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1. Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study.

Author

Paller, Amy S, Flohr, Carsten, Eichenfield, Lawrence F, Irvine, Alan D, Weisman, Jamie, Soung, Jennifer, Pinto Correia, Ana, Natalie, Chitra R, Rodriguez Capriles, Claudia, Pierce, Evangeline, Reifeis, Sarah, Gontijo Lima, Renata, Armengol Tubau, Clara, Laquer, Vivian, and Weidinger, Stephan

Subjects
Adolescents, Efficacy, IL-13, Lebrikizumab, Moderate-to-severe atopic dermatitis, Safety, Depression, Mental Health, Clinical Research, Pediatric, Patient Safety, Clinical Trials and Supportive Activities, Brain Disorders, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Clinical Sciences
Abstract

IntroductionAtopic dermatitis (AD) is a chronic inflammatory skin disorder with limited treatment options for adolescents with moderate-to-severe disease. Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, demonstrated clinical benefit in previous Phase 3 trials: ADvocate1 (NCT04146363), ADvocate2 (NCT04178967), and ADhere (NCT04250337). We report 52-week safety and efficacy outcomes from ADore (NCT04250350), a Phase 3, open-label study of lebrikizumab in adolescent patients with moderate-to-severe AD. The primary endpoint was to describe the proportion of patients who discontinued from study treatment because of adverse events (AEs) through the last treatment visit.MethodsAdolescent patients (N = 206) (≥ 12 to

Published
2023

3. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE)

Author

Blauvelt, Andrew, Guttman-Yassky, Emma, Paller, Amy S., Simpson, Eric L., Cork, Michael J., Weisman, Jamie, Browning, John, Soong, Weily, Sun, Xian, Chen, Zhen, Kosloski, Matthew P., Kamal, Mohamed A., Delevry, Dimittri, Chuang, Chien-Chia, O’Malley, John T., and Bansal, Ashish

Published
2022
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5. What is your diagnosis? Cecal smear in a peafowl

Author

Pacholec, Christina, primary, Carvallo, Francisco, additional, LeCuyer, Tessa E., additional, Todd, Stephanie Michelle, additional, Ramirez‐Barrios, Roger, additional, Weisman, Jamie, additional, and Zimmerman, Kurt, additional

Published
2023
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6. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial

Author

Blauvelt, Andrew, de Bruin-Weller, Marjolein, Gooderham, Melinda, Cather, Jennifer C, Weisman, Jamie, Pariser, David, Simpson, Eric L, Papp, Kim A, Hong, H Chih-Ho, Rubel, Diana, Foley, Peter, Prens, Errol, Griffiths, Christopher E M, Etoh, Takafumi, Pinto, Pedro Herranz, Pujol, Ramon M, Szepietowski, Jacek C, Ettler, Karel, Kemény, Lajos, Zhu, Xiaoping, Akinlade, Bolanle, Hultsch, Thomas, Mastey, Vera, Gadkari, Abhijit, Eckert, Laurent, Amin, Nikhil, Graham, Neil M H, Pirozzi, Gianluca, Stahl, Neil, Yancopoulos, George D, and Shumel, Brad

Published
2017
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7. What Is Your Diagnosis? Cecal smear in a Peafowl

Author

Pacholec, Christina, Carvallo, Francisco R., Todd, Stephanie Michelle, Ramirez-Barrios, Roger, Weisman, Jamie, Zimmerman, Kurt, Pacholec, Christina, Carvallo, Francisco R., Todd, Stephanie Michelle, Ramirez-Barrios, Roger, Weisman, Jamie, and Zimmerman, Kurt

Published
2023

8. What is your diagnosis? Cecal smear in a peafowl.

Author

Pacholec, Christina, Carvallo, Francisco, LeCuyer, Tessa E., Todd, Stephanie Michelle, Ramirez‐Barrios, Roger, Weisman, Jamie, and Zimmerman, Kurt

Subjects
PEAFOWL, DIAGNOSIS, LIFE sciences, VETERINARY medicine, CYTOLOGY, MUCUS, GRANULATION tissue
Abstract

This article discusses a case of blackhead disease, also known as histomonosis, in a peafowl. The peafowl exhibited weight loss and was found to have a dilated cecum filled with a white caseous material and feces. Cytologic evaluation revealed a protozoal infection, likely Histomonas meleagridis, as well as nematodes. Histopathology confirmed the diagnosis of blackhead disease, with transmural ulcerative to granulomatous typhlitis. The article provides information on the transmission, clinical signs, and diagnostic methods for histomonosis, emphasizing the importance of environmental prevention and separate rearing of turkeys and chickens. [Extracted from the article]

Published
2024
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9. Real-World Findings on the Characteristics and Treatment Exposures of Patients with Hidradenitis Suppurativa from US Claims Data

Author

Garg, Amit, primary, Naik, Haley B., additional, Alavi, Afsaneh, additional, Hazen, Paul, additional, Hsiao, Jennifer L., additional, Shi, Vivian Y., additional, Weisman, Jamie, additional, Tran, Tanja, additional, Rudnik, Jan, additional, Jedrzejczyk, Adam, additional, Pansar, Ingrid, additional, and Kimball, Alexa B., additional

Published
2022
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11. IL‐17A is a pertinent therapeutic target for moderate‐to‐severe hidradenitis suppurativa: Combined results from a pre‐clinical and phase II proof‐of‐concept study

Author

Kimball, Alexa B., primary, Loesche, Christian, additional, Prens, Errol P., additional, Bechara, Falk G., additional, Weisman, Jamie, additional, Rozenberg, Izabela, additional, Jarvis, Philip, additional, Peters, Thomas, additional, Roth, Lukas, additional, Wieczorek, Grazyna, additional, Kolbinger, Frank, additional, and Jemec, Gregor B. E., additional

Published
2022
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13. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa

Author

Glatt, Sophie, primary, Jemec, Gregor B. E., additional, Forman, Seth, additional, Sayed, Christopher, additional, Schmieder, George, additional, Weisman, Jamie, additional, Rolleri, Robert, additional, Seegobin, Seth, additional, Baeten, Dominique, additional, Ionescu, Lucian, additional, Zouboulis, Christos C., additional, and Shaw, Stevan, additional

Published
2021
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18. Comparative effectiveness of less commonly used systemic monotherapies and common combination therapies for moderate to severe psoriasis in the clinical setting

Author

Takeshita, Junko, Wang, Shuwei, Shin, Daniel B., Callis Duffin, Kristina, Krueger, Gerald G., Kalb, Robert E., Weisman, Jamie D., Sperber, Brian R., Stierstorfer, Michael B., Brod, Bruce A., Schleicher, Stephen M., Robertson, Andrew D., Linn, Kristin A., Shinohara, Russell T., Troxel, Andrea B., Van Voorhees, Abby S., and Gelfand, Joel M.

Published
2014
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19. Correction to : Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3)

Author

Blauvelt, Andrew, Papp, Kim A., Griffiths, Christopher E. M., Puig Sanz, Lluís, Weisman, Jamie, Dutronc, Yves, Kerr, Lisa Farmer, Ilo, Dapo, Mallbris, Lotus, Augustin, Matthias, and Universitat Autònoma de Barcelona

Subjects
Dermatology, General Medicine, Original Research Article
Abstract

Background Patients with psoriasis who have an inadequate response to one biologic may benefit from switching to a new biologic, such as ixekizumab, a high affinity monoclonal antibody that selectively targets interleukin (IL)-17A. Objective Our aim was to assess the response to ixekizumab in patients with moderate-to-severe plaque psoriasis who did not respond adequately to etanercept using a post-hoc analysis in two phase III studies. Methods For the subanalyses in two phase III trials (UNCOVER-2 and -3), non-response was defined by either failure to have a static physician global assessment (sPGA) of 0/1 in UNCOVER-2 or failure to have at least 75% improvement in psoriasis area and severity index (PASI 75) in UNCOVER-3 at Week 12 of each study. Non-responders treated with twice-weekly etanercept 50 mg in the first 12 weeks received two injections of placebo at Week 12 (4-week wash-out period), followed by ixekizumab every 4 weeks (Q4W) for Weeks 16–60. Non-responders to placebo in the first 12 weeks were administered ixekizumab 160 mg at Week 12, followed by ixekizumab Q4W for Weeks 16–60. Results After switching to ixekizumab Q4W, a substantial proportion of patients with moderate-to-severe psoriasis who did not respond to etanercept experienced rapid and durable improvement in all efficacy evaluations. Among sPGA 0/1 (UNCOVER-2) and PASI 75 (UNCOVER-3) non-responders to etanercept, 73.0% achieved sPGA 0/1 and 78.2% achieved PASI 75, respectively, after 12 weeks of ixekizumab treatment. Safety profiles in patients switched from etanercept to ixekizumab were similar to those in patients switched from placebo to ixekizumab. Conclusion Patients who were non-responders to etanercept after 12 weeks, as defined by failure to meet sPGA 0/1 (UNCOVER-2) or PASI 75 (UNCOVER-3), achieved high levels of response 12 weeks after switching to ixekizumab. Studies are registered with ClinicalTrials.gov (NCT01597245 and NCT01646177).

Published
2021

20. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa:A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial

Author

Glatt, Sophie, Jemec, Gregor B.E., Forman, Seth, Sayed, Christopher, Schmieder, George, Weisman, Jamie, Rolleri, Robert, Seegobin, Seth, Baeten, Dominique, Ionescu, Lucian, Zouboulis, Christos C., Shaw, Stevan, Glatt, Sophie, Jemec, Gregor B.E., Forman, Seth, Sayed, Christopher, Schmieder, George, Weisman, Jamie, Rolleri, Robert, Seegobin, Seth, Baeten, Dominique, Ionescu, Lucian, Zouboulis, Christos C., and Shaw, Stevan

Abstract

Importance: Hidradenitis suppurativa (HS) is a chronic inflammatory disease with a high burden for patients and limited existing therapeutic options. Objective: To evaluate the efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin 17A and 17F in individuals with moderate to severe HS. Design, Setting, and Participants: This phase 2, double-blind, placebo-controlled randomized clinical trial with an active reference arm was performed from September 22, 2017, to February 21, 2019. The study included a 2- to 4-week screening period, a 12-week treatment period, and a 20-week safety follow-up. Of 167 participants screened at multiple centers, 90 were enrolled. Eligible participants were 18 to 70 years of age with a diagnosis of moderate to severe HS 12 months or more before baseline. Interventions: Participants with HS were randomized 2:1:1 to receive bimekizumab (640 mg at week 0, 320 mg every 2 weeks), placebo, or reference arm adalimumab (160 mg at week 0, 80 mg at week 2, and 40 mg every week for weeks 4-10). Main Outcomes and Measures: The prespecified primary efficacy variable was the proportion of participants with a 50% or greater reduction from baseline in the total abscess and inflammatory nodule count with no increase in abscess or draining fistula count (Hidradenitis Suppurativa Clinical Response [HiSCR] at week 12. Exploratory variables included proportion achieving a modified HiSCR with 75% reduction of HiSCR criteria (HiSCR75) or a modified HiSCR with 90% reduction of HiSCR criteria (HiSCR90), change in Patient's Global Assessment of Pain, and Dermatology Life Quality Index total scores. Results: Eighty-eight participants received at least 1 dose of study medication (61 [69%] female; median age, 36 years; range, 18-69 years). Seventy-three participants completed the study, including safety follow-up. Bimekizumab demonstrated a higher HiSCR rate vs placebo at week 12 (57.3% vs 26.1%; po

Published
2021

21. Factors associated with adverse COVID-19 outcomes in patients with psoriasis—insights from a global registry–based study

Author

Mahil, Satveer K., primary, Dand, Nick, additional, Mason, Kayleigh J., additional, Yiu, Zenas Z.N., additional, Tsakok, Teresa, additional, Meynell, Freya, additional, Coker, Bola, additional, McAteer, Helen, additional, Moorhead, Lucy, additional, Mackenzie, Teena, additional, Rossi, Maria Teresa, additional, Rivera, Raquel, additional, Mahe, Emmanuel, additional, Carugno, Andrea, additional, Magnano, Michela, additional, Rech, Giulia, additional, Balogh, Esther A., additional, Feldman, Steven R., additional, De La Cruz, Claudia, additional, Choon, Siew Eng, additional, Naldi, Luigi, additional, Lambert, Jo, additional, Spuls, Phyllis, additional, Jullien, Denis, additional, Bachelez, Hervé, additional, McMahon, Devon E., additional, Freeman, Esther E., additional, Gisondi, Paolo, additional, Puig, Luis, additional, Warren, Richard B., additional, Di Meglio, Paola, additional, Langan, Sinéad M., additional, Capon, Francesca, additional, Griffiths, Christopher E.M., additional, Barker, Jonathan N., additional, Smith, Catherine H., additional, Shah, Aadarsh, additional, Barea, Alberto, additional, Romero-Maté, Alberto, additional, Singapore, Alekya, additional, Paolino, Alexandra, additional, Mwale, Alice, additional, Morales Callaghan, Ana Maria, additional, Martinez, Ana, additional, DeCrescenzo, Andrew, additional, Pink, Andrew E., additional, Jones, Ann, additional, Sergeant, Ann, additional, Essex, Annette, additional, Bewley, Anthony, additional, Makrygeorgou, Areti, additional, van Huizen, Astrid, additional, Pérez-Suárez, Beatriz, additional, Farida, Benhadou, additional, Claréus, Birgitta Wilson, additional, Prims, Carla Tubau, additional, Davis, Carrie, additional, Quinlan, Catherine, additional, Maybury, Catriona, additional, Cesar, Gonzalez A., additional, Barclay, Charlotte, additional, Greco, Claudio, additional, Brassard, Danielle, additional, Cummings, Deanna, additional, Kolli, Deepti, additional, Descamps, Vincent, additional, Genao, Diana Ruiz, additional, Carras, Efrossini, additional, Hawryluk, Elena, additional, Martínez-García, Eliseo, additional, Klujszo, Elzbieta, additional, Dwyer, Emily, additional, Toni, Emmanuel, additional, Sonkoly, Enikö, additional, Loayza, Enrique, additional, Daudén, Esteban, additional, Valenzuela, Fernando, additional, Popov, Georgi, additional, King, Georgie, additional, Celine, Girard, additional, Aparicio, Gloria, additional, Johnston, Graham A., additional, Cardozo, Gustavo Anibal, additional, Pearson, Ian, additional, Yanguas, Ignacio, additional, Weisman, Jamie, additional, Carolan, Jennifer E., additional, Hughes, Jenny, additional, Ortiz-Salvador, Jose-Maria, additional, Carrascosa, Jose-Manuel, additional, Schwartz, Joseph J., additional, Jackson, Karina, additional, Kerisit, Kathryn G., additional, Wu, Keith, additional, Asfour, Leila, additional, de Graaf, Leontien, additional, Lesort, Cécile, additional, Meuleman, Lieve, additional, Eidsmo, Liv, additional, Skov, Lone, additional, Gribben, Lorraine, additional, Rustin, Malcolm, additional, Velasco, Manel, additional, Panchal, Manisha, additional, Lakhan, Manpreet, additional, Franco, Manuel D., additional, Svensson, Marie-Louise, additional, Vandaele, Mark, additional, Marovt, Maruska, additional, Zargari, Omid, additional, De Caso, Pablo, additional, Varela, Paulo, additional, Jenkin, Peter, additional, Phan, Céline, additional, Hampton, Philip, additional, Goldsmith, Portia, additional, Bak, Rachel, additional, Speeckaert, Reinhart, additional, Romiti, Ricardo, additional, Woolf, Richard, additional, Mercado-Seda, Rogelio, additional, Khatun, Rohima, additional, Ceovic, Romana, additional, Taberner, Rosa, additional, Cohen, Russell W., additional, Stefanescu, Simina, additional, Kirk, Sarah, additional, Reeken, Saskia, additional, Ayob, Shanti, additional, Pérez-Barrio, Silvia, additional, Piaserico, Stefano, additional, Hoey, Susannah, additional, Torres, Tiago, additional, Talme, Toomas, additional, Desai, Trupti V., additional, van Geest, Adrienne J., additional, King, Victoria, additional, Di Lernia, Vito, additional, Koreja, Zahira, additional, and Hasab, Vito Zeeshaan, additional

Published
2021
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25. Comparative Effectiveness of Commonly Used Systemic Treatments or Phototherapy for Moderate to Severe Plaque Psoriasis in the Clinical Practice Setting

Author

Gelfand, Joel M., Wan, Joy, Callis Duffin, Kristina, Krueger, Gerald G., Kalb, Robert E., Weisman, Jamie D., Sperber, Brian R., Stierstorfer, Michael B., Brod, Bruce A., Schleicher, Stephen M., Bebo, Bruce F., Jr, Troxel, Andrea B., Shin, Daniel B., Steinemann, Jane M., Goldfarb, Jennifer, Yeung, Howa, and Van Voorhees, Abby S.

Published
2012
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26. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: A randomized, double-blinded, placebo-controlled phase 3 trial

Author

Paller, Amy S., primary, Siegfried, Elaine C., additional, Thaçi, Diamant, additional, Wollenberg, Andreas, additional, Cork, Michael J., additional, Arkwright, Peter D., additional, Gooderham, Melinda, additional, Beck, Lisa A., additional, Boguniewicz, Mark, additional, Sher, Lawrence, additional, Weisman, Jamie, additional, O'Malley, John T., additional, Patel, Naimish, additional, Hardin, Megan, additional, Graham, Neil M.H., additional, Ruddy, Marcella, additional, Sun, Xian, additional, Davis, John D., additional, Kamal, Mohamed A., additional, Khokhar, Faisal A., additional, Weinreich, David M., additional, Yancopoulos, George D., additional, Beazley, Bethany, additional, Bansal, Ashish, additional, and Shumel, Brad, additional

Published
2020
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27. Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis

Author

Simpson, Eric L., primary, Paller, Amy S., additional, Siegfried, Elaine C., additional, Boguniewicz, Mark, additional, Sher, Lawrence, additional, Gooderham, Melinda J., additional, Beck, Lisa A., additional, Guttman-Yassky, Emma, additional, Pariser, David, additional, Blauvelt, Andrew, additional, Weisman, Jamie, additional, Lockshin, Benjamin, additional, Hultsch, Thomas, additional, Zhang, Qin, additional, Kamal, Mohamed A., additional, Davis, John D., additional, Akinlade, Bolanle, additional, Staudinger, Heribert, additional, Hamilton, Jennifer D., additional, Graham, Neil M. H., additional, Pirozzi, Gianluca, additional, Gadkari, Abhijit, additional, Eckert, Laurent, additional, Stahl, Neil, additional, Yancopoulos, George D., additional, Ruddy, Marcella, additional, and Bansal, Ashish, additional

Published
2020
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28. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa:3-year results of a phase 3 open-label extension study

Author

Zouboulis, Christos C., Okun, Martin M., Prens, Errol P., Gniadecki, Robert, Foley, Peter A., Lynde, Charles, Weisman, Jamie, Gu, Yihua, Williams, David A., Jemec, Gregor B.e., Zouboulis, Christos C., Okun, Martin M., Prens, Errol P., Gniadecki, Robert, Foley, Peter A., Lynde, Charles, Weisman, Jamie, Gu, Yihua, Williams, David A., and Jemec, Gregor B.e.

Published
2019

29. Life, death and thinner thighs

Author

Weisman, Jamie

Subjects
Aging -- Evaluation, Fashion and beauty, Health
Abstract

A woman called Jamie Weisman, a dermatologist by profession was diagnosed with a rare immune disorder, making her susceptible to illness as an AIDS patient. Jamie tells her patients that we should not let ourselves be defined by our appearances and not get scared of getting old, rather just concentrate on being healthy.

Published
2003

30. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label extension study

Author

Zouboulis, Christos C., primary, Okun, Martin M., additional, Prens, Errol P., additional, Gniadecki, Robert, additional, Foley, Peter A., additional, Lynde, Charles, additional, Weisman, Jamie, additional, Gu, Yihua, additional, Williams, David A., additional, and Jemec, Gregor B.E., additional

Published
2019
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31. Ixekizumab Results in Persistent Clinical Improvement in Moderateto-Severe Genital Psoriasis During a 52 Week, Randomized, Placebo-Controlled, Phase 3 Clinical Trial.

Author

GUENTHER, Lyn, POTTS BLEAKMAN, Alison, WEISMAN, Jamie, POULIN, Yves, SPELMAN, Lynda, BURGE, Russel, ERICKSON, Janelle, TODD, Kristin, BERTRAM, Clinton C., and RYAN, Caitriona

Subjects
PSORIASIS, CLINICAL trials, SEXUAL intercourse, SYMPTOMS, ITCHING
Abstract

Ixekizumab was efficacious in treating moderate-tosevere genital psoriasis over 12 weeks. We evaluated the long-term efficacy and safety of ixekizumab for up to 52 weeks. Patients were randomized to 80 mg ixekizumab every 2 weeks or to placebo through Week 12, then received 80 mg open-label ixekizumab every 4 weeks through Week 52. In patients initially randomized to ixekizumab, clear or almost clear genital skin was achieved for 73% of patients at Week 12 and 75% at Week 52. Persistent improvements were also observed for overall psoriasis, genital itch, and the impact of genital psoriasis on the frequency of sexual activity. The safety profile was consistent with studies of ixekizumab in patients with moderate-to-severe plaque psoriasis. Ixekizumab provided rapid and persistent improvements in the signs and symptoms of genital psoriasis for up to 52 weeks of treatment. [ABSTRACT FROM AUTHOR]

Published
2020
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33. Doctor --- also a patient --- considers the options

Author

Weisman, Jamie

Subjects
Medicine -- Practice, Insurance industry, Insurance industry, General interest, News, opinion and commentary
Abstract

As tempers rise in the health-care debate, I feel the need to add my voice as one of the people who would be most affected by changes to the current [...]

Published
2009

34. The story your doctor will never tell you.

Author

Remen, Rachel Naomi, Weisman, Jamie, and Klass, Perri

Subjects
MEDICAL practice, PATIENTS, CARING
Abstract

Comments on the effects of a memorable medical case on the views of the practice of medicine. Lesson on living life passionately; Knowledge of being a patient in becoming a better doctor; Discovery of the limits of the power and influence of physicians.

Published
2002

35. Heart in His Hands.

Author

Weisman, Jamie

Subjects
CARDIOLOGISTS, COLLEGE teachers
Abstract

Presents an interview with cardiologists and Emory University School of Medicine Professor Doctor John Stone in Atlanta, Georgia. Views on compassionate medicine; Ways to cultivate compassion as a teacher of medical students; Factors influencing the decision of Stone to become a doctor.

Published
2001

36. A Second Chance.

Author

Weisman,, Jamie

Subjects
*LIVER surgery, *TRANSPLANTATION of organs, tissues, etc., *INFANT diseases, *HEALTH
Abstract

Reports on the Bourgeois family and their infant son's struggle with tyrosinemia, a liver disease. Difficulty of getting a liver donation for Blake; Mother Melissa's decision to donate a portion of her liver in a living-related transplant; Efforts of Dr. Thomas Heffron, director of pediatric liver transplantation at Children's Hospital Health Care of Atlanta-Egleston; Details of such a liver transplant; Joy over the transplant's success.

Published
2000

37. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of a phase 3 open-label extension study.

Author

Zouboulis, Christos C, Okun, Martin M, Prens, Errol P, Gniadecki, Robert, Foley, Peter A, Lynde, Charles, Weisman, Jamie, Gu, Yihua, Williams, David A, and Jemec, Gregor B E

Abstract

Background: The optimal long-term dosing strategy for adalimumab (ADA) in hidradenitis suppurativa/acne inversa (HS) was evaluated by pooling the results of the PIONEER phase 3 trials and an open-label extension (OLE) study.Objective: To assess the response to and tolerability of long-term administration of ADA in HS.Methods: The durations of the PIONEER I/II periods A, B, and OLE were 12, 24, and 52 or more weeks, respectively. Patients who entered the OLE and received ADA (40 mg every week continuously) and responders plus partial responders (PRRs) were evaluated. Primary efficacy assessments included measurement of HS clinical response (HiSCR), lesion counts, skin pain, and Dermatology Life Quality Index (DLQI). Treatment-emergent adverse events were assessed.Results: At week 12, 52.3% of those receiving ADA weekly and 73.0% of PRRs achieved HiSCR. Achievement of HiSCR was maintained through week 168 in 52.3% of patients who received ADA weekly and 57.1% of PRRs. Sustained improvement in lesion counts, skin pain, and DLQI score were also observed. The safety profile throughout the OLE was similar to the profiles observed in the PIONEER studies.Limitations: The OLE was uncontrolled.Conclusion: Continuous weekly dosing with ADA, 40 mg, is a reasonable treatment option for long-term control of moderate-to-severe HS. [ABSTRACT FROM AUTHOR]

Published
2018
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38. Ixekizumab Results in Persistent Clinical Improvement in Moderate-to-Severe Genital Psoriasis During a 52 Week, Randomized, Placebo-Controlled, Phase 3 Clinical Trial.

Author

Guenther L, Potts Bleakman A, Weisman J, Poulin Y, Spelman L, Burge R, Erickson J, Todd K, Bertram CC, and Ryan C

Subjects
Adult, Antibodies, Monoclonal, Humanized pharmacology, Dermatologic Agents pharmacology, Female, Humans, Male, Psoriasis pathology, Treatment Outcome, Antibodies, Monoclonal, Humanized therapeutic use, Dermatologic Agents therapeutic use, Genitalia pathology, Psoriasis drug therapy
Abstract

Ixekizumab was efficacious in treating moderate-to-severe genital psoriasis over 12 weeks. We evaluated the long-term efficacy and safety of ixekizumab for up to 52 weeks. Patients were randomized to 80 mg ixekizumab every 2 weeks or to placebo through Week 12, then received 80 mg open-label ixekizumab every 4 weeks through Week 52. In patients initially randomized to ixekizumab, clear or almost clear genital skin was achieved for 73% of patients at Week 12 and 75% at Week 52. Persistent improvements were also observed for overall psoriasis, genital itch, and the impact of genital psoriasis on the frequency of sexual activity. The safety profile was consistent with studies of ixekizumab in patients with moderate-to-severe plaque psoriasis. Ixekizumab provided rapid and persistent improvements in the signs and symptoms of genital psoriasis for up to 52 weeks of treatment.

Published
2020
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39. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials

Author

Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, and Ardeleanu M

Subjects
Adult, Black or African American statistics & numerical data, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Humanized, Asian People statistics & numerical data, Dermatitis, Atopic diagnosis, Double-Blind Method, Female, Humans, Injections, Subcutaneous, Male, Middle Aged, Placebos administration & dosage, Placebos adverse effects, Quality of Life, Severity of Illness Index, Treatment Outcome, White People statistics & numerical data, Young Adult, Antibodies, Monoclonal administration & dosage, Dermatitis, Atopic drug therapy
Abstract

Dupilumab, a monoclonal antibody that blocks the shared receptor subunit for interleukin (IL)-4 and IL-13, is currently approved for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD). The efficacy and safety of dupilumab for AD among racial subgroups is unknown. This post hoc analysis from three phase 3 trials assessed the efficacy and safety of dupilumab vs placebo by racial subgroup (White, Asian, Black/African American). Data from LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02277769), and CHRONOS (NCT02260986) were pooled. Outcomes included mean and percent change from baseline to week 16 in the key therapeutic domains Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (NRS), Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure, as well as Investigator’s Global Assessment and pain or discomfort assessed by the European Quality of Life-5 Dimensions 3 level questionnaire. A total of 2,058 patients (White n=1,429, Asian n=501, Black/African American n=128) were included in the current analysis. Baseline demographics and disease characteristics were balanced between treatment groups and racial subgroups. In the three trials, dupilumab significantly (P<0.0001) improved all assessed outcomes compared with placebo in the White and Asian subgroups. In the smaller Black/African American subgroup, dupilumab significantly (P<0.0001) improved EASI endpoints and mean changes in Peak Pruritus NRS and DLQI vs placebo, with positive numeric trends favoring dupilumab in all other endpoints. Dupilumab was generally well tolerated, with an acceptable safety profile in all racial subgroups. Serious adverse events occurred more frequently with placebo; treatment discontinuations due to adverse events were rare in all treatment groups. Significant clinical improvement and a favorable benefit-risk profile can be achieved with dupilumab treatment in patients of White, Asian, and Black/African American racial subgroups with moderate-to-severe AD inadequately controlled with topical medications. ClinicalTrials.gov identifiers: NCT02277743, NCT02277769, NCT02260986

Published
2019

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