Celltrion has announced the US Food and Drug Administration (FDA) approval of expanded indications for adalimumab-aaty (Yuflyma) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients ≥ 12 years of age and uveitis (UV) in pediatric patients ≥ 2 years of age.

"Adolescent HS and pediatric UV are chronic inflammatory conditions that can have serious sequelae and place a significant burden on patients, their families, and caregivers. It impacts patients physically and also emotionally and socially," Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, said in a statement.

 "With this label expansion, [adalimumab] is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians."

Adalimumab-aaty is a high-concentration, low-volume and citrate-free adalimumab biosimilar approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, HS, and UV. Of note, the latest approval expands the indications for HS and UV to include pediatric and adolescent populations.

The recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector. First introduced in the US market in July 2023, its April 2025 interchangeable designation was supported by data from the phase 3 interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab continuously and those who alternated between reference adalimumab and adalimumab-aaty during the dosing interval of week 25-27.

On May 23, 2025, the FDA granted an expanded interchangeable designation for adalimumab-aaty to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations, making it fully interchangeable with the reference product, adalimumab (Humira), across all marketed dosage forms and strengths. Currently, adalimumab-aaty is available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution for injection in autoinjectors.

As described in the release from Celltrion, the Company offers adalimumab-aaty in both branded and unbranded versions, with 2 pricing options to meet differing patient needs and improve patient affordability.

"The expansion of pediatric indications for [adalimumab-aaty] highlights our commitment to addressing unmet needs in both adult and pediatric immune-mediated diseases," Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, said in a statement.

 "The approval of pediatric indications for [adalimumab-aaty] and unbranded adalimumab-aaty strengthens our growing immunology portfolio and supports broader patient access to high-quality, affordable treatments."

Celltrion. FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States. October 17, 2025. Accessed October 17, 2025. 

https://www.celltrion.com/en-us/company/media-center/press-release/4207

Celltrion. U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab). April 14, 2025. Accessed October 17, 2025. 

https://www.celltrion.com/en-us/company/media-center/press-release/3894?page=1&searchWord=adalimumab-aaty&selectType=

Celltrion. Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths. May 23, 2025. Accessed October 17, 2025. 

https://www.celltrion.com/en-us/company/media-center/press-release/3981?page=1&searchWord=adalimumab-aaty&selectType=

Articles

Celltrion has received FDA approval for expanded indications of adalimumab-aaty (Yuflyma) and its unbranded version, now including treatment for hidradenitis suppurativa in adolescents and uveitis in pediatric patients. This high-concentration, low-volume, citrate-free biosimilar is now fully interchangeable with Humira across all dosage forms. The approval is based on phase 3 study data demonstrating similar pharmacokinetics, efficacy, safety, and immunogenicity. Celltrion offers both branded and unbranded versions with two pricing options to enhance patient affordability and access.

The FDA approved expanded indications for adalimumab-aaty (Yuflyma) and its unbranded version to include the treatment of adolescent HS and pediatric UV.

FDA Approves Adalimumab-aaty (Yuflyma) Pediatric Indications in Hidradenitis Suppurativa, Uveitis

All biologic drugs are significantly more efficacious among children with 

 versus placebo, recent findings suggest, though ixekizumab ranked highest for complete skin clearance.

The systematic review and meta-analysis yielding such findings had been conducted to compare biologic treatments for pediatric patients with moderate-to-severe plaque psoriasis. Abdulmajeed Sulaiman Alharbi, from Imam Abdulrahman bin Faisal University’s College of Medicine in Saudi Arabia, led a team of investigators in authoring the analysis.

Alharbi et al noted that while there had previously been a network meta-analysis conducted to establish the optimal biologic agent for psoriasis, only a limited number of trials had been used in this study and had implemented interim data exclusively.2

“We believe it is necessary to overcome the limitations to provide more robust findings; hence, we aim to conduct a network meta-analysis utilizing newly published definitive findings from older trials and findings from newer trials exploring a broader range of interventions,” Alharbi and coauthors wrote.

Review and Meta-Analysis Design and Findings

The investigative team implemented Embase, PubMed, and the Cochrane CENTRAL databases for their comprehensive search of all records available up to May 2024, without imposing language restrictions. The team's meta-analysis included data if research met the following criteria for evaluation: (1) randomized controlled trials (RCTs); (2) exclusive enrollment of pediatric subjects <18 years old; (3) investigated moderate-to-severe plaque psoriasis; (4) assessed biologic treatments; and (5) reported at least a single example of the investigators' pre-specified primary outcomes.

RCTs that met Alharbi and colleagues' criteria were identified from the aforementioned databases. Then, the investigators would perform a fixed-effects frequentist network meta-analysis (NMA). They would then calculate the surface under the cumulative ranking curve (SUCRA) as well as mean treatment rankings. 

The primary endpoints used in this review were the proportions of individuals attaining ≥75%, ≥90%, and 100% improvement in their Psoriasis Area and Severity Index scores (PASI75, PASI90, PASI100), as well as a Children’s Dermatology Life Quality Index (CDLQI) score of 0 or 1 (CDLQI 0/1) at the 12–16-week marks. The team also looked at safety outcomes for the 12–20-week period. They would then calculate absolute risk differences per 1000 patients compared to placebo, with 95% confidence intervals (CIs) to present point estimates of response to biologics.

Ultimately, Alharbi et al included 7 RCTs encompassing 1016 pediatric patients with psoriasis in this review. They concluded that all biologics showed significantly higher PASI75 and PASI90 response rates compared to those of placebo. According to participants' SUCRA rankings, ixekizumab was shown to have the highest likelihood of patient attainment of PASI100 (SUCRA: 0.9; Mean Rank: 1.8).

They also found high-dose secukinumab ranked best for PASI90 responses among participants (SUCRA: 0.8; Mean Rank: 3.0). For both PASI75 (SUCRA: 0.9; Mean Rank: 2.2) and CDLQI 0/1 (SUCRA: 0.8; Mean Rank: 2.2) outcomes, the most favorable performance was standard-dose ustekinumab. All available biologics were consequently shown to be significantly more effective than placebo.

Despite this conclusion, the investigators did not identify statistically significant differences among the biologics themselves in treating moderate-to-severe pediatric plaque psoriasis. They did highlight that the review's results underscore the necessity for larger, adequately powered clinical research to further clarify the optimal biologic therapy for this patient population.

“Our research explored an understudied area and provided new insights, but regardless, it was subject to certain limitations,” the investigative team wrote.

 “There was a scarcity of studies, with even fewer direct comparisons of the pertinent interventions. This limited our ability to perform a more exhaustive analysis and impacted the robustness of our results.”

Aljalfan AA, Alharbi AS, Alamrie R, et al. Biologics for treatment of paediatric plaque psoriasis: A systematic review and network meta-analysis. J Eur Acad Dermatol Venereol. 2025; 00: 1–13. 

Huang IH, Yu CL, Chi CC, et al. Biologics for pediatric moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis. J Dtsch Dermatol Ges J Ger Soc Dermatol. 2022; 20(9): 1201–1209.

A recent systematic review and meta-analysis evaluated the efficacy of biologic treatments for pediatric patients with moderate-to-severe plaque psoriasis. The study, led by Abdulmajeed Sulaiman Alharbi, included seven randomized controlled trials with 1016 pediatric patients. Findings indicated that all biologics were significantly more effective than placebo, with ixekizumab ranking highest for complete skin clearance (PASI100). High-dose secukinumab and standard-dose ustekinumab also showed favorable outcomes. Despite these findings, no statistically significant differences were observed among the biologics, highlighting the need for larger, more comprehensive studies.

This systematic review and meta-analysis of available randomized controlled trials compared biologics for psoriasis, such as ixekizumab, secukinumab, and ustekinumab.

Biologics Compared in Systematic Review for Moderate-to-Severe Pediatric Psoriasis

A new study suggests that adding omalizumab may help patients who experience 

“A semi-rush protocol with omalizumab loading 1 to 2 weeks prior was well tolerated,” wrote study investigator Kris Capper, MD, from Fiona Stanley Hospital in Western Australia, and colleagues.

Venom immunotherapy remains the only disease-modifying treatment for honeybee venom allergy. However, some patients develop severe allergic reactions during therapy, leaving them vulnerable to both the venom allergy and its treatment. Investigators hypothesized that omalizumab, an anti-IgE monoclonal antibody, could improve venom immunotherapy tolerance.

To test this, they conducted a retrospective chart review to assess the efficacy of adjunct omalizumab in honeybee venom immunotherapy and to identify predictors of requiring omalizumab.

 The sample included 354 adults undergoing honeybee venom immunotherapy at Fiona Stanley Hospital from 2015 to 2024.

Among the sample, 57 (16%) experienced severe adverse events, and 36 (10%) received omalizumab. Predictors for omalizumab use included severe sting anaphylaxis, asthma, and elevated basal tryptase. Although most patients received omalizumab to manage venom immunotherapy-related adverse events, 1 patient used it to increase venom therapy dosing after reaching maintenance.

Among the 35 patients who took omalizumab while increasing their venom immunotherapy dose, 22 (63%) were able to continue treatment without needing omalizumab, 7 (20%) had to stop because of severe allergic reactions, and 5 (14%) remained on omalizumab. Excluding the 5 patients who chose not to or couldn’t continue omalizumab, the success rate had increased up to 73%.

The most common protocol used a 12-week venom immunotherapy dose increase up to 100 μg, with patients starting omalizumab (300 mg) 2 weeks before and then receiving 150 mg every 2 weeks until they reached maintenance. Most severe allergic reactions happened after stopping omalizumab. In 3 cases, these reactions were managed by restarting omalizumab and aiming for a higher maintenance venom immunotherapy dose.

Adverse events are not uncommon in venom immunotherapy. A 2015 meta-analysis of 4844 patients across 46 studies reported that 28.7% experienced adverse reactions, including systemic reactions in 14%.

Managing such cases can be challenging. In 2021, a clinician sought guidance through the American Academy of Allergy, Asthma & Immunology’s “Ask the Expert” after a 68-year-old patient developed throat tightness and voice changes during venom immunotherapy.

 Responding expert Dennis K. Ledford, MD, FAAAI, a professor of allergy and immunology at the University of South Florida, advised increasing pre-treatment with high-dose H1 antihistamines and staggering different venoms (e.g., wasp on one day, mixed vespid on another). Ledford recommended considering omalizumab only if reactions persisted, given its cost, coverage limitations, and potential difficulty discontinuing the drug mid-therapy.

“The omalizumab is of potential value, but I have no recommendation on securing approval other than submitting the reference below and the practice parameter describing the benefit of omalizumab and venom immunotherapy for the treatment of a potentially life-threatening condition,” Ledford wrote.

However, these new findings reinforce that omalizumab may serve as a valuable adjunctive therapy in patients who otherwise cannot tolerate venom immunotherapy, offering a path forward for continuing life-saving desensitization.

Capper K, McGettigan B, Willis C, Stevenson B. Omalizumab enables bee venom desensitisation in patients with anaphylactic reactions to venom immunotherapy. 

. Published online October 8, 2025. doi:10.1016/j.jaip.2025.09.038

Smith A. Dangers of Bee Venom Therapy. Hcplive.com. Published July 2015. Accessed October 16, 2025. https://www.hcplive.com/view/dangers-of-bee-venom-therapy

Anaphylaxis to venom immunotherapy. Aaaai.org. Published 2021. Accessed October 16, 2025. https://www.aaaai.org/allergist-resources/ask-the-expert/answers/2021/venom-immuno

A recent study indicates that omalizumab, an anti-IgE monoclonal antibody, may enhance tolerance in patients undergoing venom immunotherapy for honeybee venom allergies. The study involved a retrospective chart review of 354 adults, revealing that 16% experienced severe adverse events, with 10% receiving omalizumab. Predictors for omalizumab use included severe sting anaphylaxis, asthma, and elevated basal tryptase. The findings suggest omalizumab as a valuable adjunctive therapy, particularly for patients unable to tolerate venom immunotherapy, despite its cost and potential discontinuation challenges.

A new study found that adjunct omalizumab helped most patients safely continue honeybee venom immunotherapy after prior severe allergic reactions.

Omalizumab May Improve Tolerance to Venom Immunotherapy

HELIOS-B: Open-Label Extension Proves Vutrisiran’s Long-Term Efficacy, With Ronald Witteles, MD

Vutrisiran has demonstrated significant clinical benefit in patients with 

transthyretin amyloidosis with cardiomyopathy (ATTR-CM)

 compared to placebo, based on 12-month data from an open-label extension of the HELIOS-B trial presented at the 

Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025

ATTR-CM is a progressive and frequently fatal disease, characterized by deposition of misfolded transthyretin protein in the heart. Vutrisiran inhibits hepatic transthyretin production, leading to rapid knockdown of the pathogenic protein. In the HELIOS-B trial, the subcutaneously administered RNA interface therapy was shown to lower the risk of the primary composite endpoint of all-cause mortality (ACM) and recurrent cardiovascular (CV) events compared to placebo.

 sat down with Ronald Witteles, MD, co-director of the Stanford Amyloid Center and the Stanford Multidisciplinary Sarcoidosis Program at the Stanford University School of Medicine, to discuss the study and his thoughts on vutrisiran fitting into the broader ATTR-CM treatment landscape.

“We wanted to look at people who had followed for up to 12 months of open-label extension data,” Witteles told 

. “The takeaway from all of that was that vutrisiran works, it works well, and the longer that patients are on it, you will have further separation of the curves. We can also see that patients who started on placebo and then switched to the open-label extension clearly had disease progression by several markers: quality of life, cardiac biomarkers, et cetera.”

HELIOS-B was a phase 3 interventional global trial, during which 655 patients were tested across 79 locations. The trial comprised a 33-36-month double-blind period, followed by a 2-year open-label extension. Investigators included 2 arms receiving vutrisiran; the first had been taking tafamidis on baseline, and the second had not. The latter was measured separately as the monotherapy population.

To be included, patients were required to have a documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis. Additionally, patients were required to exhibit a medical history of 

 with ≥1 before hospitalization for heart failure or clinical evidence of heart failure.

Patients were excluded from the study if they had known primary amyloidosis or leptomeningeal amyloidosis, if they had New York Heart Association Class IV heart failure or Class III heart failure and were at risk based on prespecified criteria, or had a polyneuropathy disability, among other conditions.

Primary outcomes included a composite endpoint of ACM and recurrent CV events, as well as hospitalizations and urgent heart failure visits. Secondary outcomes included change from baseline in 6-minute walk test and change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary, among others.

Patients receiving vutrisiran in the first phase of HELIOS-3 exhibited reduced risk of the primary composite endpoint in both the overall population and the monotherapy population. Patients who completed this period were eligible to enter the extension, which saw all patients receive vutrisiran 25mg Q3M. During this study, Witteles and colleagues measured mortality and CV events to determine the long-term efficacy of the drug.

Ultimately, the 466 patients in the extension study exhibited sustained improvement across key measures of disease progression through the first 12 months of the study. The long-term safety and tolerability profile was also consistent with vutrisiran’s established profile.

“If you look at the subjects who started and ended on vutrisiran, their average troponin level was a little lower all the way out at 48 months than it was at baseline. So that tells us something as well,” Witteles said. “The big take-home message is that you don’t want to wait to start therapy. That is lost functional status, it’s lost progression of disease.”

Editor's Note: Witteles reports disclosures with Alexion, Alnylam, AstraZeneca, BridgeBio, Novo Nordisk, and Pfizer.

Garcia-Pavia P, Witteles R, Morbach C, et al. HELIOS-B: 12-Month Results From the Open-Label Extension Period of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy. Presented at the Heart Failure Society of America Annual Scientific Meeting 2025. Minneapolis, MN. September 26-29, 2025.

Alnylam Pharmaceuticals. HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy. ClinicalTrials.gov identifier: NCT04153149. Updated May 13, 2025. Accessed October 16, 2025. 

https://clinicaltrials.gov/study/NCT04153149

Alnylam Pharmaceuticals. New Data from Landmark HELIOS-B Phase 3 Study Presented at ESC Congress 2025 Demonstrate Vutrisiran’s Long-Term Cardiovascular Benefit in ATTR-CM. August 31, 2025. Accessed October 16, 2025. 

https://investors.alnylam.com/press-release?id=29256

Videos

Witteles highlights the uniform improvement after the tafamidis and vutrisiran arms were both moved to the same vutrisiran dose.

Credit: Amsterdam University Medical Center

Telitacicept has demonstrated markedly higher response rates compared to placebo in addition to standard therapy for people with 

 in a phase 3 trial, although accordingly higher rates of adverse events (AEs) were also observed.

“These data support the central role of B-cells in the pathobiology of lupus. By targeting both BAFF and APRIL, it was possible to achieve excellent clinical results that suggest the effective restoration of immune balance in at least some of the patients. With this mechanism of action, telitacicept could significantly reduce the burden of lupus,” Ronald van Vollenhoven, MD, PhD, Professor of Rheumatology at Amsterdam University Medical Center, said in a statement.

 “This approach could represent an important new addition to the therapeutic landscape for lupus.”

The new findings are from a phase 3 trial conducted in China, results of which were published in 

be held in Chicago, Illinois, on October 25 to 29. In the trial, participants with active SLE were randomly assigned 1:1 to receive telitacicept (160 mg) or placebo subcutaneously once weekly for 52 weeks, in addition to standard therapy. The trial primarily evaluated response on the modified SLE Responder Index 4 (SRI-4) at week 52. Response on the composite endpoint is defined as reduction of at least 4 points in the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, no new disease activity as measured on the British Isles Lupus Assessment Group index, and no worsening in the Physician’s Global Assessment score.

The trial screen 433 adults, 335 of which underwent randomization to telitacicept (n = 167) or placebo (n = 168). Investigators found that at week 52, significantly more participants receiving telitacicept (67.1%) had a modified SRI-4 response than those receiving placebo (32.7%; adjusted difference, 34.5%; 95% CI, 24.3-44.7; 

<.001). Furthermore, 70.1% of the telitacicept group compared to 40.5% of the placebo group achieved a reduction of at least 4 points from baseline in the SELENA-SLEDAI score (difference, 29.6%; 95% CI, 13.1-46.1).

Investigators did observe significant differences in the safety profiles between the placebo and telitacicept groups. The telitacicept group had a higher incidence (74.9%) of AEs considered related to treatment then placebo (50%), including upper respiratory tract infections (31.7% vs. 19.0%), a reduced serum IgG level (15.6% vs. 1.2%), reduced serum IgM levels (15.0% vs. 0.6%), and injection-site reactions (12.6% vs. 0.6%).

“We are humbled by what these results represent for patients and the scientific community, and by the recognition that comes with their publication in The New England Journal of Medicine, which underscores the global acceptance of the quality and rigor of clinical research emerging from China. For the first time, a therapy in a Phase 3 trial is delivering more than double the clinical response seen with the current standard of care in lupus. These data present a compelling case for potentially broadening telitacicept’s use as a new standard of care worldwide,” Jean-Paul Kress, MD, Chief Executive Officer and Chairman of Vor Bio, added.

 “Lupus has challenged researchers and clinicians for decades. To see a dual BAFF/APRIL approach deliver this level of efficacy, durability, and consistency across multiple indications, while maintaining a favorable safety profile, affirms our belief that telitacicept has the potential to redefine how autoimmune diseases are treated.”

Vor Bio has also announced that findings from another phase 3 trial of telitacicept conducted in China, in people with primary Sjögren disease, will be presented at the upcoming American College of Rheumatology meeting in a late-breaking abstract. The meeting will be held in Chicago, Illinois, from October 25-29.

van Vollenhoven RF, Wang L, Merrill JT, et al. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. 

. 2025;393(15):1475-1485. doi:10.1056/NEJMoa2414719

Vor Bio Announces Publication of China Phase 3 Study of Telitacicept in Systemic Lupus Erythematosus in The New England Journal of Medicine. News release. Vor Biopharma. October 16, 2025. 

https://www.globenewswire.com/news-release/2025/10/16/3167846/0/en/Vor-Bio-Announces-Publication-of-China-Phase-3-Study-of-Telitacicept-in-Systemic-Lupus-Erythematosus-in-The-New-England-Journal-of-Medicine.html

Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025. News release. Vor Biopharma. October 14, 2025. https://www.globenewswire.com/news-release/2025/10/14/3166097/0/en/Telitacicept-Demonstrates-Clinically-Meaningful-and-Statistically-Significant-Impact-on-ESSDAI-Compared-to-Placebo-in-Late-Breaking-China-Phase-3-Results-in-Primary-Sj%C3%B6gren-s-Disea.html

Telitacicept has shown significantly higher response rates than placebo in a phase 3 trial for systemic lupus erythematosus (SLE), although it also resulted in increased adverse events. The trial, conducted in China, demonstrated telitacicept's efficacy in reducing disease activity and improving clinical outcomes by targeting BAFF and APRIL. Despite the higher incidence of adverse events, the results suggest telitacicept could become a new standard of care for lupus. Further research is ongoing, including trials for primary Sjögren's disease.

However, a notable higher rate of treatment-related adverse events warrants caution.

Telitacicept Significantly Improves Lupus Response Rates Above SOC Alone 

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Skin of Color Savvy: The Science of Curly Hair, With Crystal Aguh, MD, and Loren Krueger, MD

, dermatologists Crystal Aguh, MD, and Loren Krueger, MD, explored the biological, cultural, and clinical considerations behind curly and coily hair patterns. This podcast by 

, features a discussion underscoring the ways in which textured hair care represents a critical—and often overlooked—component of dermatologic expertise.

Curly hair is inherently more fragile than straight hair, with structural features that make it prone to dryness, breakage, and inflammation-related disease. According to Aguh, this fragility parallels the challenges of dry skin: without proper moisture retention and care, minor issues can progress into medical disease. For dermatologists, understanding textured hair is therefore not elective—it is essential to preventing conditions such as traction alopecia, acquired trichorrhexis nodosa, and central centrifugal cicatricial alopecia (CCCA).

Krueger emphasized that nearly every form of alopecia—from androgenetic to autoimmune variants—can present in patients with curly hair, but diagnostic precision requires recognizing when styling practices contribute to disease. She noted that effective management involves more than identifying pathology; it requires guiding patients toward healthier styling behaviors while respecting their cultural identities and lifestyle constraints.

For clinicians unfamiliar with curly hair care, Aguh recommended starting with the basics—what she calls a “soak and smear” method for the hair, analogous to the technique used for eczema management. Patients should be advised to cleanse weekly with a non-drying shampoo, condition regularly, and seal in moisture with a leave-in product, oil, or emollient. These steps help reinforce the hair cuticle and prevent cumulative damage that predisposes to breakage.

The conversation also addressed styling practices frequently described as “protective,” such as braids, twists, and sew-in weaves. Both dermatologists noted that these should instead be viewed as “styles of convenience”—useful in moderation but potentially harmful if worn too tightly or for extended periods. Appropriate guidance includes limiting braided styles to six to eight weeks, avoiding back-to-back installations, and recognizing that tightness and scalp pain are early indicators of follicular injury.

Age-related hair fragility and chemical exposure further complicate outcomes. Patients accustomed to long-standing styling routines often underestimate how aging, coloring, or relaxing can weaken the hair over time. Dermatologists must therefore distinguish between true hair loss and breakage-related thinning to prevent unnecessary laboratory testing or scalp biopsies.

Ultimately, the “science of curls” reflects the intersection of biology, identity, and daily care. By integrating practical knowledge of hair texture into routine dermatologic evaluation, clinicians can enhance outcomes, foster trust, and deliver more culturally responsive care for all patients.

To learn more about SOCS’s mentorship programs and initiatives, visit 

This October 16 Skin of Color Savvy highlights the often overlooked topic of curly hair in dermatology.

A recent study showed that magnetic seizure therapy offered comparable efficacy to modified electroconvulsive therapy (ECT) with superior cognitive protection and safety in adolescents with 

“While [ECT] outperformed [magnetic seizure therapy] in BDI-II reduction…reflecting its rapid antidepressant action, [magnetic seizure therapy’s] superiority in cognitive preservation – evidenced by [Montreal Cognitive Assessment] total score improvement…and specific gains in memory, orientation, and executive function – highlights its potential to safeguard neurodevelopment in this vulnerable group,” wrote investigator Wei Wang, from Shandong Mental Health Center, and colleagues.

ECT is an effective, often lifesaving treatment for MDD but can cause cognitive side effects like memory impairment, which may be especially harmful to adolescents. Conversely, magnetic seizure therapy uses high-frequency magnetic stimulation to induce seizures while sparing deeper brain structures, like the hippocampus, potentially reducing cognitive effects. Early studies suggest magnetic seizure therapy provides similar efficacy to ECT with less cognitive impact, though adolescent data remain limited.

Investigators conducted a prospective, assessor-blinded randomized controlled trial between March 1 and April 30, 2025, at Shandong Mental Health Center to compare magnetic seizure therapy with modified ECT for adolescent MDD in terms of cognitive protection and suicidality improvement.

The primary outcome was the Beck Depression Inventory-II (BDI-II) percentage reduction, and secondary outcomes included Montreal Cognitive Assessment scores (total score and subdomains of visuospatial/executive function, naming, attention, language, abstraction, memory, orientation), Columbia-Suicide Severity Rating Scale, and adverse events per CTCAE 5.0, and reorientation time. Investigators assessed these outcomes at baseline and 7 days post-treatment.

The sample included 120 adolescents aged 13 – 18 years with treatment-resistant MDD (baseline BDI-II ≥ 29). The study excluded participants with comorbid bipolar disorder or schizophrenia, intracranial metal implants, epilepsy, severe physical illness, or prior exposure to either therapy.

Investigators randomized participants 1:1 to receive magnetic seizure therapy (n = 60; mean age, 15.15 years; 78.33% females) or modified ECT (n = 60; mean age, 15.20 years; 80% females) for 12 – 16 sessions, 3 times weekly. Magnetic seizure therapy used the NS7000 device with stimulation at the Cz position, 100 Hz frequency, 100% intensity, and 8 – 10 seconds per second. Meanwhile, the modified ECT used the Thymatron System IV, with bilateral stimulation dosed according to age. Participants received anesthesia (propofol 1.5 – 20 mg and succinylcholine 0.5 mg/kg) and continued SSRIs without benzodiazepines or mood stabilizers.

Modified ECT led to greater BDI-II reductions (51.8% vs 46.5%; 

<.001), with similar response rates between treatments (90.0% vs 91.1%; 

 =.081). However, magnetic seizure therapy showed significant improvements in the total cognitive score (difference, 1.32; 95% confidence interval [CI], 0.92 – 1.70; 

 <0.001), especially in memory (difference, 1.20; 95% CI, 0.99 – 1.41; 

<.001), orientation (difference, 0.66; 95% CI, 0.45 – 0.87; 

 <.001), and executive function subdomains (difference, 0.50; 95% CI, 0.35 – 0.65; 

 <.001). The study reported lower subjective cognitive complaints in the magnetic seizure therapy arm (20% vs 62%; 

Magnetic seizure therapy also improved suicidality outcomes more effectively (4.91±0.29 to 0.78±0.90 vs. 4.98±0.14 to 1.12±0.69; 

 =.036), with a greater remission rate (33.3% vs. 16.0%; 

 =.044). The study found no significant group difference regarding severity scores (

Investigators observed a stronger correlation between Montreal Cognitive Assessment change and suicidality improvement in magnetic seizure therapy (95% CI, 0.48 – 0.74, 

 =.008). The mediation analysis demonstrated a partial mediating role of Montreal Cognitive Assessment improvement in magnetic seizure therapy (95% CI, 0.10 - 0.54;

Safety findings favored magnetic seizure therapy, with fewer adverse events (28.9% vs 64.0%; 

 <.001) and shorter reorientation time (6.9±1.8 vs 18.7±6.8 minutes; 

 <.001). Adverse events included short-term memory loss (20.0% vs. 62.0%; 

“[Magnetic seizure therapy] offers a balanced treatment for adolescent MDD, matching [modified ECT’s] antidepressant efficacy while excelling in cognitive protection and suicidality reduction,” investigators concluded.

 “The mediating role of cognitive improvement suggests a novel mechanism, positioning [magnetic seizure therapy] as a promising option for preserving neurodevelopment and mitigating suicide risk. Long-term, multicenter trials are needed to optimize its clinical application.”

Wang W, Lu Y, Mi GL, Li XJ, Zhang DN, Qi SF. Cognitive preservation advantage and efficacy balance of magnetic seizure therapy in adolescent Major Depressive Disorder: a randomized controlled trial revealing efficacy cognition decoupling phenomenon. 

. 2025;60(5):196-201. doi:10.1708/4583.45901

Chen S, Sheng J, Yang F, et al. Magnetic Seizure Therapy vs Modified Electroconvulsive Therapy in Patients With Bipolar Mania: A Randomized Clinical Trial. 

. 2024;7(4):e247919. Published 2024 Apr 1. doi:10.1001/jamanetworkopen.2024.7919

Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. 

. 2024;81(3):240-249. doi:10.1001/jamapsychiatry.2023.4599

A study compared magnetic seizure therapy to modified electroconvulsive therapy (ECT) in adolescents with major depressive disorder (MDD), finding similar efficacy but superior cognitive protection with magnetic seizure therapy. While ECT showed greater reduction in depression scores, magnetic seizure therapy excelled in cognitive preservation, particularly in memory, orientation, and executive function. It also demonstrated better outcomes in suicidality reduction and fewer adverse events. The study suggests magnetic seizure therapy as a promising treatment for adolescent MDD, emphasizing the need for further long-term, multicenter trials to optimize its clinical application.

A study found magnetic seizure therapy matched ECT’s antidepressant efficacy while offering better cognitive preservation and fewer adverse events.

Magnetic Seizure Therapy Rivals ECT, Protects Cognition in Adolescent MDD

FDA Clears Santreva-ATK for Patients with Peripheral Artery Disease With Subhash Banerjee, MD

On September 29, 2025, parent company AngioSafe revealed multiple clinical milestones achieved by its Santreva-ATK Endovascular Revascularization Catheter, including 510(k) clearance from the 

Santreva-ATK is the first wire-free, external power-free, intraplaque chronic total occlusion (CTO) crossing and 1-step vessel preparation platform for femoropopliteal arteries. The device is intended for use in patients with 

 exhibiting CTOs, which are encountered up to 50% of the time in patients with symptomatic PAD. These lesions are a leading cause of failed interventions, prolonged procedure times, and adverse events. Current tools for managing CTOs are limited, leaving clinicians with relatively few methods of treatment.

These approvals are a product of positive results from the RESTOR-1 clinical trial, which investigated the device’s efficacy in treating patients with CTOs in PAD. Santreva-ATK successfully crossed CTOs in 90% of participants, compressing plaque and recanalizing CTOs to prepare vessels for further imaging and final treatment.

 sat down with lead investigator Subhash Banerjee, MD, an interventional cardiologist with Baylor Scott & White, to discuss the implications of this new technology and how it will relieve the burden of this underserved patient population.

“In this study, which is very unique to any study done before in the CTO space in PAD, we were not only studying whether we crossed the blockage successfully, but also how we crossed,” Banerjee told 

. “Did we cross through the center of the plaque or the body of the blockage? In doing so, did we damage or tear the walls of the blood vessel that we are crossing?”

RESTOR-1 was a prospective, multi-center, pivotal study conducted across 14 sites in the US. For inclusion, patients had to be ≥22 years of age, have PAD of category 2-5 as defined by Rutherford Clinical Classification, and have PAD in the target extremity confirmed via imaging and/or magnetic resonance angiography (MRA). Patients were excluded if they exhibited systemic infection or an infection in the same extremity as the target lesion, if the lesion was within a native vein, synthetic vessel grafts, or stent occlusion, or if the patient had plans for an intervention in the contralateral limb or target limb during the study, among other conditions.

A total of 133 patients were ultimately enrolled in the trial; each participant was treated with Santreva-ATK, which facilitated the intraluminal placement of guidewires beyond CTOs in the peripheral vasculature. Outcome measures included the ability of the catheter to place the guidewire in the absence of device-related major adverse events through discharge or 24 hours post-operation, whichever came first.

Investigators found a mean CTO crossing time of 25 minutes between all patients, with a median of 9 minutes. The trial exhibited a 90% success rate with a mean Lumen gain of >55%. Investigators recorded no device-related MAEs or embolization, as well as no major perforations, flow-limiting dissections, or bailout stents. Significant improvements in Rutherford Classification and pain scores were also recorded.

“The implications can be very profound,” Banerjee said. “The greatest contribution of this technology, in my view, would be to democratize peripheral CTO procedures. That means operators at various stages in their lives or careers can take on these procedures and help more patients because of a combination of higher success and, importantly, not causing any major serious complications in the patients.”

According to a press release from AngioSafe, Santreva-ATK is planned to launch in the US in October of 2025. Highlights from the RESTOR-1 results was presented at the Amputation Prevention Symposium Europe Congress on October 14, 2025.

Editor's Note: Banerjee reports disclosures with AngioSafe, Esperion, GE Healthcare, Kaneka, Teleflex, Ca

AngioSafe Unveils Atheroplasty Innovation Following DA 501(k) Clearance, CE Mark Approval, and First Real-World Procedures with Santreva-ATK Endovascular Revascularization Catheter. September 29, 2025. Accessed October 16, 2025. 

https://www.angiosafe.com/press-releases/angiosafe-unveils-atheroplasty-innovation-following-fda-510k-clearance-ce-mark-approval-and-first-real-world-procedures-with-santreva-atk-endovascular-revascularization-catheter/

AngioSafe, Inc. AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study) (RESTOR-1). ClinicalTrials.gov identifier: NCT04663867. Updated November 4, 2024. Accessed October 16, 2025. 

https://www.clinicaltrials.gov/study/NCT04663867

Santreva-ATK, the first wire-free endovascular revascularization catheter for crossing chronic total occlusions, is expected to begin sale in October 2025.

FDA Clears Santreva-ATK for Patients with Peripheral Artery Disease, With Subhash Banerjee, MD

Novartis has announced positive final results from the phase 3 APPLAUSE-IgAN study of iptacopan (Fabhalta) in adults with IgA nephropathy (IgAN).

As described in an October 16, 2025, press release from the Company, the oral alternative complement pathway inhibitor demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over 2 years. Of note, Novartis described plans to use these data to support regulatory submissions for iptacopan in 2026.

“Progressive diseases such as IgAN present an urgent need for interventions that can ultimately improve kidney health. Many people with IgAN commonly experience fear and anxiety of disease progression,” Ruchira Glaser, Development Unit Head, Cardiovascular, Renal & Metabolic, Novartis, said in a statement.

 “We are excited about today’s positive Phase III APPLAUSE-IgAN results showing slowed eGFR decline, which add to the growing evidence of Fabhalta as a targeted therapy to preserve long-term kidney function, giving hope to people living with this condition.”

Iptacopan received US Food and Drug Administration (FDA) approval in December 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), later receiving accelerated approval in August 2024 for the reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression. Most recently, in 2025, iptacopan received FDA approval for the treatment of adults with C3 glomerulopathy (C3G), making it the first treatment approved for this ultra-rare kidney disease.

The oral alternative complement pathway inhibitor is also being studied in atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis, and lupus nephritis, with ongoing studies evaluating the safety and efficacy profiles in these investigational indications to support potential regulatory submissions.

APPLAUSE-IgAN is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral iptacopan 200 mg in 477 adults with primary IgAN. Patients were randomly assigned to iptacopan or placebo, in addition to supportive care, defined as a stable dose of maximally-tolerated renin-angiotensin system inhibitor therapy with or without a stable dose of SGLT2i.

The primary endpoints of the study for the interim and final analysis, respectively, are proteinuria reduction at 9 months as measured by UPCR and the annualized total eGFR slope over 24 months. During the final analysis, the following secondary endpoints were assessed:

Proportion of participants reaching UPCR <1 g/g without receiving corticosteroids/immunosuppressants or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating kidney replacement therapy

Time from randomization to first occurrence of composite kidney failure endpoint event (reaching either sustained ≥30% decline in eGFR relative to baseline or sustained eGFR <15 mL/min/1.73 m2 or maintenance dialysis or receipt of kidney transplant or death from kidney failure)

Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire

The main study population enrolled patients with an eGFR ≥30 mL/min/1.73 m2 and UPCR ≥1 g/g at baseline. In addition, a smaller cohort of patients with severe renal impairment, defined as eGFR 20–30 mL/min/1.73 m2 at baseline, was also enrolled to provide additional information but not contributing to the main efficacy analyses.

As described by Novartis, in APPLAUSE-IgAN, iptacopan was well tolerated with a favorable safety profile in line with previously reported data. The Company plans to present data from the APPLAUSE-IgAN final analysis at future medical meetings.

Novartis. Novartis Fabhalta® (iptacopan) meets Phase III primary endpoint, slows kidney function decline in patients with IgA nephropathy (IgAN). October 16, 2025. Accessed October 16, 2025. 

https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-meets-phase-iii-primary-endpoint-slows-kidney-function-decline-patients-iga-nephropathy-igan

Campbell P. Iptacopan Receives Accelerated Approval for Reducing Proteinuria in IgA Nephropathy. HCPLive. August 8, 2024. Accessed October 16, 2025. 

https://www.hcplive.com/view/iptacopan-receives-accelerated-approval-for-reducing-proteinuria-in-iga-nephropathy

Campbell P. FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy. HCPLive. March 20, 2025. Accessed October 16, 2025. 

https://www.hcplive.com/view/fda-approves-oral-iptacopan-fabhalta-as-first-c3-glomerulopathy-therapy

Novartis has reported positive results from the phase 3 APPLAUSE-IgAN study, demonstrating that iptacopan significantly slows the progression of IgA nephropathy (IgAN) compared to placebo. The study's primary endpoint was the annualized total slope of eGFR decline over two years. Iptacopan, an oral alternative complement pathway inhibitor, has previously received FDA approvals for various conditions, including paroxysmal nocturnal hemoglobinuria and C3 glomerulopathy. The drug is also being investigated for other renal and autoimmune conditions, with ongoing studies assessing its safety and efficacy.

Final results from APPLAUSE-IgAN demonstrate iptacopan’s superiority versus placebo for slowing IgAN progression and will be used to support its full approval.

APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint

 experienced meaningful improvements in emotional well-being and daily functioning after 48 weeks of ritlecitinib 50 mg use, according to recent long-term data.

These findings were the result of the ALLEGRO-2b/3 analysis (NCT03732807), the results of which had previously shown that ritlecitinib treatment led to notable hair regrowth and other patient-reported improvements versus placebo.

 During the 24-week placebo-controlled trial phase, improvements in AA Patient Priority Outcomes (AAPPO) emotional symptoms (ES) or activity limitations (AL) were not noted.

In this analysis, authored by investigators such as Ernest H. Law, PharmD, PhD, from Pfizer, Inc., the investigators looked at AAPPO scores in patients from the aforementioned study given a 50-mg ritlecitinib maintenance dose (+/− 4-week loading dose of 200 mg) and those given subtherapeutic ritlecitinib 10 mg through the 48-week mark.

“This post hoc analysis of ALLEGRO-2b/3 data compares improvements in AAPPO ES and AL domain and item scores between the ritlecitinib 50-mg QD maintenance dose…and the subtherapeutic ritlecitinib 10-mg QD dose through Week 48,” Law and colleagues wrote.

The investigative team highlighted that within the ALLEGRO-2b/3 studies, a total of 718 eligible study participants were randomized to be treated with either a placebo or 1 of a possible 5 dosing regimens of ritlecitinib. This 48-week study was double-blinded consisted of an initial 24-week placebo-controlled period. This period was later followed by a 24-week extension, during which those taking part who were previously given a placebo transitioned to active ritlecitinib therapy.

In this exploratory analysis, an assessment of 3 ritlecitinib treatment cohorts was conducted. These arms were as follows: (a) study subjects given 50 mg once-per-day (QD) only; (b) subjects initiating with a 200 mg QD loading dose for a 4-week course followed by a 50 mg QD maintenance dose (200/50 mg); and (c) the pooled population of all study participants who were given any 50-mg dose, combining both a and b groups. The comparison group consisted of individuals who were given a subtherapeutic 10-mg QD dose.

The Alopecia Areata Patient Priority Outcomes (AAPPO) instrument, a validated 11-item self-administered questionnaire, was implemented by Law and coauthors to evaluate the effect of alopecia areata in individuals aged ≥12 years. Changes in least squares mean (LSM) from the point of baseline (CFBs) were calculated by the investigators for domain scores across the full analysis set as well as for those who showed baseline domain scores which were ≥1.

Law and colleagues looked at item-level shifts, analyzing them for participants with baseline item scores ≥2. This was carried out since lower baseline scores (on a 0–4 scale) would suggest less frequent or severe impacts related to hair-loss.

In this post-hoc analysis, 325 participants were included. There were 132 in the 200/50-mg cohort, 130 in the 50-mg cohort, and 63 in the 10-mg cohort. Across all of the 50-mg arms of this analysis, Law and coauthors found that LSM CFBs in the Emotional Symptoms (ES) and Activity Limitations (AL) domain scores generally improved through the 48-week mark. They noted statistically significant differences versus the 10-mg arm, observed starting at the 34-week mark for ES and the 40-week mark for AL.

Long-term data indicates that adults with alopecia areata experienced significant improvements in emotional well-being and daily functioning after 48 weeks of ritlecitinib 50 mg treatment. The ALLEGRO-2b/3 analysis compared the effects of a 50 mg maintenance dose to a subtherapeutic 10 mg dose, revealing notable enhancements in emotional symptoms and activity limitations. Statistically significant improvements were observed from week 34 for emotional symptoms and week 40 for activity limitations. The study suggests that extended follow-up may be necessary to fully capture psychosocial benefits.

These post hoc findings suggest psychosocial burden may improve following hair regrowth with ritlecitinib.


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