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1. Endoscopic diagnosis and management of adult inflammatory bowel disease: a consensus document from the American Society for Gastrointestinal Endoscopy IBD Endoscopy Consensus Panel

Author

Shen, Bo, Abreu, Maria T., Cohen, Erica R., Farraye, Francis A., Fischer, Monika, Feuerstadt, Paul, Kapur, Saurabh, Ko, Huaibin M., Kochhar, Gursimran S., Liu, Xiuli, Mahadevan, Uma, McBride, Deborah L., Navaneethan, Udayakumar, Regueiro, Miguel, Ritter, Tim, Sharma, Prateek, and Lichtenstein, Gary R.

Published
2025
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2. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies

Author

Abrahamovych, Orest, Abu-farsakh, Niazy, Afanasieva, Halyna, Akpinar, Hale, Al Kharrat, Houssam, Altintas, Engin, Altwegg, Romain, Andreev, Pavel, Aomatsu, Kazuki, Araki, Hiroshi, Argollo, Marjorie, Ariel, Federico, Armuzzi, Alessandro, Ashida, Toshifumi, Augustyn, Monika, Aumais, Guy, Azum, Martín, Baert, Filip, Balaz, Jozef, Balderramo, Domingo, Begun, Jakob, Berova, Temenuzhka, Billiauws, Lore, Blanco, Antonio, Bortlik, Martin, Bossa, Fabrizio, Bunkova, Elena, Cabello, Mercedes, Cao, Qian, Caprioli, Flavio, Cerqueira, Rute, Chachu, Karen, Chamouard, Patrick, Chen, Chunxiao, Chen, Yan, Chen, Baili, Chen, Dongfeng, Chen, Hong, Chen, Youxiang, Chen, Chou-chen, Cheon, Jaehee, Chen, Minhu, Chiu, Cheng-tang, Choi, Changhwan, Chow, Elizabeth, Cicala, Michele, Cintra, Aderson, Danilkiewicz, Wit, Datsenko, Olena, De Hertogh, Gert, De María, Julio, Del Valle Torrealba Medina, Leyanira, Deliang, Liu, Desreumaux, Pierre, Dewint, Pieter, Ding, Shigang, Doherty, Glen, Draganova, Raina, Dutré, Joris, Duvall, George, Egan, Laurence, Fahed, Julien, Fechner, Lars, Fedurco, Miroslav, Ferhat Celik, Aykut, Fernandez, Juan, Filip, Rafal, Fishman, Sigal, Flores, Cristina, Fogel, Ronald, Fowler, Sharyle, Francesconi, Carlos, Fujii, Toshimitsu, Fujiya, Mikihiro, Fukata, Masayuki, Fukuhara, Seiichiro, Furumoto, Yohei, G.Kiss, Gyula, Gachowski, Waldemar, Gao, Xiang, Gasbarrini, Antonio, Gawdis-wojnarska, Beata, Gaya, Daniel, Geccherle, Andrea, Gilletta De Saint Joseph, Cyrielle, Gimenez, Edgardo, Gionchetti, Paolo, Goldin, Eran, Golovchenko, Oleksandr, Gonciarz, Maciej, Gonen, Can, Gonzales, Chad, Gonzalez, Raquel, Gonzalez Segura, Gaston Julian, Gridnyev, Oleksiy, Gu, Fang, Gupta, Nitin, Gyokeres, Tibor, Haines, Melissa, Hebuterne, Xavier, Hedin, Charlotte, Hellstrom, Per, Hilmi, Ida Normiha, Hirai, Fumihito, Hisabe, Takashi, Hlavaty, Tibor, Hoentjen, Frank, Holtmann, Gerald, Horiki, Noriyuki, Horny, Ivo, Horvat, Gyula, Horvath, Frantisek, Hoshi, Namiko, Hosomi, Shuhei, Hospodarskyy, Ihor, Hou, Xiaohua, Hrdlicka, Ludek, Hu, Naizhong, Huang, Vivian, Huang, Caibin, Inaba, Tomoki, Ishiguro, Yoh, Ishihara, Shunji, Ishikawa, Takeshi, Iskandar, Heba, Israeli, Eran, Itaba, Soichi, Ivanishyn, Olha, Izbéki, Ferenc, Jain, Animesh, Jairath, Vipul, Jang, Byung Ik, Jiang, Chunmeng, Jones, Michael, Kagaya, Takashi, Kalimullina, Dilara, Karakina, Marina, Karatas, Ali, Kashimura, Hiroshi, Keret, Dan, Khovaeva, Yaroslava, Kierkus, Jaroslaw, Kim, Taeoh, Kim, Youngho, Kim, Hyo Jong, Klaus, Jochen, Kleczkowski, Dariusz, Klopocka, Maria, Kobayashi, Taku, Kobielusz-gembala, Iwona, Kojima, Yuichiro, Koo, Ja Seol, Kopon, Adam, Kopp, James, Koyama, Fumikazu, Koynarski, Vasil, Kravchenko, Tetiana, Kudo, Masatoshi, Kusunoki, Ryusaku, Kwon, Kwangan, Laclav, Martin, Lago, Paula, Laharie, David, Lasa, Juan, Lateef, Syed, Latinovic Radakovic, Tatjana, Lee, Kang Moon, Leszczyszyn, Jaroslaw, Li, Yan, Liu, Mei, Liu, Eashen, Lobaton Ortega, Triana, Lopatin, Denis, Lopes, Susana, Lovric Jovanovic, Mileva, Lubini, Marcio, Lukas, Milan, Maaser, Christian, Machytka, Evzen, Maemoto, Atsuo, Magro, Fernando, Marcet, Jorge, Marini, Eduardo, Marusawa, Hiroyuki, Matous, Jan, Matsumoto, Takayuki, Mendu, Shoba, Miao, Yinglei, Mihaly, Emese, Miheller, Pal, Ministro, Paula, Miyabayashi, Hideharu, Mohl, Wolfgang, Molnar, Martin, Moore, Gregory, Moran Faienzo, Gabriela, Morral, Eugeni Domenech, Motoya, Satoshi, Murali, Narayanachar, Mustaffa, Nazri Mohamad, Naem, Mohamed, Nakai, Katsuhiko, Nakajima, Koichi, Nakamoto, Yasunari, Nakamura, Masanao, Nancey, Stephane, Navaneethan, Udayakumar, Nawawi, Khairul Najmi Muhammad, Ninomiya, Tomoyuki, Novak, Janos, Oki, Motoji, Oliveira Santana, Genoile, Onizawa, Michio, Ono, Yohei, Osada, Taro, Osipenko, Marina, Owczarek, Danuta, Parente, Jose Miguel, Patel, Kamal, Patel, Bhaktasharan, Pedersen, Peder, Petroniene, Rima, Petrov, Asen, Petrova, Elina, Piquet, Marie-astrid, Pokrotnieks, Juris, Poroshina, Elena, Portela, Francisco, Pruthi, Jatinder S., Prystupa, Lyudmila, Pukitis, Aldis, Qiu, Yun, Rafalsky, Vladimir, Rainis, Tova, Ramos Junior, Odery, Rashid, Mohammed, Rayyan, Yasser, Reshetko, Olga, Ribeiro, Tarsila, Rivero, Montserrat, Roblin, Xavier, Romatowski, Jacek, Rowbotham, David, Ruffinengo, Orlando Enrique, Rydzewska-wyszkowska, Grazyna, Sablin, Oleg, Sai, Souken, Saibeni, Simone, Said, Rosaida Hj. Md., Sakuraba, Hirotake, Samaan, Mark, Sandborn, William, Saruta, Masayuki, Sauk, Jenny, Savarino, Edoardo Vincenzo, Schultz, Michael, Schulze, Joerg, Sedghi, Shahriar, Seidler, Ursula, Seksik, Philippe, Senturk, Omer, Shelton, Edward, Shimizu, Masahito, Shin, Sungjae, Shukla, Richa, Sigal, Michael, Silva Junior, Roberto, Simoes Neto, Joaquim, Siroky Jr., Milan, Smajstrla, Vit, Smid, Vaclav, Smiley, Sarah, Soledad Brunatto, Luciana, Stanislavchuk, Mykola, Stokesberry, David, Stone, Christian, Suiter, Daniel, Suzuki, Takayoshi, Svorcan, Petar, Takagi, Sho, Takagi, Tomohisa, Takamura, Masaaki, Takayama, Tetsuji, Takeuchi, Ken, Tanaka, Akihito, Tanaka, Hiroki, Tanash, Omar, Tang, Wen, Tankova, Ludmila, Teixeira Campos, Luciana, Thin, Lena, Tkachev, Alexander, Tolmanis, Ivars, Tsarynna, Nataliia, Tsonev, Nikolay, Tulassay, Zsolt, Ueo, Tetsuya, Unal, Nalan, Valuyskikh, Ekaterina, Van Dop, Willemijn, Vasilevskaya, Olga, Venugopal, Kannan, Verstockt, Bram, Viamonte, Manuel, Vyshyvanyuk, Vira, Wang, Bangmao, Wang, Xiaoyan, Wang, Jiangbin, Wang, Yufang, Wei, Shu-chen, Weisshof, Roni, Wisam, Sbeit, Wojcik, Katarzyna, Yakovlev, Alexey, Yasuda, Hiroshi, Ye, Byongduk, Yen, Hsu-heng, Yilmaz, Hasan, Yokoyama, Yoko, Yoon, Hyuk, Yoshida, Takeshi, Yurkiv, Andriy, Zaha, Osamu, Zaltman, Cyrla, Zhan, Qiang, Zhang, Hongjie, Zhang, Shutian, Zhu, Lanxiang, Zou, Duowu, Zou, Xiaoping, Zureikat, Firas, Rubin, David T, Allegretti, Jessica R, Panés, Julián, Shipitofsky, Nicole, Yarandi, Shadi S, Huang, Kuan-Hsiang Gary, Germinaro, Matthew, Wilson, Rebbecca, Zhang, Hongyan, Johanns, Jewel, Feagan, Brian G, Hisamatsu, Tadakazu, Lichtenstein, Gary R, Bressler, Brian, Peyrin-Biroulet, Laurent, Sands, Bruce E, and Dignass, Axel

Published
2025
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5. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study

Author

Abrahamovych, Orest, Afanasieva, Halyna, Aitova, Lilia, Altintas, Engin, Altwegg, Romain, Andreev, Pavel, Aomatsu, Kazuki, Augustyn, Monika, Balestrieri, Paola, Begun, Jakob, Brunatto, Luciana, Bulgheroni, Diego, Bunkova, Elena, Cabello, Mercedes, Cao, Qian, Caprioli, Flavio, Cerqueira, Rute, Chen, Baili, Chen, Chou-Chen, Chen, Chou-Pin, Chiu, Cheng-Tang, Choi, Chang Hwan, Cicala, Michele, Datsenko, Olena, Dewint, Pieter, Domenech, Eugeni, Dutré, Joris, Duvall, George, Fernandez, Juan, Filip, Rafal, Fogel, Ronald, Fowler, Sharyle, Fujii, Toshimitsu, Fukata, Masayuki, Furumoto, Yohei, Gasbarrini, Antonio, Gawdis-Wojnarska, Beata, Gilletta, Cyrielle, Gionchetti, Paolo, Goldin, Eran, Golovchenko, Oleksandr, Gonciarz, Maciej, Gonen, Can, Segura, Gaston Gonzalez, Gridnyev, Oleksii, Gyokeres, Tibor, Hébuterne, Xavier, Hedin, Charlotte, Hellström, Per, Hilmi, Ida Normiha, Horný, Ivo, Horvat, Gyula, Hoshi, Namiko, Hrdlicka, Ludek, Ishihara, Shunji, Ivanishyn, Olha, Jang, Byung Ik, Junior, Odery, Kagaya, Takashi, Kanmura, Shuji, Karakina, Marina, Katsuhiko, Nakai, Kierkus, Jaroslaw, Kim, Hyo Jong, Kim, Tae-Oh, Kim, Young-Ho, Kiss, Gyula G., Klaus, Jochen, Kleczkowski, Dariusz, Klopocka, Maria, Kobayashi, Taku, Kobielusz-Gembala, Iwona, Koo, Ja Seol, Kopon, Adam, Kravchenko, Tetiana, Kudo, Masatoshi, Kwon, Kwang An, Lago, Paula, Laharie, David, Lawrance, Ian, Leszczyszyn, Jaroslaw, Li, Yan, Lukas, Milan, Maaser, Christian, Maemoto, Atsuo, Marusawa, Hiroyuki, McBride, Matthew, Mendu, Shoba, Miheller, Pal, Miyabayashi, Hideharu, Mohl, Wolfgang, Moore, Gregory, Motoya, Satoshi, Murali, Narayanachar, Naem, Mohammed, Nakajima, Koichi, Nakamoto, Yasunari, Nancey, Stéphane, Neto, Joaquim, Onizawa, Michio, Ono, Yohei, Osada, Taro, Osipenko, Marina, Owczarek, Danuta, Patel, Bhaktasharan, Patel, Kamal, Petrova, Elina, Poroshina, Elena, Portela, Francisco, Prystupa, Lyudmyla, Rivero, Monserrat, Roblin, Xavier, Romatowski, Jacek, Rydzewska, Grazyna, Saibeni, Simone, Sakuraba, Hirotake, Samaan, Mark, Schultz, Michael, Schulze, Joerg, Sedghi, Shahriar, Seidler, Ursula, Shin, Sung Jae, Stanislavchuk, Mykola, Stokesberry, David, Suzuki, Takayoshi, Taguchi, Hiroki, Tankova, Lyudmila, Thin, Lena, Tkachev, Alexander, Torrealba, Leyanira, Tsarynna, Nataliia, Tulassay, Zsolt, Ueo, Tetsuya, Valuyskikh, Ekaterina, Vasilevskaya, Olga, Viamonte, Manuel, Wei, Shu-Chen, Weisshof, Roni, Wojcik, Katarzyna, Ye, Byong Duk, Yen, Hsu-Heng, Yoon, Hyuk, Yoshida, Kosuke, Yurkiv, Andriy, Zaha, Osamu, Zhan, Qiang, Peyrin-Biroulet, Laurent, Allegretti, Jessica R., Rubin, David T., Bressler, Brian, Germinaro, Matthew, Huang, Kuan-Hsiang (Gary), Shipitofsky, Nicole, Zhang, Hongyan, Wilson, Rebbecca, Han, Chenglong, Feagan, Brian G., Sandborn, William J., Panés, Julian, Hisamatsu, Tadakazu, Lichtenstein, Gary R., Sands, Bruce E., and Dignass, Axel

Published
2023
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9. Corticosteroid-Free Remission Through 3 Years of Upadacitinib Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Data From the Phase 3 Long-Term Extension Study U-ACTIVATE.

Author

Lichtenstein, Gary R.

Subjects
ADRENOCORTICAL hormones, ULCERATIVE colitis, DISEASE remission, TREATMENT effectiveness, TREATMENT duration, JANUS kinases, NEUROTRANSMITTER uptake inhibitors, TIME
Abstract

Upadacitinib was superior to placebo across clinical, endoscopic, and histologic endpoints; was effective in achieving corticosteroid-sparing treatment; and was well tolerated in the U-ACHIEVE maintenance study. In the U-ACTIVATE LTE trial, a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical program, corticosteroid-free and symptomatic remission was achieved with upadacitinib maintenance treatment and was maintained in more than 80% of patients through 48 weeks. Patients from the LTE study were further assessed up to 96 weeks. Most of these patients achieved and maintained corticosteroid-free CR, suggesting that upadacitinib continues to have a persistent benefit, is an excellent long-term treatment option for moderately to severely active UC, and can spare patients from corticosteroid use. [ABSTRACT FROM AUTHOR]

Published
2024

10. Efficacy, Safety and Immunogenicity of Subcutaneous Infliximab (CT-P13 SC) Monotherapy vs Combination Therapy With Immunosuppressants -- Post Hoc Analysis of LIBERTY-CD and LIBERTY-UC Studies.

Author

Lichtenstein, Gary R.

Subjects
IMMUNOGENETICS, COMBINATION drug therapy, PATIENT safety, IMMUNOSUPPRESSIVE agents, CROHN'S disease, ULCERATIVE colitis, TREATMENT effectiveness, DRUG efficacy, INFLIXIMAB, BIOSIMILARS, SUBCUTANEOUS injections
Abstract

Post hoc analysis of data from this prospective study found no significant difference in efficacy of therapy in patients who had a clinical response or patients on monotherapy or on immunosuppression at week 52 or 104. Although the rate of antidrug antibodies was lower with combination therapy, there was no difference in efficacy, biomarker profiles, or safety outcomes. If this study was conducted in a fashion similar to the SONIC trial, in which half of patients were prospectively randomized to monotherapy and half were given combination therapy, differences may have been observed, such as better outcomes in those on an immunomodulator and CT-P13 SC. [ABSTRACT FROM AUTHOR]

Published
2024

21. Optimizing the quality of endoscopy in inflammatory bowel disease: focus on surveillance and management of colorectal dysplasia using interactive image- and video-based teaching

Author

Cheifetz, Adam, Chiorean, Michael, East, James E., Farraye, Francis A., Leighton, Jonathan A., Levesque, Barrett G., Lichtenstein, Gary R., Marion, James F., Matsumoto, Takayuki, Mönkemüller, Klaus, Picco, Michael F., Odze, Robert, Raju, Gottumukkala S., Rutter, Matt, Rex, Douglas K., Shen, Bo, Shergill, Amandeep, Subramanian, Venkat, Kaltenbach, Tonya R., Soetikno, Roy M., DeVivo, Rebecca, Laine, Loren A., Barkun, Alan, and McQuaid, Kenneth R.

Published
2017
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28. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study.

Author

Peyrin-Biroulet, Laurent, Allegretti, Jessica R., Rubin, David T., Bressler, Brian, Germinaro, Matthew, Huang, Kuan-Hsiang (Gary), Shipitofsky, Nicole, Zhang, Hongyan, Wilson, Rebbecca, Han, Chenglong, Feagan, Brian G., Sandborn, William J., Panés, Julian, Hisamatsu, Tadakazu, Lichtenstein, Gary R., Sands, Bruce E., and Dignass, Axel

Abstract

The QUASAR Phase 2b Induction Study evaluated the efficacy and safety of guselkumab, an interleukin-23p19 subunit antagonist, in patients with moderately to severely active ulcerative colitis (UC) with prior inadequate response and/or intolerance to corticosteroids, immunosuppressants, and/or advanced therapy. In this double-blind, placebo-controlled, dose-ranging, induction study, patients were randomized (1:1:1) to receive intravenous guselkumab 200 or 400 mg or placebo at weeks 0/4/8. The primary endpoint was clinical response (compared with baseline, modified Mayo score decrease ≥30% and ≥2 points, rectal bleeding subscore ≥1-point decrease or subscore of 0/1) at week 12. Guselkumab and placebo week-12 clinical nonresponders received subcutaneous or intravenous guselkumab 200 mg, respectively, at weeks 12/16/20 (uncontrolled study period). The primary analysis population included patients with baseline modified Mayo scores ≥5 and ≤9 (intravenous guselkumab 200 mg, n = 101; 400 mg, n = 107; placebo, n = 105). Week-12 clinical response percentage was greater with guselkumab 200 mg (61.4%) and 400 mg (60.7%) vs placebo (27.6%; both P <.001). Greater proportions of guselkumab-treated vs placebo-treated patients achieved all major secondary endpoints (clinical remission, symptomatic remission, endoscopic improvement, histo-endoscopic mucosal improvement, and endoscopic normalization) at week 12. Among guselkumab week-12 clinical nonresponders, 54.3% and 50.0% of patients in the 200- and 400-mg groups, respectively, achieved clinical response at week 24. Safety was similar among guselkumab and placebo groups. Guselkumab intravenous induction was effective vs placebo in patients with moderately to severely active UC. Guselkumab was safe, and efficacy and safety were similar between guselkumab dose groups. ClinicalTrials.gov number: NCT04033445. [Display omitted] Improvement at 12 weeks was greater with intravenous guselkumab vs placebo. Guselkumab-treated patients without a clinical response at 12 weeks benefited from additional guselkumab administered subcutaneously. Guselkumab was well tolerated. [ABSTRACT FROM AUTHOR]

Published
2023
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30. Risk of Lymphoma in Patients With Inflammatory Bowel Disease Treated With Azathioprine and 6-Mercaptopurine: A Meta-analysis

Author

Kotlyar, David S., Lewis, James D., Beaugerie, Laurent, Tierney, Ann, Brensinger, Colleen M., Gisbert, Javier P., Loftus, Edward V., Jr., Peyrin-Biroulet, Laurent, Blonski, Wojciech C., Van Domselaar, Manuel, Chaparro, Maria, Sandilya, Sandipani, Bewtra, Meenakshi, Beigel, Florian, Biancone, Livia, and Lichtenstein, Gary R.

Published
2015
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32. Efficacy of Risankizumab Maintenance Therapy by Clinical Remission and Endoscopic Improvement Status in Patients With Moderately to Severely Active Ulcerative Colitis: Post Hoc Analysis of the COMMAND Phase 3 Study.

Author

Lichtenstein, Gary R.

Subjects
DISEASE duration, ULCERATIVE colitis, DISEASE remission, TREATMENT effectiveness, MONOCLONAL antibodies, DRUG efficacy, ENDOSCOPIC gastrointestinal surgery, EVALUATION
Abstract

A benefit with risankizumab compared with placebo was observed in patients with an inadequate response to prior nonadvanced therapy (29.7% vs 8.4%) and in patients with an inadequate response to prior advanced therapy (11.4% vs 4.3%). In this study, there were several important findings: (1) the proportion of patients who had prior failure to advanced therapy was numerically higher for patients who did not achieve CR or EI at maintenance week 0 than for those who achieved it; (2) the rates of each clinical, endoscopic, and histologic outcome were generally numerically higher with risankizumab vs placebo regardless of CR or EI status at maintenance week 52; and (3) among patients with clinical response to the induction treatment who did not achieve CR or EI, risankizumab 360 mg SC demonstrated numerically higher rates of improvement in all presented outcomes over risankizumab 180 mg SC at maintenance week 52. This study highlights that exposure to risankizumab was associated with improved outcome regardless of week 12 (early) outcomes. [ABSTRACT FROM AUTHOR]

Published
2024

33. Long-Term Endoscopic and Histological Outcomes of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis With Up to 3 Years of Treatment.

Author

Lichtenstein, Gary R.

Subjects
THERAPEUTIC use of monoclonal antibodies, ULCERATIVE colitis, SEVERITY of illness index, DISEASE remission, DRUG efficacy, ENDOSCOPIC gastrointestinal surgery, QUALITY of life, HISTOLOGY
Abstract

This study demonstrated that mirikizumab maintained endoscopic and histologic outcomes through an additional 2 years of continuous treatment for a total of 3 years. In addition, individuals who achieved long-term durable and sustained endoscopic and histologic outcomes with mirikizumab had in aggregate achieved an overall better health-related QOL. Remarkably, nearly three-quarters (70%) of patients who achieved CR at week 52 were able to achieve histologic and endoscopic remission without neutrophils on histology at week 152, and nearly half (47%) of all clinical remitters at week 52 were able to achieve endoscopic normalization at week 152. [ABSTRACT FROM AUTHOR]

Published
2024

34. The Efficacy of Maintenance Treatment With Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 QUASAR Maintenance Study Results at Week 44 by Biologic/Janus Kinase Inhibitor History.

Author

Lichtenstein, Gary R.

Subjects
THERAPEUTIC use of monoclonal antibodies, PATIENT safety, ULCERATIVE colitis, SEVERITY of illness index, JANUS kinases, MONOCLONAL antibodies, DRUG efficacy, NEUROTRANSMITTER uptake inhibitors
Abstract

It is recognized that individuals with prior exposure to anti-tumor necrosis factor (TNF) drugs often have a lower chance of success with subsequent anti-TNF therapies (ie, the effectiveness may be reduced and patients may be less likely to achieve remission or may require switching to a different medication class altogether). Similar findings have been seen with S1P receptor modulators. This study evaluated pooled induction data from 4 randomized controlled trials (1562 patients) and related that S1P receptor modulators may be more effective in inducing CR compared with placebo in patients with moderately to severely active UC and prior biologic exposure. The same finding has been seen in UC patients with prior biologic use who initiate JAK inhibitor therapy, whereas the GEMINI trials have shown that vedolizumab is more effective in patients who have not previously received anti-TNF medications compared with patients with prior failure of anti-TNF therapy. [ABSTRACT FROM AUTHOR]

Published
2024

35. Safety of Long-Term Ozanimod Treatment Up to 5 Years in Patients With Moderately to Severely Active Ulcerative Colitis: An Interim Analysis of the True North Open-Label Extension.

Author

Lichtenstein, Gary R.

Subjects
INFECTION risk factors, THERAPEUTIC use of monoclonal antibodies, PATIENT safety, DRUG side effects, CLINICAL trials, TERMINATION of treatment, ULCERATIVE colitis, TREATMENT effectiveness, SPHINGOSINE-1-phosphate, DRUG efficacy, INFLIXIMAB, CELL receptors, DRUG tolerance
Abstract

In the True North Study, which assessed ozanimod vs placebo, it is comforting to see that no new safety concerns were identified. A significant number of patients (43%) persisted on medication for up to 5 years. The rate of treatment discontinuation owing to AEs was low. With 2681 PY of follow-up, the study has not yet achieved adequate power to assess for the presence of uncommon events such as lymphoma. Continued follow-up will be necessary. [ABSTRACT FROM AUTHOR]

Published
2024

36. Histologic and Combined Histologic and Endoscopic Outcomes After Guselkumab Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Week 44 Results From the Phase 3 QUASAR Maintenance Study.

Author

Lichtenstein, Gary R.

Subjects
ANTI-inflammatory agents, ANTIULCER drugs, ULCERATIVE colitis, TREATMENT effectiveness, SEVERITY of illness index, MONOCLONAL antibodies, ENDOSCOPIC gastrointestinal surgery, HISTOLOGY
Abstract

Clinically meaningful improvements in endoscopic and histologic outcomes compared with placebo (guselkumab withdrawal) were notably present in both the biologic/JAK inhibitor--naive patient subpopulation and also in the patients who had an inadequate response or intolerance to biologics and/or JAK inhibitors. As expected, patients who received placebo after responding to initial therapy had progressive worsening of histologic and combined histologic and endoscopic outcomes. The findings of this study have important clinical implications for patient care. [ABSTRACT FROM AUTHOR]

Published
2024

37. Corticosteroid-Sparing Effects of Treatment With Guselkumab in Patients With Moderate to Severely Active Ulcerative Colitis: Phase 3 QUASAR Maintenance Study Results Through Week 44.

Author

Lichtenstein, Gary R.

Subjects
THERAPEUTIC use of monoclonal antibodies, ADRENOCORTICAL hormones, ULCERATIVE colitis, SEVERITY of illness index, TREATMENT effectiveness, ORAL drug administration, MONOCLONAL antibodies
Abstract

In the QUASAR phase 3 induction trial, guselkumab was demonstrated to be effective for achieving CR in patients with moderately to severely active UC. In the QUASAR randomized withdrawal maintenance study, 50.0% (P<.001) of patients with moderately to severely active UC receiving SC guselkumab 200 mg every 4 weeks and 45.2% (P<.001) of patients receiving SC guselkumab 100 mg every 8 weeks achieved the primary endpoint of CR at week 44 compared with placebo (18.9%). Among patients with moderately to severely active UC who were receiving concomitant oral corticosteroids at maintenance baseline, the majority of guselkumab-treated patients eliminated corticosteroids within 8 weeks. These impressive and clinically relevant findings highlight the fact that patients who were receiving maintenance treatment with guselkumab who achieved CR at week 44 did so without concomitant use of oral corticosteroids. [ABSTRACT FROM AUTHOR]

Published
2024

38. Efficacy and Safety of Guselkumab Maintenance Therapy Among Guselkumab Induction Week 24 Clinical Responders: Results From the Phase 3 QUASAR Maintenance Study.

Author

Lichtenstein, Gary R.

Subjects
ANTI-inflammatory agents, ANTIULCER drugs, PATIENT safety, ULCERATIVE colitis, TREATMENT effectiveness, SEVERITY of illness index, MONOCLONAL antibodies, DRUG efficacy
Abstract

Of the patients who did not initially respond to 3 induction doses, 60.6% (123 of 203) achieved clinical response to 3 further doses and entered the maintenance study phase. This more refractory population of UC patients (who did not respond initially by week 12 but did respond after 3 further doses of guselkumab 200 mg SC at weeks 12, 16, and 20) had higher UC disease burden and were able to maintain or improve endoscopic, histologic, symptomatic, and QOL outcomes. Safety results were consistent with the overall population and safety profile of guselkumab in its approved indications. Overall, the results support continuing guselkumab treatment in this more refractory patient population. [ABSTRACT FROM AUTHOR]

Published
2024

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