10 results on '"DeLozier, Amy"'
Search Results
2. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7
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Thyssen, Jacob P., Buhl, Timo, Fernández-Peñas, Pablo, Kabashima, Kenji, Chen, Sherry, Lu, Na, DeLozier, Amy M., Casillas, Marta, and Ständer, Sonja
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- 2021
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3. Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial
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Michaud, Kaleb, Pope, Janet E., Emery, Paul, Zhu, Baojin, Gaich, Carol L., DeLozier, Amy M., Zhang, Xiang, Dickson, Christina L., and Smolen, Josef S.
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- 2019
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4. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate‐to‐severe atopic dermatitis with inadequate response, intolerance or contraindication to ciclosporin: results from a randomized, placebo‐controlled, phase III clinical trial (BREEZE‐AD4)*
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Bieber, Thomas, Reich, Kristian, Paul, Carle, Tsunemi, Yuichiro, Augustin, Matthias, Lacour, Jean‐Philippe, Ghislain, Pierre‐Dominique, Dutronc, Yves, Liao, Ran, Yang, Fan E., Brinker, Dennis, DeLozier, Amy M., Meskimen, Eric, Janes, Jonathan M., and Eyerich, Kilian
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CLINICAL trials ,ATOPIC dermatitis ,PHARYNGITIS ,BARICITINIB ,ITCHING ,CYCLOSPORINE ,VENOUS thrombosis - Abstract
Summary: Background: Baricitinib, an oral selective Janus kinase (JAK)1 and JAK 2 inhibitor, was shown to improve the signs and symptoms of moderate‐to‐severe atopic dermatitis (AD). Objectives: To evaluate the efficacy and safety of baricitinib with background topical corticosteroids (TCS) in patients with moderate‐to‐severe AD and inadequate response, intolerance or contraindication to ciclosporin A (CA). Methods: In this double‐blind, randomized, placebo‐controlled, phase III study, patients were randomized 1: 1: 2: 1 to placebo (N = 93), baricitinib 1 mg (N = 93), 2 mg (N = 185) or 4 mg (N = 92) with background TCS. The primary endpoint was the proportion of patients receiving baricitinib 4 mg or 2 mg (+ TCS) vs. placebo + TCS who achieved ≥ 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) at week 16. Results: Baricitinib 4 mg + TCS was superior to placebo + TCS for EASI 75 (4 mg: 32%, placebo: 17%, P = 0·031) at week 16 and for improvements in itch, skin pain and number of night‐time awakenings owing to itch. Improvements were maintained through 52 weeks of treatment. Treatment‐emergent adverse events (TEAEs) were more common with baricitinib than placebo (+ TCS); most were mild or moderate. The most frequent TEAEs with baricitinib 4 mg + TCS were nasopharyngitis, herpes simplex, influenza and headache. No deaths or deep vein thromboses were reported. Conclusions: Baricitinib 4 mg + TCS improved the signs and symptoms of moderate‐to‐severe AD through 52 weeks of treatment in patients with inadequate response, intolerance or contraindication to CA. The safety profile was consistent with previous studies of baricitinib in moderate‐to‐severe AD. What is already known about this topic?Ciclosporin A is indicated for the treatment of atopic dermatitis that is refractory to topical therapies. However, its use is limited by safety concerns and it may not provide adequate response for some patients.Baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor, has been shown to improve the signs and symptoms of moderate‐to‐severe atopic dermatitis as a monotherapy or in combination with topical corticosteroids. What does this study add?Baricitinib combined with background low‐ or moderate‐potency topical corticosteroids provided improvements in the signs and symptoms of moderate‐to‐severe atopic dermatitis through 1 year of treatment in patients with a contraindication, intolerance or failure to respond to ciclosporin A.The most common treatment‐emergent adverse events with baricitinib 4 mg were nasopharyngitis, herpes simplex, influenza and headache.The safety profile was consistent with previous studies in patients with moderate‐to‐severe atopic dermatitis. [ABSTRACT FROM AUTHOR]
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- 2022
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5. Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study.
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Rosmarin, David, Fretzin, Scott, Strowd, Lindsay, Casillas, Marta, DeLozier, Amy M., Dawson, Zach, Chen, Sherry, Lu, Na, and Thyssen, Jacob P.
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Background: Skin pain (discomfort/soreness) is a common symptom associated with atopic dermatitis (AD). Objective: To evaluate rapid changes in skin pain severity with baricitinib, and its impact on patient quality of life (QoL) in adults with moderate-to-severe AD who were inadequate responders to topical therapy. Methods: Adult patients with moderate-to-severe AD who were inadequate responders to topical therapies (N = 440, BREEZE-AD5 [NCT03435081]) were randomized to once-daily placebo, baricitinib 1 mg, or baricitinib 2 mg for 16 weeks. Change in Skin Pain Numeric Rating Scale (NRS) scores were assessed for the randomized population. Skin Pain NRS and Dermatology Life Quality Index (DLQI) scores were assessed for Skin Pain Response groups and patients with Body Surface Area (BSA) 10% to 50%. Results: Skin Pain NRS improvement was significant versus placebo by day 1 baricitinib 2 mg (least squares mean [LSM] difference −4.4%, P =.048) and by day 2 for baricitinib 1 mg (−6.7%, P =.011). As measured weekly, improvement was significant starting at Week 1 and remained significant through Week 16 for both doses. At Week 16, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI (P <.0001). At week 16, LSM DLQI change from baseline was −11.1 for all Skin Pain NRS responders versus −3.5 for nonresponders (P <.0001). Patients with BSA 10% to 50% showed similar trends. Conclusions: Patients with moderate-to-severe AD, treated with baricitinib, reported rapid improvements in skin pain severity by day 1 for baricitinib 2 mg and day 2 for baricitinib 1 mg and remained effective through 16 weeks of treatment, which positively impacted patient QoL. [ABSTRACT FROM AUTHOR]
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- 2022
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6. Improvement in sleep and itch and enhanced quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a phase 3 trial of baricitinib therapy.
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Lio, Peter A., Simpson, Eric L., Han, George, Soung, Jennifer, Ball, Susan, Sun, Luna, Casillas, Marta, DeLozier, Amy M., Ding, Yuxin, and Eichenfield, Lawrence F.
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ATOPIC dermatitis ,ITCHING ,CLINICAL trials ,BARICITINIB ,SLEEP - Abstract
Baricitinib previously demonstrated improvements in itch and sleep disturbance versus placebo in adults with moderate-to-severe atopic dermatitis (AD). Examine if itch and sleep improvements are associated with better quality of life (QoL) and productivity in patients with AD. Data were drawn from BREEZE-AD5 (NCT03435081). Itch and sleep improvement at Week 16 were defined using ≥4-point improvements in the Itch Numeric Rating Scale and ≥1.5 decreases in the number of nighttime awakenings since baseline, respectively. Patients with and without improvements were compared on Dermatology Life Quality Index (DLQI) and Work Productivity and Activity Impairment-AD scores. Changes from baseline were analyzed using ANCOVA with last observation carried forward. Proportions were analyzed using logistic regression with non-responder imputation. Greater proportions of patients with versus without itch improvement indicated no impact of AD on QoL (37.7 vs. 1.8%). Patients with itch improvement had greater decreases in work time impaired (−29.3 vs. −5.6%). More patients with versus without sleep improvement reported no effect of AD on QoL (25.5 vs. 1.1%); patients with better sleep experienced larger reductions in work time spent impaired (−33.3 vs. −6.1%). Patients with AD who experienced itch and sleep improvement had significantly better QoL and productivity. [ABSTRACT FROM AUTHOR]
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- 2022
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7. Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5).
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Simpson, Eric L., Forman, Seth, Silverberg, Jonathan I., Zirwas, Matthew, Maverakis, Emanual, Han, George, Guttman-Yassky, Emma, Marnell, Daniel, Bissonnette, Robert, Waibel, Jill, Nunes, Fabio P., DeLozier, Amy M., Angle, Robinette, Gamalo, Margaret, Holzwarth, Katrin, Goldblum, Orin, Zhong, Jinglin, Janes, Jonathan, and Papp, Kim
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Background: Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults.Objective: To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy.Methods: Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with ≥2-point improvement.Results: At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P < .001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P < .001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies.Limitations: Short-term clinical trial results may not be generalizable to real-world settings.Conclusion: Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks. [ABSTRACT FROM AUTHOR]- Published
- 2021
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8. Conversion of Functional Assessment of Chronic Illness Therapy–Fatigue to Patient‐Reported Outcomes Measurement Information System Fatigue Scores in Two Phase III Baricitinib Rheumatoid Arthritis Trials.
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Bingham, Clifton O., Bartlett, Susan J., Kannowski, Carol, Sun, Luna, DeLozier, Amy M., and Cella, David
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CHRONIC diseases ,RHEUMATOID arthritis ,BARICITINIB ,HEALTH outcome assessment ,CLINICAL trials - Abstract
Objective: The Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐F) is validated for measuring fatigue in rheumatoid arthritis (RA). However, 10 of 13 FACIT‐F items are identified as relevant to patients with RA. The Patient‐Reported Outcomes Measurement Information System (PROMIS) uses an item response theory–calibrated T score metric. The PROMIS Fatigue item bank includes the FACIT‐F items, enabling score conversion. The performance of converted PROMIS Fatigue scores has not been evaluated in RA populations or clinical trials. Our objective was to assess the performance of converted PROMIS Fatigue scores in 2 RA clinical trials of baricitinib. Methods: Crosswalk tables and pattern‐scoring methods converted FACIT‐F scores to PROMIS Fatigue for both the 13‐item FACIT‐F and the 10‐item RA‐optimized FACIT‐F instrument, in 2 RA clinical trials evaluating baricitinib, RA‐BEAM, and RA‐BEACON. RA‐BEAM patients had an inadequate response to methotrexate. RA‐BEACON patients had an inadequate response or intolerance to ≥1 tumor necrosis factor inhibitor. Baricitinib was compared to all treatment arms via analysis of covariance on PROMIS Fatigue score conversions. Results: Baseline FACIT‐F–derived PROMIS Fatigue scores reflected severe fatigue across treatment groups and were similar using different scoring methods. At week 24 in both studies, baricitinib was associated with clinically meaningful improvements in PROMIS Fatigue scores. PROMIS Fatigue scores were consistent for conversion methods and for the 13‐item or 10‐item FACIT‐F. Conclusion: All 4 conversion methods showed differentiation of active treatment compared with placebo from week 12, supporting the use of the PROMIS Fatigue and converting the 10‐item FACIT‐F to assess fatigue and demonstrate treatment benefit in RA clinical trials on a standardized metric. [ABSTRACT FROM AUTHOR]
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- 2021
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9. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study.
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Guttman-Yassky, Emma, Silverberg, Jonathan I., Nemoto, Osamu, Forman, Seth B., Wilke, August, Prescilla, Randy, de la Peña, Amparo, Nunes, Fabio P., Janes, Jonathan, Gamalo, Margaret, Donley, David, Paik, Jim, DeLozier, Amy M., Nickoloff, Brian J., and Simpson, Eric L.
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Background Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. Objectives The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). Methods In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. Results Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [ P =.027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%). Limitations A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. Conclusions Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD. [ABSTRACT FROM AUTHOR]
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- 2019
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10. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)
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Bernard Combe, Amy M. DeLozier, Joel M. Kremer, Li Xie, Josef S Smolen, Ivaylo Stoykov, Mark C. Genovese, Terence Rooney, Paul Bird, Juan Sanchez Burson, Douglas E Schlichting, Carol L. Gaich, [Smolen, Josef S.] Med Univ Vienna, Vienna, Austria, [Smolen, Josef S.] Hietzing Hosp, Vienna, Austria, [Kremer, Joel M.] Albany Med Coll, Albany, NY 12208 USA, [Gaich, Carol L.] Eli Lilly & Co, Indianapolis, IN 46285 USA, [DeLozier, Amy M.] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Schlichting, Douglas E.] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Xie, Li] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Stoykov, Ivaylo] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Rooney, Terence] Eli Lilly & Co, Indianapolis, IN 46285 USA, [Bird, Paul] Univ New South Wales, Sydney, NSW, Australia, [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Rheumatol, Seville, Spain, [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Ophthalmol, Seville, Spain, [Sanchez Burson, Juan Miguel] Valme Univ Hosp, Div Immunol, Seville, Spain, [Genovese, Mark C.] Stanford Univ, Med Ctr, Palo Alto, CA 94304 USA, [Combe, Bernard] Univ Montpellier, Lapeyronie Hosp, Montpellier, France, Eli Lilly and Company, Incyte Corporation, Medizinische Universität Wien = Medical University of Vienna, Albany Medical College, University of New South Wales [Sydney] (UNSW), Valme University Hospital, Stanford University Medical Center, Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Albany medical college, University of New South Wales [Sydney] ( UNSW ), Institut de Génétique Moléculaire de Montpellier ( IGMM ), and Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS )
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Baricitinib ,[SDV]Life Sciences [q-bio] ,Arthritis ,Efficiency ,DMARDs (biologic) ,Clinical-trials ,Logistic regression ,Severity of Illness Index ,Arthritis, Rheumatoid ,0302 clinical medicine ,Surveys and Questionnaires ,Immunology and Allergy ,030212 general & internal medicine ,Pain Measurement ,Sulfonamides ,Connective tissue disease ,3. Good health ,Outcomes research ,Rheumatoid arthritis ,DMARDs (synthetic) ,Adult ,medicine.medical_specialty ,Immunology ,Rheumatoid Arthritis ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Patient perspective ,Abatacept ,03 medical and health sciences ,Young Adult ,Rheumatology ,Double-Blind Method ,Internal medicine ,Disease-activity ,medicine ,Improvement ,Humans ,Necrosis-factor inhibitors ,In patient ,Patient Reported Outcome Measures ,Protein Kinase Inhibitors ,030203 arthritis & rheumatology ,[ SDV ] Life Sciences [q-bio] ,business.industry ,Questionnaire ,Presenteeism ,Clinical and Epidemiological Research ,medicine.disease ,Methotrexate ,Purines ,Tofacitinib ,Physical therapy ,Quality of Life ,Azetidines ,Pyrazoles ,Quality-of-life ,Therapy ,business - Abstract
Objectives To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to >= 1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI = 1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).Methods In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.Results 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI = 3.56; p
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- 2017
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