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Tag: Severe

  • The FDA Just Approved a Powerful Biologic for Children as Young as 6 with Severe Psoriasis or Psoriatic Arthritis

    The FDA Just Approved a Powerful Biologic for Children as Young as 6 with Severe Psoriasis or Psoriatic Arthritis

    Children as young as 6 years old with moderate-to-severe plaque psoriasis or active psoriatic arthritis now have access to one of the most effective biologics in dermatology and rheumatology, following an FDA approval announced June 26, 2026.

    AbbVie announced that the FDA has approved risankizumab (Skyrizi) for children 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for active psoriatic arthritis in the same age group. A new 55 mg prefilled syringe was simultaneously approved to support weight-based dosing for patients weighing less than 40 kg, filling a critical gap in pediatric treatment access.

    Risankizumab is now the first and only interleukin-23 (IL-23) inhibitor approved in the United States for pediatric patients 6 years of age and older who weigh less than 40 kg with either plaque psoriasis or psoriatic arthritis.

    Why This Matters

    According to Drug Topics, approximately 30 percent of people who develop psoriasis first experience symptoms before age 18. For these patients, severe psoriatic disease can mean painful, visible skin lesions that affect school participation, social development, and mental health in addition to causing physical discomfort.

    Psoriatic arthritis in children — called juvenile psoriatic arthritis or psoriatic juvenile idiopathic arthritis — causes joint pain, swelling, and stiffness that can impair a child’s ability to walk, write, or participate in normal childhood activities. Before biologics in this class were available for children, treatment options were more limited, and some children were treated off-label with adult formulations in adult doses, which is not ideal from a pharmacokinetic standpoint.

    “Plaque psoriasis and psoriatic arthritis can affect much more than skin and joints — these conditions can shape daily life and disrupt important childhood experiences,” said Roopal Thakkar, MD, executive vice president of research and development at AbbVie.

    What We Know So Far

    Risankizumab is a humanized IgG1 monoclonal antibody that selectively blocks the p19 subunit of IL-23, a cytokine that drives the inflammatory cascade responsible for the skin plaques and joint inflammation in psoriatic disease. It was first approved for adults with moderate-to-severe plaque psoriasis in 2019 and has since received approvals for adult psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

    The pediatric approval is supported by data from the Phase 3 OptIMMize clinical trial program, which enrolled children and adolescents aged 6 through 17. Key findings from the trial:

    In adolescents aged 12 to 17: At week 16, 85.2 percent of risankizumab-treated patients achieved PASI75 (75% reduction in psoriasis severity), comparable to ustekinumab (85.7%). However, PASI100 (complete clearance) favored risankizumab at 40.7% versus 17.9% for ustekinumab.

    In children aged 6 to 11: Response rates at week 16 were high: PASI75 in 86.7%, PASI90 in 76.7%, and PASI100 (complete clearance) in 43.3%. Nearly all patients (90.0%) achieved a physician global assessment score of clear or almost clear.

    Durability: In adolescents who responded and continued treatment through week 52, approximately 95% maintained clear or almost clear skin — a strong durability finding for this age group.

    The safety profile in pediatric patients was consistent with the established adult safety profile, according to AbbVie and Contemporary Pediatrics.

    Who Qualifies for Skyrizi — Children and Dosing

    Age: 6 years and older

    Conditions: Moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; OR active psoriatic arthritis

    Dosing by weight:

    • Children weighing less than 40 kg: 55 mg subcutaneous injection (new weight-based formulation)
    • Children weighing 40 kg or more: 150 mg subcutaneous injection (same as adult dosing)

    Administration schedule: An initial dose, followed by a dose 4 weeks later, then maintenance dosing every 12 weeks thereafter — the same schedule used in adults.

    The psoriatic arthritis approval for children 6 and older is supported by the OptIMMize psoriasis data plus population pharmacokinetic modeling from well-controlled adult PsA studies.

    What Doctors and Experts Say

    Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and a lead OptIMMize study investigator, called the approval significant: “These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with these conditions.”

    Medscape’s analysis noted that this is the first IL-23 inhibitor to reach the under-40 kg pediatric population, distinguishing Skyrizi from other biologics in this class that have not yet reached this weight category in children.

    What the Evidence Shows — and What It Does Not

    MedicalDaily Evidence Check

    • Study type: Phase 3 randomized controlled trial (OptIMMize psoriasis program) — active-controlled in adolescents; single-arm open-label in children 6 to 11
    • Participants: Children and adolescents aged 6–17 with moderate-to-severe plaque psoriasis; PsA approval additionally supported by adult data plus PK modeling
    • Published in: Journal of Investigative Dermatology (conference data); FDA review completed June 26, 2026
    • What it found: High rates of PASI75, PASI90, and PASI100 at week 16 with durable responses through week 52
    • Key limitation: The psoriatic arthritis approval for children is partially supported by adult study data extrapolation through PK modeling rather than a dedicated pediatric PsA efficacy trial
    • Safety limitation noted: Detailed pediatric adverse event rates and serious adverse event rates were not publicly released in the press announcement

    What You Can Do Now

    • If your child has moderate-to-severe plaque psoriasis or psoriatic arthritis that has not been adequately controlled with topical therapies, ask your pediatric dermatologist or pediatric rheumatologist about risankizumab at your next appointment.
    • Before starting any biologic, standard screening includes tuberculosis testing, hepatitis B testing, and a review of current infections — discuss these with your child’s specialist.
    • The European Commission approved risankizumab for pediatric plaque psoriasis (ages 6 and up) on June 23, 2026 — just days before the U.S. approval — making this a global regulatory milestone for pediatric psoriatic disease.

    Cost and Access: What Patients Should Know

    Skyrizi is a biologic specialty medication. Insurance coverage and prior authorization requirements vary by plan. AbbVie has a patient support program — myAbbVie Assist — for eligible patients who need help with access or cost. Contact your specialty pharmacy or AbbVie’s patient support team for current assistance program details.

    The Bottom Line

    Skyrizi (risankizumab) is now FDA-approved for children 6 and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis — making it the first and only IL-23 inhibitor available for the under-40 kg pediatric population in the United States. Clinical trial data showed high rates of complete skin clearance in both adolescents and younger children, with durable responses through a year of treatment. Families of children with severe psoriatic disease should ask their pediatric specialist whether risankizumab is appropriate.

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  • New York City Reports First Severe Mpox Clade I Case — A More Dangerous Strain Now Showing Up Across America

    New York City Reports First Severe Mpox Clade I Case — A More Dangerous Strain Now Showing Up Across America

    New York City has confirmed its first case of mpox caused by clade I — the more dangerous variant of the virus — raising concern among public health officials as the more infectious and more severe form of mpox continues to arrive in major U.S. cities. The NYC Health Department issued a formal advisory noting that there is no known local community transmission tied to this case, but health commissioner Dr. Alister Martin confirmed the virus is now present in the city and urged residents to be aware of symptoms and vaccination options.

    As of May 9, 2026, the NYC Department of Health reported 79 mpox cases in New York City in 2026 alone, including at least a small number of clade I cases. Nationally, the CDC confirmed more than 20 clade I mpox cases in the United States as of June 2026, all linked to recent international travel or contact with travelers from affected regions in Central and Eastern Africa or Western Europe.

    Clade I vs. Clade II: Why This Strain Is More Concerning

    Most Americans became familiar with mpox during the 2022 global outbreak, which was caused by clade II — a less severe form of the virus with a survival rate above 99.9%. Clade I is different. According to Fox News senior medical analyst Dr. Marc Siegel, “Clade I causes more severe symptoms and can be life-threatening.” In the ongoing outbreak in the Democratic Republic of the Congo, clade I has had a case fatality rate significantly higher than clade II. Complications can include severe skin lesions, pneumonia, brain inflammation, and bacterial superinfections.

    While clade I spreads through the same routes as clade II — primarily close physical contact, sexual contact, kissing, and contact with infected skin lesions or respiratory droplets at close range — it does not spread through casual airborne contact over long distances. The CDC has assessed the current risk to the general U.S. population as low, but characterizes the risk as low to moderate for men who have sex with men, who accounted for the majority of the 2022 U.S. outbreak.

    Who Should Get Vaccinated and What to Watch For

    The JYNNEOS vaccine, approved for mpox prevention, provides strong protection against both clade I and clade II. The CDC recommends the two-dose vaccine series for gay, bisexual, and other men who have sex with men aged 18 and older with specific risk factors. Anyone who traveled to or had contact with someone from the DRC, neighboring African countries, or parts of Western Europe reporting clade I cases should consult their healthcare provider immediately.

    Symptoms of mpox typically appear 3 to 17 days after exposure and begin with fever, swollen lymph nodes, muscle aches, and exhaustion, followed by a distinctive rash that progresses through several stages of fluid-filled lesions. Anyone with a new or unexplained rash — particularly after recent travel or close physical contact — should contact a healthcare provider, mention any travel history, and avoid close contact with others until evaluated. NYC offers free mpox vaccination at multiple locations across the five boroughs.

    The arrival of clade I mpox in New York City — the nation’s most densely populated metro area — is a reminder that the city’s international connectivity, while a source of enormous economic and cultural vitality, also serves as an entry point for emerging infectious diseases. Whether the public health infrastructure put in place after 2022 remains fully operational under reduced federal staffing is a question officials have not fully answered.

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  • Why They Trigger Severe Headaches and Discomfort

    Why They Trigger Severe Headaches and Discomfort

    Vision problems often cause headaches from vision problems and eye strain headaches without obvious warnings, as eyes strain to focus or align properly. Even routine activities like reading, computer work, or driving can overwork eye muscles, sending tension across temples, brows, and neck. Millions experience these discomforts, turning everyday tasks into triggers for vision-related headaches that disrupt productivity, sleep, and overall well-being.

    Uncorrected refractive errors—such as nearsightedness, farsightedness, or astigmatism—force constant lens adjustments, gradually exhausting ciliary and extraocular muscles. Dry eyes, poor lighting, or glare exacerbate the strain, often without producing symptoms until headaches intensify. Recognizing these underlying causes is the first step toward relief and preventing chronic vision-related pain.

    Why Do Vision Problems Cause Headaches?

    Headaches from vision problems arise when eyes fail to work together smoothly, forcing extra effort for the brain to process visual input. Misalignment in binocular vision dysfunction, for example, makes one eye drift slightly, requiring constant correction that fatigues eye and neck muscles, sparking eye strain headaches. Uncorrected nearsightedness or farsightedness adds accommodative stress, as internal lenses continuously adjust focus during prolonged near work, often resulting in frontal or temporal pain.

    Astigmatism further distorts light unevenly, forcing squinting that tightens scalp and neck muscles into tension-type headaches. Dry eyes, caused by infrequent blinking during digital tasks, amplify discomfort and contribute to ongoing irritation. According to a study conducted by Frontiers in Public Health, extended screen use was linked to increased eye strain and headaches, with participants showing higher rates of visual discomfort and tension-type headache development.

    Can Eye Strain Cause Headaches?

    Eye strain headaches occur when visual demands exceed the eyes’ ability to maintain focus or alignment. Digital eye strain, also called computer vision syndrome, emerges when screens sit too close, lighting produces glare, or prolonged near work forces ciliary muscles to overwork. Poor ergonomics, like monitors at improper heights, further stretches extraocular muscles, intensifying headaches.

    Other factors include convergence insufficiency, where eyes tire from crossing inward for near objects, and presbyopia in adults over 40, which increases accommodation strain. Environmental conditions, such as low humidity, dry tear films, or glare, also escalate tension and make eye strain headaches more severe. According to NVISION Eye Centers, eye strain, often resulting from prolonged screen time, reading, or driving, can lead to headaches and discomfort, though it is not always the primary cause, highlighting the importance of regular breaks, proper lighting, and addressing underlying eye conditions.

    What Vision Issues Trigger the Worst Headaches?

    Certain eyesight issues are particularly likely to produce severe vision-related headaches. Binocular vision disorders, such as vertical heterophoria, misalign the eyes slightly, demanding constant neural fusion that exhausts visual pathways. Patients often report occipital or sinus-like pain, worsened in motion or dim light.

    Unmanaged hyperopia strains the focusing system for both near and distance vision, generating cyclic headaches from accommodative spasms. Corneal conditions like keratoconus distort light and create ghosting, increasing photophobia and tension headaches. Even early glaucoma can provoke brow or temple aches, mistaken for tension headaches, delaying timely detection and treatment. According to the Centre for Sight, binocular vision disorders and irregular corneal conditions are strongly linked to severe headaches, emphasizing the importance of comprehensive eye exams for accurate diagnosis.

    Strategies to Ease Vision-Related Headaches

    Managing headaches from vision problems requires a combination of optical correction, environmental adjustments, and lifestyle practices. Key strategies include:

    • Comprehensive eye exams that assess motility, binocular function, and refractive errors.
    • Prism lenses or vision therapy to retrain eye alignment, reducing eye strain headaches by up to 70 percent.
    • Artificial tears and blink exercises to maintain corneal moisture during screen work.
    • Following the 20-20-20 rule: every 20 minutes, look at something 20 feet away for 20 seconds.
    • Blue light filters and anti-reflective coatings to minimize glare and ghosting.
    • Adjusting lighting to prevent shadows that force pupil constriction.
    • Proper ergonomics with monitor height and distance to reduce muscle fatigue.

    These measures collectively help transform silent vision strain into manageable eye care practices, preventing chronic headaches and improving overall visual comfort.

    Managing Eye Strain: Maintaining Long-Term Visual Health

    Addressing vision-related headaches goes beyond temporary relief, focusing on consistent monitoring and preventive care. Eye exams every one to two years detect early binocular issues, presbyopia, and corneal irregularities before they cause chronic pain. Integrating ergonomic setups, regular breaks, and corrective lenses supports long-term eye health. With these practices, vision-related headaches can be significantly reduced, allowing normal visual activities without persistent discomfort.

    Frequently Asked Questions

    1. Can poor posture worsen eye strain headaches?

    Yes, poor posture can increase eye strain headaches. When monitors are too high or low, neck muscles compensate, adding tension to eye muscles. This extra effort amplifies visual fatigue and pain. Adjusting posture and monitor height can significantly reduce headaches linked to eye strain.

    2. Are children at risk for vision-related headaches?

    Children can experience headaches from vision problems, often undetected because they may not report symptoms. Conditions like uncorrected nearsightedness, farsightedness, or convergence insufficiency are common causes. Eye exams are critical for early detection and intervention. Proper correction and visual exercises can prevent long-term discomfort and learning difficulties.

    3. Can glasses completely prevent vision-related headaches?

    Glasses can greatly reduce vision-related headaches if they address refractive errors correctly. They may not fully prevent headaches caused by poor ergonomics, dry eyes, or underlying binocular dysfunction. Combining glasses with environmental and lifestyle adjustments is most effective. Regular follow-ups ensure lens prescriptions remain optimal.

    4. How do blue light filters help with eye strain?

    Blue light filters reduce glare from digital screens, lessening ciliary muscle fatigue. They improve visual comfort, especially during prolonged screen use. However, they do not replace proper prescription lenses or ergonomics. Using filters alongside other strategies enhances overall eye strain management.



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  • Depression May Trigger Severe Period Pain, Sleep Disturbances May Aggravate It: Study

    Depression May Trigger Severe Period Pain, Sleep Disturbances May Aggravate It: Study

    Severe menstrual cramps can affect a woman’s mood and her mental well-being. However, a new study reveals a surprising twist: depression may actually trigger severe period pain, with sleep deprivation worsening its severity.

    Dysmenorrhea, or severe period pain, affects around 15% of women and typically occurs just before menstruation, and subsides after a few days. If the menstrual cramps occur without any underlying condition, it is called primary dysmenorrhea. This type of period pain is often caused by high levels of prostaglandins, hormone-like substances that increase uterine contractions. Secondary dysmenorrhea, however, is caused by medical conditions like endometriosis or uterine fibroids.

    In the latest study published in Briefings in Bioinformatics, researchers discovered that depression significantly impacts primary dysmenorrhea after evaluating around 600,000 cases from European populations and 8,000 from East Asian populations, finding a strong link in both groups. The researchers also conducted a genome-wide association study and identified key genes and proteins involved in this interaction.

    “Our findings provide preliminary evidence that depression may be a cause, rather than a consequence, of dysmenorrhea as we did not find evidence that period pain increased the risk of depression,” said lead author Shuhe Liu from China’s Xi’an Jiaotong – Liverpool University.

    Another interesting observation was that sleeplessness, commonly experienced by those with depression, played a key role in connecting depression and dysmenorrhea.

    “We found that increased sleep disturbances could exacerbate menstrual pain. Addressing sleep issues may therefore be crucial in managing both conditions,” Liu said.

    However, larger studies and biological experiments are needed to fully understand the causal association between menstrual pain and depression. Meanwhile, based on the current findings, the researchers are calling for improved mental health screening for individuals suffering from dysmenorrhea. Liu explained that this could lead to more personalized treatment options, reduced stigma, and better healthcare for those affected.

    “Depression and menstrual pain significantly impact women’s lives across the world, yet their connection remains poorly understood. Our collective goal is to critically investigate these issues and improve care for women by uncovering these complex connections and finding better ways to address them,” lead author Dr. John Moraros, from the Xi’an Jiaotong-Liverpool University in China told CNN.

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