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5. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Allanore, Yannick, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Matucci-Cerinic, Marco, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Kuwana, Masataka, Shima, Yoshihito, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, van Laar, Jacob M., Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Distler, Oliver, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Denton, Christopher P., Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Furst, Daniel E., Kafaja, Suzanne, Khan, M. Faisal, Khanna, Dinesh, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Lin, Celia J F, Furst, Daniel E, Goldin, Jonathan, Kim, Grace, van Laar, Jacob M, Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, and Denton, Christopher P

Published
2020
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7. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study

Author

AELION, Jacob, AMARELO-RAMOS, Juan, BALSA, Alejandro, BERGHEA, Florian, BRZEZICKI, Jan, BURNETTE, Michael, FRETZIN, Scott, GARCÍA-CARAZO, Sara, GLADSTEIN, Geoffrey, GOMEZ-REINO, Juan, GOODERHAM, Melinda, GONZÁLEZ-FERNÁNDEZ, Carlos, GOTTLIEB, Alice, GRATACOS, Jordi, HAALAND, Derek, KAMALOVA, Rima, LESZCZYNSKI, Piotr, MARTIN-MOLA, Emilio, MASLYANSKY, Alexey, NAVARRO, Federico, OPRIS, Daniela, PAPP, Kim, PERLAMUTROV, Yuriy, PHILIPP, Sandra, RACEWICZ, Artur, REBROV, Andrey, RELL-BAKALARSKA, Maria, ROSMARIN, David, RUBBERT-ROTH, Andrea, SHERGY, William, SHIRINSKY, Ivan, SONIN, Dmitry, STANISLAV, Marina, SUKHAREV, Alexey, TEMNIKOV, Vadim, VINOGRADOVA, Irina, WAYTZ, Paul, YAKUSHEVICH, Vladimir, Deodhar, Atul, Gottlieb, Alice B, Boehncke, Wolf-Henning, Dong, Bin, Wang, Yuhua, Zhuang, Yanli, Barchuk, William, Xu, Xie L, and Hsia, Elizabeth C

Published
2018
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8. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial

Author

Adams, Luthando, Ally, Mahmood M, du Plooy, Maria C, Louw, Ingrid C, Nayiager, Savithree, Nel, Christoffel B, Nel, Debra, Reuter, Helmuth, Soloman, Ahmed S, Spargo, Catherine E, Hall, Stephen, Rischmueller, Maureen, Sharma, Shunil D, Will, Robert K, Youssef, Peter P, Arroyo, Caroline, Baes, Rosario P, Dulos, Roger B, Hao, Llewellyn T, Lanzon, Allan E, Lichauco, Juan Javier T, Mangubat, Jill H, Ramiterre, Edgar B, Reyes, Bernadette Heizel M, Tan, Perry P, Choe, Jung-Yoon, Kang, Young Mo, Kwon, Seong Ryul, Lee, Sang-Heon, Lee, Shin-Seok, Yoo, Dae-Hyun, Lin, Hsiao-Yi, Luo, Shue-Fen, Tsai, Shih-Tzu, Tsai, Wen-Chan, Tseng, Jui-Cheng, Wei, Cheng-Chung C, Asavatanabodee, Paijit, Nantiruj, Kanokrat, Nilganuwong, Surasak, Uea-Areewongsa, Parichat, Majstorovic, Ljubinka Bozic, Bacic, Suada Mulic, Batalov, Anastas Z, Georgieva-Slavcheva, Gabriela, Mihailova, Mariyana, Nikolov, Nikolay G, Penev, Dimitar P, Spasov, Yuliy A, Stanimirova, Krasimira, Todorov, Stoyan, Toncheva, Antoaneta R, Yordanova, Nadezhda, Mosterova, Zdenka, Novosad, Libor, Prochazkova, Leona, Stehlikova, Helena, Stejfova, Zuzana, Kiseleva, Natalia, Pank, Lea, Savi, Triin, Alexandra, Balbir-Gurman, Amital, Howard, Mevorach, Dror, Rosner, Itzhak A, Mihailova, Anna, Stumbra-Stumberga, Evija, Basijokiene, Vida, Lietuvininkiene, Virginija, Unikiene, Dalia, Brzezicki, Jan, Dudek, Anna M, Glowacka-Kulesz, Maria B, Grabowicz-Wasko, Barbara, Hajduk-Kubacka, Sabina, Hilt, Joanna, Hrycaj, Pawel, Jeka, Slawomir, Kolasa, Renata, Krogulec, Marek, Mastalerz, Hanna, Olak-Popko, Anna, Owczarek, Elzbieta, Ruzga, Zofia, Walczak, Alina, Ancuta, Codrina I, Ancuta, Ioan, Balanescu, Andra R, Berghea, Florian, Bojin, Silvia, Arvunescu, Mihaela A Ianuli, Ionescu, Ruxandra M, Mociran, Eugenia, Pavel, Mariana, Rednic, Simona, Voie, Adriana, Zainea, Carmen M, Bugrova, Olga V, Demin, Alexander, Ershova, Olga B, Gavrisheva, Inna A, Krechikova, Diana G, Kuropatkin, Gennady V, Marusenko, Irina M, Menshikova, Irina V, Noskov, Sergey M, Rebrov, Andrey P, Smakotina, Svetlana A, Yakushin, Sergey S, Zhilyaev, Evgeny, Ramos, Juan Jose Amarelo, Garcia, Francisco Javier Blanco, Nebro, Antonio Fernandez, Esteban, Silvia Perez, Burson, Juan Miguel Sanchez, Sala, Raimon Sanmarti, Ataman, Sebnem, Hizmetli, Sami, Kuru, Omer, Douglas, Karen M, Emery, Paul, Moots, Robert J, Ong, Voon H, Sheeran, Thomas P, Faraawi, Rafat Y, Lessard, Clode, Mendoza, Carlos Abud, Avila-Armengol, Hilario Ernesto, Zapata, Francisco I Avila, Irazoque-Palazuelos, Fedra Consuelo, Cecena, Marco Antonio Maradiaga, Pacheco-Tena, Cesar F, Rizo-Rodriguez, Juan C, Rodriguez-Torres, Isaura M, Aelion, Jacob A, Caciolo, Barbara A, Calmes, James M, Chatpar, Prem, Dayal, Nimesh, De Jesus, Alex, Dikranian, Ara H, Diri, Erdal, Fairfax, Michael J, Fenton, Ira F, Fleischmann, Roy M, Gaylis, Norman B, George, Ronald L, Halter, Dale G, Hernandez, Paul, Hole, Susan A, Hou, Antony C, Huff, John P, Kafaja, Suzanne, Kennedy, Alastair C, Kenney, Howard, Kimmel, Steven C, Kirby, Brian S, Kivitz, Alan J, Legerton, Clarence W, Lindsey, Stephen M, Mallepalli, Jyothi R, Mathews, Steven D, Metyas, Samy K, Mizutani, Wesley T, Najam, Sabeen, Nascimento, Joao M, Pang, Shirley W, Patel, Rakesh C, Poiley, Jeffrey E, Ramirez, Carlos E, Reddy, Riteesha, Rehman, Qaiser, Schnitz, William M, Scoville, Craig D, Shergy, William J, Silverfield, Joel C, Singhal, Atul K, Smallwood-Sherrer, Yvonne R, Songcharoen, Suthin N, Stack, Michael T, Stohl, William, Su, Tien-I K, Udell, James, Waraich, Saleem, Weidmann, Charles E, Wei, Nathan, Wiesenhutter, Craig W, Winkler, Anne E, Zagar, Karen E, Berman, Alberto, Mysler, Eduardo F, Hidalgo, Rodolfo A Pardo, Venarotti, Horacio O, Sariego, Irmgadt Annelise Goecke, Calabresse, Renato E Jimenez, Ruiz-Tagle, Juan Ignacio Vargas, Vargas, Luis Fernando M Bellatin, Berrocal, Alfredo E, Portocarrero, Manuel Gustavo Leon, Jesus, Felix, Pena, Romero, Fleischmann, Roy, Mysler, Eduardo, Luo, Zhen, DeMasi, Ryan, Soma, Koshika, Zhang, Richard, Takiya, Liza, Tatulych, Svitlana, Mojcik, Christopher, Krishnaswami, Sriram, Menon, Sujatha, and Smolen, Josef S

Published
2017
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10. Efficacy and Safety of ABBV ‐3373, a Novel Anti‐Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody Drug Conjugate, in Adults with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: a Randomized, Double‐Blind , Active‐Controlled Proof‐of‐Concept Phase 2a Trial

Author

Buttgereit, Frank, primary, Aelion, Jacob, additional, Rojkovich, Bernadette, additional, Zubrzycka‐Sienkiewicz, Anna, additional, Chen, Su, additional, Yang, Yang, additional, Arikan, Dilek, additional, D'Cunha, Ronilda, additional, Pang, Yinuo, additional, Kupper, Hartmut, additional, Radstake, Timothy, additional, and Amital, Howard, additional

Published
2022
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14. Efficacy and Safety of ABBV‐3373, a Novel Anti–Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody–Drug Conjugate, in Adults with Moderate‐to‐Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Randomized, Double‐Blind, Active‐Controlled Proof‐of‐Concept Phase IIa Trial

Author

Buttgereit, Frank, Aelion, Jacob, Rojkovich, Bernadette, Zubrzycka‐Sienkiewicz, Anna, Chen, Su, Yang, Yang, Arikan, Dilek, D'Cunha, Ronilda, Pang, Yinuo, Kupper, Hartmut, Radstake, Timothy, and Amital, Howard

Subjects
*THERAPEUTIC use of monoclonal antibodies, *DRUG efficacy, *CELL receptors, *SELECTIVE estrogen receptor modulators, *MONOCLONAL antibodies, *SEVERITY of illness index, *RANDOMIZED controlled trials, *RHEUMATOID arthritis, *BLIND experiment, *DESCRIPTIVE statistics, *DATA analysis software, *PATIENT safety
Abstract

Objective: To assess the efficacy and safety of ABBV‐3373, a novel antibody–drug conjugate (ADC) composed of the anti–tumor necrosis factor (anti‐TNF) monoclonal antibody adalimumab linked to a glucocorticoid receptor modulator (GRM), compared to adalimumab, in patients with rheumatoid arthritis (RA). Methods: In this randomized, double‐blind, active‐controlled, proof‐of‐concept trial (ClinicalTrials.gov identifier: NCT03823391), adults with moderate‐to‐severe RA receiving background methotrexate were administered intravenously (IV) ABBV‐3373 100 mg every other week for 12 weeks, followed by placebo for 12 weeks, or subcutaneous adalimumab 80 mg every other week for 24 weeks. The primary end point was change from baseline in the Disease Activity Score in 28 joints using C‐reactive protein (DAS28‐CRP) at week 12, with 2 prespecified primary comparisons of ABBV‐3373 versus historical adalimumab (80 mg every other week or equivalent dose) and versus combined in‐trial/historical adalimumab. Secondary end points included change from baseline in the Clinical Disease Activity Index, Simplified Disease Activity Index, and DAS28 using erythrocyte sedimentation rate, as well as the proportion of patients achieving a DAS28‐CRP of ≤3.2 and the American College of Rheumatology 50% improvement criteria. Results: Forty‐eight patients were randomized to receive either ABBV‐3373 (n = 31) or adalimumab (n = 17). At week 12, ABBV‐3373 demonstrated a reduction in DAS28‐CRP compared to historical adalimumab (−2.65 versus −2.13; P = 0.022) and compared to combined in‐trial/historical adalimumab (−2.65 versus −2.29; probability 89.9%), with numerically greater improvement than in‐trial adalimumab (−2.51). For secondary end points, greater efficacy was observed with ABBV‐3373 compared to historical adalimumab; ABBV‐3373 was predicted with 79.3–99.5% probability to be more effective than adalimumab based on combined in‐trial/historical adalimumab data. Of the ABBV‐3373–treated patients who achieved DAS28‐CRP ≤3.2 at week 12, 70.6% maintained this response at week 24 despite switching to placebo. Four serious adverse events (SAEs) were reported with ABBV‐3373 (noncardiac chest pain, pneumonia, upper respiratory tract infection, and anaphylactic shock) and 2 SAEs with adalimumab (breast abscess and bronchitis). After increasing the duration of IV ABBV‐3373 administration from 3 minutes to 15–30 minutes, no similar events of anaphylactic shock were reported. Conclusion: Data from this proof‐of‐concept trial support the continued development of a TNF–GRM ADC for the treatment of RA, with the potential to achieve superior outcomes compared to currently available therapies. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study.

Author

Östör, Andrew, Bosch, Filip Van den, Papp, Kim, Asnal, Cecilia, Blanco, Ricardo, Aelion, Jacob, Lu, Wenjing, Wang, Zailong, Soliman, Ahmed M, Eldred, Ann, Padilla, Byron, and Kivitz, Alan

Subjects
BIOTHERAPY, THERAPEUTIC use of monoclonal antibodies, PSORIATIC arthritis, INTERLEUKINS, DRUG efficacy, PSORIASIS, TREATMENT effectiveness, PLACEBOS, RANDOMIZED controlled trials, STATISTICAL sampling, PATIENT safety, LONGITUDINAL method, CHEMICAL inhibitors
Abstract

Objective PsA is a chronic inflammatory disease in which the skin and joints are affected. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or two biologic therapies (Bio-IR) or one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated. Methods In the ongoing, phase 3, KEEPsAKE 2 trial, patients with active PsA were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16 (period 1). At week 24 (period 2), patients who received placebo were switched to risankizumab, and all patients received risankizumab 150 mg every 12 weeks from weeks 28 to 208. Results At week 24, 51.3% of risankizumab-treated patients (n  =   224) achieved ≥20% improvement in ACR criteria (ACR 20) vs 26.5% of placebo-treated patients (n  =   220; P  <   0.001). At week 52, 58.5% of patients randomized to receive continuous risankizumab achieved ACR20, and 55.7% of patients who switched from placebo to risankizumab at week 24 achieved ACR20. Similar trends were observed for other efficacy measures. Rates of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation remained stable through week 52, and no deaths were reported. Conclusion Risankizumab was well tolerated and improved symptoms of PsA in Bio-IR/csDMARD-IR patients, with a consistent long-term safety profile from weeks 24 to 52. Trial registration United States National Library of Medicine clinical trials database www.clinicaltrials.gov ; KEEPsAKE 2; NCT03671148. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial

Author

Östör, Andrew, primary, Van den Bosch, Filip, additional, Papp, Kim, additional, Asnal, Cecilia, additional, Blanco, Ricardo, additional, Aelion, Jacob, additional, Alperovich, Gabriela, additional, Lu, Wenjing, additional, Wang, Zailong, additional, Soliman, Ahmed M, additional, Eldred, Ann, additional, Barcomb, Lisa, additional, and Kivitz, Alan, additional

Published
2021
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20. Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, primary, Lin, Celia J F, additional, Furst, Daniel E, additional, Goldin, Jonathan, additional, Kim, Grace, additional, Kuwana, Masataka, additional, Allanore, Yannick, additional, Matucci-Cerinic, Marco, additional, Distler, Oliver, additional, Shima, Yoshihito, additional, van Laar, Jacob M, additional, Spotswood, Helen, additional, Wagner, Bridget, additional, Siegel, Jeffrey, additional, Jahreis, Angelika, additional, Denton, Christopher P, additional, Lucero, Eleonora, additional, Pons-Estel, Bernardo, additional, Rivero, Mariano, additional, Tate, Guillermo, additional, Smith, Vanessa, additional, De Langhe, Ellen, additional, Rashkov, Rasho, additional, Batalov, Anastas, additional, Goranov, Ivan, additional, Stoilov, Rumen, additional, Dunne, James, additional, Johnson, Sindhu R., additional, Pope, Janet E., additional, Martinović Kaliterna, Dušanka, additional, Mogensen, Mette, additional, Olesen, Anne Braae, additional, Henes, Joerg Christoph, additional, Müller-Ladner, Ulf, additional, Riemekasten, Gabriela, additional, Skapenko, Alla, additional, Vlachoyiannopoulos, Panayiotis, additional, Kiss, Emese, additional, Minier, Tünde, additional, Beretta, Lorenzo, additional, Gremese, Elisa, additional, Valentini, Gabriele, additional, Asano, Yoshihide, additional, Atsumi, Tatsuya, additional, Ihn, Hironobu, additional, Ishii, Tomonori, additional, Ishikawa, Osamu, additional, Takahashi, Hiroki, additional, Takehara, Kazuhiko, additional, Tanaka, Yoshiya, additional, Yamasaki, Yoshioki, additional, Bukauskiene, Loreta, additional, Butrimiene, Irena, additional, Medrano Ramirez, Gabriel, additional, Ramos-Remus, Cesar, additional, Sofia Rodriguez Reyna, Tatiana, additional, de Vries-Bouwstra, Jeska, additional, van Laar, Jacob M., additional, Batko, Bogdan, additional, Jeka, Slawomir, additional, Kucharz, Eugeniusz, additional, Majdan, Maria, additional, Olesinska, Marzena, additional, Smolenska, Zaneta, additional, Alves, Jose, additional, Santos, Maria, additional, Mihai, Carmen Marina, additional, Rednic, Simona, additional, Castellvi Barranco, Ivan, additional, Lopez Longo, Francisco Javier, additional, Simeon Aznar, Carmen, additional, Carreira, Patricia, additional, Walker, Ulrich A., additional, Derrett-Smith, Emma, additional, Griffiths, Bridget, additional, McKay, Neil, additional, Denton, Christopher P., additional, Aelion, Jacob, additional, Borofsky, Michael, additional, Fleischmann, Roy, additional, Forstot, Joseph Z., additional, Furst, Daniel E., additional, Kafaja, Suzanne, additional, Khan, M. Faisal, additional, Khanna, Dinesh, additional, Kohen, Michael D., additional, Martin, Richard W., additional, Mendoza-Ballesteros, Fabian, additional, Nami, Alireza, additional, Pang, Shirley, additional, Rios, Grissel, additional, Simms, Robert, additional, Sullivan, Keith Michael, additional, and Steen, Virginia D., additional

Published
2020
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21. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.

Author

Östör, Andrew, Van den Bosch, Filip, Papp, Kim, Asnal, Cecilia, Blanco, Ricardo, Aelion, Jacob, Alperovich, Gabriela, Wenjing Lu, Wang, Zailong, Soliman, Ahmed M., Eldred, Ann, Barcomb, Lisa, Kivitz, Alan, and Lu, Wenjing

Subjects
THERAPEUTIC use of monoclonal antibodies, PSORIATIC arthritis, RESEARCH, EVALUATION research, ANTIRHEUMATIC agents, TREATMENT effectiveness, COMPARATIVE studies, RANDOMIZED controlled trials, BLIND experiment, STATISTICAL sampling
Abstract

Objectives: Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.Methods: Adults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes.Results: A total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively.Conclusion: Treatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR.Trial Registration Number: NCT03671148. [ABSTRACT FROM AUTHOR]

Published
2022
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22. Apremilast monotherapy for long-term treatment of active psoriatic arthritis in DMARD-naïve patients.

Author

Wells, Alvin F, Edwards, Christopher J, Kivitz, Alan J, Bird, Paul, Guerette, Benoit, Delev, Nikolay, Paris, Maria, Teng, Lichen, and Aelion, Jacob A

Subjects
PSORIATIC arthritis, DRUG efficacy, TREATMENT duration, ANTIRHEUMATIC agents, TREATMENT effectiveness, RANDOMIZED controlled trials, BIOTHERAPY, BLIND experiment, DESCRIPTIVE statistics, PHOSPHODIESTERASE inhibitors, LONG-term health care, EVALUATION
Abstract

Objectives Apremilast monotherapy was evaluated up to 5 years in PALACE 4 (fourth PsA Long-term Assessment of Clinical Efficacy study) DMARD-naïve patients with PsA. Methods Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg or apremilast 20 mg twice a day. Placebo patients were rerandomized to apremilast at week 16 or 24. Double-blind apremilast continued to week 52, with a 4-year open-label extension (≤260 weeks of exposure). Analyses through week 260 were based on observed data. Results A total of 527 patients were treated. Among patients randomized to apremilast 30 mg at baseline, 45.5% completed week 260. At study end, 24.8% reported conventional synthetic DMARD or steroid use for any reason. At week 260, 65.8%/39.0%/20.3% of apremilast 30 mg patients achieved ACR20/ACR50/ACR70 responses, respectively. PsA sign and symptom improvements were sustained up to week 260 with continued treatment, including reductions in swollen (84.8%) and tender (76.4%) joint counts. Among apremilast 30 mg patients with baseline enthesitis or dactylitis, 71.2% achieved a Maastricht Ankylosing Spondylitis Enthesitis Score of 0 and 95.1% achieved a dactylitis count of 0. Over 50% of patients achieved a HAQ Disability Index minimal clinically important difference (≥0.35). In patients with ≥3% baseline psoriasis-involved body surface area, 60.3% and 47.6% achieved ≥50% and ≥75% improvement in Psoriasis Area and Severity Index scores, respectively. Patients continuing apremilast 20 mg also demonstrated consistent, sustained improvements. The most common adverse events were diarrhoea, nausea, headache, upper respiratory tract infection and nasopharyngitis. No new safety concerns were observed long term. Conclusions Apremilast led to sustained PsA efficacy up to 260 weeks and was well tolerated. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov), NCT01307423. [ABSTRACT FROM AUTHOR]

Published
2022
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24. Tocilizumab in systemic sclerosis:a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, Steen, Virginia D., Khanna, Dinesh, Lin, Celia J.F., Furst, Daniel E., Goldin, Jonathan, Kim, Grace, Kuwana, Masataka, Allanore, Yannick, Matucci-Cerinic, Marco, Distler, Oliver, Shima, Yoshihito, van Laar, Jacob M., Spotswood, Helen, Wagner, Bridget, Siegel, Jeffrey, Jahreis, Angelika, Denton, Christopher P., Lucero, Eleonora, Pons-Estel, Bernardo, Rivero, Mariano, Tate, Guillermo, Smith, Vanessa, De Langhe, Ellen, Rashkov, Rasho, Batalov, Anastas, Goranov, Ivan, Stoilov, Rumen, Dunne, James, Johnson, Sindhu R., Pope, Janet E., Martinović Kaliterna, Dušanka, Mogensen, Mette, Olesen, Anne Braae, Henes, Joerg Christoph, Müller-Ladner, Ulf, Riemekasten, Gabriela, Skapenko, Alla, Vlachoyiannopoulos, Panayiotis, Kiss, Emese, Minier, Tünde, Beretta, Lorenzo, Gremese, Elisa, Valentini, Gabriele, Asano, Yoshihide, Atsumi, Tatsuya, Ihn, Hironobu, Ishii, Tomonori, Ishikawa, Osamu, Takahashi, Hiroki, Takehara, Kazuhiko, Tanaka, Yoshiya, Yamasaki, Yoshioki, Bukauskiene, Loreta, Butrimiene, Irena, Medrano Ramirez, Gabriel, Ramos-Remus, Cesar, Sofia Rodriguez Reyna, Tatiana, de Vries-Bouwstra, Jeska, Batko, Bogdan, Jeka, Slawomir, Kucharz, Eugeniusz, Majdan, Maria, Olesinska, Marzena, Smolenska, Zaneta, Alves, Jose, Santos, Maria, Mihai, Carmen Marina, Rednic, Simona, Castellvi Barranco, Ivan, Lopez Longo, Francisco Javier, Simeon Aznar, Carmen, Carreira, Patricia, Walker, Ulrich A., Derrett-Smith, Emma, Griffiths, Bridget, McKay, Neil, Aelion, Jacob, Borofsky, Michael, Fleischmann, Roy, Forstot, Joseph Z., Kafaja, Suzanne, Khan, M. Faisal, Kohen, Michael D., Martin, Richard W., Mendoza-Ballesteros, Fabian, Nami, Alireza, Pang, Shirley, Rios, Grissel, Simms, Robert, Sullivan, Keith Michael, and Steen, Virginia D.

Abstract

Background: A phase 2 trial of tocilizumab showed preliminary evidence of efficacy in systemic sclerosis. We assessed skin fibrosis and systemic sclerosis-associated interstitial lung disease (SSc-ILD) in a phase 3 trial to investigate the safety and efficacy of tocilizumab, an anti-interleukin-6 receptor antibody, in the treatment of systemic sclerosis. Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial, participants were recruited from 75 sites in 20 countries across Europe, North America, Latin America, and Japan. Adults with diffuse cutaneous systemic sclerosis for 60 months or less and a modified Rodnan skin score (mRSS) of 10–35 at screening were randomly assigned (1:1) with a voice-web-response system to receive subcutaneous tocilizumab 162 mg or placebo weekly for 48 weeks, stratified by IL-6 levels; participants and investigators were masked to treatment group. The primary endpoint was the difference in change from baseline to week 48 in mRSS. Percentage of predicted forced vital capacity (FVC% predicted) at week 48, time to treatment failure, and patient-reported and physician-reported outcomes were secondary endpoints. This trial is registered with ClinicalTrials.gov (number NCT02453256) and is closed to accrual. Findings: Between Nov 20, 2015, and Feb 14, 2017, 210 individuals were randomly assigned to receive tocilizumab (n=104) or placebo (n=106). In the intention-to-treat population, least squares mean [LSM] change from baseline to week 48 in mRSS was −6·14 for tocilizumab and −4·41 for placebo (adjusted difference −1·73 [95% CI −3·78 to 0·32]; p=0·10). The shift in distribution of change from baseline in FVC% predicted at week 48 favoured tocilizumab (van Elteren nominal p=0·002 vs placebo), with a difference in LSM of 4·2 (95% CI 2·0–6·4; nominal p=0·0002), as did time to treatment failure (hazard ratio 0·63 [95% CI 0·37–1·06]; nominal p=0·08). Change in LSM from baseline to week 48 in Health Assessment Ques

Published
2020

26. Treatment of Calcinosis with Diltiazem

Author

Palmieri, Genaro M. A., Sebes, Jeno I., Aelion, Jacob A., Moinuddin, Mohamed, Ray, Morris W., Wood, George C., and Leventhal, Marvin R.

Published
1995

28. Oral abstracts 3: RA Treatment and outcomesO13. Validation of jadas in all subtypes of juvenile idiopathic arthritis in a clinical setting

Author

McErlane, Flora, Beresford, Michael W., Baildam, Eileen M., Thomson, Wendy, Hyrich, Kimme, Chieng, Alice, Davidson, Joyce, Foster, Helen E., Gardner-Medwin, Janet, Lunt, Mark, Wedderburn, Lucy, Nikiphorou, Elena, Carpenter, Lewis, Kiely, Patrick, Walsh, David, Dixey, Josh, Young, Adam, Kapoor, Sabrina R., Filer, Andrew, Fitzpatrick, Martin, Fisher, Benjamin A., Taylor, Peter C., Buckley, Christopher, McInnes, Iain, Raza, Karim, Young, Stephen P., Dougados, Maxime, Kissel, Karsten, Amital, Howard, Conaghan, Philip, Martin-Mola, Emilio, Nasonov, Evgeny, Schett, Georg, Troum, Orrin, Veldi, Tiina, Bernasconi, Corrado, Huizinga, Tom, Durez, Patrick, Genovese, Mark C., Richards, Hanno B., Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A., Lee, Sang-Heon, Codding, Christine E., Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, Mpofu, Shephard, Kavanaugh, Arthur, Emery, Paul, Fleischmann, Roy, Van Vollenhoven, Ronald, Pavelka, Karel, Guérette, Benoît, Santra, Sourav, Redden, Laura, Kupper, Hartmut, Smolen, Josef S., Wilkie, Ross, Tajar, Abdelouahid, McBeth, John, Hooper, Lindsey S., Bowen, Catherine J., Gates, Lucy, Culliford, David, Edwards, Christopher J., Arden, Nigel K., Adams, Jo, Ryan, Sarah, Haywood, Hannah, Pain, Helen, Siddle, Heidi J., Redmond, Anthony C., Waxman, Robin, Dagg, Abigail R., Alcacer-Pitarch, Begonya, Wilkins, Richard A., Helliwell, Philip S., Norton, Sam, Williams, Richard, Halls, Serena, Law, Rebecca-Jane, Jones, Jeremy, Markland, David, Maddison, Peter, Thom, Jeanette, Parker, Ben, Urowitz, Murray B., Gladman, Dafna D., Bruce, Ian, Croca, Sara C., Pericleous, Charis, Yong, Harry, Isenberg, David, Giles, Ian, Rahman, Anisur, Ioannou, Yiannis, Warrell, Clare E., Dobarro, David, Handler, Clive, Denton, Christopher P., Schreiber, Benjamin E., Coghlan, John G., Betteridge, Zoe E., Woodhead, Felix, Bunn, Christopher, Abraham, David, Desai, Sujal, du Bois, Roland, Wells, Athol, McHugh, Neil, Abignano, Giuseppina, Aydin, Sibel, Castillo-Gallego, Conception, Woods, Daniel, Meekings, Adam, McGonagle, Dennis, Del Galdo, Francesco, Vila, Josephine, Mitchell, Sheryl, Bowman, Simon, Price, Elizabeth, Pease, Colin T., Andrews, Jacqueline, Bombardieri, Michele, Sutcliffe, Nurhan, Pitzalis, Constantino, Lanyon, Peter, Hunter, John, Gupta, Monica, McLaren, John, Regan, Marian, Cooper, Annie, Vadivelu, Saravanan, Coady, David, Griffiths, Bridget, Lendrem, Dennis, Foggo, Heather, Tarn, Jessica, Ng, Wan-Fai, Goodhead, Charlotte, Shekar, Priya, Kelly, Clive, Francis, Gail, Bailey, Ann-Marie, Thompson, Lynsey, Hamilton, Jennifer, Salisbury, Chris, Foster, Nadine E., Bishop, Annette, Coast, Jo, Franchini, Angelo, Hall, Jeanette, Hollinghurst, Sandra, Hopper, Cherida, Grove, Sean, Kaur, Surinder, Montgomery, Alan, Paskins, Zoe, Sanders, Tom, Croft, Peter R., Hassell, Andy B., Coxon, Domenica E., Frisher, Martin, Jordan, Kelvin P., Jinks, Clare, Peat, George, Monk, Helen L., Muller, Sara, Mallen, Christian, Hider, Samantha L., Roddy, Edward, and Hayward, Richard

Abstract

Background: Juvenile Arthritis Disease Activity Score (JADAS) is a 4 variable composite disease activity (DA) score for JIA (including active 10, 27 or 71 joint count (AJC), physician global (PGA), parent/child global (PGE) and ESR). The validity of JADAS for all ILAR subtypes in the routine clinical setting is unknown. We investigated the construct validity of JADAS in the clinical setting in all subtypes of JIA through application to a prospective inception cohort of UK children presenting with new onset inflammatory arthritis. Methods: JADAS 10, 27 and 71 were determined for all children in the Childhood Arthritis Prospective Study (CAPS) with complete data available at baseline. Correlation of JADAS 10, 27 and 71 with single DA markers was determined for all subtypes. All correlations were calculated using Spearman's rank statistic. Results: 262/1238 visits had sufficient data for calculation of JADAS (1028 (83%) AJC, 744 (60%) PGA, 843 (68%) PGE and 459 (37%) ESR). Median age at disease onset was 6.0 years (IQR 2.6-10.4) and 64% were female. Correlation between JADAS 10, 27 and 71 approached 1 for all subtypes. Median JADAS 71 was 5.3 (IQR 2.2-10.1) with a significant difference between median JADAS scores between subtypes (p < 0.01). Correlation of JADAS 71 with each single marker of DA was moderate to high in the total cohort (see Table 1). Overall, correlation with AJC, PGA and PGE was moderate to high and correlation with ESR, limited JC, parental pain and CHAQ was low to moderate in the individual subtypes. Correlation coefficients in the extended oligoarticular, rheumatoid factor negative and enthesitis related subtypes were interpreted with caution in view of low numbers. Conclusions: This study adds to the body of evidence supporting the construct validity of JADAS. JADAS correlates with other measures of DA in all ILAR subtypes in the routine clinical setting. Given the high frequency of missing ESR data, it would be useful to assess the validity of JADAS without inclusion of the ESR. Disclosure statement: All authors have declared no conflicts of interest. Table 1Spearman's correlation between JADAS 71 and single markers DA by ILAR subtype ILAR Subtype Systemic onset JIA Persistent oligo JIA Extended oligo JIA Rheumatoid factor neg JIA Rheumatoid factor pos JIA Enthesitis related JIA Psoriatic JIA Undifferentiated JIA Unknown subtype Total cohort Number of children 23 111 12 57 7 9 19 7 17 262 AJC 0.54 0.67 0.53 0.75 0.53 0.34 0.59 0.81 0.37 0.59 PGA 0.63 0.69 0.25 0.73 0.14 0.05 0.50 0.83 0.56 0.64 PGE 0.51 0.68 0.83 0.61 0.41 0.69 0.71 0.9 0.48 0.61 ESR 0.28 0.31 0.35 0.4 0.6 0.85 0.43 0.7 0.5 0.53 Limited 71 JC 0.29 0.51 0.23 0.37 0.14 -0.12 0.4 0.81 0.45 0.41 Parental pain 0.23 0.62 0.03 0.57 0.41 0.69 0.7 0.79 0.42 0.53 Childhood health assessment questionnaire 0.25 0.57 -0.07 0.36 -0.47 0.84 0.37 0.8 0.66 0.47

Published
2017

29. Three Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

Author

Deodhar, Atul, primary, Gensler, Lianne S., additional, Sieper, Joachim, additional, Clark, Michael, additional, Calderon, Cesar, additional, Wang, Yuhua, additional, Zhou, Yiying, additional, Leu, Jocelyn H., additional, Campbell, Kim, additional, Sweet, Kristen, additional, Harrison, Diane D., additional, Hsia, Elizabeth C., additional, Heijde, Désirée, additional, Ariel, Frederico, additional, Asnal, Cecilia Adma, additional, Berman, Alberto, additional, Citera, Gustavo, additional, Rodriguez, Graciela, additional, Savio, Veronica Gabriela, additional, Bird, Paul, additional, Griffiths, Hedley, additional, Nicholls, David, additional, Rischmueller, Maureen, additional, Zochling, Jane, additional, De Vlam, Kurt, additional, Malaise, Michel, additional, Toukap, Adrien Nzeusseu, additional, Van den Bosch, Filip, additional, Vanhoof, Johan, additional, Bonfiglioli, Rubens, additional, Keiserman, Mauro, additional, Scotton, Antonio Scafuto, additional, Xavier, Ricardo, additional, Ximenes, Antonio Carlos, additional, Atanasov, Assen, additional, Goranov, Ivan, additional, Kazmin, Ivan, additional, Licheva, Rodina Nestorova, additional, Nikolov, Nikolay, additional, Oparanov, Boycho, additional, Stoilov, Rumen, additional, Bessette, Louis, additional, Rodrigues, Jude, additional, Bortilik, Ladislav, additional, Dokoupilova, Eva, additional, Dvoarak, Zdenek, additional, Galatikova, Dagmar, additional, Nemec, Petr, additional, Podrazilova, Lucie, additional, Simkova, Gabriela, additional, Stejfova, Zuzana, additional, Moravcova, Radka, additional, Vitek, Petr, additional, Cantagrel, Alain, additional, Baillet, Athan, additional, Banneville, Beatrice, additional, Combe, Bernard, additional, Breban, Maxime, additional, Nguyen, Minh, additional, Goupille, Philippe, additional, Braun, Juergen, additional, Everding, Andrea, additional, Kekow, Joern, additional, Koenig, Ramona, additional, Rubbert‐Roth, Andrea, additional, Witte, Torsten, additional, Bartha, Attila, additional, Drescher, Edit, additional, Kerekes, Kata, additional, Kovacs, Attila, additional, Pulai, Judit, additional, Rojkovich, Bernadette, additional, Szanto, Sandor, additional, Toth, Edit, additional, Avila, Hilario, additional, Torre, Igancio Garcia, additional, Irazoque, Fedra, additional, Maradiaga, Marco, additional, Pacheco, Cesar, additional, Brzosko, Marek, additional, Dudek, Anna, additional, Jeka, Slawomir, additional, Krogulec, Marek, additional, Kwiatkowska, Brygida, additional, Wiland, Piotr, additional, Wojciechowski, Rafal, additional, Zielinska, Agnieszka, additional, Santos, Helena, additional, Bugrova, Olga, additional, Christyakov, Valery, additional, Gorbunov, Vladimir, additional, Ilivanova, Elena, additional, Zemerova, Elena, additional, Kamalova, Rima, additional, Kameneva, Tatyana, additional, Macievskaya, Galina, additional, Marusenko, Irina, additional, Maslyansky, Alexey, additional, Myasoedova, Svetlana, additional, Myasoutova, Leisan, additional, Nemtsov, Boris, additional, Nesmeyanova, Olga, additional, Plaksina, Tatyana, additional, Pokrovskaya, Tatyana, additional, Polyakova, Svetlana, additional, Rebrov, Andrey, additional, Savina, Liudmila, additional, Smakotina, Svetlana, additional, Stanislav, Marina, additional, Ukhanova, Olga, additional, Vinogradova, Irina, additional, Zonova, Elena, additional, Baek, Han Joo, additional, Kim, Tae‐Hwan, additional, Lee, ChangKeun, additional, Lee, SangHeon, additional, Lee, Sang‐Hoon, additional, Lee, Shin‐Seok, additional, Park, Sung‐Hwan, additional, Song, YeongWook, additional, Suh, Chang‐Hee, additional, Ramos, Juan Amarelo, additional, Blanco, Franciso Javier, additional, Collantes, Eduardo, additional, Diaz, Miguel Consuelo, additional, Vivar, Maria Luz Garcia, additional, Gratacos, Jordi, additional, Juanola, Xavier, additional, Chen, Der‐Yuan, additional, Chen, Hsiang‐Cheng, additional, Chen, Kun‐Hung, additional, Chen, Ying‐Chou, additional, Chiu, Ying‐Ming, additional, Luo, Shue‐Fen, additional, Tsai, Shih‐Tzu, additional, Tseng, Jui‐Cheng, additional, Wei, Cheng‐Chung, additional, Weng, Meng‐Yu, additional, Abrahamovych, Orest, additional, Reshotko, Dmytro, additional, Golovchenko, Oleksandr, additional, Hospodarsky, Ihor, additional, Iaremenko, Oleg, additional, Levchenko, Olena, additional, Dudnyk, Oleksandr, additional, Garmish, Olena, additional, Grishyna, Olena, additional, Protsenko, Galyna, additional, Rekalov, Dmytro, additional, Smiyan, Svitlana, additional, Stanislavchuk, Mykola, additional, Trypilka, Svitlana, additional, Tseluyko, Vira, additional, Turianytsia, Samvel, additional, Vasylets, Viktoriya, additional, Virstyuk, Nataliya, additional, Kleban, Yaroslav, additional, Ciurtin, Coziana, additional, Gaffney, Karl, additional, Gunasekera, Wiranthi, additional, Mackay, Kirsten, additional, Packham, Jon, additional, Sengupta, Raj, additional, Tahir, Hasan, additional, Aelion, Jacob, additional, Bennett, Ralph, additional, Deodhar, Atul, additional, Gonzalez‐Paoli, Julio, additional, Griffin, Robert M., additional, Grisanti, Michael, additional, Mallepalli, Jyothi, additional, Peters, Eric, additional, Schechtman, Joy, additional, and Singhal, Atul, additional

Published
2018
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30. ABT ‐122, a Bispecific Dual Variable Domain Immunoglobulin Targeting Tumor Necrosis Factor and Interleukin‐17A, in Patients With Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Author

Genovese, Mark C., primary, Weinblatt, Michael E., additional, Aelion, Jacob A., additional, Mansikka, Heikki T., additional, Peloso, Paul M., additional, Chen, Kun, additional, Li, Yihan, additional, Othman, Ahmed A., additional, Khatri, Amit, additional, Khan, Nasser S., additional, and Padley, Robert J., additional

Published
2018
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31. Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis

Author

Genovese, Mark C, primary, Weinblatt, Michael E, additional, Mease, Philip J, additional, Aelion, Jacob A, additional, Peloso, Paul M, additional, Chen, Kun, additional, Li, Yihan, additional, Liu, John, additional, Othman, Ahmed A, additional, Khatri, Amit, additional, Mansikka, Heikki T, additional, and Leszczyński, Piotr, additional

Published
2018
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32. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study

Author

Deodhar, Atul, primary, Gottlieb, Alice B, additional, Boehncke, Wolf-Henning, additional, Dong, Bin, additional, Wang, Yuhua, additional, Zhuang, Yanli, additional, Barchuk, William, additional, Xu, Xie L, additional, Hsia, Elizabeth C, additional, AELION, Jacob, additional, AMARELO-RAMOS, Juan, additional, BALSA, Alejandro, additional, BERGHEA, Florian, additional, BRZEZICKI, Jan, additional, BURNETTE, Michael, additional, FRETZIN, Scott, additional, GARCÍA-CARAZO, Sara, additional, GLADSTEIN, Geoffrey, additional, GOMEZ-REINO, Juan, additional, GOODERHAM, Melinda, additional, GONZÁLEZ-FERNÁNDEZ, Carlos, additional, GOTTLIEB, Alice, additional, GRATACOS, Jordi, additional, HAALAND, Derek, additional, KAMALOVA, Rima, additional, LESZCZYNSKI, Piotr, additional, MARTIN-MOLA, Emilio, additional, MASLYANSKY, Alexey, additional, NAVARRO, Federico, additional, OPRIS, Daniela, additional, PAPP, Kim, additional, PERLAMUTROV, Yuriy, additional, PHILIPP, Sandra, additional, RACEWICZ, Artur, additional, REBROV, Andrey, additional, RELL-BAKALARSKA, Maria, additional, ROSMARIN, David, additional, RUBBERT-ROTH, Andrea, additional, SHERGY, William, additional, SHIRINSKY, Ivan, additional, SONIN, Dmitry, additional, STANISLAV, Marina, additional, SUKHAREV, Alexey, additional, TEMNIKOV, Vadim, additional, VINOGRADOVA, Irina, additional, WAYTZ, Paul, additional, and YAKUSHEVICH, Vladimir, additional

Published
2018
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34. Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE)

Author

Nash, Peter, Ohson, Kamal, Walsh, Jessica, Delev, Nikolay, Nguyen, Dianne, Teng, Lichen, Gómez-Reino, Juan J., Aelion, Jacob, Nash, Peter, Ohson, Kamal, Walsh, Jessica, Delev, Nikolay, Nguyen, Dianne, Teng, Lichen, Gómez-Reino, Juan J., and Aelion, Jacob

Abstract

[Abstract] Objective Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA. Methods Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52. Results Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo). Conclusions In biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports.

Published
2018

36. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial

Author

Fleischmann, Roy, primary, Mysler, Eduardo, additional, Hall, Stephen, additional, Kivitz, Alan J, additional, Moots, Robert J, additional, Luo, Zhen, additional, DeMasi, Ryan, additional, Soma, Koshika, additional, Zhang, Richard, additional, Takiya, Liza, additional, Tatulych, Svitlana, additional, Mojcik, Christopher, additional, Krishnaswami, Sriram, additional, Menon, Sujatha, additional, Smolen, Josef S, additional, Adams, Luthando, additional, Ally, Mahmood M, additional, du Plooy, Maria C, additional, Louw, Ingrid C, additional, Nayiager, Savithree, additional, Nel, Christoffel B, additional, Nel, Debra, additional, Reuter, Helmuth, additional, Soloman, Ahmed S, additional, Spargo, Catherine E, additional, Rischmueller, Maureen, additional, Sharma, Shunil D, additional, Will, Robert K, additional, Youssef, Peter P, additional, Arroyo, Caroline, additional, Baes, Rosario P, additional, Dulos, Roger B, additional, Hao, Llewellyn T, additional, Lanzon, Allan E, additional, Lichauco, Juan Javier T, additional, Mangubat, Jill H, additional, Ramiterre, Edgar B, additional, Reyes, Bernadette Heizel M, additional, Tan, Perry P, additional, Choe, Jung-Yoon, additional, Kang, Young Mo, additional, Kwon, Seong Ryul, additional, Lee, Sang-Heon, additional, Lee, Shin-Seok, additional, Yoo, Dae-Hyun, additional, Lin, Hsiao-Yi, additional, Luo, Shue-Fen, additional, Tsai, Shih-Tzu, additional, Tsai, Wen-Chan, additional, Tseng, Jui-Cheng, additional, Wei, Cheng-Chung C, additional, Asavatanabodee, Paijit, additional, Nantiruj, Kanokrat, additional, Nilganuwong, Surasak, additional, Uea-Areewongsa, Parichat, additional, Majstorovic, Ljubinka Bozic, additional, Bacic, Suada Mulic, additional, Batalov, Anastas Z, additional, Georgieva-Slavcheva, Gabriela, additional, Mihailova, Mariyana, additional, Nikolov, Nikolay G, additional, Penev, Dimitar P, additional, Spasov, Yuliy A, additional, Stanimirova, Krasimira, additional, Todorov, Stoyan, additional, Toncheva, Antoaneta R, additional, Yordanova, Nadezhda, additional, Mosterova, Zdenka, additional, Novosad, Libor, additional, Prochazkova, Leona, additional, Stehlikova, Helena, additional, Stejfova, Zuzana, additional, Kiseleva, Natalia, additional, Pank, Lea, additional, Savi, Triin, additional, Alexandra, Balbir-Gurman, additional, Amital, Howard, additional, Mevorach, Dror, additional, Rosner, Itzhak A, additional, Mihailova, Anna, additional, Stumbra-Stumberga, Evija, additional, Basijokiene, Vida, additional, Lietuvininkiene, Virginija, additional, Unikiene, Dalia, additional, Brzezicki, Jan, additional, Dudek, Anna M, additional, Glowacka-Kulesz, Maria B, additional, Grabowicz-Wasko, Barbara, additional, Hajduk-Kubacka, Sabina, additional, Hilt, Joanna, additional, Hrycaj, Pawel, additional, Jeka, Slawomir, additional, Kolasa, Renata, additional, Krogulec, Marek, additional, Mastalerz, Hanna, additional, Olak-Popko, Anna, additional, Owczarek, Elzbieta, additional, Ruzga, Zofia, additional, Walczak, Alina, additional, Ancuta, Codrina I, additional, Ancuta, Ioan, additional, Balanescu, Andra R, additional, Berghea, Florian, additional, Bojin, Silvia, additional, Arvunescu, Mihaela A Ianuli, additional, Ionescu, Ruxandra M, additional, Mociran, Eugenia, additional, Pavel, Mariana, additional, Rednic, Simona, additional, Voie, Adriana, additional, Zainea, Carmen M, additional, Bugrova, Olga V, additional, Demin, Alexander, additional, Ershova, Olga B, additional, Gavrisheva, Inna A, additional, Krechikova, Diana G, additional, Kuropatkin, Gennady V, additional, Marusenko, Irina M, additional, Menshikova, Irina V, additional, Noskov, Sergey M, additional, Rebrov, Andrey P, additional, Smakotina, Svetlana A, additional, Yakushin, Sergey S, additional, Zhilyaev, Evgeny, additional, Ramos, Juan Jose Amarelo, additional, Garcia, Francisco Javier Blanco, additional, Nebro, Antonio Fernandez, additional, Esteban, Silvia Perez, additional, Burson, Juan Miguel Sanchez, additional, Sala, Raimon Sanmarti, additional, Ataman, Sebnem, additional, Hizmetli, Sami, additional, Kuru, Omer, additional, Douglas, Karen M, additional, Emery, Paul, additional, Ong, Voon H, additional, Sheeran, Thomas P, additional, Faraawi, Rafat Y, additional, Lessard, Clode, additional, Mendoza, Carlos Abud, additional, Avila-Armengol, Hilario Ernesto, additional, Zapata, Francisco I Avila, additional, Irazoque-Palazuelos, Fedra Consuelo, additional, Cecena, Marco Antonio Maradiaga, additional, Pacheco-Tena, Cesar F, additional, Rizo-Rodriguez, Juan C, additional, Rodriguez-Torres, Isaura M, additional, Aelion, Jacob A, additional, Caciolo, Barbara A, additional, Calmes, James M, additional, Chatpar, Prem, additional, Dayal, Nimesh, additional, De Jesus, Alex, additional, Dikranian, Ara H, additional, Diri, Erdal, additional, Fairfax, Michael J, additional, Fenton, Ira F, additional, Fleischmann, Roy M, additional, Gaylis, Norman B, additional, George, Ronald L, additional, Halter, Dale G, additional, Hernandez, Paul, additional, Hole, Susan A, additional, Hou, Antony C, additional, Huff, John P, additional, Kafaja, Suzanne, additional, Kennedy, Alastair C, additional, Kenney, Howard, additional, Kimmel, Steven C, additional, Kirby, Brian S, additional, Legerton, Clarence W, additional, Lindsey, Stephen M, additional, Mallepalli, Jyothi R, additional, Mathews, Steven D, additional, Metyas, Samy K, additional, Mizutani, Wesley T, additional, Najam, Sabeen, additional, Nascimento, Joao M, additional, Pang, Shirley W, additional, Patel, Rakesh C, additional, Poiley, Jeffrey E, additional, Ramirez, Carlos E, additional, Reddy, Riteesha, additional, Rehman, Qaiser, additional, Schnitz, William M, additional, Scoville, Craig D, additional, Shergy, William J, additional, Silverfield, Joel C, additional, Singhal, Atul K, additional, Smallwood-Sherrer, Yvonne R, additional, Songcharoen, Suthin N, additional, Stack, Michael T, additional, Stohl, William, additional, Su, Tien-I K, additional, Udell, James, additional, Waraich, Saleem, additional, Weidmann, Charles E, additional, Wei, Nathan, additional, Wiesenhutter, Craig W, additional, Winkler, Anne E, additional, Zagar, Karen E, additional, Berman, Alberto, additional, Mysler, Eduardo F, additional, Hidalgo, Rodolfo A Pardo, additional, Venarotti, Horacio O, additional, Sariego, Irmgadt Annelise Goecke, additional, Calabresse, Renato E Jimenez, additional, Ruiz-Tagle, Juan Ignacio Vargas, additional, Vargas, Luis Fernando M Bellatin, additional, Berrocal, Alfredo E, additional, Portocarrero, Manuel Gustavo Leon, additional, Jesus, Felix, additional, and Pena, Romero, additional

Published
2017
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37. Long-term (104-Week) Efficacy and Safety of Apremilast Monotherapy in DMARD-Naive Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial and Open-Label Extension (PALACE 4)

Author

Wells, Alvin F., Schett, Georg, Edwards, Christopher, Adebajo, Adewale, Kivitz, Alan, Shah, Kamal, Hu, ChiaChi, and Aelion, Jacob A.

Subjects
animal structures, ddc: 610, 610 Medical sciences, Medicine
Abstract

Introduction: Apremilast (APR), an oral phosphodiesterase 4 inhibitor, helps regulate immune responses in psoriatic arthritis (PsA). PALACE 4 compared APR monotherapy efficacy/safety with placebo in DMARD-naïve patients with active PsA. Methods: Patients were randomized (1:1:1) to placebo,[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

38. Secukinumab improves multiple parameters of disease activity in subjects with active ankylosing spondylitis through 52 weeks of subcutaneous therapy: data from the phase 3 MEASURE 2 study

Author

Braun, Jürgen, Sieper, Joachim, Aelion, Jacob A., Emery, Paul, Deodhar, Atul, Porter, Brian, Andersson, Mats, and Richards, Hanno B.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Introduction: Disease activity in ankylosing spondylitis (AS) encompasses a wide range of clinical manifestations. As such, a number of composite and single component activity measures exist. The objective is to describe the effect of subcutaneous (s.c) treatment with secukinumab on multiple parameters[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

39. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3)

Author

Edwards, Christopher J., Blanco García, Francisco J, Crowley, Jeffrey, Birbara, Charles A., Jaworski, Janusz, Aelion, Jacob, Stevens, Randall M., Vessey, Adele, Zhan, Xiaojiang, Bird, Paul, Edwards, Christopher J., Blanco García, Francisco J, Crowley, Jeffrey, Birbara, Charles A., Jaworski, Janusz, Aelion, Jacob, Stevens, Randall M., Vessey, Adele, Zhan, Xiaojiang, and Bird, Paul

Abstract

[Abstract] Objective. To evaluate apremilast treatment in patients with active psoriatic arthritis, including current skin involvement, despite prior therapy with conventional disease-modifying antirheumatic drugs and/or biologic agents. Methods. Patients (N=505) were randomised (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily. Rescue therapy with apremilast was designated at week 16 for placebo patients not achieving 20% improvement in swollen and tender joint counts. At week 24, the remaining placebo patients were then randomised to apremilast 20 mg twice daily or 30 mg twice daily. The efficacy and safety of apremilast were assessed over 52 weeks. Results. At week 16, significantly more patients receiving apremilast 20 mg twice daily (28%) and 30 mg twice daily (41%) achieved 20% improvement in American College of Rheumatology response criteria versus placebo (18%; p=0.0295 and p<0.0001, respectively), and mean decrease in the Health Assessment Questionnaire-Disability Index score was significantly greater with apremilast 30 mg twice daily (−0.20) versus placebo (−0.07; p=0.0073). In patients with baseline psoriasis body surface area involvement ≥3%, significantly more apremilast 30 mg twice daily patients achieved 50% reduction from baseline Psoriasis Area and Severity Index score (41%) versus placebo (24%; p=0.0098) at week 16. At week 52, observed improvements in these measures demonstrated sustained response with continued apremilast treatment. Most adverse events were mild to moderate in severity; the most common were diarrhoea, nausea, headache and upper respiratory tract infection. Conclusions. Apremilast demonstrated clinically meaningful improvements in psoriatic arthritis and psoriasis at week 16; sustained improvements were seen with continued treatment through 52 weeks. Apremilast was generally well tolerated and demonstrated an acceptable safety profile.

Published
2016

40. Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study

Author

Damjanov, Nemanja, primary, Tlustochowicz, Malgorzata, additional, Aelion, Jacob, additional, Greenwald, Maria, additional, Diehl, Annette, additional, Bhattacharya, Indranil, additional, Peeva, Elena, additional, Menon, Sandeep, additional, and Gourley, Ian, additional

Published
2016
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42. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebocontrolled PALACE 4 trial.

Author

Wells, Alvin F, Edwards, Christopher J, Kivitz, Alan J, Bird, Paul, Nguyen, Dianne, Paris, Maria, Teng, Lichen, and Aelion, Jacob A

Subjects
ANTIRHEUMATIC agents, DIARRHEA, HEADACHE, NAUSEA, PSORIATIC arthritis, RESPIRATORY infections, TERMINATION of treatment, RANDOMIZED controlled trials, TREATMENT effectiveness, BLIND experiment, SEVERITY of illness index, DISEASE duration, APREMILAST, TREATMENT duration, THERAPEUTICS
Abstract

Objectives. The PALACE 4 trial evaluated apremilast monotherapy in patients with active PsA who were DMARD-naive. Methods. Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg twice a day or apremilast 30 mg twice a day. At week 16 or 24, placebo patients were rerandomized to apremilast. Double-blind apremilast treatment continued to week 52, with extension up to 4 years. The primary endpoint was the proportion of patients achieving ≽20% improvement in ACR response criteria (ACR20) at week 16; secondary endpoints included the mean change in the HAQ Disability Index (HAQ-DI) score at week 16. Results. A total of 527 patients with mean disease duration of 3.4 years and high disease activity were randomized and received treatment. More apremilast patients achieved ACR20 response at week 16 [placebo, 15.9%; 20 mg, 28.0% (P = 0.0062); 30 mg, 30.7% (P =0.0010)]. The mean HAQ-DI improvements were -0.17 (20 mg; P = 0.0008) and -0.21 (30 mg; P < 0.0001) vs 0.03 (placebo). Both apremilast doses showed significant ACR50 responses vs placebo at week 16 and improvements in secondary efficacy measures (swollen/tender joint counts) and psoriasis assessments, with sustained improvements through week 52. Common adverse events (AEs) over 52 weeks were diarrhoea, nausea, headache and upper respiratory tract infection; most events were mild or moderate. Serious AEs and AEs leading to discontinuation were comparable between groups. Laboratory abnormalities were infrequent and transient. Conclusions. In DMARD-naive patients, apremilast monotherapy improved PsA signs/symptoms over 52 weeks and was generally well tolerated. [ABSTRACT FROM AUTHOR]

Published
2018
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43. One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study.

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, Mpofu, Shephard, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Ligozio, Gregory, and Mpofu, Shephard

Abstract

OBJECTIVE: To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis. METHODS: In this 52-week, double-blind, placebo-controlled (up to Week 20) study (NCT00928512), patients responding inadequately to disease-modifying antirheumatic drugs (DMARD) or biologics were randomized to receive monthly subcutaneous injections of secukinumab (25, 75, 150, or 300 mg), or placebo. The efficacy and safety results up to Week 20 have been reported previously. Here, efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented. RESULTS: Of 237 patients randomized, 174 (73.4%) completed the study. Patients with improved American College of Rheumatology (ACR) and 28-joint Disease Activity Score (DAS28) C-reactive protein (CRP) responses at Week 16 sustained their responses through Week 52. In patients taking 150 mg of secukinumab, responses were improved through Week 52 (ACR50: Week 16 = 45%, Week 52 = 55%; DAS28-CRP ≤ 2.6: Week 16 = 25%, Week 52 = 40%). The rate of adverse events (AE) from weeks 20 to 60 was 64.8%, with most AE being mild to moderate in severity. The overall rate of infections was 31.9%, most being mild. The most predominant infection was nasopharyngitis, and was not associated with dose or concurrent neutropenia. Serious AE were reported in 21 patients (8.9%). There were 3 reports of malignancies (ovarian, lung, basal cell), and no deaths between weeks 20 and 60. CONCLUSION: Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab. The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks.

Published
2014

44. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Mazurov, Vadim, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, Mpofu, Shephard, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Richards, Hanno B, Supronik, Jerzy, Dokoupilova, Eva, Mazurov, Vadim, Aelion, Jacob A, Lee, Sang-Heon, Codding, Christine E, Kellner, Herbert, Ikawa, Takashi, Hugot, Sophie, and Mpofu, Shephard

Abstract

OBJECTIVE: To assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleukin-17A antibody, in patients with rheumatoid arthritis (RA). METHODS: Patients (n=237) with inadequate response to methotrexate were randomly assigned to receive monthly subcutaneous injections of secukinumab 25 mg, 75 mg, 150 mg, 300 mg or placebo. The primary endpoint was the American College of Rheumatology 20% response (ACR20) at week 16. RESULTS: Demographics and baseline characteristics were comparable across all treatment groups. The primary efficacy endpoint was not achieved: the proportion of ACR20 responders at week 16 with secukinumab 25-300 mg was 36.0-53.7% versus placebo (34%). Disease activity score in 28 joints (DAS28)-C-reactive protein (CRP) was a secondary endpoint and clinically relevant decreases with secukinumab 75-300 mg were reported versus placebo. Serum high sensitivity CRP levels at week 16 were significantly reduced with secukinumab 75 mg, 150 mg and 300 mg doses versus placebo. The safety profile of secukinumab was consistent with that seen with other biological agents. Most adverse events (AE) were mild to moderate in severity. Infections were slightly more frequent with secukinumab than placebo. Six serious AE were reported: secukinumab 75 mg (one), secukinumab 300 mg (four) and placebo (one). CONCLUSIONS: ACR20 response rates differed between secukinumab 75 mg, 150 mg and 300 mg doses and placebo; however, the primary efficacy endpoint was not achieved. Greater decreases in DAS28 were observed with secukinumab 75 mg, 150 mg and 300 mg than placebo. There were no unexpected safety signals and no specific organ-related toxicities. Further trials with secukinumab in the treatment of RA are warranted.

Published
2013

45. One-year Efficacy and Safety Results of Secukinumab in Patients With Rheumatoid Arthritis: Phase II, Dose-finding, Double-blind, Randomized, Placebo-controlled Study

Author

Genovese, Mark C., primary, Durez, Patrick, additional, Richards, Hanno B., additional, Supronik, Jerzy, additional, Dokoupilova, Eva, additional, Aelion, Jacob A., additional, Lee, Sang-Heon, additional, Codding, Christine E., additional, Kellner, Herbert, additional, Ikawa, Takashi, additional, Hugot, Sophie, additional, Ligozio, Gregory, additional, and Mpofu, Shephard, additional

Published
2014
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46. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study

Author

Genovese, Mark C, primary, Durez, Patrick, additional, Richards, Hanno B, additional, Supronik, Jerzy, additional, Dokoupilova, Eva, additional, Mazurov, Vadim, additional, Aelion, Jacob A, additional, Lee, Sang-Heon, additional, Codding, Christine E, additional, Kellner, Herbert, additional, Ikawa, Takashi, additional, Hugot, Sophie, additional, and Mpofu, Shephard, additional

Published
2012
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