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Here: evidence that disease-modifying therapies can positively affect the long-term evolution of multiple sclerosis.

Disease Modifying Therapies: Do They Modify Short- and Long-Term in Multiple Sclerosis?

A 5-year-old boy with a history of atopic dermatitis since 6 weeks of age, presents with a rash around his mouth that has been present for approximately 1 year. The patient’s mother reports that desonide topical cream was applied to the affected area for about 5 days, which initially resulted in improvement, however the rash returned after this medication was discontinued. The rash also recently improved after the patient took amoxicillin for an infection. She also notes that the patient has been licking his lips more frequently.

On examination there is an erythematous papulopustular eruption restricted to the perioral region, with sparing of the vermillion border. Mild hyperpigmentation is noted on the patient’s neck. There is no active involvement of other areas of the body.

The eruption has been present for 1 year and is restricted to the perioral region. What is included in your differential? 

Clinical Topics

Rash Around the Mouth of a 5-year-old Child

The mother of a 10-year-old boy brings him in for evaluation of his moles (which are all benign). During the visit, the mother asks about the lesions on the first 2 knuckles of his right hand; she initially noticed them several months earlier. The boy is otherwise healthy.

White Knuckles


These 2 patients presented with a swollen hand and rapidly proximally progressive edema secondary to a bite.

These 2 patients presented with a swollen hand and rapidly proximally progressive edema secondary to a bite. What creature did the biting?

Swollen Hands-What’s Biting?

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma.

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma. The violaceous color and configuration of the skin lesions suggests which of the following? 

Hard Purple Nodules: Your Dx?

The lesion on this 6-year-old boy occupies almost the entire left side of his nose. The mother attributed it to an injury her son had sustained 2½ weeks earlier, when he was hit in the face by a baseball.

Is this lesion the result of an injury, as the boy’s mother suspected, or something else?

Scaly Plaque on the Nose

The FDA has approved a label expansion for fremanezumab-vfrm (Ajovy),   adding an indication for preventive treatment of 

 aged 6 to 17 years who weigh at least 45 kilograms (99 pounds).

According to today's announcement from fremanezumab developer Teva, the approval makes the medication the first 

calcitonin gene-related peptide (CGRP) antagonist

 indicated for both pediatric episodic migraine prevention and adult migraine prevention in the US. Fremanezumab is administered once monthly via a 225 mg/1.5 mL single-dose injection, either in-office or at home.

“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” Chris Fox, Teva executive vice president, US commercial and innovative franchise lead and head of global marketing business, said in the announcement. The approval addresses a long-standing treatment gap in the pediatric population, she added, and offers "families added support as they navigate the challenges of this condition.”

The expanded pediatric indication for fremanezumab was supported by data from the phase 3 SPACE study (NCT03539393), a randomized, double-blind, placebo-controlled, parallel-group trial involving children and young teens with a history of fewer than 14 headache days per month. The study enrolled 237 participants aged 6 to 17 years and demonstrated that fremanezumab significantly reduced migraine frequency over a 12-week period compared with placebo, while maintaining a safety profile consistent with previous findings.

Participants in SPACE were stratified into 2 age groups: 6–11 years and 12–17 years. At study completion, fremanezumab-treated patients showed a greater mean reduction in monthly migraine days (–2.5) compared with those receiving placebo (–1.4; 

 =.021). Monthly headache days (MHDs) were also significantly reduced with fremanezumab (–2.6) vs placebo (–1.5; 

 =.017). A higher proportion of patients treated with fremanezumab achieved at least a 50% reduction in monthly migraine days (47.2%) compared with placebo (27.0%; 

 = .002). The benefits were consistent across the 2 age groups and between sexes, according to the study.

Fremanezumab was generally well tolerated among the young SPACE participants. Adverse events (AEs) were reported in 55% of those receiving fremanezumab and 49% of those in the placebo arm.  receiving placebo. The incidence of serious AEs and treatment discontinuations due to AEs was low, occurring in fewer than 3% and 1% of patients, respectively.

 The medication's no-loading-dose treatment pathway may help reduce treatment burden and improve adherence for families. 

One in 10 children and adolescents in the US experience migraine known as one of the most common and disabling neurologic conditions.

 Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.

Fremanezumab was originally approved in 2018 for preventive treatment of migraine in adults with dosing options of 225 mg monthly or 675 mg quarterly. 

For full prescribing information, clinicians can visit: 

https://www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf

FDA approves expanded indication for AJOVY® (fremanezumab-vfrm), the first anti-CGRP preventive treatment for pediatric episodic migraine. News release. Teva. August 6, 2025. Accessed August 6, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/FDA-Approves-Expanded-Indication-for-AJOVY-fremanezumab-vfrm-The-First-Anti-CGRP-Preventive-Treatment-for-Pediatric-Episodic-Migraine/default.aspx 

Hershey AD, Szperka CL, Barbanti P, et al. Efficacy and safety of fremanezumab for the preventive treatment of episodic migraine in children and adolescents: a phase 3, randomized, double-blind, placebo-controlled study(PL5.001). 

 2025;104(7_suppl 1). doi:10.1212/WNL.0000000000211143 

2.Teva presents positive efficacy and safety data of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescents from phase 3 SPACE trial. News release. Teva Pharmaceuticals. December 4, 2024. Accessed August 6, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-Positive-Efficacy-and-Safety-Data-of-AJOVY-fremanezumab-for-the-Prevention-of-Episodic-Migraine-in-Children-and-Adolescents-from-Phase-3-SPACE-Trial/default.aspx

Al Khalili Y, Asuncion RMD, Chopra P. Migraine headache in childhood. In: 

. StatPearls Publishing. Updated March 4, 2023. Accessed August 6, 2025. https://pubmed.ncbi.nlm.nih.gov/32491745/

Fremanezumab is now the only CGRP antagonist indicated for prevention of migraine in adults and preventive treatment of episodic migraine in pediatric patients. 

Fremanezumab Label Expanded for Treatment of Episodic Migraine in Children Aged 6 to 17 Years

Roberto Bergamaschi, MD

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