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8. Sustained hair regrowth with continued ritlecitinib treatment through week 48 in patients with alopecia areata with or without early target responses: Post hoc analysis of the ALLEGRO phase 2b/3 trial

Author

Piliang, Melissa, Lynde, Charles, King, Brett, Mirmirani, Paradi, Sinclair, Rodney, Senna, Maryanne, Forman, Seth, Bordone, Lindsey, De La Cueva Dobao, Pablo, Wolk, Robert, Zwillich, Samuel H., Tran, Helen, Wajsbrot, Dalia, Ahmed, Haytham Mohamed, and Takiya, Liza

Published
2024
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13. Preserving the Voices of Adult Educators

Author

Bogner, Len A. and King, Brett P.

Abstract

The Adult Education Interview Series (AEIS) started at the University of Central Oklahoma (UCO) and was inspired by the use of TED talks and other similar videos in online and distance education courses. It is a collaboration between the Adult Education and Safety Science Department and the Center for eLearning and Connected Environments at UCO. The intent of the AEIS is twofold: to preserve the history and stories of adult educators and to analyze the interviews to determine common or contradictory themes that provide insight into perspectives of professionals in the field. By understanding the perspectives of the field, we can better ascertain where the field was, is and where it might be going. The AEIS is to be an open resource that can be accessed by any member of AHEA for their Adult Education courses. [For the complete proceedings, see ED576985.]

Published
2017

18. Inhibition of type 1 immunity with tofacitinib is associated with marked improvement in longstanding sarcoidosis

Author

Damsky, William, Wang, Alice, Kim, Daniel J., Young, Bryan D., Singh, Katelyn, Murphy, Michael J., Daccache, Joseph, Clark, Abigale, Ayasun, Ruveyda, Ryu, Changwan, McGeary, Meaghan K., Odell, Ian D., Fazzone-Chettiar, Ramesh, Pucar, Darko, Homer, Robert, Gulati, Mridu, Miller, Edward J., Bosenberg, Marcus, Flavell, Richard A., and King, Brett

Published
2022
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19. Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis.

Author

Mesinkovska, Natasha, King, Brett, Zhang, Xingqi, Guttman‐Yassky, Emma, Magnolo, Nina, Sinclair, Rodney, Mizuashi, Masato, Shapiro, Jerry, Peeva, Elena, Banerjee, Anindita, Takiya, Liza, Cox, Lori Ann, Wajsbrot, Dalia, Kerkmann, Urs, Law, Ernest, Wolk, Robert, and Schaefer, Gregor

Abstract

This post‐hoc analysis of the ALLEGRO phase 2b/3 study (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral Janus kinase 3/TEC family kinase inhibitor, in patients with alopecia totalis (AT) and alopecia universalis (AU). Patients aged ≥ 12 years with alopecia areata (AA) and ≥50% scalp hair loss received once‐daily ritlecitinib 50 or 30 mg (± 4‐week 200‐mg loading dose) or placebo for 24 weeks. In a subsequent 24‐week extension period, the ritlecitinib groups continued their doses and patients initially assigned to placebo switched to ritlecitinib (200/50 or 50 mg daily). In this analysis, clinician‐ and patient‐reported hair regrowth outcomes were assessed at weeks 24 and 48 in four AA subgroups: AT/AU, AT, AU, and non‐AT/AU. Safety was monitored throughout. Of the 718 randomized patients, 151 (21%) and 147 (20%) were defined as having AT or AU, respectively. At week 24, Severity of Alopecia Tool (SALT) score ≤20 (≤20% scalp hair loss) response rates were higher in the ritlecitinib‐treated AT/AU, AT, and AU groups (7%–14%, 7%–21%, and 4%–10%, respectively) vs the placebo group (0% in the AT/AU, AT, and AU groups). The proportions of patients with a SALT score of ≤20 increased through week 48 (AT/AU, 13%–31%; AT, 11%–27%; AU, 6%–41%). Additionally, at week 24, 25%–43%, 32%–42%, and 12%–50% of patients with AT/AU, AT, and AU, respectively, who received ritlecitinib achieved a moderately or greatly improved response based on the Patient Global Impression of Change scale. Response rates generally increased through week 48 and were similar across AA subgroups. In patients with AT/AU, ritlecitinib was well tolerated with a safety profile consistent with that of the overall AA population. Ritlecitinib demonstrated clinical efficacy, patient‐reported improvement, and an acceptable safety profile in patients with AT and AU through week 48. A plain language summary of this study is available at https://doi.org/10.25454/pfizer.figshare.26879161. Clinicaltrials.gov: NCT03732807. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Efficacy and safety of ritlecitinib in vitiligo patients across Fitzpatrick skin types with biomarker analyses.

Author

Peeva, Elena, Yamaguchi, Yuji, Ye, Zhan, King, Brett, Picardo, Mauro, Sloan, Abigail, Ezzedine, Khaled, Del Duca, Ester, Estrada, Yeriel, Hassan‐Zahraee, Mina, He, Wen, Hyde, Craig, Bar, Johnathan, Facheris, Paola, and Guttman‐Yassky, Emma

Subjects
KINASE inhibitors, VITILIGO, BIOMARKERS, PLACEBOS
Abstract

Efficacy and safety of ritlecitinib (an oral JAK3/TEC family kinase inhibitor) were evaluated in patients with nonsegmental vitiligo (NSV) across Fitzpatrick skin types (FSTs). Patients with FST I‐III ('light skin'; n = 247) and FST IV‐VI ('dark skin'; n = 117) received once‐daily ritlecitinib 50 mg (with/without 4‐week loading dose), low‐dose ritlecitinib or placebo for 24 weeks. At baseline, patients with light skin displayed higher CLM‐1 and NCR1 serum levels than patients with dark skin (p < 0.05). At 24 weeks, ritlecitinib 50 mg improved the extent of depigmentation measured by percent change from baseline in facial‐vitiligo area scoring index (placebo‐adjusted mean difference [90% CI]) in patients with light (−15.2 [−24.7, −5.8]; p = 0.004) and dark (−37.4 [−50.3, −24.4]; p < 0.0001) skin, with continuous re‐pigmentation through week 48. Treatment‐emergent adverse events were similar across FSTs. At weeks 4 and 24, ritlecitinib 50 mg reduced CXCL11 serum levels (p < 0.001) in patients with light skin, whereas patients with dark skin had increased levels at week 4 (p = 0.05) and no significant change at week 24. Ritlecitinib 50 mg decreased IL‐9 and IL‐22 expression levels in dark skin compared with light skin (qPCR; p < 0.05). These differences in immune dysregulations may explain why NSV patients with dark skin respond to therapy earlier than patients with light skin. [ABSTRACT FROM AUTHOR]

Published
2024
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27. The Alopecia Areata Consensus of Experts (ACE) study part II: Results of an international expert opinion on diagnosis and laboratory evaluation for alopecia areata

Author

Meah, Nekma, Wall, Dmitri, York, Katherine, Bhoyrul, Bevin, Bokhari, Laita, Asz-Sigall, Daniel, Bergfeld, Wilma F., Betz, Regina C., Blume-Peytavi, Ulrike, Callender, Valerie, Chitreddy, Vijaya, Combalia, Andrea, Cotsarelis, George, Craiglow, Brittany, Donovan, Jeff, Eisman, Samantha, Farrant, Paul, Green, Jack, Grimalt, Ramon, Harries, Matthew, Hordinsky, Maria, Irvine, Alan D., Itami, Satoshi, Jolliffe, Victoria, King, Brett, Lee, Won-Soo, McMichael, Amy, Messenger, Andrew, Mirmirani, Paradi, Olsen, Elise, Orlow, Seth J., Piraccini, Bianca Maria, Rakowska, Adriana, Reygagne, Pascal, Roberts, Janet L., Rudnicka, Lidia, Shapiro, Jerry, Sharma, Pooja, Tosti, Antonella, Vogt, Annika, Wade, Martin, Yip, Leona, Zlotogorski, Abraham, and Sinclair, Rodney D.

Published
2021
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28. A neutrophil activation signature predicts critical illness and mortality in COVID-19

Author

Meizlish, Matthew L., Pine, Alexander B., Bishai, Jason D., Goshua, George, Nadelmann, Emily R., Simonov, Michael, Chang, C-Hong, Zhang, Hanming, Shallow, Marcus, Bahel, Parveen, Owusu, Kent, Yamamoto, Yu, Arora, Tanima, Atri, Deepak S., Patel, Amisha, Gbyli, Rana, Kwan, Jennifer, Won, Christine H., Dela Cruz, Charles, Price, Christina, Koff, Jonathan, King, Brett A., Rinder, Henry M., Wilson, F. Perry, Hwa, John, Halene, Stephanie, Damsky, William, van Dijk, David, Lee, Alfred I., and Chun, Hyung J.

Published
2021
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30. A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata.

Author

Anderson, Samira, Cavaletti, Guido, Hood, Linda J., Polydefkis, Michael, Herrmann, David N., Rance, Gary, King, Brett, McMichael, Amy J., Senna, Maryanne M., Kim, Brian S., Napatalung, Lynne, Wolk, Robert, Zwillich, Samuel H., Schaefer, Gregor, Gong, Yankun, Sisson, Melanie, and Posner, Holly B.

Subjects
AUDITORY evoked response, NERVE fibers, ALOPECIA areata, DOG diseases, HISTOLOGY, ADULTS, STIMULUS intensity
Abstract

Reversible axonal swelling and brainstem auditory evoked potential (BAEP) changes were observed in standard chronic (9‐month) toxicology studies in dogs treated with ritlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor, at exposures higher than the approved 50‐mg human dose. To evaluate the clinical relevance of the dog toxicity finding, this phase 2a, double‐blind study assessed BAEP changes and intraepidermal nerve fiber (IENF) histology in adults with alopecia areata treated with ritlecitinib. Patients were randomized to receive oral ritlecitinib 50 mg once daily (QD) with a 4‐week loading dose of 200 mg QD or placebo for 9 months (placebo‐controlled phase); they then entered the active‐therapy extension and received ritlecitinib 50 mg QD (with a 4‐week loading dose of 200 mg in patients switching from placebo). Among the 71 patients, no notable mean differences in change from baseline (CFB) in Waves I–V interwave latency (primary outcome) or Wave V amplitude on BAEP at a stimulus intensity of 80 dB nHL were observed in the ritlecitinib or placebo group at Month 9, with no notable differences in interwave latency or Wave V amplitude between groups. The CFB in mean or median IENF density and in percentage of IENFs with axonal swellings was minimal and similar between groups at Month 9. Ritlecitinib treatment was also not associated with an imbalanced incidence of neurological and audiological adverse events. These results provide evidence that the BAEP and axonal swelling finding in dogs are not clinically relevant in humans. [ABSTRACT FROM AUTHOR]

Published
2024
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34. Predicting perimetric defects from en face maps of retinal nerve fibre layer reflectance.

Author

Swanson, William H., King, Brett J., Alluwimi, Muhammed S., and Malik, Rizwan

Abstract

Purpose: To develop criteria to predict visual hemifields with deep perimetric defects based on retinal nerve fibre layer (RNFL) reflectance, in a transparent process whose components can be assessed by independent laboratories analysing data from their own small groups. Methods: The analysis was carried out in four stages, using three independent groups of patients—30, 33 and 62 participants—with glaucoma and age‐similar controls. The first stage used Group 1 to develop a criterion for RNFL reflectance images at 24, 36 or 48 μm below the inner limiting membrane (ILM). The second stage evaluated the criterion using Group 2. The third stage developed a second criterion to improve performance for Groups 1 and 2 combined. The fourth stage evaluated the second criterion with Group 3. Confidence intervals for sensitivity and specificity were then computed by combining results from all three groups. Results: The first criterion identified all hemifields with deep defects and no hemifields from controls, using a within‐eye reference for healthy RNFL. For Group 2, specificity remained high but sensitivity was reduced. The second criterion improved sensitivity by using location‐specific reference values. For Group 3, sensitivity remained high but reduced specificity was found. Confidence intervals showed substantial overlap for the two criteria. Conclusions: We developed two criteria to identify patients with deep perimetric defects with high specificity and sensitivity. Several improvements are warranted: automated identification of the fovea‐disc angle and optic disc locations, evaluation of normal variation in patterns of RNFL thickness, improved segmentation of ILM and major vasculature, reduction of within‐eye variability in RNFL reflectance of healthy eyes, assessment of effects of image quality, assessment of effects of comorbidity and effectiveness of other devices. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Inhibition of T-cell activity in alopecia areata: recent developments and new directions.

Author

Passeron, Thierry, King, Brett, Seneschal, Julien, Steinhoff, Martin, Jabbari, Ali, Ohyama, Manabu, Tobin, Desmond J., Randhawa, Simran, Winkler, Aaron, Telliez, Jean-Baptiste, Martin, David, and Lejeune, Alexandre

Subjects
ALOPECIA areata, CYTOTOXIC T cells, T cells, T cell receptors, DRUG development, HAIR follicles, BALDNESS
Abstract

Alopecia areata (AA) is an autoimmune disease that has a complex underlying immunopathogenesis characterized by nonscarring hair loss ranging from small bald patches to complete loss of scalp, face, and/or body hair. Although the etiopathogenesis of AA has not yet been fully characterized, immune privilege collapse at the hair follicle (HF) followed by T-cell receptor recognition of exposed HF autoantigens by autoreactive cytotoxic CD8+ T cells is now understood to play a central role. Few treatment options are available, with the Janus kinase (JAK) 1/2 inhibitor baricitinib (2022) and the selective JAK3/tyrosine kinase expressed in hepatocellular carcinoma (TEC) inhibitor ritlecitinib (2023) being the only US Food and Drug Administration--approved systemic medications thus far for severe AA. Several other treatments are used off-label with limited efficacy and/or suboptimal safety and tolerability. With an increased understanding of the T-cell--mediated autoimmune and inflammatory pathogenesis of AA, additional therapeutic pathways beyond JAK inhibition are currently under investigation for the development of AA therapies. This narrative review presents a detailed overview about the role of T cells and T-cell--signaling pathways in the pathogenesis of AA, with a focus on those pathways targeted by drugs in clinical development for the treatment of AA. A detailed summary of new drugs targeting these pathways with expert commentary on future directions for AA drug development and the importance of targeting multiple T-cell--signaling pathways is also provided in this review. [ABSTRACT FROM AUTHOR]

Published
2023
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