Search

Your search keyword '"Abrams, Ken"' showing total 47 results
Start Over Author "Abrams, Ken"
47 results on '"Abrams, Ken"'

7. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab

Author

Grom, Alexei A., Ilowite, Norman T., Pascual, Virginia, Brunner, Hermine I., Martini, Alberto, Lovell, Daniel, Ruperto, Nicolino, Leon, Karolynn, Lheritier, Karine, Abrams, Ken, Cuttica, Ruben, Emminger, Wolfgang, Goffin, Laurence, Joos, Rik, Lauwerys, Bernard, Wouters, Carine, Hilário, Maria Odete Esteves, de Oliveira, Sheila Knupp Feitosa, Len, Claudio, Radominski, Sebastiao, Sztajnbok, Flavio Roberto, Haddad, Elie, Hofer, Michael, Houghton, Kristin, Huber, Adam, Saurenmann, Traudel, Schneider, Rayfel, Tucker, Lori, Bader-Meunier, Brigitte, Desjonqueres, Marine, Fischbach, Michel, Kone-Paut, Isabelle, Marie, Isabelle, Mogenet, Agnes, Mouy, Richard, Quartier, Pierre, Berner, Reinhard, Foeldvari, Ivan, Foell, Dirk, Frosch, Michael, Haas, Johannes-Peter, Horneff, Gerd, Hufnagel, Markus, Kallinich, Tilmann, Kuemmerle-Deschner, Jasmin, Lehmann, Hartwig, Lutz, Thomas, Thon, Angelika, Trauzeddel, Ralf, Tzaribachev, Nikolay, Weibarth-Riedel, Elisabeth, Chrousos, Georgios, Trachana, Maria, Vougiouka, Olga, Constantin, Tamas, Barash, Judith, Berkun, Yackov, Brik, Riva, Harel, Liora, Nahum, Amit, Pade, Shay, Uziel, Yosef, Alessio, Maria, Cimaz, Rolando, Corona, Fabrizia, Gerloni, Valeria, Wulffraat, N. M., Ferrandiz, Manuel, Rutkowska-Sak, Lidia, Alekseeva, Ekaterina, Chasnyk, Vyacheslav, Nasonov, Evgeny, Stanislav, Marina, Anton, Jordi, Calvo, Inmaculada, Gamir, Mari Luz, Robledillos, Juan Carlos, Magnusson, Bo, Erguven, Muferet, Kasapcopur, Ozgur, Ozdogan, Huri, Ozen, Seza, Unsal, Erbil, Chieng, Alice, Foster, Helen, McCann, Liza, Ramanan, Athimalaip, Southwood, Taunton, Wilkinson, Nicholas, Woo, Patricia, Higgins, Gloria Christine, Kingsbury, Daniel, Lopez-Benitez, Jorge, Marzan, Katherine, Morris, Paula, Natter, Marc, and Schikler, Kenneth Noel

Published
2016
Full Text
View/download PDF

8. Characterization Of Changes In Gene Expression and Inflammatory Proteins In Systemic Juvenile Idiopathic Arthritis Patients On Canakinumab Therapy.: 1692

Author

Nirmala, Nanguneri R, Wulffraat, Nico, Brunner, Hermine, Quartier, Pierre, Brik, Riva, McCann, Liza, Ozdogan, Huri, Rutkowska-Sak, Lidia, Schneider, Rayfel, Gerloni, Valeria, Harel, Liora, Terreri, Maria, Houghton, Kristin, Joos, Rik, Kingsbury, Daniel, Lopez-Benitez, Jorge M., Brachat, Arndt, Bek, Stephan, Schumacher, Martin, Valentin, Marie-Anne, Gram, Hermann, Abrams, Ken, Martini, Alberto, Ruperto, Nicolino, and Lovell, Daniel J.

Published
2013

9. Zoledronic acid and clinical fractures and mortality after hip fracture

Author

Lyles, Kenneth W., Colon-Emeric, Cathleen S., Magaziner, Jay S., Adachi, Jonathan D., Pieper, Carl F., Mautalen, Carlos, Hyldstrup, Lars, Recknor, Chris, Nordsletten, Lars, Moore, Kathy A., Lavecchia, Catherine, Jie Zhang, Mesenbrink, Peter, Hodgson, Patricia K., Abrams, Ken, Orloff, John J., Horowitz, Zebulun, Eriksen, Erik Fink, and Boonen, Steven

Subjects
Zoledronic acid -- Patient outcomes, Zoledronic acid -- Research, Hip joint -- Fractures, Hip joint -- Drug therapy, Hip joint -- Care and treatment, Hip joint -- Prevention
Abstract

The effectiveness of zoledronic acid in prevention of new clinical fractures, to patients undergone hip fracture surgery is studied. Results concluded yearly infusion of zoledronic acid within 90 days of hip fracture surgery reduced risk of new clinical fractures raising survival rate.

Published
2007

11. Two Randomized Trials of Canakinumab in Systemic Juvenile Idiopathic Arthritis

Author

Ruperto, Nicolino, Brunner, Hermine I., Quartier, Pierre, Constantin, Tamás, Wulffraat, Nico, Horneff, Gerd, Brik, Riva, McCann, Liza, Kasapcopur, Ozgur, Rutkowska-Sak, Lidia, Schneider, Rayfel, Berkun, Yackov, Calvo, Inmaculada, Erguven, Muferet, Goffin, Laurence, Hofer, Michael, Kallinich, Tilmann, Oliveira, Sheila K., Uziel, Yosef, Viola, Stefania, Nistala, Kiran, Wouters, Carine, Cimaz, Rolando, Ferrandiz, Manuel A., Flato, Berit, Gamir, Maria Luz, Kone-Paut, Isabelle, Grom, Alexei, Magnusson, Bo, Ozen, Seza, Sztajnbok, Flavio, Lheritier, Karine, Abrams, Ken, Kim, Dennis, Martini, Alberto, and Lovell, Daniel J.

Published
2012
Full Text
View/download PDF

12. Secukinumab Efficacy in Psoriatic Arthritis

Author

Gottlieb, Alice B., primary, Mease, Philip J., additional, Kirkham, Bruce, additional, Nash, Peter, additional, Balsa, Alejandro C., additional, Combe, Bernard, additional, Rech, Jürgen, additional, Zhu, Xuan, additional, James, David, additional, Martin, Ruvie, additional, Ligozio, Gregory, additional, Abrams, Ken, additional, and Pricop, Luminita, additional

Published
2020
Full Text
View/download PDF

14. OP0055 EFFICACY OF CANAKINUMAB, ON A REDUCED DOSE OR A PROLONGED DOSE INTERVAL WITHOUT CONCOMITANT CORTICOSTEROIDS AND METHOTREXATE, IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

Author

Quartier, Pierre, primary, Alexeeva, Ekaterina, additional, Wouters, Carine, additional, Calvo, Inmaculada, additional, Kallinich, Tilmann, additional, Wulffraat, Nico, additional, Wei, Xiaoling, additional, Slade, Alan, additional, Abrams, Ken, additional, and Martini, Alberto, additional

Published
2019
Full Text
View/download PDF

16. Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open‐Label, Randomized Study.

Author

Quartier, Pierre, Alexeeva, Ekaterina, Constantin, Tamàs, Chasnyk, Vyacheslav, Wulffraat, Nico, Palmblad, Karin, Wouters, Carine, I. Brunner, Hermine, Marzan, Katherine, Schneider, Rayfel, Horneff, Gerd, Martini, Alberto, Anton, Jordi, Wei, Xiaoling, Slade, Alan, Ruperto, Nicolino, Abrams, Ken, Emminger, W., Ulbrich, A., and Fodor, S.

Subjects
THERAPEUTIC use of monoclonal antibodies, SUBCUTANEOUS injections, DRUG therapy, METHOTREXATE, MONOCLONAL antibodies, JUVENILE idiopathic arthritis, LOGISTIC regression analysis, RANDOMIZED controlled trials, DISEASE remission, DESCRIPTIVE statistics
Abstract

Objective: To evaluate the efficacy and safety of 2 canakinumab monotherapy tapering regimens in order to maintain complete clinical remission in children with systemic juvenile idiopathic arthritis (JIA). Methods: The study was designed as a 2‐part phase IIIb/IV open‐label, randomized trial. In the first part, patients received 4 mg/kg of canakinumab subcutaneously every 4 weeks and discontinued glucocorticoids and/or methotrexate as appropriate. Patients in whom clinical remission was achieved (inactive disease for at least 24 weeks) with canakinumab monotherapy were entered into the second part of the trial, in which they were randomized 1:1 into 1 of 2 treatment arms. In arm 1, the dose of canakinumab was reduced from 4 mg/kg to 2 mg/kg and then to 1 mg/kg, followed by discontinuation. In arm 2, the 4 mg/kg dose interval was prolonged from every 4 weeks, to every 8 weeks, and then to every 12 weeks, followed by discontinuation. In both arms, canakinumab exposure could be reduced provided systemic JIA remained in clinical remission for 24 weeks with each step. The primary objective was to assess whether >40% of randomized patients in either arm maintained clinical remission of systemic JIA for 24 weeks in the first part of the study. Results: In part 1 of the study, 182 patients were enrolled, with 75 of those patients randomized before entering part 2 of the trial. Among the 75 randomized patients, clinical remission was maintained for 24 weeks in 27 (71%) of 38 patients in arm 1 (2 mg/kg every 4 weeks) and 31 (84%) of 37 patients in arm 2 (4 mg/kg every 8 weeks) (P ≤ 0.0001 for arm 1 versus arm 2 among those meeting the 40% threshold). Overall, 25 (33%) of 75 patients discontinued canakinumab, and clinical remission was maintained for at least 24 weeks in all 25 of these patients. No new safety signals were identified. Conclusion: Reduction of canakinumab exposure may be feasible in patients who have achieved clinical remission of systemic JIA, but consistent interleukin‐1 inhibition appears necessary to maintain this response. [ABSTRACT FROM AUTHOR]

Published
2021
Full Text
View/download PDF

17. Investigation of the efficacy and safety of secukinumab treatment in juvenile idiopathic arthritis subtypes of juvenile psoriatic and enthesitis-related arthritis: Design of a randomized, double-blind, placebo controlled, multicenter study

Author

Föll, Dirk, Veit, Justyna, Ilsley, Emma, and Abrams, Ken

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Background: Secukinumab (AIN457), an anti-interleukin-17A monoclonal antibody has demonstrated a significant clinically meaningful efficacy on signs and symptoms, structure and function in adults with ankylosing spondylitis (AS)[ref:1] or psoriatic arthritis (PsA)[ref:2], both approved[for full text, please go to the a.m. URL], 45. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2017

18. Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy

Author

Brachat, Arndt H, Grom, Alexei A, Wulffraat, Nico, Brunner, Hermine I, Quartier, Pierre, Brik, Riva, McCann, Liza, Ozdogan, Huri, Rutkowska-Sak, Lidia, Schneider, Rayfel, Gerloni, Valeria, Harel, Liora, Terreri, Maria, Houghton, Kristin, Joos, Rik, Kingsbury, Daniel, Lopez-Benitez, Jorge M, Bek, Stephan, Schumacher, Martin, Valentin, Marie-Anne, Gram, Hermann, Abrams, Ken, Martini, Alberto, Lovell, Daniel J, Nirmala, Nanguneri R, Ruperto, Nicolino, and Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

Subjects
SJIA, Canakinumab, Journal Article, Gene expression, Juvenile idiopathic arthritis, Interleukin-1β, Biomarkers
Abstract

BACKGROUND: Canakinumab is a human anti-interleukin-1β (IL-1β) monoclonal antibody neutralizing IL-1β-mediated pathways. We sought to characterize the molecular response to canakinumab and evaluate potential markers of response using samples from two pivotal trials in systemic juvenile idiopathic arthritis (SJIA). METHODS: Gene expression was measured in patients with febrile SJIA and in matched healthy controls by Affymetrix DNA microarrays. Transcriptional response was assessed by gene expression changes from baseline to day 3 using adapted JIA American College of Rheumatology (aACR) response criteria (50 aACR JIA). Changes in pro-inflammatory cytokines IL-6 and IL-18 were assessed up to day 197. RESULTS: Microarray analysis identified 984 probe sets differentially expressed (≥2-fold difference; P

Published
2017

19. Additional file 1: of Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy

Author

Brachat, Arndt, Grom, Alexei, Wulffraat, Nico, Brunner, Hermine, Quartier, Pierre, Brik, Riva, McCann, Liza, Ozdogan, Huri, Rutkowska-Sak, Lidia, Rayfel Schneider, Gerloni, Valeria, Harel, Liora, Terreri, Maria, Houghton, Kristin, Joos, Rik, Kingsbury, Daniel, Lopez-Benitez, Jorge, Bek, Stephan, Schumacher, Martin, Marie-Anne Valentin, Gram, Hermann, Abrams, Ken, Martini, Alberto, Lovell, Daniel, Nanguneri Nirmala, and Ruperto, Nicolino

Abstract

Table S1 Definition of adapted ACR JIA response. Table S2 Genes with â Ľ3-fold differential expression between patients with SJIA and healthy controls, prior to canakinumab treatment. Table S3 List of independent ethics committees or institutional review boards (trial 1). Table S4 List of independent ethics committees or institutional review boards (trial 2). (DOCX 53 kb)

Published
2017
Full Text
View/download PDF

20. CI-TAB: View for the Blind.

Author

Abrams, Ken

Abstract

The article describes the development and content of a comprehensive career education program for blind elementary and secondary students. Eight areas are explored in the program: job search skills, job behavior, hygiene and grooming, purchase habits, budgeting, banking, home management, and health care. (CL)

Published
1979

22. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study

Author

Mease, Philip, primary, van der Heijde, Désirée, additional, Landewé, Robert, additional, Mpofu, Shephard, additional, Rahman, Proton, additional, Tahir, Hasan, additional, Singhal, Atul, additional, Boettcher, Elke, additional, Navarra, Sandra, additional, Meiser, Karin, additional, Readie, Aimee, additional, Pricop, Luminita, additional, and Abrams, Ken, additional

Published
2018
Full Text
View/download PDF

23. Rate and clinical presentation of macrophage activation syndrome in patients with systemic juvenile idiopathic arthritis treated with canakinumab

Author

Grom, Alexei A, Ilowite, Norman T, Pascual, Virginia, Brunner, Hermine I, Martini, Alberto, Lovell, Daniel, Ruperto, Nicolino, Leon, Karolynn, Lheritier, Karine, Abrams, Ken, University of Zurich, and Grom, Alexei A

Subjects
2403 Immunology, 10036 Medical Clinic, 2745 Rheumatology, 2723 Immunology and Allergy, 610 Medicine & health
Published
2016

24. In Children With Systemic Juvenile Idiopathic Arthritis With And Without Fever Canakinumab is Long Term Safe and Efficacious

Author

Horneff, Gerd, Ruperto, Nicola, Brunner, Hermine, Quartier, Pierre, Constantin, Tamas, Alexeeva, Ekaterina, Kone-Paut, Isabelle, Marzan, Katherine, Wulffraat, Nico, Schneider, Rayfel, Padeh, Shai, Chasnyk, Vyacheslav, Wouters, Carine, Kümmerle-Deschner, Jasmin, Kallinich, Tilmann, Lauwerys, Bernard. R., Haddad, Elie, Nasonov, Evgeny, Trachana, Maria, Vougiouka, Olga, Abrams, Ken, Leon, Karolynn, Lheritier, Karine, Martini, Alberto, and Lovell, Daniel J.

Subjects
ddc: 610, fungi, food and beverages, 610 Medical sciences, Medicine
Abstract

Introduction: Rapid and sustained efficacy of canakinumab (CAN) were previously demonstrated in patients with systemic juvenile idiopathic arthritis (SJIA)1. However, little is known about potential differences in response to CAN treatment between pts with vs. without SJIA associated fever. The objective[for full text, please go to the a.m. URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

25. Pharmacokinetics of Canakinumab treated CAPS Children younger than 2 Years old

Author

Kümmerle-Deschner, Jasmin, Kalabus, James, Brogan, Paul, Hofer, Michael, Lauwerys, Bernard. R., Speziale, Antonio, Laxer, Ronald, Sun, Haiying, Abrams, Ken, Leon, Karolynn, and Junge, Guido

Subjects
ddc: 610, fungi, food and beverages, 610 Medical sciences, Medicine
Abstract

Introduction: Canakinumab (CAN) is indicated for the treatment of cryopyrin-associated periodic syndrome (CAPS) in patients ≥2 years of age1. However, information on the pharmacokinetics (PK) of CAN in patients, 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

26. Wirksamkeit von Canakinumab bei Biologika-naiven versus Biologika-exponierten sJIA-Patienten

Author

Kallinich, Tilmann, Quartier, Pierre, Grom, Alexei, Ruperto, Nicola, Brunner, Hermine, Schikler, Kenneth, Erguven, Muferet, Goffin, Laurence, Hofer, Michael, Marzan, Katherine, Gaillez, Corine, Lheritier, Karine, Abrams, Ken, Martini, Alberto, and Lovell, Daniel J.

Subjects
ddc: 610, systemische juvenile idiopathische Arthritis, 610 Medical sciences, Medicine
Abstract

Einleitung: In 2 Phase III Studien [ref:1] zu Canakinumab (CAN) bei aktiver sJIA hatten >60% der Patienten früher bereits ein Biologikum erhalten und wurden infolge von mangelnder Wirksamkeit oder aus Verträglichkeitsgründen auf CAN umgestellt, wodurch sie möglicherweise[for full text, please go to the a.m. URL], 42. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 28. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 24. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2014

27. Canakinumab reverses overexpression of inflammatory response genes in tumour necrosis factor receptor-associated periodic syndrome

Author

Torene, Rebecca, primary, Nirmala, Nanguneri, additional, Obici, Laura, additional, Cattalini, Marco, additional, Tormey, Vincent, additional, Caorsi, Roberta, additional, Starck-Schwertz, Sandrine, additional, Letzkus, Martin, additional, Hartmann, Nicole, additional, Abrams, Ken, additional, Lachmann, Helen, additional, and Gattorno, Marco, additional

Published
2016
Full Text
View/download PDF

30. Industry Voices—Why hiring clinician executives is critical for all businesses.

Author

Rhee, Kyu, Abrams, Ken, and Feinglass, Shamiram

Subjects
EXECUTIVES, HUMAN voice, BUSINESS enterprises, PHYSICIANS
Abstract

Companies in every industry need to increasingly look at the health of both the business as well as employees, and leaders with clinical experience can help. [ABSTRACT FROM AUTHOR]

Published
2023

31. A 24-month open-label study of canakinumab in neonatal-onset multisystem inflammatory disease

Author

Sibley, Cailin H, primary, Chioato, Andrea, additional, Felix, Sandra, additional, Colin, Laurence, additional, Chakraborty, Abhijit, additional, Plass, Nikki, additional, Rodriguez-Smith, Jackeline, additional, Brewer, Carmen, additional, King, Kelly, additional, Zalewski, Christopher, additional, Kim, H Jeffrey, additional, Bishop, Rachel, additional, Abrams, Ken, additional, Stone, Deborah, additional, Chapelle, Dawn, additional, Kost, Bahar, additional, Snyder, Christopher, additional, Butman, John A, additional, Wesley, Robert, additional, and Goldbach-Mansky, Raphaela, additional

Published
2014
Full Text
View/download PDF

32. Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy

Author

Brachat, Arndt, Grom, Alexei, Wulffraat, Nico, Brunner, Hermine, Quartier, Pierre, Brik, Riva, McCann, Liza, Ozdogan, Huri, Rutkowska-Sak, Lidia, Schneider, Rayfel, Gerloni, Valeria, Harel, Liora, Terreri, Maria, Houghton, Kristin, Joos, Rik, Kingsbury, Daniel, Lopez-Benitez, Jorge, Bek, Stephan, Schumacher, Martin, Valentin, Marie-Anne, Gram, Hermann, Abrams, Ken, Martini, Alberto, Lovell, Daniel, Nirmala, Nanguneri, and Ruperto, Nicolino

Abstract

Canakinumab is a human anti-interleukin-1β (IL-1β) monoclonal antibody neutralizing IL-1β-mediated pathways. We sought to characterize the molecular response to canakinumab and evaluate potential markers of response using samples from two pivotal trials in systemic juvenile idiopathic arthritis (SJIA). Gene expression was measured in patients with febrile SJIA and in matched healthy controls by Affymetrix DNA microarrays. Transcriptional response was assessed by gene expression changes from baseline to day 3 using adapted JIA American College of Rheumatology (aACR) response criteria (50 aACR JIA). Changes in pro-inflammatory cytokines IL-6 and IL-18 were assessed up to day 197. Microarray analysis identified 984 probe sets differentially expressed (≥2-fold difference; P< 0.05) in patients versus controls. Over 50% of patients with ≥50 aACR JIA were recognizable by baseline expression values. Analysis of gene expression profiles from patients achieving ≥50 aACR JIA response at day 15 identified 102 probe sets differentially expressed upon treatment (≥2-fold difference; P< 0.05) on day 3 versus baseline, including IL-1β, IL-1 receptors (IL1-R1 and IL1-R2), IL-1 receptor accessory protein (IL1-RAP), and IL-6. The strongest clinical response was observed in patients with higher baseline expression of dysregulated genes and a strong transcriptional response on day 3. IL-6 declined by day 3 (≥8-fold decline; P< 0.0001) and remained suppressed. IL-18 declined on day 57 (≥1.5-fold decline, P≤ 0.002). Treatment with canakinumab in SJIA patients resulted in downregulation of innate immune response genes and reductions in IL-6 and clinical symptoms. Additional research is needed to investigate potential differences in the disease mechanisms in patients with heterogeneous gene transcription profiles. Clinicaltrials.gov: NCT00886769(trial 1). Registered on 22 April 2009; NCT00889863(trial 2). Registered on 21 April 2009.

Published
2017
Full Text
View/download PDF

35. A 24-month open-label study of canakinumab in neonatal-onset multisystem inflammatory disease.

Author

Sibley, Cailin H., Chioato, Andrea, Felix, Sandra, Colin, Laurence, Chakraborty, Abhijit, Plass, Nikki, Rodriguez-Smith, Jackeline, Brewer, Carmen, King, Kelly, Zalewski, Christopher, Kim, H. Jeffrey, Bishop, Rachel, Abrams, Ken, Stone, Deborah, Chapelle, Dawn, Kost, Bahar, Snyder, Christopher, Butman, John A., Wesley, Robert, and Goldbach-Mansky, Raphaela

Published
2015
Full Text
View/download PDF

43. Tapering Canakinumab Monotherapy in Patients with Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results from an Open‐label, Randomized Phase IIIb/IV Study

Author

Pierre, Quartier, Ekaterina, Alexeeva, Constantin, Tamàs, Vyacheslav, Chasnyk, Nico, Wulffraat, Karin, Palmblad, Carine, Wouters, Hermine, Brunner, Katherine, Marzan, Rayfel, Schneider, Gerd, Horneff, Martini, Alberto, Jordi, Anton, Xiaoling, Wei, Alan, Slade, Ruperto, Nicolino, Ken, Abrams, Wolfgang, Emminger, Andrea, Ulbrich, Sugarka, Fodor, Lien, Desomer, Bernard, Lauwerys, Bénédicte, Brichard, Cécile, Boulanger, Gabriel, Levy, Laurence, Goffin, Phu Quoc Le, Marcia, Bandeira, Christina Feitosa Pelajo, Sheila Knupp Feitosa, Christianne, Costa, Marta Cristine Felix Rodrigues, Clovis Artur Almeida da Silva, Lucia Maria Mattei de, Katia, Kozu, Ronald, Laxer, Kristin, Houghton, Lori, Tucker, Kimberly, Morishita, Agnes, Mogenet, Richard, Mouy, Brigitte Bader Meunier, Candice, Meyzer, Michaela, Semeraro, Ouafa, Ben‐brahim, Isabelle, Kone‐paut, Caroline, Galeotti, Linda, Rossi, Perrine, Dusser, Bilade, Cherquaoui, Alexandre, Belot, Agnes, Duquesne, Freychet, Caroline, Laurent, Audrey, Marine, Desjonqueres, Ivan, Foeldvari, Antonia, Kienast, Barbara, Willig, Deborah, Barthel, Joachim, Peitz, Stefanie, Wintrich, Tilman Felix Geikowski, Anna Carina Schulz, Markus, Hufnagel, Marc, Hirdes, Rouven, Kubicki, Janbernd, Kirschner, Ales, Janda, Andre, Jacob, Cornelia, Emerich, Anna, Raab, Gonza, Ngoumou, Kirsten, Minden, Mareike, Lieber, Sae‐Lim von Stuckrad, Jasmin Kuemmerle Deschner, Sandra, Hansmann, Tom, Schleich, Ines Maria Magunia, Joachim, Riethmuller, Nicole, Anders, Hartwig, Lehmann, Jan de Laffolie, Thomas, Lutz, Juergen, Grulich‐henn, Johannes, Pfeil, Astrid, Helling‐bakki, Ralf, Trauzeddel, Daniel, Haselbusch, Henryk, Kolbeck, Elisabeth, Weissbarth‐riedel, Anja, Froehlich, Andrea, Ponyi, Diana, Garan, Ilonka, Orban, Krisztina, Sevcic, Yonatan, Butbul, Riva, Brik, Philip, Hashkes, Ori, Toker, Ruby, Haviv, Yosef, Uziel, Rubi, Haviv, Veronica, Moshe, Michal, Rothschild, Liora, Harel, Gil, Amarilyo, Rotem, Tal, Mohamad Hamad Said, Irit, Tirosh, Shiri, Spielman, Maya, Gerstein, Ravelli, Angelo, Schiappapietra, Benedetta, Varnier, GIULIA CAMILLA, Finetti, Martina, Marasini, Maurizio, Caorsi, Roberta, Rosina, Silvia, Federici, Silvia, Irene, Pontikaki, Pier Luigi Meroni, Valeri, Gerloni, Nicola, Ughi, Tania, Ubiali, Maria, Alessio, Roberto Della Casa, Sebastiaan Jozef Vastert, Joost Frans Swart, van Royen‐Kerhof, A., Ellen, Schatorje, Van Iperen‐Schutte, G., Lidia, Rutkowska‐sak, Izabela, Szczygielska, Malgorzata, Kwiatkowska, Maria, Marusak‐banacka, Piotr, Gietka, Kseniya, Isaeva, Rina, Denisova, Ludmila, Snegireva, Margarita, Dubko, Mikhail, Kostik, Natalia, Buchinskaia, Olga, Kalashnikova, Sergey, Avrusin, Vera, Masalova, Esmeralda Nunez Cuadros, Gisela, Diez, Rocio Galindo Zavala, Rosa Bou Torrent, Estibaliz, Iglesias, Joan, Calzada, Violeta, Bittermann, Alina Lucica Boteanu, Maria Luz Gamir, Inmaculada, Calvo, Berta, Lopez, Isabel, Gonzalez, Laura, Fernandez, Daniel Clemente Garulo, Juan Carlos Lopez Robledillo, Rosa, Merino, Rosa, Alcobendas, Agustin, Remesal, Sara, Murias, Magnusson, Bo, Ozgur, Kasapcopur, Kenan, Barut, Amra, Adrovic, Sezgin, Sahin, Muferet, Erguven, Refia Gozdenur Savci, Seza, Ozen, Selcan, Demir, Yelda, Bilginer, Zehra Serap Avci, Ezgi Deriz Batu, Andreas, Reiff, Anusha, Ramanatham, Diana, Brown, Bracha, Shaham, Shirley, Parks, Michal, Cidon, Gloria, Higgins, Charles, Spencer, Jenny, Rossette, Karla, Jones, Sharon Bout Tabaku, Shelli, Farley, Shoghik, Akoghlanian, Quartier, Pierre, Alexeeva, Ekaterina, Tamàs, Constantin, Chasnyk, Vyacheslav, Wulffraat, Nico, Palmblad, Karin, Wouters, Carine, Brunner, Hermine, Marzan, Katherine, Schneider, Rayfel, Horneff, Gerd, Martini, Alberto, Anton, Jordi, Wei, Xiaoling, Slade, Alan, Ruperto, Nicolino, Abrams, Ken, Emminger, Wolfgang, Ulbrich, Andrea, Fodor, Sugarka, Desomer, Lien, Lauwerys, Bernard, Brichard, Bénédicte, Boulanger, Cécile, Levy, Gabriel, Goffin, Laurence, Quoc Le, Phu, Bandeira, Marcia, Feitosa Pelajo, Christina, Knupp Feitosa, Sheila, Costa, Christianne, Cristine Felix Rodrigues, Marta, Artur Almeida da Silva, Clovi, Maria Mattei de, Lucia, Kozu, Katia, Laxer, Ronald, Houghton, Kristin, Tucker, Lori, Morishita, Kimberly, Mogenet, Agne, Mouy, Richard, Bader Meunier, Brigitte, Meyzer, Candice, Semeraro, Michaela, Ben‐brahim, Ouafa, Kone‐paut, Isabelle, Galeotti, Caroline, Rossi, Linda, Dusser, Perrine, Cherquaoui, Bilade, Belot, Alexandre, Duquesne, Agne, Caroline, Freychet, Audrey, Laurent, Desjonqueres, Marine, Foeldvari, Ivan, Kienast, Antonia, Willig, Barbara, Barthel, Deborah, Peitz, Joachim, Wintrich, Stefanie, Felix Geikowski, Tilman, Carina Schulz, Anna, Hufnagel, Marku, Hirdes, Marc, Kubicki, Rouven, Kirschner, Janbernd, Janda, Ale, Jacob, Andre, Emerich, Cornelia, Raab, Anna, Ngoumou, Gonza, Minden, Kirsten, Lieber, Mareike, von Stuckrad, Sae‐lim, Kuemmerle Deschner, Jasmin, Hansmann, Sandra, Schleich, Tom, Maria Magunia, Ine, Riethmuller, Joachim, Anders, Nicole, Lehmann, Hartwig, de Laffolie, Jan, Lutz, Thoma, Grulich‐henn, Juergen, Pfeil, Johanne, Helling‐bakki, Astrid, Trauzeddel, Ralf, Haselbusch, Daniel, Kolbeck, Henryk, Weissbarth‐riedel, Elisabeth, Froehlich, Anja, Ponyi, Andrea, Garan, Diana, Orban, Ilonka, Sevcic, Krisztina, Butbul, Yonatan, Brik, Riva, Hashkes, Philip, Toker, Ori, Haviv, Ruby, Uziel, Yosef, Haviv, Rubi, Moshe, Veronica, Rothschild, Michal, Harel, Liora, Amarilyo, Gil, Tal, Rotem, Hamad Said, Mohamad, Tirosh, Irit, Spielman, Shiri, Gerstein, Maya, Ravelli, Angelo, Schiappapietra, Benedetta, Camilla Varnier, Giulia, Finetti, Martina, Marasini, Maurizio, Caorsi, Roberta, Rosina, Silvia, Federici, Silvia, Pontikaki, Irene, Luigi Meroni, Pier, Gerloni, Valeri, Ughi, Nicola, Ubiali, Tania, Alessio, Maria, DELLA CASA, Roberto, Jozef Vastert, Sebastiaan, Frans Swart, Joost, van Royen‐Kerhof, A., Schatorje, Ellen, Van Iperen‐Schutte, G., Rutkowska‐sak, Lidia, Szczygielska, Izabela, Kwiatkowska, Malgorzata, Marusak‐banacka, Maria, Gietka, Piotr, Isaeva, Kseniya, Denisova, Rina, Snegireva, Ludmila, Dubko, Margarita, Kostik, Mikhail, Buchinskaia, Natalia, Kalashnikova, Olga, Avrusin, Sergey, Masalova, Vera, Nunez Cuadros, Esmeralda, Diez, Gisela, Galindo Zavala, Rocio, Bou Torrent, Rosa, Iglesias, Estibaliz, Calzada, Joan, Bittermann, Violeta, Lucica Boteanu, Alina, Luz Gamir, Maria, Calvo, Inmaculada, Lopez, Berta, Gonzalez, Isabel, Fernandez, Laura, Clemente Garulo, Daniel, Carlos Lopez Robledillo, Juan, Merino, Rosa, Alcobendas, Rosa, Remesal, Agustin, Murias, Sara, Magnusson, Bo, Kasapcopur, Ozgur, Barut, Kenan, Adrovic, Amra, Sahin, Sezgin, Erguven, Muferet, Gozdenur Savci, Refia, Ozen, Seza, Demir, Selcan, Bilginer, Yelda, Serap Avci, Zehra, Deriz Batu, Ezgi, Reiff, Andrea, Ramanatham, Anusha, Brown, Diana, Shaham, Bracha, Parks, Shirley, Cidon, Michal, Higgins, Gloria, Spencer, Charle, Rossette, Jenny, Jones, Karla, Bout Tabaku, Sharon, Farley, Shelli, and Akoghlanian, Shoghik

Published
2021

44. Secukinumab Efficacy in Psoriatic Arthritis: Machine Learning and Meta-analysis of Four Phase 3 Trials.

Author

Gottlieb AB, Mease PJ, Kirkham B, Nash P, Balsa AC, Combe B, Rech J, Zhu X, James D, Martin R, Ligozio G, Abrams K, and Pricop L

Subjects
Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Bayes Theorem, Clinical Trials, Phase III as Topic, Double-Blind Method, Humans, Machine Learning, Arthritis, Psoriatic diagnosis, Arthritis, Psoriatic drug therapy
Abstract

Background: Using a machine learning approach, the study investigated if specific baseline characteristics could predict which psoriatic arthritis (PsA) patients may gain additional benefit from a starting dose of secukinumab 300 mg over 150 mg. We also report results from individual patient efficacy meta-analysis (IPEM) in 2049 PsA patients from the FUTURE 2 to 5 studies to evaluate the efficacy of secukinumab 300 mg, 150 mg with and without loading regimen versus placebo at week 16 on achievement of several clinically relevant difficult-to-achieve (higher hurdle) endpoints., Methods: Machine learning employed Bayesian elastic net to analyze baseline data of 2148 PsA patients investigating 275 predictors. For IPEM, results were presented as difference in response rates versus placebo at week 16., Results: Machine learning showed secukinumab 300 mg has additional benefits in patients who are anti-tumor necrosis factor-naive, treated with 1 prior anti-tumor necrosis factor agent, not receiving methotrexate, with enthesitis at baseline, and with shorter PsA disease duration. For IPEM, at week 16, all secukinumab doses had greater treatment effect (%) versus placebo for higher hurdle endpoints in the overall population and in all subgroups; 300-mg dose had greater treatment effect than 150 mg for all endpoints in overall population and most subgroups., Conclusions: Machine learning identified predictors for additional benefit of secukinumab 300 mg compared with 150 mg dose. Individual patient efficacy meta-analysis showed that secukinumab 300 mg provided greater improvements compared with 150 mg in higher hurdle efficacy endpoints in patients with active PsA in the overall population and most subgroups with various levels of baseline disease activity and psoriasis., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Published
2021
Full Text
View/download PDF

46. Long-term safety and efficacy of canakinumab in cryopyrin-associated periodic syndrome: results from an open-label, phase III pivotal study in Japanese patients.

Author

Yokota S, Imagawa T, Nishikomori R, Takada H, Abrams K, Lheritier K, Heike T, and Hara T

Subjects
Adolescent, Adult, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Humanized, Child, Child, Preschool, Cryopyrin-Associated Periodic Syndromes diagnosis, Cryopyrin-Associated Periodic Syndromes immunology, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Immunosuppressive Agents adverse effects, Injections, Subcutaneous, Japan, Male, Middle Aged, Recurrence, Remission Induction, Time Factors, Treatment Outcome, Young Adult, Antibodies, Monoclonal administration & dosage, Cryopyrin-Associated Periodic Syndromes drug therapy, Immunosuppressive Agents administration & dosage
Abstract

Objectives: To assess the long-term safety and efficacy of canakinumab in Japanese patients with cryopyrin-associated periodic syndrome (CAPS)., Methods: In this open-label phase 3 study, Japanese patients aged ≥2 years with CAPS received canakinumab 2-8 mg/kg subcutaneously every 8 weeks. The duration of the core treatment phase was 24 weeks followed by 22 months extension phase. The primary objective was the proportion of patients free of clinical and serologic relapse at week 24., Results: The study enrolled 19 Japanese patients (median age, 14 years; range, 2-48 years) with CAPS [MWS, 7 (36.8%); NOMID, 12 (63.2%)] for a median of 109 weeks. Fifteen patients (79%) achieved a complete response by day 15, 18 (94.7%) by week 24 and all by week 48. At the end of the study, 18 (95%) were free from relapse and 11 (57.9%) were assessed as having no disease activity by the PGA. Thirteen (68%) patients (MWS, 4; NOMID, 9) had their canakinumab dose increased during the trial. All patients experienced at least one adverse event (AE), the most common being infections (100%) and 5 (26.3%) reported serious AEs. No deaths were reported and the only patient who discontinued the study early withdrew consent., Conclusions: Regular canakinumab treatment every 8 weeks at dose levels from 2-8 mg/kg, based on the clinical need, represents a successful strategy to induce rapid and complete response while maintain long-term disease control in Japanese patients with CAPS. The safety profile of canakinumab was consistent with that observed from previous studies.

Published
2017

47. Improvement in pruritus in children with atopic dermatitis using pimecrolimus cream 1%.

Author

Fowler J, Johnson A, Chen M, and Abrams K

Subjects
Adolescent, Case-Control Studies, Child, Child, Preschool, Dermatologic Agents administration & dosage, Double-Blind Method, Drug Administration Schedule, Emollients, Follow-Up Studies, Humans, Immunosuppressive Agents administration & dosage, Pharmaceutical Vehicles, Placebos, Severity of Illness Index, Tacrolimus administration & dosage, Tacrolimus therapeutic use, Time Factors, Treatment Outcome, Calcineurin Inhibitors, Dermatitis, Atopic drug therapy, Dermatologic Agents therapeutic use, Immunosuppressive Agents therapeutic use, Peptidylprolyl Isomerase antagonists & inhibitors, Pruritus drug therapy, Tacrolimus analogs & derivatives
Abstract

The objective of this study was to assess time to onset of pruritus improvement in a pediatric population treated with pimecrolimus cream 1%. This 8-day, double-blinded, vehicle-controlled study randomized 174 children and adolescents (aged 2-17 years) with mild to moderate atopic dermatitis (AD) and moderate to severe pruritus to twice-daily applications of pimecrolimus cream 1% or vehicle. There were no significant between-group differences in demographics or baseline disease characteristics. Pruritus was assessed by subjects using a 4-point pruritus severity scale (0-3). The primary efficacy variable was time to a 1 point or more improvement in pruritus score from baseline. The 2 treatment groups were compared using log-rank testing of the time-to-event data. In the per-protocol (PP) population, median times to a 1 point or more improvement in pruritus score were 48 and 72 hours for pimecrolimus and vehicle groups, respectively (P = .038). From day 3 onward, significantly more subjects (P = .023) in the pimecrolimus group versus the vehicle group reported complete pruritus resolution. Pimecrolimus cream 1% improved pruritus within 48 hours in children and adolescents with mild to moderate AD and achieved complete resolution of pruritus in a significantly greater number of subjects in the pimecrolimus group versus the vehicle group by the end of the 7-day treatment period (P = .008).

Published
2007

Catalog

Books, media, physical & digital resources
See catalog results