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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 

The discontinuation of biologic therapy prior to the end of the first trimester and not before conception could limit 

 during pregnancy, new findings suggest, given the high risk of flares observed when biologics are discontinued pre-conception.

These conclusions represent the result of a retrospective multicentric study authored by such investigators as E. Burle, from the Toulouse University Hospital Department of Dermatology and Allergology in France. Burle and colleagues highlighted that psoriasis has previously been linked to a risk increase for preterm birth as well as low birth weight.

They added that a balance of the potential risks that can be attributed to biologics is necessary to be evaluated alongside the possible negative consequences of psoriasis.

“The aim of this retrospective multicentric study was to assess the real-life practice of dermatologists in managing pregnant and breastfeeding women treated with biologics,” Burle and coauthors wrote.

The trial investigators conducted their research with the aim of assessing the effectiveness and safety of biologics in pregnant patients living with psoriasis, focusing on maternal and fetal outcomes. They also focused on the ways in which the skin condition progresses during pregnancy and at the time of delivery, along with the postpartum management of biologics and influences on breastfeeding decisions.

There were 71 women aged between 21 - 42 years included at the time of their pregnancies. During the initiation of biologic treatments, these womens' average Psoriasis Area and Severity Index (PASI) was noted to be 16.6 (±9). their Dermatology Life Quality Index (DLQI) scores averaged 17.6 (±5). On average, biologic therapies were noted to have been implemented for 2.5 years prior to pregnancy, by which point mean DLQI and PASI scores had risen to 1.7 and 1.2, respectively.

Once they learned of their pregnancies, 50.7% of these 71 participants ceased their use of biologics. An additional 29.6% discontinued their utilization of biologics during their pregnancies, mostly in the initial trimester. Burle and coauthors noted that 5.6% of the subjects continued biologic use throughout their pregnancy, and 14.1% discontinued their treatments prior to their children's conceptions.

Retrospective evaluations of psoriasis took place among these trial participants during their pregnancies.

 Burle et al highlighted that 52.2% of these 67 subjects reported disease flares, 41.8% reported no changes, and 4.5% noted improvement. Among those who stopped biologics during pregnancy, 66.7% of 21 noted that their skin conditions remained stable, compared to just 33.3% of the 36 who discontinued at the time of pregnancy discovery and 20% of 10 who stopped prior to conception.

Such distinctions were shown by the investigative team to be statistically significant (

 < .02, Chi-square test), suggestinng a higher likelihood of disease flare in those who discontinued treatment prior to their becoming pregnant. In terms of safety analyses, there was no risk increase for congenital abnormalities, miscarriage, or infections identified in the mothers, fetuses, or infants.

Notably, however, exacerbations of participants' psoriasis were found to be common following their children's delivery. Specifically, flares impacted 73% of the cohort. Burle and colleagues added that a subset of 6.3% reported having a rebound, wherein psoriasis symptoms worsened past baseline severity. Biologic drugs were typically found to have been restarted an average of 2.2 months postpartum (±2.6 months), at which time the mean PASI score was 9.1.

When they were asked about infant feeding decisions, 59.3% were shown to have chosen not to breastfeed. Among these individuals, the investigators highlighted that 43.8% cited the need to resume biologics as the reason for forgoing breastfeeding.

Overall, these conclusions support the notion clinicians often diverge from the Summary of Product Characteristics (SmPC) without raising the risk of spontaneous miscarriage or birth defects. These data align with existing evidence suggesting the relative safety of biologics during pregnancy. Nonetheless, many women either unnecessarily avoid breastfeeding or delay treatment reinitiation due to a lack of clear, evidence-based guidelines.

Currently, European recommendations offer no direction on postpartum timing for restarting biologics. In contrast, guidance for inflammatory bowel disease suggests restarting biologics within 24 hours following a vaginal birth or within 48 hours after a cesarean section, provided there is no infection. While live vaccines are contraindicated in the first year of life for infants exposed to biologics in utero due to rare complications like fatal BCG infections post-infliximab, no such risks have been reported with IL-17 or IL-23 inhibitors.

“In conclusion, discontinuing biologic agents before the end of the first trimester and not before conception could limit psoriasis flares during pregnancy,” they concluded.

 “We recommend a multidisciplinary approach with a gynaecologist and propose a therapeutic algorithm for psoriasis management during pregnancy.”

Burle E, Tran C, Paul C, et al. Withdrawal of biologic agents before pregnancy is associated with psoriasis flare. J Eur Acad Dermatol Venereol. 

Bröms G, Haerskjold A, et al. Effect of maternal psoriasis on pregnancy and birth outcomes: a population-based cohort study from Denmark and Sweden. Acta Derm Venereol. 2018; 98(8): 728–734.

Articles

Discontinuing biologic therapy before the end of the first trimester, rather than pre-conception, may reduce psoriasis flares during pregnancy. A retrospective multicentric study involving 71 women assessed the impact of biologics on maternal and fetal outcomes, revealing that discontinuation pre-conception increased flare risk. The study found no increased risk of congenital abnormalities or miscarriages. Postpartum, psoriasis exacerbations were common, with many women avoiding breastfeeding to resume biologics. The findings suggest a need for clear guidelines on biologic management during pregnancy and postpartum.

These data resulted from a sub-study of the open-label extension (OLE) of the randomized, placebo-controlled phase 3 ‘Balance’ analysis.

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Psoriasis Flare Associated with Withdrawal from Biologics Prior to Pregnancy

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration approval of sebetralstat (Ekterly) for hereditary angioedema (HAE), topline phase 2 data for rilparencel in patients with 

, a supplemental New Drug Application (sNDA) submission for lumateperone (Caplyta) for 

relapse prevention, the FDA’s public release of > 200 CRLs issued from 2020-2024, and a Breakthrough Therapy designation for TSND-201 (methylone) for the treatment of PTSD.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of July 06, 2025—let’s jump in!

Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema

On July 7, 2025, the FDA approved KalVista Pharmaceuticals’ sebetralstat (Ekterly), the first and only oral, on-demand therapy for the treatment of acute attacks of HAE in adult and pediatric patients ≥ 12 years of age. The decision was supported by data from the phase 3 KONFIDENT and KONFIDENT-S open-label extension trials.

Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial

ProKidney Corp announced statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the phase 2 REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes.

The data showed annual estimated glomerular filtration rate (eGFR) slope decline improvement in patients who received 2 scheduled rilparencel injections, 1 in each kidney, approximately 3 months apart. Notably, evidence of a dose response was also observed in a second group of patients who received a single rilparencel injection followed by a second injection only if kidney function worsened and a re-dosing trigger was met.

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

On July 8, 2025, Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for lumateperone (Caplyta) to prevent schizophrenia relapse based on long-term phase 3 data showing treatment with lumateperone led to a 63% reduction in the risk of relapse in adults with schizophrenia compared to placebo.

FDA Publishes CRLs for Past Drug, Biological Product Applications

On July 10, 2025, the FDA announced the public release of > 200 Complete Response Letters (CRLs) issued in response to applications submitted to the Agency for approval of drugs or biological products between 2020 and 2024. The initial batch of published decision letters are associated with since-approved applications.

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” FDA Commissioner Marty Makary, MD, MPH, said in a statement. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

FDA Grants TSND-201 Breakthrough Therapy Designation for PTSD

On July 10, 2025, Transcend Therapeutics announced the FDA granted TSND-201 (methylone) Breakthrough Therapy designation for the treatment of PTSD. TSND-201, a rapid-acting neuropathogen, is a proprietary formulation of methylone. Its primary site of action is at the monoamine transporters, with no activity at 5HT-2a (thus not hallucinogenic).

“A rapid-acting, durable treatment for PTSD would be a paradigm shift in psychiatry—and offer a potential lifeline for patients," said Murray B. Stein, MD, MPH, distinguished professor of psychiatry and public health at the University of California San Diego and a consultant to Transcend. "The current treatment standard, SSRIs, can take up to 12 weeks to show maximal effect and often cause side effects during that time. Even then, many patients on SSRIs don't get adequate benefit. This designation offers new hope that faster, more effective treatment may be within reach."

The recent developments in healthcare include the FDA's approval of sebetralstat for hereditary angioedema, marking it as the first oral, on-demand treatment for acute attacks. ProKidney Corp's phase 2 trial of rilparencel showed promising results in improving eGFR slope in CKD and diabetes patients. Johnson & Johnson submitted an sNDA for lumateperone to prevent schizophrenia relapse. The FDA released over 200 CRLs from 2020-2024 to enhance transparency. Additionally, TSND-201 received Breakthrough Therapy designation for PTSD, highlighting its potential as a rapid-acting treatment.

Stay updated with the latest healthcare breakthroughs, including FDA news, clinical trial data, and regulatory submissions, in this week's essential news roundup.

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The HCPFive: Top News for Healthcare Providers from the Week of 07/06

Education chair, Biologic Coordinators of Dermatology

Advocating for Patients: Securing Access to Nonsteroidal Topicals Like Roflumilast

 RX Review Special Report, Mona Shahriari, MD, Associate Clinical Professor of Dermatology at Yale University, sits down with David Hartigan, a biologic coordinator with Biologic Coordinators of Dermatology, to discuss strategies for overcoming access challenges to non-steroidal topicals like roflumilast foam for people with plaque psoriasis (PsO) on the scalp.

In this clip, recognizing that efficacy is irrelevant without availability, Shahriari and Hartigan share key documentation and communication tips that can help clinicians and staff navigate insurance approvals more efficiently.

Hartigan emphasizes the importance of accurate, detailed documentation—including treatment area, body surface area (BSA), and prior medication history—within provider notes and prior authorizations. He notes a recent trend in payers requesting evidence of concurrent topical therapy, especially non-steroidals, for patients already on biologics. Shahriari adds that correct ICD coding and alignment with FDA indications are essential for ensuring age- and condition-specific approval.

Both highlight the growing role of specialty pharmacies in simplifying access by applying manufacturer copay programs and proactively sourcing alternative funding. They also stress the value of persistence—sharing success stories where staff-led appeals and thorough documentation reversed initial denials. Shahriari, a patient herself, reinforces the medication’s utility as a safe, simple, and steroid-free option she routinely relies on and recommends.

Lastly, they emphasize the importance of advocacy and the responsibility clinicians and coordinators have in securing the therapies their patients need.

Editor's note: The FDA approved Arcutis Biotherapeutics's roflumilast under the name Zoryve as the first foam option available for scalp psoriasis in May 2025.

Tackling Real-World Barriers in Scalp Psoriasis Treatment Delivery

Formulation Matters: Managing Scalp Psoriasis Across Hair Types

The Role of Roflumilast in Long-Term Psoriasis Management

Counseling Patients With Psoriasis on Roflumilast and Nonsteroidal Topicals

Bridging and Enhancing Biologic Response With Targeted Topicals for Scalp Psoriasis

is Assistant Clinical Professor of Dermatology at Yale University School of Medicine, the Associate Director of Clinical Trials at CCD Research and a senior editor for the Journal of Psoriasis and Psoriatic arthritis. She also hosts 

is a biologic coordinator for Optima Dermatology and the Education Chair for Biologic Coordinators of Dermatology. 

Relevant disclosures for Shahriari include AbbVie, Dermira, Cara, Dermavant, Novartis, Union, BMS, Leo, Eli Lilly, Sanofi, Regeneron, UCB, and others. Hartigan reports no relevant disclosures.

Arcutis Biotherapeutics. Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older - Arcutis Biotherapeutics. Arcutis Biotherapeutics. Published May 22, 2025. Accessed May 22, 2025. 

https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/

Videos

In this video, the last in a 6-part series, panelists discuss recent advancements in PsO management.

Video Series

Advocating for Patients With Psoriasis: Securing Access to Nonsteroidal Topicals Like Roflumilast

 RX Review Special Report, Mona Shahriari, MD, Associate Clinical Professor of Dermatology at Yale University, sits down with David Hartigan, a biologic coordinator with Biologic Coordinators of Dermatology, to explore integrating topical roflumilast into the treatment regimens of patients on biologics, particularly for managing residual or scalp psoriasis. 

In this clip, Shahriari emphasizes that even among patients with moderate-to-severe disease on systemic therapy, topicals remain essential to maintaining long-term disease control. She outlines 3 key roles for roflumilast in biologic workflows. First, it serves as a therapeutic bridge while patients await biologic approval or navigate insurance delays. Second, for patients hesitant to initiate systemic therapy, it provides a non-steroidal, well-tolerated alternative that can manage symptoms while allowing time for decision-making. Finally, among patients already receiving biologics, tapinarof functions as a reliable adjunct for addressing breakthrough lesions—what she refers to as “touch-up paint”—helping maintain clearance and potentially delaying or avoiding unnecessary treatment switches.

She highlights the importance of minimizing disruptions in effective biologic regimens and notes that roflumilast can be safely used in combination with systemic agents, with no FDA contraindications. This flexibility allows for seamless integration into existing care plans while reducing the administrative burden on biologic coordinators and preserving therapeutic continuity.

In this video, the fifth in a 6-part series, panelists discuss recent advancements in PsO management.

 RX Review Special Report, Mona Shahriari, MD, Associate Clinical Professor of Dermatology at Yale University, sits down with David Hartigan, a biologic coordinator with Biologic Coordinators of Dermatology, to discuss patient counseling strategies and the importance of empathy when introducing new therapies such as topical roflumilast. 

In this clip, Hartigan highlights the unique role biologic coordinators play in patient education, often fielding extended conversations that reinforce provider messaging and address individual concerns about new treatments.

The discussion centers on counseling patients who are hesitant to start roflumilast due to its recent approval or skepticism from past topical treatment failures. Hartigan emphasizes that trust-building, concise communication, and reinforcing key differentiators, such as roflumilast's non-steroidal profile and favorable tolerability, are critical for improving patient acceptance and adherence. He notes that patients often ask whether the product will be effective after previous disappointments and express concerns over out-of-pocket costs.

Hartigan and Shahriari underscore that consistent messaging across the care team and validating the patient experience through empathy are essential. By acknowledging patient frustrations, reaffirming shared goals, and providing practical context around therapeutic decisions, coordinators can help ensure smoother transitions to new treatments and support long-term disease management in chronic plaque PsO.

In this video, the fourth in a 6-part series, panelists discuss recent advancements in PsO management.

In this video, the third in a 6-part series, panelists discuss recent advancements in PsO management.

In this video, the second in a 6-part series, panelists discuss recent advancements in PsO management.

In this video, the first in a 6-part series, panelists discuss recent advancements in PsO management.

Discover cutting-edge insights on schizophrenia, mood disorders, and digital therapeutics at the 2025 Southern California Psychiatry Conference.

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Muscarinic Agonists, Mood Disorders, and More: Highlights from So Cal Psych 2025

Majcher discusses innovations in ocular imaging and the importance of educating patients on early warning signs of myopia to halt disease progression.

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The Need for Earlier and More Effective Myopia Management with Carolyn Majcher, OD

Thomas discusses emerging therapies, new technologies, and the reform needed to help these new developments reach the patients in need of them.

Optometry’s Future and the Need for Change, with Randall Thomas, OD, MPH

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.

Study findings highlight the cost-effectiveness of more frequent HCV testing among people who inject drugs compared with no testing and less frequent testing.

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Frequent HCV Testing Cost-Effective Among PWID, Analysis Suggests

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

Discover how recent advancements in biologic therapies transform severe asthma treatment, emphasizing personalized care and the importance of biomarker-driven decisions.

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Biomarkers, Biologics, and Beyond: Managing Severe Asthma in the Real World

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

The FDA also announced an updated PDUFA date of December 13, 2025 for the self-administered nasal spray.

FDA News

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FDA Accepts Response to CRL for Etripamil (Cardamyst) for Treating PSVT

Capricor Therapeutics intends to resubmit a BLA for the potential first-in-class treatment with topline data from the ongoing HOPE-3 trial in Q3 2025.

Latest News

Psoriasis Flare Associated with Withdrawal from Biologics Prior to Pregnancy

The HCPFive: Top News for Healthcare Providers from the Week of 07/06

Advocating for Patients With Psoriasis: Securing Access to Nonsteroidal Topicals Like Roflumilast

Bridging and Enhancing Biologic Response With Targeted Topicals for Scalp Psoriasis

Counseling Patients With Psoriasis on Roflumilast and Nonsteroidal Topicals