was uncommon but present among Nigerian MSM in this study. Consistent screening for L-serovars of CT, or presumptive treatment for LGV in cases with a high suspicion for this diagnosis, could potentially improve patient outcomes and decrease transmission.
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- 2018
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11. High levels of unprotected anal intercourse and never testing for HIV among men who have sex with men in Nigeria: evidence from a cross-sectional survey for the need for innovative approaches to HIV prevention
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Waimar Tun, Sylvia Adebajo, Katherine Andrinopoulos, and Lung Vu
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Adult ,Male ,medicine.medical_specialty ,Multivariate analysis ,Adolescent ,Cross-sectional study ,Sexual Behavior ,media_common.quotation_subject ,Health Behavior ,Social Stigma ,Psychological intervention ,Nigeria ,HIV Infections ,Dermatology ,Logistic regression ,Health Services Accessibility ,Men who have sex with men ,Condoms ,Risk-Taking ,Acquired immunodeficiency syndrome (AIDS) ,medicine ,Humans ,Mass Screening ,Homosexuality ,Homosexuality, Male ,Psychiatry ,media_common ,Unsafe Sex ,business.industry ,virus diseases ,medicine.disease ,Cross-Sectional Studies ,Infectious Diseases ,Cohabitation ,Population Surveillance ,Crime ,business ,Needs Assessment ,Demography - Abstract
Objectives To describe sexual risk behaviour, correlates of unprotected anal intercourse (UAI) and never testing for HIV and its implications for HIV prevention interventions among men who have sex with men (MSM) in Nigeria and other similar contexts. Methods A cross-sectional survey was administered to 712 MSM in Abuja, Ibadan and Lagos, recruited through respondent-driven sampling (RDS). Levels of sexual risk behaviour and never having tested for HIV prior to the survey were calculated using weighted data for each city and unweighted data for the pooled sample. Correlates of UAI and never testing for HIV were determined using multiple logistic regression. Results The risk for HIV and STI among MSM in Nigeria is high, with 43.4% reporting UAI at last sex, 45.1% never having been tested for HIV and 53.9% reporting exchange of sex for resources in the past 6 months. Correlates of UAI in multivariate analysis included living in Ibadan, marriage or cohabitation with a woman, identification as bisexual, not having tested for HIV and being HIV-positive. Correlates of not having tested for HIV in multivariate analysis included living in Ibadan, young age, less education, unemployment and report of UAI. Conclusions HIV testing is low and associated with UAI. Findings merit targeted and innovative approaches for HIV prevention for MSM, especially access to HIV self-testing. Attention to social and structural determinants of health-seeking and sexual risk behaviour is also needed, including the criminalisation of homosexuality and social marginalisation of MSM.
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- 2013
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12. Asymptomatic lymphogranuloma venereum among Nigerian men who have sex with men
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Crowell, Trevor A, primary, Hardick, Justin, additional, Lombardi, Kara, additional, Parker, Zahra, additional, Kokogho, Afoke, additional, Amusu, Senate, additional, Odeyemi, Sunday, additional, Ivo, Andrew, additional, Baral, Stefan D, additional, Nowak, Rebecca G, additional, Adebajo, Sylvia, additional, Charurat, Manhattan E, additional, Ake, Julie, additional, and Gaydos, Charlotte A, additional
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- 2018
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13. OP0169 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (104-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Pooled Results from Three Phase 3, Randomized, Controlled Trials
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Dafna D. Gladman, Juan J. Gomez-Reino, Georg Schett, M. McIlraith, Eric Lespessailles, A. Kavanaugh, Adewale Adebajo, P. J. Mease, Maurizio Cutolo, Jürgen Wollenhaupt, C. Birbara, C. Hu, and Christopher J Edwards
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medicine.medical_specialty ,business.industry ,Immunology ,Enthesitis ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Dactylitis ,law.invention ,Psoriatic arthritis ,Pooled analysis ,Rheumatology ,Randomized controlled trial ,law ,Phosphodiesterase 4 Inhibitor ,Internal medicine ,medicine ,Immunology and Allergy ,In patient ,Apremilast ,medicine.symptom ,business ,medicine.drug - Abstract
Background Apremilast (APR), a PDE4 inhibitor, helps regulate immune responses in psoriatic arthritis (PsA). PALACE 1-3 compared APR efficacy/safety with placebo (PBO) in patients (pts) with active PsA despite prior conventional DMARDs and/or biologics, including efficacy assessment across multiple aspects of disease. Enthesitis and dactylitis are hallmark features of PsA that lead to pain and disability. Objectives Evaluate the impact of APR treatment over 104 wks on enthesitis and dactylitis in a pooled analysis of PALACE 1-3. Methods Pts were randomized (1:1:1) to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline (BL) DMARD use (yes/no). The PBO-controlled phase continued to Wk 24, with an early escape option at Wk 16. Double-blind APR treatment continued to Wk 52; pts could then continue to receive APR for up to an additional 4 years during an open-label extension phase. Data were pooled across PALACE 1-3 to allow for analysis of robust numbers of pts with pre-existing enthesopathy and/or dactylitis. Enthesitis was evaluated based on Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) (range 0-13), which indicates the number of painful entheses out of 13 entheses sites. The dactylitis count (range 0-20) is the number of digits (hands/feet) with dactylitis present; each digit is rated as 0 (none) or 1 (present). Results Long-term improvement in enthesitis and dactylitis severity was seen in pts with enthesitis and/or dactylitis at BL who were receiving APR at 104 weeks, as shown by reductions in MASES and dactylitis counts (Table). Mean changes in MASES were -57.5% (APR30) and -55.1% (APR20) at Wk 104. MASES scores of 0, indicating no pain at any of the entheses assessed, were achieved by 48.7% (APR30) and 51.5% (APR20) of pts. Mean changes in dactylitis count were -80.0% (APR30) and -75.8% (APR20) at Wk 104. Dactylitis counts decreased to 0 in 77.5% (APR30) and 72.9% (APR20) of pts. Over 104 wks, most AEs were mild/moderate in severity; in general, no increase was seen in AE incidence/severity with longer term exposure. Conclusions Over 104 wks, APR continued to demonstrate efficacy in PsA treatment, including improvements in enthesitis and dactylitis. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 104 wks. Disclosure of Interest D. Gladman Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, A. Kavanaugh Grant/research support from: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, A. Adebajo: None declared, J. Gomez-Reino Grant/research support from: Roche and Schering-Plough, Consultant for: Bristol-Myers Squibb, Pfizer Inc, Roche, Schering-Plough, and UCB SA, Speakers bureau: Bristol-Myers Squibb, Roche, Schering-Plough, and Wyeth, J. Wollenhaupt Grant/research support from: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, Consultant for: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, M. Cutolo Grant/research support from: Actelion, Bristol-Myers Squibb, and Sanofi-Aventis, Consultant for: Actelion, Bristol-Myers Squibb, and Sanofi-Aventis, G. Schett Grant/research support from: Abbott, Celgene Corporation, Roche, and UCB, Consultant for: Abbott, Celgene Corporation, Roche, and UCB, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, and Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, and Servier, M. McIlraith Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, C. Edwards Grant/research support from: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Consultant for: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, C. Birbara Grant/research support from: Amgen, Bristol-Myers Squibb, Incyte, Eli Lilly, Merck, and Pfizer Inc, P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB,Celgene Corporation, Novartis, and Roche, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB,Celgene Corporation, Novartis, and Roche, Speakers bureau: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB
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- 2015
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14. Effects of needs-based patient education on self-efficacy and health outcomes in people with rheumatoid arthritis: a multicentre, single blind, randomised controlled trial
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Ndosi, M, primary, Johnson, D, additional, Young, T, additional, Hardware, B, additional, Hill, J, additional, Hale, C, additional, Maxwell, J, additional, Roussou, E, additional, and Adebajo, A, additional
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- 2015
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15. THU0420 Long-Term (104-Week) Efficacy and Safety Profile of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results from a Phase III, Randomised, Controlled Trial and Open-Label Extension (Palace 1)
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Kavanaugh, A., primary, Adebajo, A., additional, Gladman, D., additional, Gomez-Reino, J., additional, Hall, S., additional, Lespessailles, E., additional, Mease, P., additional, Schett, G., additional, Shah, K., additional, Hu, C., additional, and Wollenhaupt, J., additional
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- 2015
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16. OP0169 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (104-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Pooled Results from Three Phase 3, Randomized, Controlled Trials
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Gladman, D., primary, Kavanaugh, A., additional, Adebajo, A., additional, Gomez-Reino, J., additional, Wollenhaupt, J., additional, Cutolo, M., additional, Schett, G., additional, Lespessailles, E., additional, McIlraith, M., additional, Hu, C., additional, Edwards, C., additional, Birbara, C., additional, and Mease, P., additional
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- 2015
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17. THU0432 Long-Term (104-Week) Safety Profile of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, In Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials
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Mease, P., primary, Adebajo, A., additional, Gladman, D., additional, Gomez-Reino, J., additional, Hall, S., additional, Kavanaugh, A., additional, Lespessailles, E., additional, Schett, G., additional, Shah, K., additional, Teng, L., additional, and Wollenhaupt, J., additional
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- 2015
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18. AB0805 Long-Term Impact of Apremilast on Physical Function in Patients with Psoriatic Arthritis Using the HAQ-DI Assessment
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Zhang, F., primary, Clancy, Z., additional, Li, S., additional, Kavanaugh, A., additional, Adebajo, A., additional, and Wollenhaupt, J., additional
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- 2015
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19. SAT0562 Long-Term (104-Week) Efficacy and Safety of Apremilast Monotherapy in Dmard-Naïve Patients with Psoriatic Arthritis: A Phase 3, Randomized, Controlled Trial and Open-Label Extension (Palace 4)
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Wells, A., primary, Edwards, C., additional, Adebajo, A., additional, Kivitz, A., additional, Bird, P., additional, Shah, K., additional, Hu, C., additional, and Aelion, J., additional
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- 2015
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20. SP0048 Overcoming Barriers to Health Literacy in Ethnic Populations using a Multi-Lingual Interactive Mind-Map
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Adebajo, A., primary
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- 2015
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21. Evaluating the effect of HIV prevention strategies on uptake of HIV counselling and testing among male most-at-risk-populations in Nigeria; a cross-sectional analysis
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Adebajo, Sylvia, primary, Eluwa, George, additional, Njab, Jean, additional, Oginni, Ayo, additional, Ukwuije, Francis, additional, Ahonsi, Babatunde, additional, and Lorenc, Theo, additional
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- 2015
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22. THU0420 Long-Term (104-Week) Efficacy and Safety Profile of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results from a Phase III, Randomised, Controlled Trial and Open-Label Extension (Palace 1)
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Dafna D. Gladman, A. Kavanaugh, C. Hu, Eric Lespessailles, K. Shah, P. J. Mease, Stephen Hall, Juan J. Gomez-Reino, Adewale Adebajo, Jürgen Wollenhaupt, and Georg Schett
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medicine.medical_specialty ,business.industry ,Immunology ,Schering-Plough ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Safety profile ,Psoriatic arthritis ,Rheumatology ,Randomized controlled trial ,law ,Internal medicine ,Phosphodiesterase 4 Inhibitor ,medicine ,Immunology and Allergy ,In patient ,Apremilast ,Open label ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, helps regulate immune responses in psoriatic arthritis (PsA). PALACE 1 compared the efficacy and safety of APR with placebo (PBO) in patients with active PsA despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. Objectives Evaluate the efficacy and safety of APR treatment over 104 weeks. Methods Patients were randomized (1:1:1) to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Patients whose swollen/tender joint counts (SJC/TJC) had not improved ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if they were initially randomized to PBO, or continued on their initial APR dose. At Week 24, all remaining PBO patients were re-randomized to APR20 or APR30. Double-blind APR treatment continued to Week 52; patients could continue APR for up to 4 additional years. Results 504 randomized patients received ≥1 dose of study medication (PBO: n=168; APR20: n=168; APR30: n=168). At Week 52, 53.2% of patients receiving APR30 and 59.6% of patients receiving APR20 achieved a modified ACR20 response (Table); $≈ $80% (285/344) of patients completing Week 52 were still receiving APR at the data cutoff during their second year of APR exposure. Patients taking APR demonstrated sustained improvements at Week 104 as shown by modified ACR20/ACR50/ACR70 response rates, SJC/TJC mean percent change, HAQ-DI mean change, proportion of patients with HAQ-DI exceeding the minimal clinically important difference (MCID) ≥0.30 threshold, mean change in DAS-28 (CRP), achievement of DAS (CRP) 52 to ≤104, adverse events (AEs) occurring in ≥5% of APR-exposed patients were nasopharyngitis and upper respiratory tract infection; most AEs were mild/moderate in severity. Diarrhea (1.7%) and nausea (1.2%) occurred at lower rates in Weeks >52 to ≤104 than in Weeks 0 to ≤52 (15.3% and 12.4%, respectively). Serious AEs occurred in 4.7% (APR30) and 6.4% (APR20) of patients over Weeks >52 to ≤104. Fewer discontinuations due to AEs occurred during Weeks >52 to ≤104 (1.5%) vs. Weeks 0 to ≤52 (8.2%). Conclusions Over 104 weeks, APR demonstrated sustained clinically meaningful improvements in signs and symptoms of PsA, including physical function, and associated psoriasis. APR continued to demonstrate an acceptable safety profile and was generally well tolerated. Disclosure of Interest A. Kavanaugh Grant/research support from: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, A. Adebajo: None declared, D. Gladman Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, J. Gomez-Reino Grant/research support from: Roche and Schering-Plough, Consultant for: Bristol-Myers Squibb, Pfizer Inc, Roche, Schering-Plough, and UCB SA, Speakers bureau: Bristol-Myers Squibb, Roche, Schering-Plough, and Wyeth; S. Hall Consultant for: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GlaxoSmithKline, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, and Wyeth; Paid instructor for: Boehringer Ingelheim, MSD, Roche Schering Plough, Servier, and Wyeth., Speakers bureau: Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, and Wyeth, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, and Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, and Servier, P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, and Roche, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, and Roche, Speakers bureau: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, G. Schett Grant/research support from: Abbott, Celgene Corporation, Roche, and UCB, Consultant for: Abbott, Celgene Corporation, Roche, and UCB, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, J. Wollenhaupt Grant/research support from: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, Consultant for: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB
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- 2015
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23. THU0432 Long-Term (104-Week) Safety Profile of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, In Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials
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A. Kavanaugh, Dafna D. Gladman, P. J. Mease, Stephen Hall, Juan J. Gomez-Reino, Adewale Adebajo, Georg Schett, Eric Lespessailles, L. Teng, K. Shah, and Jürgen Wollenhaupt
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medicine.medical_specialty ,business.industry ,Immunology ,Schering-Plough ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Psoriatic arthritis ,Safety profile ,Rheumatology ,Randomized controlled trial ,Tolerability ,law ,Internal medicine ,Phosphodiesterase 4 Inhibitor ,medicine ,Immunology and Allergy ,In patient ,Apremilast ,business ,medicine.drug - Abstract
Background Apremilast (APR), a phosphodiesterase 4 inhibitor, helps regulate the immune responses in psoriatic arthritis (PsA). PALACE 1-3 compared APR efficacy/safety with placebo (PBO) in patients (pts) with active PsA despite prior conventional DMARDs and/or biologics. Objectives Overall APR safety/tolerability was assessed in a pooled analysis of PALACE 1-3, with APR exposure ≤104 wks. Methods Pts were randomized (1:1:1) to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). The PBO-controlled phase continued to Wk 24, with an early escape option at Wk 16. Double-blind APR treatment continued to Wk 52; pts could continue to receive APR during an open-label, long-term treatment phase. We report safety findings from the APR-exposure period (Wks 0 to ≤104). Results 1493 pts were randomized and received ≥1 dose of study medication (PBO: n=495; APR20: n=501; APR30: n=497). A total of 1441 (1209.3 pt-yrs) and 1028 (907.7 pt-yrs) pts received APR in the Wk 0 to ≤52 and Wk >52 to ≤104 periods, respectively. During Wks 0 to ≤52, AEs occurring in ≥5% of APR-exposed pts were diarrhea, nausea, headache, URTI, and nasopharyngitis (Table). Most AEs were mild/moderate in severity during the Wk 0 to ≤104 APR-exposure period; in general, no increase was seen in the incidence/severity of AEs with longer term exposure. During Wks >52 to ≤104, diarrhea (2.9%), nausea (1.8%), and headache (3.0%) occurred at lower rates vs Wks 0 to ≤52 (Table). In Wks 0 to ≤52, 87 pts reported serious AEs (SAEs) vs 71 pts in Wks >52 to ≤104. In few system organ classes, there were numerically more pts reporting SAEs but it did not indicate any specific organ involvement. The vast majority of the SAEs were reported by 1 pt each. There was no increase in cardiac, malignant neoplasm, opportunistic infection, or psychiatric disorder related SAEs and no cases of tuberculosis (new/reactivation) reported with either APR dose. Discontinuations due to AEs occurred at a lower rate (2.3%) during Wks >52 to ≤104. Marked laboratory abnormalities were generally infrequent and most returned to baseline with continued treatment or were associated with a concurrent medical condition. Conclusions APR demonstrated an acceptable safety profile and was generally well tolerated for up to 104 wks, with no new safety concerns identified with long-term exposure. These data continue to support the lack of a need for specific laboratory monitoring with APR. Disclosure of Interest P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, and Roche, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, UCB, Celgene Corporation, Novartis, and Roche, Speakers bureau: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB, A. Adebajo: None declared, D. Gladman Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, J. Gomez-Reino Grant/research support from: Roche and Schering-Plough, Consultant for: Bristol-Myers Squibb, Pfizer Inc, Roche, Schering-Plough, and UCB SA, Speakers bureau: Bristol-Myers Squibb, Roche, Schering-Plough, and Wyeth, S. Hall Consultant for: Boehringer Ingelheim, MSD, Roche Schering Plough, Servier, and Wyeth., Paid instructor for: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GlaxoSmithKline, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, and Wyeth, Speakers bureau: Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, and Wyeth;, A. Kavanaugh Grant/research support from: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, and Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, and Servier, G. Schett Grant/research support from: Abbott, Celgene Corporation, Roche, and UCB, Consultant for: Abbott, Celgene Corporation, Roche, and UCB, K. Shah Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, J. Wollenhaupt Grant/research support from: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, Consultant for: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB
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- 2015
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24. SAT0562 Long-Term (104-Week) Efficacy and Safety of Apremilast Monotherapy in Dmard-Naïve Patients with Psoriatic Arthritis: A Phase 3, Randomized, Controlled Trial and Open-Label Extension (Palace 4)
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Adewale Adebajo, K. Shah, C. Hu, Paul Bird, Alvin F. Wells, Jacob A. Aelion, Christopher J Edwards, and Alan Kivitz
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Immunology ,Population ,medicine.disease ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Dactylitis ,law.invention ,Therapy naive ,Psoriatic arthritis ,Rheumatology ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Immunology and Allergy ,Apremilast ,Open label ,education ,business ,medicine.drug - Abstract
Background Apremilast (APR) is an oral phosphodiesterase 4 inhibitor that helps regulate the immune response that causes joint inflammation and other manifestations of psoriatic arthritis (PsA), including skin disease. Objectives Compare the efficacy and safety of APR monotherapy with placebo (PBO) in patients with active PsA who were DMARD-naive for up to 104 weeks. Methods Patients were randomized (1:1:1) to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Patients whose swollen/tender joint counts (SJC/TJC) had not improved by ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if they were initially randomized to PBO, or continued on their initial APR dose. At Week 24, all remaining PBO patients were re-randomized to APR20 or APR30. Double-blind treatment continued to Week 52; patients could continue to receive APR for up to 4 additional years. Results 527 patients were included in the modified intent-to-treat population in which patients who were randomized in error and did not receive study medication were excluded (PBO: n=176; APR20: n=175; APR30: n=176). At Week 52, a modified ACR20 response was achieved by 58.0% (119/205 [APR30]) and 55.4% (107/193; [APR20]) of patients (Table); $≈ $84% of patients completing 1 year of APR treatment were maintained on therapy at the data cutoff during their second year of APR exposure. At Week 104, patients taking APR demonstrated sustained improvements, as shown by modified ACR20/ACR50/ACR70 response rates, SJC/TJC mean percent change, HAQ-DI mean change, proportion of patients with HAQ-DI exceeding the MCID ≥0.30 threshold, changes in MASES and dactylitis severity scores, and PASI-50/PASI-75 responses (Table). During Weeks >52 to ≤104, the most common adverse events (AEs) among APR-exposed patients were upper respiratory tract infection (4.8%) and nasopharyngitis (3.2%); serious AEs occurred in 5.3%. In general, no change in the types of AEs and no increase in the incidence/severity of AEs were seen with longer-term exposure. Diarrhea and nausea occurred at lower rates in Weeks >52 to ≤104 vs. Weeks 0 to ≤52. Conclusions Over 104 weeks, APR monotherapy demonstrated sustained response and improvements in PsA signs/symptoms, including enthesitis, dactylitis, physical function, and psoriasis. The ACR20 response was 61% for patients receiving APR30 therapy for 2 years. APR continued to demonstrate an acceptable safety profile and was generally well tolerated. Disclosure of Interest A. Wells Grant/research support from: Celgene Corporation, C. Edwards Grant/research support from: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Consultant for: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, A. Adebajo: None declared, A. Kivitz Grant/research support from: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Consultant for: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Speakers bureau: Pfizer Inc, P. Bird Grant/research support from: Celgene Corporation, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, J. Aelion Grant/research support from: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Consultant for: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, and UCB
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- 2015
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25. AB0805 Long-Term Impact of Apremilast on Physical Function in Patients with Psoriatic Arthritis Using the HAQ-DI Assessment
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Z. Clancy, F. Zhang, A. Kavanaugh, Adewale Adebajo, Jürgen Wollenhaupt, and S. Li
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Minimal clinically important difference ,Immunology ,Population ,Physical function ,medicine.disease ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Clinical trial ,Psoriatic arthritis ,Rheumatology ,Internal medicine ,medicine ,Physical therapy ,Immunology and Allergy ,In patient ,Apremilast ,business ,education ,medicine.drug - Abstract
Background The safety and efficacy of apremilast (APR), including improvements in physical disability, were compared with placebo in the PALACE 1 study of patients who had active psoriatic arthritis despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. Physical function is a substantial burden in patients with psoriatic arthritis, and the Health Assessment Questionnaire-Disability Index (HAQ-DI) is commonly used in clinical trials to assess this impairment. 1 Objectives Assess the long-term (104-week) impact of APR therapy on physical function in patients enrolled in the PALACE 1 study. Methods Patients were randomized (1:1:1) to receive placebo, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Patients whose swollen and tender joint counts had not improved by ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if they were initially randomized to placebo, or continued on their initial APR dose. At Week 24, all patients remaining on placebo were re-randomized to APR20 or APR30. Treatment efficacy analysis at Week 16 was performed based on the intent-to-treat population, and analyses at Week 52 and Week 104 were based on data as observed. Physical function, a prespecified secondary end point, was measured in patients using the Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Proportion of patients achieving minimal clinically important differences (MCID) in the HAQ-DI score (improvements of ≥0.13 or ≥0.30 from baseline) were collected. Results At Week 16, the change from baseline in physical function was significantly improved with APR30 vs. placebo, as measured by the HAQ-DI score (Table). Improvements in physical function were maintained at Weeks 52 and 104. At Week 52, 59.8% (APR30) and 60.0% (APR20) of patients achieved HAQ-DI MCID ≥0.13 and 44.7% (APR30) and 45.8% (APR20) achieved MCID ≥0.30. At Week 104, 62.4% (APR30) and 57.7% (APR20) achieved HAQ-DI MCID ≥0.13 and 54.5% (APR30) and 51.5% (APR20) achieved MCID ≥0.30. Conclusions Patients treated with APR30 reported clinically meaningful improvements in physical function compared with those treated with placebo, as measured by the HAQ-DI scores at Week 16. Improvements in physical function were maintained long term at Weeks 52 and 104 References Lee S, et al. The burden of psoriatic arthritis. PT35:680-689. Kwok T, Pope JE. J Rheumatol 2010;37:1024-1028. Mease PJ, et al. Ann Rheum Dis 2004;63(Suppl 1):391.9. Disclosure of Interest F. Zhang Employee of: Celgene Corporation, Z. Clancy Employee of: Celgene Corporation, S. Li Employee of: Celgene Corporation, A. Kavanaugh Grant/research support from: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, Consultant for: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, A. Adebajo: None declared, J. Wollenhaupt Grant/research support from: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, Consultant for: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB
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26. A hunt for the source of sepsis
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Thistleton, S., primary, Grandidge, L., additional, Sharlala, H., additional, and Adebajo, A., additional
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- 2014
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27. OP0203-HPR Does Enat-Focused Education Improve Health Outcomes in Ra? A Randomised Controlled Trial: Table 1
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Hardware, B., primary, Young, T., additional, Johnson, D.B., additional, Ndosi, M., additional, Hale, C., additional, Maxwell, J.R., additional, Roussou, E., additional, and Adebajo, A., additional
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- 2014
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28. THU0572-HPR Osteomalacia: Developing an Interactive Education Tool for South Asian Populations
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Robinson, S., primary, Adebajo, A., additional, Heliwell, P., additional, Rahman, A., additional, Raza, K., additional, Samanta, A., additional, Johnson, M., additional, Bishop, P., additional, Kumar, K., additional, and Walker, D., additional
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- 2014
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29. SAT0389 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (52-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Results from the Palace 4 Phase 3, Randomized, Controlled Trial
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Edwards, C., primary, Wells, A., additional, Adebajo, A., additional, Kivitz, A., additional, Bird, P., additional, Shah, K., additional, Hu, C., additional, Stevens, R.M., additional, and Aelion, J., additional
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- 2014
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30. SAT0382 Palace 4, A Phase 3, Randomized, Controlled TRIAL of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Treatment of Psoriatic Arthritis: Long-Term (52-WEEK) Improvements in Physical Function
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Wells, A., primary, Edwards, C., additional, Adebajo, A.O., additional, Kivitz, A.J., additional, Bird, P., additional, Shah, K., additional, Hu, C., additional, Stevens, R.M., additional, and Aelion, J.A., additional
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- 2014
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31. AB0758 Change in Weight from Baseline during the Palace Clinical Trial Program with Apremilast, an Oral Phosphodiesterase 4 Inhibitor: Pooled Results from 3 Phase 3, Randomized, Controlled Trials
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Mease, P., primary, Gladman, D., additional, Kavanaugh, A., additional, Adebajo, A., additional, Gomez-Reino, J., additional, Wollenhaupt, J., additional, Schett, G., additional, Shah, K., additional, Hu, C., additional, Stevens, R., additional, Edwards, C., additional, and Birbara, C., additional
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- 2014
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32. AB0746 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, and the Impact of Baseline Weight and BMI on ACR20 and HAQ-DI Response: Pooled Results from 3 Phase 3, Randomized, Controlled Trials
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Schett, G., primary, Mease, P., additional, Gladman, D., additional, Kavanaugh, A., additional, Adebajo, A., additional, Gomez-Reino, J., additional, Wollenhaupt, J., additional, Cutolo, M., additional, Lespessailles, E., additional, Hu, C., additional, Stevens, R., additional, Edwards, C., additional, and Birbara, C., additional
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- 2014
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33. SAT0377 Long-Term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: A Phase 3, Randomized, Controlled Trial
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Adebajo, A., primary, Wells, A., additional, Edwards, C., additional, Kivitz, A., additional, Bird, P., additional, Shah, K., additional, Hu, C., additional, Stevens, R., additional, and Aelion, J., additional
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- 2014
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34. SAT0408 Long-Term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials
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Mease, P.J., primary, Kavanaugh, A., additional, Gladman, D., additional, Adebajo, A.O., additional, Gomez-Reino, J.J., additional, Wollenhaupt, J., additional, Cutolo, M., additional, Schett, G., additional, Lespessailles, E., additional, Shah, K., additional, Hu, C., additional, Stevens, R., additional, Edwards, C., additional, and Birbara, C., additional
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- 2014
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35. OP0078 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (52-WEEK) Improvement in Measures of Disease Activity in Patients with Psoriatic Arthritis: Results from 3 Phase 3, Randomized, Controlled Trials
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Kavanaugh, A., primary, Cutolo, M., additional, Mease, P., additional, Gladman, D., additional, Adebajo, A., additional, Gomez-Reino, J., additional, Wollenhaupt, J., additional, Schett, G., additional, Lespessailles, E., additional, Hu, C., additional, Stevens, R., additional, Edwards, C., additional, and Birbara, C., additional
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- 2014
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36. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor
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Kavanaugh, Arthur, primary, Mease, Philip J, additional, Gomez-Reino, Juan J, additional, Adebajo, Adewale O, additional, Wollenhaupt, Jürgen, additional, Gladman, Dafna D, additional, Lespessailles, Eric, additional, Hall, Stephen, additional, Hochfeld, Marla, additional, Hu, ChiaChi, additional, Hough, Douglas, additional, Stevens, Randall M, additional, and Schett, Georg, additional
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- 2014
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37. SAT0377 Long-Term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: A Phase 3, Randomized, Controlled Trial
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Adewale Adebajo, R. Stevens, Alan Kivitz, K. Shah, Christopher J Edwards, Alvin F. Wells, C. Hu, Paul Bird, and Jacob A. Aelion
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medicine.medical_specialty ,education.field_of_study ,Nausea ,business.industry ,Incidence (epidemiology) ,Immunology ,Population ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Discontinuation ,law.invention ,Rheumatology ,Tolerability ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Immunology and Allergy ,Apremilast ,medicine.symptom ,education ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 4 compared the efficacy/safety of APR with placebo (PBO) in patients (pts) with active PsA who were DMARD-naive. Objectives Assess safety and tolerability of APR for up to 52 wks. Methods Pts were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Pts with
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38. SAT0382 Palace 4, A Phase 3, Randomized, Controlled TRIAL of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Treatment of Psoriatic Arthritis: Long-Term (52-WEEK) Improvements in Physical Function
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Jacob A. Aelion, Adewale Adebajo, Alan Kivitz, R. Stevens, K. Shah, C. Hu, Paul Bird, Alvin F. Wells, and Christopher J Edwards
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medicine.medical_specialty ,business.industry ,Immunology ,Physical function ,General Biochemistry, Genetics and Molecular Biology ,Acr20 response ,law.invention ,Safety profile ,Rheumatology ,Randomized controlled trial ,law ,Phosphodiesterase 4 Inhibitor ,Internal medicine ,Immunology and Allergy ,Medicine ,In patient ,Apremilast ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 4 compared APR efficacy/safety with placebo (PBO) in patients (pts) with active PsA who were DMARD-naive. Objectives Evaluate the impact of APR over 52 wks on physical function among PALACE 4 pts. Methods Pts were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Pts with Results At Wk 16, a significantly greater proportion of pts treated with APR achieved a modified ACR20 response vs PBO (primary endpoint). Mean changes in HAQ-DI at Wk 16 (key secondary endpoint) were 0.03 (PBO), -0.17 (APR20; P=0.0008), and -0.21 (APR30; P Conclusions Over 52 wks, APR continued to demonstrate clinically meaningful improvements in physical function in active PsA pts who were DMARD-naive. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 wks. References Kwok T. J Rheumatol. 2010;37:1024. Mease PJ. J Rheumatol. 2011;38:2461. Revicki DA. Health Qual Life Outcomes. 2008;6:75. Disclosure of Interest A. Wells Grant/research support: Celgene Corporation, C. Edwards Grant/research support: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Consultant for: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, A. Adebajo: None declared, A. Kivitz Grant/research support: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Consultant for: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Speakers bureau: Pfizer Inc, P. Bird Grant/research support: Celgene Corporation, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, J. Aelion Grant/research support: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Consultant for: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, and UCB DOI 10.1136/annrheumdis-2014-eular.1096
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39. THU0572-HPR Osteomalacia: Developing an Interactive Education Tool for South Asian Populations
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P. Heliwell, Kanta Kumar, Anisur Rahman, Ash Samanta, Karim Raza, Adewale Adebajo, David Walker, Mark Rd Johnson, P. Bishop, and Sandra Robinson
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User information ,Medical education ,business.industry ,media_common.quotation_subject ,First language ,Immunology ,Focus group ,General Biochemistry, Genetics and Molecular Biology ,Test (assessment) ,Presentation ,Rheumatology ,Feeling ,Immunology and Allergy ,Medicine ,The Internet ,business ,Knowledge transfer ,media_common - Abstract
Background Osteomalacia is a significant population health risk that preferentially affects darker skinned people where English may not be the first language. Objectives We were interested to develop an e-based interactive, multi language tool, based on the Mind-Map and giving information in an accessible layered fashion suitable for people with poor English language skills. Methods The Mind-Map wasused as the “home” page. Hyperlinks gave the user options to link to more detailed information. It was possible to take any route through the information and to return from any screen to the original Mind-Map screen. The tool was designed to give the user information in layers. The first layers of the tool are the basic knowledge the user requires to make informed decisions and choices. Further layers lead the user to more in depth information and links to the internet. Only the first layer of the tool was translated into Urdu. The translation was reviewed by a panel of six educated Urdu speakers in the UK to ensure that the translation was correct. A focus group of 10 Urdu speakers from Stourbridge was used to test the tool. A presentation using the tool was performed and their reactions to it recorded. The participants were given the DVD to take away with them. Two months later the group was reconvened and the discussion recorded and transcribed. Results All participants felt that they had learned a lot about Osteomalacia. There was a feeling that this was a very important issue and they were surprised how little they knew about it. The content was judged to be of appropriate detail. It was felt that only the first layer would be used in a presentation but some users may be interested in having more information. It was also suggested that presenting it in English to encourage people to speak enough English to interact with healthcare professionals would be helpful. There were suggestions on how this should be used with presentations in communities but also in schools. They felt that this was a community tool rather than just hospital based. One participant had already given presentations to their community and reported very good informal feedback. Conclusions We have produced a bi-lingual interactive tool to educate people about Osteomalacia and its treatment. Initial reactions show it to be suitable for the intended audience. We now intend to study this for knowledge transfer and change of behaviour. Acknowledgements We would like to acknowledge the contribution of the focus group from Stourbridge Birmingham. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4424
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40. OP0078 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (52-WEEK) Improvement in Measures of Disease Activity in Patients with Psoriatic Arthritis: Results from 3 Phase 3, Randomized, Controlled Trials
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Dafna D. Gladman, Eric Lespessailles, A. Kavanaugh, Juan J. Gomez-Reino, Adewale Adebajo, Maurizio Cutolo, Philip J. Mease, R. Stevens, C. Birbara, Christopher J Edwards, Georg Schett, C. Hu, and Jürgen Wollenhaupt
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medicine.medical_specialty ,business.industry ,Immunology ,Schering-Plough ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Disease activity ,Psoriatic arthritis ,Rheumatology ,Randomized controlled trial ,law ,Phosphodiesterase 4 Inhibitor ,Internal medicine ,medicine ,Immunology and Allergy ,In patient ,Apremilast ,Antirheumatic drugs ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. The PALACE 1, 2, and 3 trials compared the efficacy and safety of APR with placebo (PBO) in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. Objectives Evaluate the impact of APR over 52 weeks on PsA disease activity. Methods Patients were randomized 1:1:1 to receive PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Patients with Results At Week 16, a significantly greater proportion of patients treated with APR achieved a modified ACR20 response vs PBO (primary endpoint). In patients initially randomized to APR and completing 52 weeks, ACR20 response was sustained over 52 weeks. APR20 and APR30 demonstrated improvement in disease activity vs PBO at Week 16, as measured by the DAS-28 (CRP), modified PsARC response, and good or moderate EULAR response. Among patients who were continuously treated with APR through 52 weeks sustained improvements were observed at Week 52 (Table). The most common adverse events reported during the PBO-controlled period (PAL 1-3; pooled) were diarrhea (12.2%), nausea (10.1%), and headache (8.0%). The safety profile of APR through 52 weeks was similar to that observed with APR for up to 24 weeks of treatment (PBO-controlled period). Conclusions APR demonstrated clinically meaningful improvements in measures of PsA disease activity through Week 52. APR demonstrated an acceptable safety profile and was generally well tolerated through 52 weeks. Disclosure of Interest A. Kavanaugh Grant/research support: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc., Roche, and UCB, M. Cutolo Grant/research support: Actelion, Bristol-Myers Squibb, and Sanofi-Aventis, Consultant for: Actelion, Bristol-Myers Squibb, and Sanofi-Aventis, P. Mease Grant/research support: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genetech, Janssen, Eli Lilly, Pfizer Inc.,Celgene Corporation, Novartis, Roche and UCB, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genetech, Janssen, Eli Lilly, Pfizer Inc., Celgene Corporation, Novartis, Roche and UCB, Speakers bureau: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genetech, Janssen, Eli Lilly, Pfizer Inc., and UCB, D. Gladman Grant/research support: AbbVie, Amgen, Bristol-Myers Squibb, Celgene corporation, Janssen, Pfizer Inc., Novartis and UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene corporation, Janssen, Pfizer Inc., Novartis and UCB, A. Adebajo: None declared, J. Gomez-Reino Grant/research support: Roche and Schering Plough, Consultant for: Bristol-Myers Squibb, Pfizer Inc., Roche, Schering Plough, and UCB SA, Speakers bureau: Bristol-Myers Squibb, Roche, Schering Plough, and Wyeth, J. Wollenhaupt Grant/research support: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc., and UCB, Consultant for: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc., and UCB, G. Schett Grant/research support: Abbott, Celgene Corporation, Roche, and UCB, Consultant for: Abbott, Celgene Corporation, Roche, and UCB, E. Lespessailles Grant/research support: Amgen, Eli Lilly, Novartis, and Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, and Servier, C. Hu Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, C. Edwards Grant/research support: Celgene Corporation, Pfizer Inc., Roche, and Samsung, Consultant for: Celgene Corporation, Pfizer Inc., Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc., and Roche, C. Birbara Grant/research support: Bristol-Myers Squibb, Incyte, Eli Lilly, Merck, and Pfizer Inc. DOI 10.1136/annrheumdis-2014-eular.1827
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41. AB0746 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, and the Impact of Baseline Weight and BMI on ACR20 and HAQ-DI Response: Pooled Results from 3 Phase 3, Randomized, Controlled Trials
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A. Kavanaugh, Philip J. Mease, Eric Lespessailles, Dafna D. Gladman, Jürgen Wollenhaupt, Juan J. Gomez-Reino, Maurizio Cutolo, Christopher J Edwards, Georg Schett, C. Birbara, C. Hu, Adewale Adebajo, and R. Stevens
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medicine.medical_specialty ,business.industry ,Immunology ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Acr20 response ,law.invention ,Rheumatology ,Randomized controlled trial ,law ,Baseline weight ,Internal medicine ,Phosphodiesterase 4 Inhibitor ,Clinical endpoint ,Immunology and Allergy ,Medicine ,Disease characteristics ,Apremilast ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 1, 2, and 3 compared the efficacy and safety of APR with placebo (PBO) in patients with active psoriatic arthritis (PsA) despite prior disease-modifying antirheumatic drugs and/or biologics. Objectives Assess the impact of baseline weight and body mass index (BMI) on clinical response to APR over 24 weeks in a pooled analysis. Methods Patients were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Patients with Results 1493 patients were randomized, received ≥1 dose of study medication (PBO: n=496; APR20: n=500; APR30: n=497), and were comparable across treatment groups for demographics, disease characteristics, and prior/concurrent therapy. At baseline, mean (SD) weight was 85.7 (20.6) kg and mean (SD) BMI was 29.9 (6.5) kg/m 2 . APR administration resulted in statistically significant and clinically meaningful improvement in ACR20 response (primary endpoint) in all 3 PALACE trials. APR30 was associated with significant improvements in Health Assessment Questionnaire-Disability Index (HAQ-DI) vs PBO at Week 16 (key secondary endpoint) across all 3 trials. At Week 16, similar ACR20 response rates and improvements in HAQ-DI were observed across all weight and BMI ranges (Table). A favorable treatment effect for both APR treatment groups vs PBO was observed, irrespective of baseline body weight or BMI. Overall, the treatment effect was dose-dependent, with greater effects generally observed in APR30 over APR20 patients. These treatment effects were generally maintained at Week 24. Conclusions APR demonstrated a favorable treatment effect in patients with active PsA. Comparable improvements in the signs and symptoms of PsA and physical function were observed across a broad range of baseline weight and BMI values. Results suggest no dose adjustment is required to account for baseline body weight or BMI. Disclosure of Interest G. Schett Grant/research support: Abbott, Celgene Corporation, Roche, P. Mease Grant/research support: Celgene Corporation, Novartis, and Roche, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB, D. Gladman Grant/research support: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, A. Kavanaugh Consultant for: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, A. Adebajo: None declared, J. Gomez-Reino Grant/research support: Bristol-Myers Squibb, Roche, Schering-Plough, and Wyeth; and has received research grants from Roche and Schering-Plough, Consultant for: Bristol-Myers Squibb, Pfizer Inc, Roche, Schering-Plough, and UCB SA, J. Wollenhaupt Grant/research support: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, M. Cutolo Grant/research support: Actelion, Bristol-Myers Squibb, and, E. Lespessailles Grant/research support: Amgen, Eli Lilly, Novartis, and Servier, C. Hu Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, C. Edwards Grant/research support: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, C. Birbara Grant/research support: Amgen, Bristol-Myers Squibb, Incyte, Eli Lilly, Merck, and DOI 10.1136/annrheumdis-2014-eular.1773
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42. SAT0389 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (52-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Results from the Palace 4 Phase 3, Randomized, Controlled Trial
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C. Hu, Christopher J Edwards, Paul Bird, Alan Kivitz, R. Stevens, Adewale Adebajo, K. Shah, Alvin F. Wells, and Jacob A. Aelion
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medicine.medical_specialty ,business.industry ,Immunology ,Enthesitis ,medicine.disease ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Dactylitis ,law.invention ,Psoriatic arthritis ,Rheumatology ,Randomized controlled trial ,law ,Phosphodiesterase 4 Inhibitor ,Internal medicine ,medicine ,Immunology and Allergy ,In patient ,Apremilast ,medicine.symptom ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 4 compared the efficacy/safety of APR with placebo (PBO) in patients (pts) with active PsA who were DMARD-naive. Objectives Evaluate the impact of APR treatment over 52 wks on enthesitis and dactylitis among PALACE 4 pts. Methods Pts were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Pts with Results At Wk 16, a significantly greater proportion of pts receiving APR20 or APR30 achieved the modified ACR20 response vs PBO (primary endpoint). In pts initially randomized to APR and with enthesitis (n=228) and dactylitis (n=173) at BL, APR was associated with improvements in enthesitis and dactylitis over 52 wks, as evidenced by reductions in the MASES and dactylitis count. At Wk 16, median percent changes in MASES were 0.0% (PBO), -20.0% (APR20; P =0.2948), and -50.0% (APR30; P =0.0008). In pts initially randomized to APR and completing 52 wks, median percent changes in MASES were -66.7% (APR20) and -75% (APR30) (Table); 39.6% (APR20) and 45.9% (APR30) of pts achieved a score of 0, indicating no pain at any of the entheses assessed. Median percent changes in dactylitis count at Wk 16 were -50.0% (PBO), -70.8% (APR20; P =0.0691), and -69.2% (APR30; P =0.1494). In pts initially randomized to APR and completing 52 wks, both doses resulted in a median 100% decrease in the dactylitis count; a dactylitis count of 0 was achieved in 68.6% (APR20) and 68.8% (APR30) of pts. The most common AEs reported during the PBO-controlled period were nausea (12.6%), diarrhea (9.4%), and headache (6.0%). The safety profile of APR for up to 52 wks was similar to that observed with APR for up to 24 wks of treatment (PBO-controlled period). Conclusions Among pts continuously treated with APR through 52 wks, sustained improvements in both enthesitis and dactylitis were observed in pts with active PsA, who had enthesitis and dactylitis at BL. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 wks. Disclosure of Interest C. Edwards Grant/research support: Celgene Corporation, Pfizer Inc., Roche and Samsung, Consultant for: Celgene Corporation, Pfizer Inc., Roche and Samsung, Speakers bureau: Abbott, Glaxo-Smith Kline, Pfizer Inc., and Roche, A. Wells Grant/research support: Celgene Corporation, A. Adebajo: None declared, A. Kivitz Grant/research support: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc., and UCB, Consultant for: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc., and UCB, Speakers bureau: Pfizer Inc., P. Bird Grant/research support: Celgene Corporation, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, J. Aelion Grant/research support: Ardea, AstraZeneca, Bristol-MyersSquibb, CelgeneCorporation, CentocorGalapagos, Genetech, GlaxoSmithKline, HumanGenomeSciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, NovoNordisk, PfizerInc., Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Consultant for: Ardea, AstraZeneca, Bristol-MyersSquibb, CelgeneCorporation, CentocorGalapagos, Genetech, GlaxoSmithKline, HumanGenomeSciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, NovoNordisk, PfizerInc., Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, and UCB DOI 10.1136/annrheumdis-2014-eular.1574
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43. SAT0408 Long-Term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials
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Eric Lespessailles, Georg Schett, Philip J. Mease, Dafna D. Gladman, K. Shah, Jürgen Wollenhaupt, A. Kavanaugh, Adewale Adebajo, Juan J. Gomez-Reino, C. Hu, Christopher J Edwards, C. Birbara, R. Stevens, and Maurizio Cutolo
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medicine.medical_specialty ,education.field_of_study ,Nausea ,business.industry ,Incidence (epidemiology) ,Immunology ,Population ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Discontinuation ,Rheumatology ,Randomized controlled trial ,Tolerability ,law ,Internal medicine ,medicine ,Immunology and Allergy ,Apremilast ,medicine.symptom ,education ,business ,medicine.drug - Abstract
Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 1, 2, and 3 compared the efficacy and safety of APR with placebo (PBO) in patients with active PsA despite prior conventional DMARDs and/or biologics. Objectives The overall safety and tolerability of APR was assessed in a pooled analysis of PALACE 1, 2, and 3, with APR exposure ≥52 wks. Methods Patients were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline (BL) DMARD use (yes/no). Patients with Results 1,493 patients received study medication (PBO: 495; APR20: 501; APR30: 497) and were included in the safety population. The APR-exposure period included 720 patients treated with APR20 (766.4 patient-yrs) and 721 with APR30 (769.0 patient-yrs). The nature, incidence, and severity of AEs were comparable through the 24-wk and 52-wk periods (Table). The most common AEs were diarrhea (14.3%), nausea (12.6%), headache (10.1%), URTI (10.3%), and nasopharyngitis (7.4%). Most AEs were mild or moderate in severity. Discontinuations due to AEs (APR20: 7.5%; APR30: 8.3%) were low, occurring primarily in the first 24 wks of treatment. Serious AEs (SAEs) occurred in 6.8% (APR20) and 7.2% (APR30) of patients. One death occurred (APR20) due to multiorgan failure not suspected to be treatment-related. Diarrhea and nausea were predominantly mild and occurred at a reduced incidence after the first month of dosing, with the highest incidence reported in the first 2 wks of treatment. Most cases resolved within 30 days despite continued therapy and without medical intervention. Discontinuation due to GI AEs was 4% through Wk 52, with nausea (1.7%) and diarrhea (1.5%) being the most common. There was 1 case of diarrhea and 1 case of nausea reported as an SAE in the 0 to ≥24-wk period, and no additional cases reported in the 0 to ≥52-wk period. Exposure-adjusted incidence rates of major adverse cardiac events, serious infections including systemic opportunistic infection, or malignancies were comparable to PBO. Laboratory abnormalities were infrequent and transient with no trends or patterns observed. Conclusions APR demonstrated an acceptable safety profile and was generally well tolerated through 52 wks; the nature, incidence, and severity of AEs were comparable through the 24-wk and 52-wk periods. These data do not indicate a need for laboratory monitoring. Disclosure of Interest P. Mease Grant/research support: Celgene Corporation, Novartis, and Roche, Consultant for: Abbott, Amgen, Biogen Idec, Bristol-Myers Squibb, Genentech, Janssen, Eli Lilly, Pfizer Inc, and UCB, A. Kavanaugh Grant/research support: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor-Janssen, Pfizer Inc, Roche, and UCB, D. Gladman Grant/research support: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Pfizer Inc, Novartis, and UCB, A. Adebajo: None declared, J. Gomez-Reino Grant/research support: Roche and Schering-Plough, Consultant for: Bristol-Myers Squibb, Pfizer Inc, Roche, Schering-Plough, and UCB SA, Speakers bureau: Bristol-Myers Squibb, Roche, Schering-Plough, and Wyeth, J. Wollenhaupt Grant/research support: Abbott, Bristol-Myers Squibb, MSD, Pfizer Inc, and UCB, M. Cutolo Grant/research support: Actelion, Bristol-Myers Squibb, and G. Schett Grant/research support: Abbott, Celgene Corporation, Roche, E. Lespessailles Grant/research support: Amgen, Eli Lilly, Novartis, and Servier, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, C. Edwards Grant/research support: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, C. Birbara Grant/research support: Amgen, Bristol-Myers Squibb, Incyte, Eli Lilly, Merck, and DOI 10.1136/annrheumdis-2014-eular.5589
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44. Pattern of osteoarthritis in a West African teaching hospital
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A O Adebajo
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Adult ,Male ,musculoskeletal diseases ,medicine.medical_specialty ,Knee Joint ,Immunology ,Nigeria ,Osteoarthritis ,Hand disease ,General Biochemistry, Genetics and Molecular Biology ,Teaching hospital ,Joint disease ,Sex Factors ,Rheumatology ,Internal medicine ,Epidemiology ,medicine ,Humans ,Immunology and Allergy ,Prospective Studies ,Hospitals, Teaching ,Prospective cohort study ,Aged ,business.industry ,Age Factors ,Middle Aged ,medicine.disease ,Spine ,West african ,Chronic Disease ,Etiology ,Physical therapy ,Female ,business ,Research Article - Abstract
The study of the pattern of osteoarthritis in different populations may yield valuable aetiological clues and also allow subtypes to be defined. Over one year 252 osteoarthritic joints from 140 patients seen at a West African teaching hospital were prospectively reviewed. The knee was the joint most often affected. Hip and hand disease, as well as Heberden's nodes, were uncommon. Joint disease was predominantly monoarticular; no patient had three or more sites affected.
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45. High levels of unprotected anal intercourse and never testing for HIV among men who have sex with men in Nigeria: evidence from a cross-sectional survey for the need for innovative approaches to HIV prevention
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Vu, Lung, primary, Andrinopoulos, Katherine, additional, Tun, Waimar, additional, and Adebajo, Sylvia, additional
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- 2013
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46. LB0001 Long-Term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis
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Kavanaugh, A., primary, Mease, P. J., additional, Adebajo, A. O., additional, Wollenhaupt, J., additional, Hu, C., additional, Shah, K., additional, Stevens, R. M., additional, and Gomez-Reino, J. J., additional
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47. FRI0446 A national audit of patients with rheumatoid arthritis of black and minority ethnic origin
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Panchal, S., primary, Moorthy, A., additional, Hayat, S., additional, Pande, I., additional, Adebajo, A.O., additional, Chakravarty, K., additional, and Samanta, A., additional
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- 2013
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48. SAT0299 Apremilast: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials in patients with Psoriatic Arthritis
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Mease, P. J., primary, Kavanaugh, A., additional, Adebajo, A. O., additional, Gomez-Reino, J. J., additional, Wollenhaupt, J., additional, Cutolo, M., additional, Schett, G., additional, Lespessailles, E., additional, Shah, K., additional, Hu, C., additional, Stevens, R., additional, Edwards, C. J., additional, and Birbara, C. A., additional
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49. FRI0446 A national audit of patients with rheumatoid arthritis of black and minority ethnic origin
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Arumugam Moorthy, Adewale Adebajo, K. Chakravarty, Ash Samanta, S. Hayat, Ira Pande, and Sonia Panchal
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medicine.medical_specialty ,education.field_of_study ,Referral ,business.industry ,Immunology ,Population ,Ethnic origin ,Guideline ,General Biochemistry, Genetics and Molecular Biology ,Rheumatology ,Internal medicine ,Family medicine ,Cohort ,Physical therapy ,Immunology and Allergy ,Medicine ,Outpatient clinic ,Health education ,business ,education - Abstract
Background The National Institute for Health & Clinical Excellence (NICE) issued guidelines for the management of rheumatoid arthritis (RA). It proposes urgent referral for specialist treatment if more than three months delay since symptom onset; offer combination disease modifying anti-rheumatic drugs (DMARDs) as first line treatment and if not appropriate to initiate monotherapy with fast escalation 1 . The British Society of Rheumatology (BSR) conducted a national audit to determine the speed of referral and onset of DMARD therapy 2 in RA patients. There were delays from onset of symptoms to referral, review by specialists and diagnosis to DMARD therapy. There is a perception there may be differences between ethnic groups in time of onset of symptoms to referral to a specialist centre and further institution of DMARDs. Objectives We aimed to audit the above features in centres that are geographically located within areas containing a high BME population. Methods Four centres were identified and a prospective proforma was devised and piloted. Consecutive BME RA patients on DMARDS that attended outpatient clinics were audited over an 8 week period and analysed. A brief comparison with a cohort of 23 Caucasian patients collected contemporaneously from Leicester was made in addition to the BSR National DMARD audit. Results In total 101 patients were audited. 81% female with average age 50-59 years and disease duration of 6-10 years. 46% were Asian, 23% Afro-Caribbean and 23% Caucasian. 38% (BME group) compared with 7% (Caucasians) had more than six-months time delay from symptom onset to specialist referral. Time from referral to specialist treatment greater than three months was 24% BME group vs. 14% Caucasian group vs. 7% BSR group. 21% BME group vs. 3% Caucasian group vs. 18.7% BSR group had a delay of more than three months from diagnosis to initiation of DMARD therapy. 19% of the BME group had monotherapy in comparison to 16% of the Caucasian group. 22% of the BME group had biologic therapy with an average of 2-5 years post diagnosis, whilst no Caucasians had biologic therapy. Conclusions Our results highlight differences in time from presentation and initiation of treatment for RA patients of BME origin. There may be a range of ethnically specific culturally centred reasons for such delays 3,4 . Culturally different migrant and non-migrant internal or national minorities can inadvertently become the objects of discrimination and exclusion. It is paramount that we gain further understanding of these reasons and cultural differences in order to educate and facilitate appropriate healthcare and support within this population. By empowering individual patients and their communities through culturally appropriate health education we can hopefully encourage patients to seek medical attention early and engage in the benefits of potentially toxic DMARDs and Biologics. References NICE Clinical Guideline 79, February 2009 www.rheumatology.org.uk Kumar et al. Delay in presentation to primary care physicians is the main reason why patients with rheumatoid arthritis are seen late by rheumatologists. Rheumatology 2007 46(9): 1438-1440 Kumar et al. The influence of ethnicity on the extent of, and reasons underlying, delay in general practitioner consultation in patients with RA. Rheumatology 2010 49(5): 1005-1012 Disclosure of Interest None Declared
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50. LB0001 Long-Term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis
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Juan J. Gomez-Reino, R. Stevens, K. Shah, Jürgen Wollenhaupt, P. J. Mease, A. Kavanaugh, Adewale Adebajo, and C. Hu
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medicine.medical_specialty ,business.operation ,business.industry ,Abbott Laboratories ,Immunology ,Placebo ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Safety profile ,Psoriatic arthritis ,Rheumatology ,Randomized controlled trial ,law ,Phosphodiesterase 4 Inhibitor ,Internal medicine ,Immunology and Allergy ,Medicine ,In patient ,Apremilast ,business ,medicine.drug - Abstract
Background Apremilast (APR) modulates a network of pro- and anti-inflammatory mediators. Objectives The PALACE 1 study compared the efficacy and safety of APR with placebo (PBO) in patients with active PsA despite prior DMARDs and/or biologics over 24 wks. At wk 24, all patients were randomized to APR through wk 52. Methods Patients were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). At wk 16, patients with Results 504 patients were randomized. At wk 16, significantly more APR20 (31.3%; P =0.0140) and APR30 patients (40.0%; P Conclusions Apremilast administered to patients with PsA beyond 24 wks continued to demonstrate meaningful clinical response. For patients who completed 52 wks of the study, ACR20 response rates up to 65% were observed. Apremilast continued to be well tolerated with an acceptable longer-term safety profile. Disclosure of Interest A. Kavanaugh Grant/research support from: Abbott, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Celgene, Centocor-Janssen, Pfizer, Roche and UCB, P. Mease Grant/research support from: Abbvie, Amgen, BiofenIdec, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Glaxo SmithKline, Lilly, Merck, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Amgen, BiofenIdec, Bristol-Myers Squibb, Genentech, Janssen, Glaxo SmithKline, Lilly, Pfizer, UCB, A. Adebajo: None Declared, J. Wollenhaupt Consultant for: Abbott Laboratories, Bristol-Myers Squibb, MSD, Pfizer and UCB, C. Hu Employee of: Celgene Corporation, K. Shah Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, J. Gomez-Reino Grant/research support from: Roche and Schering-Plough, Consultant for: Bristol-Myers Squibb, Pfizer, Roche, Schering-Plough and UCB SA, Speakers bureau: Bristol-Myers Squibb, Roche, Schering-Plough and Wyeth
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- 2013
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