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253 results on '"Swearingen, Christopher J"'

3. Lorecivivint, a Novel Intraarticular CDC‐like Kinase 2 and Dual‐Specificity Tyrosine Phosphorylation‐Regulated Kinase 1A Inhibitor and Wnt Pathway Modulator for the Treatment of Knee Osteoarthritis: A Phase II Randomized Trial

Author

Yazici, Yusuf, McAlindon, Timothy E, Gibofsky, Allan, Lane, Nancy E, Clauw, Daniel, Jones, Morgan, Bergfeld, John, Swearingen, Christopher J, DiFrancesco, Anita, Simsek, Ismail, Tambiah, Jeyanesh, and Hochberg, Marc C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Arthritis, Chronic Pain, Clinical Trials and Supportive Activities, Aging, Cancer, Pain Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Musculoskeletal, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Imidazoles, Indazoles, Injections, Intra-Articular, Male, Middle Aged, Osteoarthritis, Knee, Pain Measurement, Protein Kinase Inhibitors, Protein Serine-Threonine Kinases, Protein-Tyrosine Kinases, Pyridines, Treatment Outcome, Wnt Signaling Pathway, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectiveTo assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to severely symptomatic knee osteoarthritis (OA).MethodsSubjects in this 52-week, phase IIa, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial received a single 2-ml intraarticular injection of lorecivivint (dose of 0.03 mg, 0.07 mg, or 0.23 mg) or placebo. Efficacy was assessed based on change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score subscales for pain and function (scale 0-100 for each) and change from baseline in the radiographic medial joint space width (JSW). Baseline-adjusted analysis of covariance with multiple imputation was performed separately to evaluate efficacy. This proof-of-concept study evaluated the intent-to-treat population as well as a prespecified group of subjects with unilateral symptoms of knee OA (designated UNI) and an additional post hoc subgroup of subjects with unilateral symptoms but without widespread pain (designated UNI WP-).ResultsIn this trial, 455 subjects were randomized to a treatment group. The primary end point, significant improvement in the WOMAC pain score compared with placebo at week 13, was not met by any lorecivivint dose group (mean ± SD change from baseline, -23.3 ± 2.2 in the 0.03 mg group, -23.5 ± 2.1 in the 0.07 mg group, -21.3 ± 2.2 in the 0.23 mg group, and -22.1 ± 2.1 in the placebo group; each P > 0.05 versus placebo). All groups (including placebo) demonstrated clinically meaningful (≥20-point) improvements from baseline in the WOMAC pain score. The durability of response was evaluated through week 52. In the prespecified UNI group and post hoc UNI WP- group at week 52, treatment with 0.07 mg lorecivivint significantly improved the WOMAC pain score (between-group difference versus placebo, -8.73, 95% confidence interval [95% CI] -17.44, -0.03 [P = 0.049] and -11.21, 95% CI -20.99, -1.43 [P = 0.025], respectively) and WOMAC function score (between-group difference versus placebo, -10.26, 95% CI -19.82, -0.69 [P = 0.036] and -13.38, 95% CI -24.33, -2.43 [P = 0.017], respectively). Relative to baseline, the mean change in the medial JSW at week 52 was -0.04 mm in the 0.03 mg cohort, -0.09 mm in the 0.07 mg cohort, -0.16 mm in the 0.23 mg cohort, and -0.14 mm in the placebo cohort; no treatment group achieved a significant change in medial JSW compared with placebo at week 52. In both unilateral symptom subgroups, the 0.07 mg lorecivivint dose significantly increased medial JSW compared with placebo at week 52 (medial JSW 0.39 mm, 95% CI 0.06, 0.72 in the UNI group [P = 0.021] and 0.42 mm, 95% CI 0.04, 0.80 in the UNI WP- group [P = 0.032]). Changes observed in the 0.03 mg and 0.23 mg dose groups were not significantly different from those in the placebo group for any of these measures. Lorecivivint appeared safe and well tolerated.ConclusionThis phase IIa, proof-of-concept trial in patients with symptomatic knee OA did not meet its primary end point. Nevertheless, the study identified a target population in whom to evaluate the potential efficacy of lorecivivint for the treatment of knee OA.

Published
2020

7. Associations of Cost Sharing With Rheumatoid Arthritis Disease Burden

Author

Dowell, Sharon, primary, Swearingen, Christopher J., additional, Pedra‐Nobre, Manuela, additional, Wollaston, Dianne, additional, Najmey, Sawsan, additional, Elliott, Cynthia Lawrence, additional, Ford, Theresa Lawrence, additional, North, Heather, additional, Dore, Robin, additional, Dolatabadi, Soha, additional, Ramanujam, Thaila, additional, Kennedy, Stacy, additional, Ott, Stephanie, additional, Jileaeva, Ilona, additional, Richardson, Amina, additional, Wright, Grace, additional, and Kerr, Gail S., additional

Published
2023
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21. sj-pdf-1-ajs-10.1177_03635465211067201 ��� Supplemental material for Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint

Author

Tambiah, Jeyanesh R.S., Simsek, Ismail, Swearingen, Christopher J., Kennedy, Sarah, Cole, Brian J., McAlindon, Timothy E., and Yazici, Yusuf

Subjects
FOS: Clinical medicine, 110323 Surgery, 110604 Sports Medicine, FOS: Health sciences, 110314 Orthopaedics
Abstract

Supplemental material, sj-pdf-1-ajs-10.1177_03635465211067201 for Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint by Jeyanesh R.S. Tambiah, Ismail Simsek, Christopher J. Swearingen, Sarah Kennedy, Brian J. Cole, Timothy E. McAlindon and Yusuf Yazici in The American Journal of Sports Medicine

Published
2022
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32. Differences in clinical manifestations, treatment, and concordance rates with two major sets of criteria for Behçet’s syndrome for patients in the US and Japan: data from a large, three-center cohort study

Author

Kobayashi, Tatsuo, Kishimoto, Mitsumasa, Swearingen, Christopher J., Filopoulos, Maria T., Ohara, Yuri, Tokuda, Yasuharu, Oshikawa, Hideto, Yoshida, Kazuki, Utsunomiya, Masako, Kimura, Makiko, Okada, Masato, Matsui, Kazuo, and Yazici, Yusuf

Published
2013
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48. Tau pathology reduction with SM07883, a novel, potent, and selective oral DYRK1A inhibitor: A potential therapeutic for Alzheimer's disease

Author

Melchior, Benoît, primary, Mittapalli, Gopi Kumar, additional, Lai, Carolyn, additional, Duong‐Polk, Karen, additional, Stewart, Joshua, additional, Güner, Bora, additional, Hofilena, Brian, additional, Tjitro, Amanda, additional, Anderson, Scott D., additional, Herman, David S., additional, Dellamary, Luis, additional, Swearingen, Christopher J., additional, Sunil, K.C., additional, and Yazici, Yusuf, additional

Published
2019
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49. Adherence to guidelines for the treatment of Behçet's syndrome in New York and Amsterdam

Author

Kerstens, Floor G., Turkstra, Franktien, Atalay, Selma, van Vugt, Richard M., Swearingen, Christopher J., Yazici, Yusuf, Rheumatology, and AII - Inflammatory diseases

Abstract

Objective. To assess adherence to published guidelines for the treatment of Behçet's syndrome (BS) in two geographic areas. Methods. We extracted guideline statements from the 2008 EULAR recommendations. Adherence to these statements was evaluated retrospectively in both New York (USA) and Amsterdam (The Netherlands), by reviewing records from patients fulfilling the ISG criteria. We analysed data per statement and event, and divided data according to the year in which an event occurred. We compared events prior to 2009 to those after publication of the EULAR recommendations (2009 and later). Results. 474 patients were evaluated, 24 of whom were from Amsterdam. Treatment adherence varied substantially across various Behçet's manifestations, ranging from 21% vs. 31% in posterior uveitis, 50% vs. 25% in arterial disease, 29% vs. 29% in arthritis and 38% vs. 55% in erythema nodosum to 65% vs. 67% in deep venous thrombosis (DVT), before and after publication of the guidelines respectively. Topical treatment of mucocutaneous disease was only 2% vs. 8%, whereas adherence in neuro-Behçet was ≥94% and 100% in gastrointestinal disease. Conclusion. Adherence to treatment guidelines varies substantially by Behçet manifestation. Lack of adherence in manifestations such as eye disease and arthritis suggests that current recommendations are not sufficient or other concurrent manifestations require more aggressive treatment. The extensive use of anti-TNF agents might indicate a shift towards more aggressive treatment. Thus, our results suggest the 2008 guidelines were not in line with treatment in clinical practice over the past years and the recent revision of the recommendations was indeed needed.

Published
2017

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