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Marie Bosslett is the assistant editor of 

 and joined the MJH Life Sciences team in October 2024. She attended Loyola University Maryland in Baltimore and earned a Bachelor of Arts in Communication with minors in marketing and writing. When she’s not writing, Marie enjoys going to concerts, reading on the beach, and spending time with friends and family.

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In case you missed it, this week we had news about the launch of deuruxolitinib for alopecia areata, Treg cel impairment in vitiligo, the top aesthetic innovations of this month, and more.

The Weekly Roundup: July 14-18

Maddi Hebebrand is an associate editor of 

and joined the MJH Life Sciences team in May 2024. She attended Baldwin Wallace University, studying Media Production and Film, and received her Masters in Digital Media from Ohio University. When she's not writing, Maddi loves to read, attend concerts and spend time with her family. 

This week, we feature top articles from our sister publications on regulatory updates, clinical trial insights, and more.

The Rx Recap: July 13-18

and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

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In this follow up to last month’s Innovations column on intellectual property and technology transfer, Raymond A. Miller, J.D., and Steve Xu, M.D., FAAD discuss how to utilize patents to maximize value for your venture.

How to use patents to maximize value for your venture

Final Thoughts: The Importance of Comparative Studies in AD

Panelists offer concluding insights and emphasize the critical role of comparative studies in advancing atopic dermatitis treatment strategies.

clinical

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Despite the chronicity and prevalence of vitiligo, therapeutic options for the condition remain limited in efficacy, accessibility, and patient adherence.

 A recent pilot study titled "Pilot Study of Tildrakizumab in the Treatment of Stable Non-Segmental Vitiligo," published in 

, explores the utility of IL-23 inhibition via tildrakizumab in managing stable nonsegmental vitiligo—a direction that aligns with the evolving landscape of immunomodulatory therapy.

Biologic agents targeting key immune pathways have revolutionized the treatment of several autoimmune dermatologic conditions. The rationale for investigating tildrakizumab, a humanized IgG1 monoclonal antibody targeting the p19 subunit of IL-23, stems from mounting evidence implicating the IL-23/Th17 axis in vitiligo pathogenesis. Elevated IL-23 serum levels have been documented in nonsegmental vitiligo, suggesting its potential role as a therapeutic target.

This investigator-initiated, open-label pilot study enrolled 12 adult patients with stable, treatment-resistant nonsegmental vitiligo. Patients received subcutaneous tildrakizumab 200 mg once monthly for 24 weeks. The primary outcomes were changes in the Vitiligo Area Scoring Index (VASI) and Vitiligo Extent Score (VES), both validated metrics to assess disease burden and repigmentation.

Eight patients completed the 24-week trial. The study found a nonsignificant mean improvement of 1.15% in VASI (95% CI, −13.77 to 16.10%; 

 = .87) and a 13.80% mean improvement in VES (95% CI, −34.99 to 30.85; 

 = .89). No patient achieved the commonly accepted clinical threshold of 50% VASI improvement. However, researchers noted that 8 patients did demonstrate improvements in VES, surpassing the minimal important change and smallest detectable change values suggested in prior studies.

Importantly, the researchers stated that the treatment was well tolerated, with no serious adverse events reported. The most common mild adverse effects included upper respiratory tract symptoms and injection site reactions. Three participants withdrew due to perceived lack of efficacy, and 1 was lost to follow-up.

Despite a lack of statistically significant repigmentation, this study offers several important insights. Firstly, it affirms the safety of tildrakizumab in this patient population. Secondly, it suggests a possible role for IL-23 blockade in maintaining disease stability, given that no participants progressed from stable to active disease. This observation aligns with hypotheses that IL-23 may influence chronic inflammation more than acute disease progression.

However, the study has notable limitations. The small sample size, single-arm open-label design, and reliance on self-reported stability reduce generalizability and introduce potential bias. Additionally, the exclusion of patients with active vitiligo and the prohibition of combination therapy (eg, phototherapy) may have limited the opportunity to detect a more pronounced therapeutic effect.

This pilot study underscores the need for continued research into the role of biologics in vitiligo, particularly IL-23 inhibitors. The study noted that future investigations should involve larger, randomized controlled trials, include both active and stable disease stages, and explore combination regimens with established treatments like phototherapy. Moreover, a longer follow-up period may be necessary to assess the durability of any observed effects and evaluate potential delayed repigmentation.

In conclusion, although tildrakizumab did not yield significant repigmentation in this small cohort with stable vitiligo, the results support further exploration of IL-23 as a therapeutic target. The path toward biologic treatment of vitiligo remains in its early stages—but each data point, including those that do not meet efficacy expectations, plays a vital role in informing the next steps.

Bergqvist C, Ezzedine K. Vitiligo: a review. 

. 2020;236(6):571-592. doi:10.1159/000506103

Lee H, Cowan TL, Huang C, et al. Pilot study of tildrakizumab in the treatment of stable non-segmental vitiligo. 

Tildrakizumab, an IL-23 inhibitor, was evaluated in a pilot study for its efficacy in treating stable non-segmental vitiligo. Despite the absence of significant repigmentation, the study confirmed the safety of tildrakizumab and suggested its potential role in maintaining disease stability. The study's limitations, including a small sample size and lack of a control group, highlight the need for further research. Future studies should consider larger, randomized trials, include both active and stable disease stages, and explore combination therapies to better assess the therapeutic potential of IL-23 inhibitors.

A pilot study evaluates tildrakizumab's safety and potential in treating stable nonsegmental vitiligo, highlighting the need for further research on IL-23 inhibitors.

IL-23 Inhibitor Fails to Improve VASI in Pilot Trial

Vitiligo remains one of the most psychologically burdensome dermatological conditions, particularly when affecting exposed anatomical regions such as the hands.

 This chronic autoimmune disease is marked by the selective destruction of melanocytes and is broadly classified into segmental vitiligo (SV) and nonsegmental vitiligo (NSV). NSV, the more prevalent subtype, often presents symmetrically, but the distribution of lesions in acral regions—including the hands and fingers—has remained poorly characterized.

A recent retrospective study sought to better define the clinical behavior of NSV lesions affecting the hands.

 Using photographic and medical records from 140 patients seen over a 10-year period at the University of Osaka Hospital, the study employed cluster analysis to classify lesion patterns and explore potential influencing factors, including dominant hand usage and smoking history. The study aimed to uncover whether acral lesions appear in predictable patterns, respond differently to treatment, or are impacted by environmental and lifestyle factors.

Distribution Patterns and Dominance-Associated Asymmetry

Consistent with existing literature, the study found that hand lesions in NSV demonstrate strong bilateral symmetry (R² = 0.9319), but the dominant hand—mostly the right hand in this cohort—tended to show more severe involvement. This finding aligns with the proposed role of the Koebner phenomenon, wherein mechanical stress from frequent hand use may trigger or exacerbate vitiligo lesions. The distal digits were particularly vulnerable, with significantly higher involvement than the proximal fingers or dorsal hands, suggesting anatomical and physiological susceptibility in these regions.

Using hierarchical clustering, hand lesions were categorized into 4 subtypes: focal/scattered (46.4%), distal digit (31.4%), universal (12.9%), and proximal digit (9.2%). The focal/scattered type was most common, especially in children, whereas the distal digit pattern—marked by periungual involvement—emerged as a distinct and diagnostically useful subtype. The universal subtype exhibited widespread dorsal hand involvement, poor treatment response, and frequent signs of disease activity. The proximal digit pattern, though least common, demonstrated unique characteristics with a higher frequency of dorsal hand involvement and earlier onset.

The study explored the role of smoking in lesion severity. Smokers exhibited significantly higher distal digit scores in a univariate analysis; however, after adjustment for confounders through multivariate ANCOVA and LASSO regression, smoking was not an independent predictor. Instead, disease duration emerged as the strongest predictor of lesion severity. Notably, stratified analyses showed a significant association between smoking and distal digit involvement in patients younger than 56 years, suggesting that age-related immune modulation may influence susceptibility.

Clinical Course and Treatment Implications

Follow-up data from 86 patients revealed progressive spreading of lesions, especially to the distal digits and interdigital areas, over an average of 2.3 years. Importantly, researchers noted lesions on the digits showed more deterioration compared with the nondigital hand areas. Treatment strategies used during follow-up were heterogeneous, reflecting real-world practices including topical corticosteroids, calcineurin inhibitors, phototherapy, and systemic corticosteroids. However, overall responsiveness of hand lesions—especially those on the digits—remained poor, consistent with existing literature that places acral sites among the least responsive to conventional treatment.

Potential Immunological and Anatomical Mechanisms

Emerging evidence suggests that anatomical differences, such as fibroblast-derived chemokine signaling and localized immune activation, may contribute to site-specific responses. Fibroblasts from dorsal hands may actively recruit cytotoxic CD8+ T cells, the study noted, sustaining inflammation and impeding repigmentation. Moreover, CD49a+ tissue-resident memory T cells may resist immunosuppressive therapy, contributing to disease persistence in acral regions.

The study's retrospective, single-center design and limited sample sizes for certain subgroups restrict generalizability. Lack of standardized treatment protocols and incomplete data on smoking status further limit conclusions. However, researchers felt the proposed classification system of hand vitiligo subtypes offers a framework for future prospective studies and therapeutic stratification.

This study provides important insights into the anatomical distribution and clinical behavior of hand vitiligo in patients with NSV. By identifying distinct distribution subtypes and their association with disease progression, dominance, and environmental factors, the research underscores the importance of individualized treatment approaches. Recognizing these subtypes may help refine prognosis, guide therapeutic decisions, and identify patients who may benefit from emerging therapies, including JAK inhibitors and targeted phototherapy. Researchers stated that future multicenter and longitudinal studies are warranted to validate these findings and optimize care for patients affected by this difficult-to-treat manifestation of vitiligo.

Akl J, Lee S, Ju HJ, et al. Estimating the burden of vitiligo: a systematic review and modelling study. 

. 2024;9(6):e386-e396. doi:10.1016/S2468-2667(24)00026-4

Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. 

. 2012;51(10):1206-1212. doi:10.1111/j.1365-4632.2011.05377.x

Yokoi K, Ishitsuka Y, Kusao K, et al. The proposed categorization of vitiligo lesions on the hands. 

. 2025;38(4):e70039. doi:10.1111/pcmr.70039

Vitiligo, particularly affecting the hands, poses significant psychological challenges due to its visible nature. A recent study analyzed 140 patients with non-segmental vitiligo (NSV) to better understand lesion patterns on the hands. The study identified four lesion subtypes and found that the dominant hand often showed more severe involvement, likely due to mechanical stress. Smoking was not an independent predictor of lesion severity, but disease duration was. The study highlights the need for individualized treatment approaches and suggests future research to validate findings and improve patient care.

A recent study reveals distinct patterns of nonsegmental vitiligo lesions on hands.

Researchers Define 4 Subtypes of Hand Vitiligo

Beyond its physical effects on the skin, psoriasis is increasingly recognized for impacting patients’ emotional and psychological health. Individuals with psoriasis are more likely to suffer from depression, anxiety, and suicidal ideation compared with the general population. This burden is multifactorial, stemming from disease visibility, stigma, chronicity, and systemic inflammation.

Biologic therapies have transformed the management of psoriasis, and IL-17 inhibitors such as bimekizumab offer targeted control of disease activity. Given the FDA warning for suicidal ideation and behavior (SI/B) listed in bimekizumab’s prescribing information, clinicians may hesitate to use it in patients with a history of mood disorders.

 A closer look at the trial data, however, reveals that bimekizumab not only has a low risk of psychiatric adverse events but may also confer meaningful mental health benefits.

Bimekizumab’s SI/B Label Warning: What the Data Really Say

 for potential SI/B, data from 9 phase 2/3 clinical trials involving more than 7166 patient-years (PYs) of exposure paint a reassuring picture

 0.13 per 100 PYs with suicidal ideation at 0.08/100 PYs, suicide attempts at 0.04/100 PYs, and completed suicide at 0.01/100 PYs.

 These rates are comparable to or lower than those seen with other anti–IL-17 and IL-23 therapies (0.09-0.54/100 PYs and 0.09-0.19/100 PYs, respectively). For example, brodalumab—a therapy with a boxed SI/B warning—has an SI/B rate of 0.49/100 PYs.

 Bimekizumab trials included rigorous psychiatric monitoring via the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) and independent adjudication of cases by a neuropsychiatric adjudication committee.

Across the 9 studies, bimekizumab was associated with consistently low depression scores and favorable trends compared with placebo and active comparators

 At week 16, 92.9% of patients treated with bimekizumab scored 0 to 4 on the Patient Health Questionnaire-9 (PHQ-9) (no/minimal depression) vs 81.1% of patients who received a placebo.

 Only 1.2% of patients on bimekizumab scored greater than or equal to 10 on the PHQ-9 (moderate to severe depression) compared with 6.3% on placebo; severe depression (PHQ-9 ≥15) occurred in just 0.7% of treated patients vs 4.1% on placebo.

Mean PHQ-9 scores remained low through 144 weeks of follow-up, suggesting durable mental health benefits with continued treatment.

Mental Health Benefits of Biologic Therapy in Psoriasis

The positive effects of biologics on mood are not unique to bimekizumab. Biologics offer more than skin-deep benefits—evidence points to direct improvements in mental health, particularly with IL-17 and IL-23 inhibitors:

 Registry data (eg, DermaReg-Pso) show that IL-17 and IL-23 inhibitors are associated with greater reductions in depressive symptoms than TNF-α inhibitors, even after adjusting for disease severity and quality of life.

 IL-17 inhibitors specifically improved core depressive symptoms, including pessimism, emotional numbness, and even suicidal ideation, suggesting a distinct neuropsychiatric impact.

 These effects may be mediated by downregulation of neuroinflammatory pathways, underscoring the role of systemic inflammation in mood disorders.

Efficacy and Long-Term Safety of Bimekizumab

Bimekizumab has demonstrated durable skin clearance with a manageable safety profile, both in trials and real-world use:

 In head-to-head trials, bimekizumab provided more days of complete clearance (PASI 100) over 52 weeks than secukinumab, ustekinumab, adalimumab, and etanercept.

 In pooled clinical trials, serious treatment-emergent adverse events occurred at 5.9/100 PYs, with low rates of major adverse cardiovascular events, malignancy, and inflammatory bowel disease. The most common adverse events included nasopharyngitis, oral candidiasis, and upper respiratory tract infections.

 A retrospective analysis (n = 51) showed similar safety signals. Fungal infections were the most frequent adverse event, with a 14% discontinuation rate. No SI/B events were reported; only 1 patient developed new-onset depression.

Clinical Considerations: Counseling and Coordinated Care

Dermatology clinicians play a key role in supporting both the mental and physical health of patients undergoing biologic therapy. Before initiating treatment, clinicians should conduct pretreatment screening using validated tools such as the PHQ-9 and the eC-SSRS to establish a mental health baseline. Open, clear communication is essential, such as addressing the FDA warning for SI/B directly while contextualizing it with supportive clinical trial and real-world data. For patients with a known psychiatric history, collaborative care is recommended, including timely referral to primary care providers or mental health professionals as appropriate.

Although bimekizumab carries a label warning for SI/B, clinical trial evidence supports a low risk and potential improvements in depression symptoms among treated patients. With its strong efficacy profile and favorable long-term safety, bimekizumab remains a valuable treatment for moderate to severe plaque psoriasis. Dermatology clinicians should feel confident in prescribing it while maintaining vigilance around mental health screening.

, is a board-certified dermatology physician assistant and medical writer in Connecticut.

Hołdrowicz A, Żebrowska A. Molecular link between psoriasis and depression-update on pathophysiology.

. 2025;26(6):2467. doi:10.3390/ijms26062467

Black C, Miller BJ. Meta-analysis of cytokines and chemokines in suicidality: distinguishing suicidal versus non suicidal patients. 

. 2015;78(1):28-37. doi:10.1016/j.biopsych.2014.10.014

Bimzelx. Prescribing information. UCB Inc; 2024. https://www.ucb-usa.com/bimzelx-prescribing-information.pdf 

Blauvelt A, Armstrong A, Merola JF, et al. Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: analysis of phase 2/3 randomized trials. 

, 2024;91(1):72-81. doi:10.1016/j.jaad.2024.02.039

Svedbom A, Ståhle M. Interleukin-17 and -23 inhibitors associated with direct effects on depressive symptoms in psoriasis: results from a register study. 

. 2023;103:adv7138. doi:10.2340/actadv.v103.7138

Warren RB, Donnelly K, Kiri S, et al. Long-term efficacy and safety of bimekizumab and other biologics in moderate to severe plaque psoriasis: updated systematic literature review and network meta-analysis. 

. 2024;14(11):3133-3147. doi:10.1007/s13555-024-01302-0

Gordon KB, Langley RG, Warren RB, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: pooled results from phase 2 and phase 3 randomized clinical trials. 

. 2022;158(7):735-744. doi:10.1001/jamadermatol.2022.1185

Zangenah N, Vazquez-Machado M, Loranger N, Elshaboury S, Hashemi K, LaChance AH. Adverse events associated with bimekizumab for moderate-to-severe plaque psoriasis: a retrospective, multicenter, post-hoc analysis. 

. 2025;20:54-55. doi:10.1016/j.jdin.2025.02.001 

Psoriasis significantly impacts patients' mental health, increasing risks of depression and anxiety. Biologic therapies, particularly IL-17 inhibitors like bimekizumab, have revolutionized psoriasis management. Despite FDA warnings for suicidal ideation and behavior (SI/B), bimekizumab shows low psychiatric adverse event rates and potential mental health benefits. Clinical trials reveal low depression scores and durable mental health improvements. Bimekizumab demonstrates superior skin clearance and a manageable safety profile. Dermatology clinicians should conduct mental health screenings and provide coordinated care, ensuring informed discussions about SI/B risks and benefits with patients.

Although bimekizumab carries a precaution for suicidal ideation and behavior, current data suggest it may improve mental health outcomes for patients with psoriasis. 

Beyond the Label: Evaluating Bimekizumab’s Mental Health Profile in Psoriasis Treatment

A recent announcement from VYNE Therapeutics highlights the evolving clinical trajectory of VYN202, an investigational oral BD2-selective BET inhibitor. The drug, which is being developed for immune-mediated diseases, including moderate to severe plaque psoriasis, encountered a clinical hold in April 2025 after nonclinical data in dogs raised safety concerns.

 However, the company says updated findings and preliminary human data suggest that VYN202 may still hold significant potential in treating immune-driven dermatologic and rheumatologic conditions.

The FDA imposed a clinical hold on VYNE’s phase 1b study following the observation of testicular toxicity in a nonclinical toxicology study involving dogs. Notably, the no-observed-adverse-effect level established in female animals supported continued testing in female patients at 0.25-mg and 0.5-mg doses. The higher 1-mg dose was excluded from the amended trial design due to a less favorable toxicological margin. The FDA has since lifted the clinical hold for these 2 lower doses—but only in female subjects—pending additional toxicology data to support resumption in male participants.

The hold prompted VYNE to unblind early clinical data, enabling preliminary evaluation of safety and efficacy outcomes across the limited number of patients already enrolled.

The phase 1b study enrolled 7 subjects in total—6 received VYN202 (across 0.25-mg, 0.5-mg, and 1-mg doses), and 1 received a placebo. Safety results from this small cohort were encouraging: No treatment-emergent serious adverse events, no study discontinuations due to adverse events, and no hematologic toxicities such as thrombocytopenia or lymphocytopenia were reported.

Importantly, all VYN202-treated subjects experienced some clinical improvement in psoriasis symptoms, including scalp involvement. Reductions in Psoriasis Area and Severity Index scores ranged from approximately 27% after 1 week to as high as 90% at week 8, suggesting a potential dose- and time-dependent response.

Serum biomarkers also showed promising trends. Pro-inflammatory cytokines commonly associated with plaque psoriasis—including IL-17A, IL-17F, IL-19, and IL-22—decreased by up to 83% in treated patients, whereas no significant changes were observed in the placebo subject. VYNE says these molecular improvements bolster the hypothesis that VYN202 exerts immunomodulatory effects by selectively targeting BD2, a domain implicated in inflammatory signaling.

Interestingly, researchers reported 2 subjects presenting with concurrent psoriatic arthritis. One (treated with VYN202 0.5 mg) reported a 4-point reduction on the joint pain numeric rating scale by week 2, accompanied by a 48% reduction in serum C-reactive protein—a key biomarker in rheumatic disease. The subject who received a placebo reported no such improvement, further suggesting potential for broader therapeutic application of VYN202 beyond cutaneous psoriasis.

Despite these positive signals, VYNE has opted to discontinue enrollment in the current psoriasis-focused phase 1b study. This decision is framed as both a risk mitigation strategy and a cost-saving measure, intended to extend the company’s cash runway into the fourth quarter of 2026. VYNE plans to redirect attention toward other immune-mediated conditions and will await top-line results from its ongoing phase 2b trial of repibresib (formerly VYN201) in nonsegmental vitiligo before announcing next steps for VYN202.

VYN202, an investigational oral BD2-selective BET inhibitor by VYNE Therapeutics, faced a clinical hold due to testicular toxicity observed in dogs. The FDA has lifted the hold for lower doses in female subjects, pending further toxicology data for males. Early phase 1b results showed no serious adverse events and promising efficacy in psoriasis, with significant reductions in PASI scores and pro-inflammatory cytokines. Despite positive signals, VYNE has paused the current study to focus on other immune-mediated conditions, awaiting further safety data and strategic alignment.

VYNE Therapeutics updates on VYN202, revealing promising early results in psoriasis treatment despite a clinical hold due to safety concerns.

Raymond A. Miller, J.D.

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