FDA approves apremilast for severe plaque psoriasis among children

The Food and Drug Administration (FDA) has expanded the approval of apremilast and included treatment of children 6 years of age and older weighing at least 20kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

There are currently no other FDA-approved oral medications for moderate to severe plaque psoriasis in this patient population.

“For the first time, children and adolescents with moderate to severe plaque psoriasis and their caregivers have an oral option to treat this chronic disease, with its highly visible, uncomfortable symptoms,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. “In the last decade, Otezla has been prescribed to over one million adults worldwide, and today’s announcement represents the potential for Otezla to offer relief to many younger patients.”

“Children living with moderate to severe plaque psoriasis often experience uncomfortable and highly visible symptoms, such as itchy, dry lesions that may bleed or cause pain. However, treatment options for this chronic immune-mediated disease are limited,” said Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation. “Until now, FDA-approved systemic treatment options for youth have been injections or infusions. The addition of an oral treatment option with a well-established safety profile is great news for children with this disease and their families.”

The FDA approval was based on results from SPROUT, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study which investigated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. The primary endpoint – static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear or almost clear with at least a 2-point reduction from baseline) – at week 16 was met with a 33.1% sPGA response for Otezla versus 10.8% for placebo (95% CI: 12.2%, 32.4%; P<0.0001). The adverse events were consistent with the known safety profile of Otezla in adult patients.

The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, tension headache and headache.

After the initial titration period, the maintenance dosage of Otezla in this patient group will be administered in either 20 or 30 mg doses, based on weight, twice daily. The recommended dose is 20 mg twice daily for pediatric patients weighing 20 kg to <50 kg, and 30 mg twice daily for those who weigh at least 50 kg.

Amgen is committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to Otezla. 

About Psoriasis

Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly, and itchy patches on the skin. Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States. About 80% of those patients have plaque psoriasis. Among pediatric patients with plaque psoriasis, one in five have moderate to severe disease. Approximately one-third of those who get psoriasis are under 18 years old when the disease first surfaces.

About Otezla® (apremilast)

Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

Since its initial FDA approval in 2014, Otezla has been prescribed to more than 1 million patients worldwide.

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Periarticular Glucocorticoid Injection Comparable to Intravenous for Pain Relief After Knee Surgery, finds study

China: A recent prospective, randomized, and controlled study has provided new insights into the effectiveness of intraoperative glucocorticoid administration methods in improving clinical outcomes after total knee arthroplasty (TKA). The research, published in the Journal of Orthopaedic Surgery, focused on evaluating whether the route of glucocorticoid administration—either intraoperative intravenous or periarticular injection—affects pain management and recovery after surgery.

The study found that intraoperative periarticular glucocorticoid injections provide comparable pain relief to IV injections during the postoperative period following TKA and may offer enhanced effectiveness by the second postoperative day. Additionally, periarticular injections do not present any increased risk or complications for patients.

Total knee arthroplasty is a common surgical procedure aimed at relieving pain and restoring function in patients with severe knee arthritis. The use of glucocorticoids, known for their anti-inflammatory properties, is a well-established practice to enhance postoperative outcomes. However, the best protocols for administering glucocorticoids are still debated. Considering this, Qingtian Li, Southern Medical University, Guangzhou, China, and colleagues aimed to compare the efficacy of glucocorticoids between intravenous and periarticular injection on clinical outcomes.

A total of 114 patients were randomly divided into two groups: the intravenous (IV) group (n = 57) and the periarticular injection (PI) group (n = 57). The IV group received 10 mg of dexamethasone intravenously, while the PI group received a 10 mg periarticular injection of dexamethasone during the procedure. Clinical outcomes were evaluated using the visual analogue scale (VAS), knee society score (KSS), range of motion (ROM), knee swelling, inflammation markers, and post-TKA complications.

The following were the key findings of the study:

  • The VAS score during walking on 2nd day postoperatively was lower in the PI group compared with the IV group (2.08 ± 1.45 versus 2.73 ± 1.69), and there was no significant difference at the other time points of VAS score in the two groups.
  • The inflammation markers, knee swelling, knee ROM, and KSS score were not statistically different.
  • The occurrence of vomiting and other complications was not significantly different between the two groups.

The study had limitations, including its single-center design, short duration, and lack of a placebo group. Additionally, the adductor nerve block used for pain management may have masked early postoperative pain. However, the researchers noted that this block was necessary to reduce pain and nausea after TKA for ethical reasons.

“The study demonstrates that intraoperative periarticular glucocorticoid injections offer comparable pain relief to IV injections following TKA, with potential added effectiveness on the second postoperative day. Additionally, periarticular glucocorticoid injections do not introduce extra risks or complications for patients,” the researchers concluded.

Reference:

Li, Q., Fang, G., Liao, W., Chen, B., Yang, Y., Liao, J., Fu, G., Ma, Y., & Zheng, Q. (2024). Intraoperative intravenous versus periarticular injection of glucocorticoids in improving clinical outcomes after total knee arthroplasty: A prospective, randomized and controlled study. Journal of Orthopaedic Surgery. https://doi.org/10.1177_10225536241256554

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Adolescent Tinnitus Linked to Age, Vitamin D Deficiency, and Anemia: Implications for Treatment Strategies

South Korea: A recent study has shed light on the significant associations between tinnitus and systemic diseases in adolescents, emphasizing the potential roles of vitamin D deficiency and anemia. The research offers critical insights into how these common conditions might interplay, influencing the auditory health of young individuals.

The findings, published in Clinical Otolaryngology, have highlighted the importance of considering vitamin D deficiency & anemia in adolescent tinnitus management.

The researchers found that tinnitus was not associated with hearing levels but was significantly impacted by age, vitamin D deficiency, and anemia. These results highlight the importance of developing targeted treatment strategies that address these factors in managing tinnitus among adolescents.

Tinnitus, characterized by a persistent ringing or buzzing in the ears, affects a notable portion of the adolescent population. While often considered a benign condition, tinnitus can be a troubling symptom that impacts daily life and mental well-being; therefore, it is important to treat it. However, determining the cause of tinnitus remains highly challenging, and treatment approaches for tinnitus continue to be controversial.

Considering the above, the researchers Sang-Yoon Han and Young Ho Kim from South Korea aimed to identify the prevalence of tinnitus in adolescents and systemic diseases as risk factors of adolescent tinnitus to find evidence for new treatment strategies.

For this purpose, the researchers utilized data from the 5th Korea National Health and Nutrition Examination Survey conducted between 2010 and 2012. They selected 1,593 adolescents with bilateral normal tympanic membranes and comprehensive physical, laboratory, and audiological examination results. They also analyzed their systemic health conditions and investigated the relationship between tinnitus and various demographic factors, systemic diseases, and hearing levels.

The following were the key findings of the study:

  • The prevalence of tinnitus in Korean adolescents was 21.7%.
  • The hearing level was not associated with tinnitus.
  • Tinnitus was significantly associated with age, 25(OH)-D level, and anaemia.
  • After controlling the other factors, age, 25(OH)-D level, and anaemia were independently related to tinnitus.

The findings showed that tinnitus among adolescents is significantly associated with vitamin D, age, and anaemia.

“Physicians should be aware of the increased likelihood of deficiencies and systemic diseases in adolescents with tinnitus. Understanding these associations could be crucial in developing more effective treatment strategies for managing tinnitus in this age group,” the researchers wrote.

In conclusion, the study highlights the significant connections between tinnitus and systemic diseases such as vitamin D deficiency and anemia. By addressing these underlying health issues, it may be possible to improve management strategies for tinnitus and enhance overall adolescent health outcomes.

Reference:

Han SY, Kim YH. Associations Between Tinnitus and Systemic Disease in Adolescents: Implications of Vitamin D Deficiency and Anaemia. Clin Otolaryngol. 2024 Jul 24. doi: 10.1111/coa.14203. Epub ahead of print. PMID: 39048535.

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JAMA study Confirms Sustained Benefits of Endovascular Thrombectomy for Basilar Artery Occlusion at 1 Year

Researchers have confirmed that endovascular thrombectomy (EVT) provides benefits in patients with acute basilar artery occlusion at 1 year, as opposed to best medical treatment. In the recent extended analysis of the ATTENTION trial, a multicenter, randomized clinical study, it was found that there was significantly better long-term functional outcome in patients undergoing EVT, with better rates of functional independence and survival at 1 year. This study was published in JAMA Neurology by Rui Li. and colleagues.

Basilar artery occlusion is a severe form of ischemic stroke with high disability and mortality rates. Whereas earlier trials have shown that EVT improves functional outcomes at 90 days compared to medical therapy alone, information on long-term outcomes beyond this period is scant. The ATTENTION trial provided pivotal evidence for the use of EVT within 12 hours from symptom onset. This extended study assessed whether benefits derived from EVT at 90 days were maintained or increased at 1 year.

The ATTENTION extension study followed-up patients with acute basilar artery occlusion treated within 12 hours of symptom onset from 36 comprehensive stroke centers. In all, 342 patients were randomized, of whom 330 [96.5%] had complete 1-year follow-up. Patients were treated in two conditions: EVT [thrombectomy group receiving mechanical endovascular thrombectomy] and best medical treatment, that is, the control group. The primary outcome was a favorable functional outcome defined as a modified Rankin Scale of 0 to 3 at 1 year. The secondary outcomes assessed functional independence, excellent outcome, level of disability across the full range of mRS scores, mortality, and health-related quality of life.

Key Findings

Primary Outcome (mRS 0-3 at 1 Year):

  • Thrombectomy group: 44.6% (99/222)

  • Control group: 19.4% (21/108)

  • The adjusted rate ratio was 2.23 (95% CI, 1.51-3.29), with statistical significance of the thrombectomy group.

Excellent Outcome (mRS 0-1 at 1 Year):

  • Thrombectomy group: 27.9% [62/222] v 19.9% at 90 days; Control group: 8.3% [9/108] v 7.9% at 90 days

Mortality

  • Thrombectomy group: 45.5% [101/222] at 1 year v 36.7% at 90 days; Control group: 63.9% [69/108] at 1 year v 55.3% at 90 days

Secondary Outcomes:

  • All mRS scores showed lower levels of disability in the thrombectomy group at 1 year.

  • The benefit of EVT was particularly magnified in those patients who achieved an excellent outcome-e.g., mRS 0-1-only, further underlining the sustained and enhanced treatment effect.

The extended analysis herein of the 1-year follow-up data reinforces long-term benefits of EVT for patients with basilar artery occlusion. In contrast with the rates at 90 days, mortality rates increased for both groups; however, EVT patients maintained better functional outcomes and further improved in achieving excellent recovery. The findings of this study point toward the importance of EVT in the management of acute basilar artery occlusion, where a considerable proportion of patients are able to achieve favorable outcomes even at 1 year post-stroke.

In conclusion, EVT establishes ongoing benefits in patients with acute basilar artery occlusion along with superior functional and improved survival at 1-year outcomes compared to best medical treatment. These results assure that timely EVT intervention is indeed associated with an improvement in the long-term prospects for the recovery of stroke patients.

Reference:

Li, R., Tao, C., Sun, J., Zhang, C., Xu, P., Yin, Y., Han, H., Yuan, G., Cui, T., Zhou, P., Chen, W., Zeng, G., Li, Y., Ma, Z., Yu, C., Su, J., Zhou, Z., Chen, Z., Wang, L., … Zhang, G. (2024). Endovascular vs medical management of acute basilar artery occlusion: A secondary analysis of a randomized clinical trial. JAMA Neurology. https://doi.org/10.1001/jamaneurol.2024.2652

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On-duty doctor abused, slapped by patient, his attendants at Dr Hedgewar Hospital

Days after resident doctors resumed work following an 11-day nationwide protest in response to assurances from the central government that security forces at all hospitals will be increased up to 25%, an on-duty junior resident doctor recently became the subject of violence after he was allegedly abused and slapped by a patient and his attendants at Dr Hedgewar Hospital in Karkardooma.
According to the police, the patient became violent after he felt pain when the doctor was addressing his wounds. This led to an escalation of the situation, during which the doctor was reportedly slapped. Additionally, the patient’s son and daughter, who were present at the scene allegedly abused the doctor and other hospital staff.
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Ratnagiri: 19-year-old nursing student reportedly drugged, raped by auto-rickshaw driver

After the brutal rape and murder of a PG trainee doctor at RG Kar Medical College Hospital in Kolkata, another shocking incident of rape has been reported by Maharashtra’s Ratnagiri. This time a 19-year-old nursing student of a private hospital in Ratnagiri was reportedly drugged and raped by an auto-rickshaw driver while she was returning home from hospital on Monday night.
According to a preliminary investigation by the police, the student booked an autorickshaw on her way back home when the driver allegedly mixed sedatives in the water and offered her to drink. Following this, she lost consciousness and the driver allegedly took her to a deserted place and allegedly raped her.
For more information, click on the link below:

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EEE, West Nile, malaria: Know the difference between these mosquito-borne diseases

The world’s deadliest animal can be squashed flat with a quick slap: It’s the mosquito.

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As climate warms, S. Korea fights new border threat: malarial mosquitoes

Near the heavily fortified border that divides North and South Korea, a monitoring device is working 24-7—not tracking missiles or troop movements, but catching malaria-carrying mosquitoes that may cross the border.

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Brazilian moms are leading the charge to secure medical marijuana for sick kids

The 4-year-old boy struggled to balance while walking through the living room. His mother’s eyes attentively followed his every move. Then a seizure knocked him to the ground, the dull thud of his small body echoing through the home.

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Ultraprocessed foods are everywhere. How bad are they?

Whether they know it or not, most Americans don’t go a day—or often a single meal—without eating ultraprocessed foods.

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