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Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Kenneth Gordon, MD
Credit: International Psoriasis Council

Leveraging data from nearly half a dozen clinical trials, results of a study from 

 is shedding new light on the effects of bimekizumab (Bimzelx) in patients with moderate to severe 

With more than 6300 person-years of follow-up data, results of the study provide an overview of the safety of the IL-17A and IL-17F inhibitor, with investigators detailing the safety data from more than 2100 patients throughout duration of the follow-up and broken down by year.

“[Bimekizumab] demonstrated good tolerability and a consistent safety profile over 4 years in patients with plaque psoriasis,” wrote investigators.

Developed and marketed by UCB, bimekizumab received its initial approval from the US Food and Drug Administration for the treatment of moderate to severe plaque psoriasis in patients in adults who are candidates for systemic therapy or phototherapy in October 2023. As of September 17, 2024, UCB had filed 5 additional supplemental Biologics License Applications with the FDA in 2024 for multiple new indications, including moderate to severe hidradenitis suppurativa, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and for a 2mL presentation.

The current study, which was presented at Maui Dermatology NP+PA Fall 2024 by Kenneth Gordon, MD, chair of Dermatology at the Medical College of Wisconsin, sought to evaluate the safety of bimekizumab use from the BE READY, BE VIVID, BE SURE, BE BRIGHT, and BE RADIANT trials. The primary aim of the study was to describe the incidence of treatment emergent adverse events per 100 patient-years for patients who received at least 1 dose of bimekizumab, with a secondary interest in stratification by year of treatment.

From the studies, investigators obtained 6324.3 patient-years of follow-up data from involving 2186 patients. The breakdown of patient-years of follow-up from each year were as follows:

2053.3 patient-years in Year 1 from 2186 patients

1904.3 patient-years in Year 2 from 2013 patients

1521.1 patient-years in Year 3 from 1803 patients

819.5 patient-years in Year 4 from 1309 patients

Results of the investigators’ analysis suggested the overall incidence rate of treatment-emergent adverse events with use bimekizumab was 170.5 per 100 patient-years. Analysis stratified according to time on treatment suggested the incidence of events decreased over time, with rates falling from 230.9 per 100 patient-years in year 1 to 99.9 per 100 patient-years in year 4.

Further analysis revealed rates of 5.5 and 2.9 per 100 patient-years of treatment for serious treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation, respectively. Investigators pointed out the most common treatment-emergent adverse events were nasopharyngitis (12.7 per 100 patient-years), oral candidiasis (8.9 per 100 patient-years), and upper respiratory tract infections (5.7 per 100 patient-years). Investigators also highlighted fewer treatment-emergent adverse events were observed with bimekizumab every 8 weeks relative to bimekizumab every 4 weeks, including a pronounced effect on oral candidiasis (6.5 per 100 patient-years vs 16.7 per 100 patient-years).

“[Exposure-adjusted incidence rates] of [treatment-emergent adverse events] remained consistent/decreased with longer [bimekizumab] exposure,” investigators concluded.

KB Gordon, D Thaci, M Gooderham. Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials . Abstract presented at Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024.

UCB. BIMZELX[®] approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. UCB. October 13, 2023. Accessed September 17, 2024. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis.

UCB. FDA accepts supplemental biologics license applications for BIMZELX[®] (bimekizumab-BKZX) for moderate to severe hidradenitis suppurativa and additional 2ML device presentations. UCB. April 4, 2024. Accessed September 17, 2024. https://www.ucb.com/stories-media/Press-Releases/article/FDA-Accepts-Supplemental-Biologics-License-Applications-for-BIMZELXR-bimekizumab-bkzx-for-Moderate-to-Severe-Hidradenitis-Suppurativa-and-Additional-2mL-Device-Presentations.

Articles

At Maui Derm NP+PA Fall 2024, bimekizumab data demonstrates a consistent safety profile in moderate to severe plaque psoriasis over 4 years, with decreasing event rates over time.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Long-Term Safety Data Highlight Potential of Bimekizumab in Plaque Psoriasis

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

People with psoriatic arthritis (PsA) and blue-collar jobs (BCol) with manual labor have increased rates of work disability compared with white-collar (WCol) workers with sedentary occupations while treatment responses did not significantly differ by occupation type.

“Because BCol workers often face higher levels of biomechanical stress on their joints and entheses, this could trigger or worsen inflammation in these areas, leading to higher disease activity or poorer response to medication among PsA patients who work in physically demanding occupations,” lead investigator Nina Colla, Department of Rheumatology, University Hospital Zurich, University of Zurich Winterthur, Switzerland, and colleagues wrote.

“Despite these hypotheses, the direct implication of work-related physical demands in PsA patients remains unexplored. It remains unclear whether PsA patients with high physical workloads experience increased disease activity or diminished treatment response.”

Colla and colleagues analyzed data from patients with PsA from the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registry from January 2000 to September 2020 classified as BCol or WCol and assessed at the initiation of a biologic or targeted synthetic disease-modifying anti-rheumatic drug (b-/tsDMARD). They compared baseline characteristics at treatment start and the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) for the 1-year remission and investigated treatment retention using Kaplan–Meier curves and Cox regression analysis.

The investigators found that of 564 patients, 29% were BCol and 71% were WCol workers, with similar baseline disease activity. BCol workers were predominantly male (79.8%) and had a higher rate of work disabilityat baseline (84.0%) than WCol workers (27.9%; 

<.01). The analysis also included 174 treatment courses in 165 patients with PsA.

They found that occupation did not significantly influence achievement of DAS28-CRP remission at 1 year. Kaplan–Meier analysis (n = 671) did indicate longer retention for BCol workers, however, this did not remain significant after adjusted Cox regression analysis.

“In conclusion, this study suggests that physically demanding occupations correlate with increased rates of work disability among PsA patients, particularly men. Further research is needed to fully understand the impact of physical workload on disease burden and to develop effective interventions for preventing long-term work disability among PsA patients,” Colla and colleagues wrote.

Other recent research with quality of life in patients with PsA has found that patients who achieve clinical disease control are 

more likely to see significant improvements

 in patient-reported outcomes (PROs) and quality of life measures.

Investigators analyzed data from 1069 patients in the SELECT-PsA 1 trial and 317 patients in the SELECT-PsA 2 trial were analyzed. Responders were defined as those who achieved MDA or VLDA, and PASDAS, DAPSA, and RAPID3 LDA or remission. Disease control was obtained by similar proportions of patients in the upadacitinib15 mg QD cohort, placebo to upadacitinib 15 mg QD cohort, and adalimumab 40 mg EOW cohort.

In both studies, responders at week 104 demonstrated more marked changes from baseline and achieved normative values in PROs compared with non-responders (

<.0001). Additionally, more responders obtained minimal clinically important differences among PROs compared with non-responders. Those who achieved MDA or VLDA were more likely to achieve PASDAS, DAPSA, and RAPID3 LDA or remission (

<.0001) for upadacitinib15 mg QD and for pooled treatment arms.

1. Colla, N, Maul, JT., Vallejo-Yagüe, E, et al. Impact of blue-collar vs. white-collar occupations on disease burden in psoriatic arthritis patients: A Swiss clinical quality management in rheumatic diseases cohort study. 

(2024). Doi: 10.1007/s10067-024-07077-1
2. Kavanaugh A, Mease P, Gossec L, et al. Association Between Achievement of Clinical Disease Control and Improvement in Patient-Reported Outcomes and Quality of Life in Patients With Psoriatic Arthritis in the Phase 3 SELECT-PsA 1 and 2 Randomized Controlled Trials. 

. Published online August 1, 2024. doi:10.1002/acr2.11714

Types of occupation did not significantly affect response to treatment. 

Psoriatic Arthritis

On the HCPLive psoriatic arthritis page, resources on the topics of medical news and expert insight into PsA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on arthritis, and more.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Patients With PsA and Blue-Collar Jobs Have High Rates of Work Disability 

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 editorial team spoke with Matthew Zirwas, MD, regarding his review of recent literature in the dermatology field and off-label drug options.

Zirwas, the director of the clinical trials and dermatitis center at Dermatologists of Greater Columbus, spoke about some of the most noteworthy articles from a wide array of journals published over the course of the last year. He noted that the talk also covered non-

Zirwas covered non-FDA approved advancements in dermatology, including oral roflumilast for psoriasis, metformin for acne, and minoxidil for nails.

Off-Label Treatment Options in Dermatology, with Matthew Zirwas, MD

“The single most useful new drug is oral roflumilast,” Zirwas said. “It’s a PDE4 inhibitor and FDA-approved for COPD, but it went generic last year so now it's cheap…It’s a really potent PDE4 inhibitor that has a randomized, double blind placebo controlled trial showing really good efficacy for psoriasis.”

Zirwas highlighted that roflumilast will lead to around 50% of patients with psoriasis achieving 90% success in Psoriasis Area and Severity Index scores (PASI 90) about 70% of patients will achieve PASI 75. These statistics, Zirwas noted, are significant for a drug that is also known to be highly safe.

“I particularly find it useful for diseases that we don't have high-efficacy, FDA-approved therapies for,” Zirwas said. “So things like lichen planus, oral lichen planus, lichen planopilaris, granuloma annulare, and cutaneous connective tissue diseases.”

Zirwas also highlighted significant challenges in acne, specifically among patients for whom topicals will not work and long-term systemic antibiotics and isotretinoin are not viable options.

“We got a good study this year comparing metformin taken orally to doxycycline, and they were very equivalent in efficacy,” Zirwas explained. “It was studied in both men and women and the dosing was 500 milligrams twice a day. Metformin is an incredibly safe drug, and one of the safest drugs that there is…For the things that usually come up with it that people get concerned about that, I want to reassure them: It doesn't cause hypoglycemia, and so we don't have to worry that giving it to non-diabetics and making them get hypoglycemic.”

For additional information on tips for off-label treatments, view the full interview segment above.

The quotes contained in this summary were edited for the purposes of clarity.

Zirwas reported being a consultant and investigator for Arcutis Biotherapeutics, and has received grants from Amgen and UCB and personal fees from AbbVie, Dermavant, EPI Health, Galderma, Genentech/Novartis, Incyte, L’Oréal, Lilly, Pfizer, Regeneron, and Sanofi.

Videos

This interview featured a literature review discussion about non-FDA approved advancements in dermatology, including oral roflumilast for psoriasis, metformin for acne, and minoxidil for nails.

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Moser reviews ongoing unmet needs in PBC and how the addition of 2 new second-line treatment options has changed the treatment landscape.

Navigating Developments in PBC Treatment, with Allison Moser, MSN, RN, FNP

 treatment landscape has undergone significant developments in the past few months with the addition of 2 new second-line treatment options, seladelpar (Livdelzi) and elafibranor (Iqirvo).

2024 annual Gastroenterology and Hepatology Advanced Practice Providers (GHAPP) conference

 in National Harbor, Maryland, Allison Moser, MSN, RN, FNP, Solid Organ Transplant Lead Advanced Practice Provider at Rush University Medical Center, spotlighted these advancements during her presentation on emerging emerging therapies in the management of PBC.

Ursodeoxycholic acid (UDCA) has long served as the first-line treatment option for patients diagnosed with PBC. Although it has demonstrated a notable impact on transplant-free survival and the development of fibrosis and esophageal varices, Moser noted as many as 40% of patients do not have an adequate response to treatment and 5% are unable to tolerate it.

“When [obeticholic acid] came out, it was really exciting that we had a second-line therapy for these patients who were either unable to tolerate UDCA or had an inadequate response,” Moser told 

. “But even with that, there's still a large percentage of patients who have an inadequate response with obeticholic acid, about 50%. So although it does have great efficacy, there's still quite an unmet need.”

With the accelerated approvals of elafibranor and seladelpar in June 2024 and August 2024, respectively, Moser described a new excitement around PBC and how the emergence of these new treatment options has helped to “put PBC in the spotlight again.”

She called attention to the rapid and sustained efficacy of both medications, describing how treatment goals and timelines have shifted in light of these therapeutic developments. Looking ahead, Moser highlighted the potential of triple therapy, describing it as “really exciting,” especially in the context of an FXR agonist and a PPAR.

Brooks, A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed September 17, 2024. 

https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis

Brooks, A. FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC. HCPLive. June 10, 2024. Accessed September 17, 2024. 

https://www.hcplive.com/view/fda-grants-accelerated-approval-to-elafibranor-iqirvo-for-pbc

Hepatology

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

 conference in Nashville, Raj Chovatiya, MD, PhD, spoke with the 

 team about his talk regarding promising therapies for patients with hidradenitis suppurativa (HS) such as interleukin (IL)-27 and janus kinase (JAK) inhibitors.

Chovatiya, clinical associate professor of medicine for the Rosalind Franklin University Chicago Medical School, was asked about his presentation’s coverage of IL-17 inhibition for HS.

Chovatiya discusses JAK inhibitors, IL-17 inhibitors, and other pipeline information for HS treatment.

Raj Chovatiya, MD, PhD: Treating Hidradenitis Suppurativa with IL-17, JAK Inhibitors

“IL-17 in general as a cytokine, we know, is really important for driving some elements of neutrophilic-related inflammation, which we know is an important part of this disease,” Chovatiya explained. “Additionally, it seems to at least be in part responsible for some of the inflammatory events that we see in the pilosebaceous unit, too. Generally speaking, it is a therapeutic strategy that makes sense.”

He added that it is not a therapeutic strategy that is going to fully reverse the course of disease, resulting in complete clearance for every patient. Nevertheless, Chovatiya noted that research suggests that the more completely IL-17 is blocked, the better results are going to be.

“It's the reason why blockade with either bimekizumab as a monoclonal antibody that binds IL-17A and F, as opposed to just simply IL-17A, or blockade with sonelokimab as a nanobody that blocks A and F…(both) probably have some of the higher reported data we've seen in terms of patients getting beyond high score of 50, high score 75 or even 90, and even potentially 100 in a small fraction of people.”

Later, he was asked about JAK inhibition treatment data for healthcare professionals to understand.

“I think that JAK inhibition also makes sense, because we know that there's a number of cytokine pathways that are important in HS and inhibition of JAK proteins can allow you to work across multiple pathways of cytokines, potentially leading to efficacy,” Chovatiya explained. “In the mid-phase results that we've seen presented thus far, it's clear that the povoricitinib and upadacitinib definitely appear to have efficacy that separates them from placebo itself.”

, view the full interview segment posted above.

The quotes used in this summary were edited for the purposes of clarity.

Chovatiya reports serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc, Regeneron, RAPT, Sanofi, Sitryx, and UCB.


In this interview segment, Chovatiya highlights HS therapies such as IL-17 inhibitors and JAK inhibitors, as well as unmet needs of patients.

Patients also experienced a substantial decrease in systolic blood pressure and diastolic blood pressure. 

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

Low Purine Diet Lowers Uric Acid in People With Gout 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Counting down the most impactful news at major medical meetings, it’s the HCPLive Five! This episode focuses on 5 key updates from the European Society of Cardiology (ESC) Congress 2024.



Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Atherosclerotic Cardiovascular Disease

Dyslipidemia

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Structural Heart Disease

HCPLive Five at ESC 2024

These poster data highlight that atopic dermatitis treatment may be suboptimal
in certain patients, demonstrating the necessity of additional effective therapy options.

Atopic Dermatitis

Atopic Dermatitis condition center page, resources on the topics of medical news and expert insight into eczema can be found. Content includes articles, interviews, videos, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Inadequate Eczema Control Observed in 30% of Patients on Topicals, Systemic Therapies

Lindsay S. Ackerman, MD, FAAD, and Jonathan Silverberg, MD, PhD, MPH, provide clinical insights on best practices for monitoring patients with atopic dermatitis who are receiving JAK inhibitors.

Peer Exchange

HCPLive® Peer Exchange panel discussions feature authoritative insights, opinions, and perspectives on important issues facing today's care professionals.

Monitoring Schedule for JAK Inhibitors in Atopic Dermatitis

Experts on atopic dermatitis compare the safety profile of JAK inhibitors with traditional and more advanced treatments currently available for patients.

Safety Profile of JAK Inhibitors and their Use in Atopic Dermatitis

Nemolizumab shows early and sustained benefits in reducing itch and sleep disturbance in moderate-to-severe atopic dermatitis, per ARCADIA data.

ARCADIA Data Highlight Long-Term Sleep, Itch Benefits of Nemolizumab in Atopic Dermatitis

Chelsie Derman is an assistant editor for 

who covers psychiatry, sleep medicine, and geriatrics. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A new study found glucagon-like peptide 1 receptor agonist use was associated with a lower risk of cirrhosis complications for patients with MASLD who did not have cirrhosis.

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Type 2 Diabetes

GLP-1 RA Linked to Lower Risk of Cirrhosis Development in Patients with MASLD

This interview at the Fall 2024 Maui Derm conference features Melodie Young, with a discussion about updates in psoriasis and psoriatic arthritis therapy for children.

Melodie Young, ASN, RN: Updates on Therapies for Pediatric Patients with Psoriasis, PsA

Notably, people with fewer vaccine doses were more likely to experience post-acute sequelae of COVID-19. 

Patients With Arthritis, IBD, Experience High Rates of Long Covid Affecting QoL 

Podcasts

The Medical Sisterhood, hosted by Mona Shahriari, MD, is the latest multimedia program from HCPLive Dermatology!

The Medical Sisterhood, with Mona Shahriari, MD

The Medical Sisterhood, hosted by Mona Shahriari, MD, is a podcast dedicated to empowering female physicians by providing a platform for shared experiences, mentorship, and support. 

Each episode delves into the unique challenges women in medicine face, including work-life balance, leadership roles, and overcoming gender biases. Through candid discussions and expert interviews, Shahriari aims to inspire women to lead fulfilling professional and personal lives on their own terms. 

e as we foster a community where women can uplift and support each other in achieving their goals!

Latest News

Long-Term Safety Data Highlight Potential of Bimekizumab in Plaque Psoriasis

Patients With PsA and Blue-Collar Jobs Have High Rates of Work Disability

Off-Label Treatment Options in Dermatology, with Matthew Zirwas, MD

Navigating Developments in PBC Treatment, with Allison Moser, MSN, RN, FNP

Raj Chovatiya, MD, PhD: Treating Hidradenitis Suppurativa with IL-17, JAK Inhibitors