0%
book appointment

FDA approves Ruxolitinib (Opzelura) for Vitiligo Therapy: A breakthrough in the field of dermatology

Abstract

The Food and Drug Administration (FDA) has authorized Ruxolitinib (Opzelura), as first at-home treatment for non-segmental vitiligo, an autoimmune condition that causes spots and patches of paler skin. Previously, it was used to treat atopic dermatitis, myelofibrosis, essential thrombocythemia, and polycythemia vera. It functions by lowering an individual’s enhanced immune response, gradually promoting the development of new, healthy skin cells, and ultimately reintroducing pigment to the afflicted area. Using this topical lotion twice daily can not only produce even skin tones but also boost patients’ self-esteem because vitiligo can be physically and psychologically upsetting. It is comparatively more efficacious and has a better safety profile than the oral forms of this medicine, although adverse effects such acne, redness, and itching at the application site, inflammation of the throat and nasal passages, headaches and fever have been observed, necessitating the need for observational studies and randomized controlled trials to demonstrate its efficacy and safety.

Action

FDA has approved Opzelura (ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is a topical Janus kinase (JAK) inhibitor currently approved for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Opzelura is the first FDA-approved pharmacologic treatment to address repigmentation in vitiligo patients. Opzelura is applied twice a day to affected areas of up to 10% of the body’s surface area. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks.

Disease or Condition

Nonsegmental vitiligo is the most common form of vitiligo. The condition involves loss of pigment (depigmentation) in patches of skin. Depigmentation may occur on the face, neck, and scalp, and around body openings such as the mouth and genitals, as well as areas that tend to experience rubbing or impact, such as the hands and arms.

Vitiligo is considered to be an autoimmune disorder. In people with vitiligo, the immune system appears to attack the pigment cells (melanocytes) in the skin. Many people with vitiligo are also affected by at least one other autoimmune disorder.

Effectiveness

Safety and effectiveness of Opzelura were demonstrated in two clinical trials, NCT04052425 and NCT04057573. In both trials, subjects with nonsegmental vitiligo were randomized to treatment with Opzelura or placebo cream twice daily for 24 weeks, followed by an additional 28 weeks of treatment with Opzelura for all subjects.

At the end of the 24-week treatment period, 30% of Opzelura patients had at least 75% improvement in the facial Vitiligo Area Scoring Index, compared with 10% of placebo patients.

Safety Information

The most common adverse reactions associated with Opzelura are application site acne, application site itching, common cold, headache, urinary tract infection, application site redness, and fever.

Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have been observed in patients treated with JAK inhibitors for inflammatory conditions.

See full prescribing information for additional information on risks associated with Opzelura.

Designation

Opzelura received priority review for this indication.

link:

https://pmc.ncbi.nlm.nih.gov/articles/PMC9486756/

Linkedin-in Instagram

Book Consultation

Mrs Reshma successfully completed her Bachelor of Science degree in nursing from Kerala University of Health Science, India in 2016. She has more than 7 years of experience in the field of nursing. She has successfully participated in a workshop on objective structured clinical examination at a national level and she has successfully published a research study in knowledge of mothers in the weaning process during her undergraduate degree. Mrs Reshma has served as a medical intensive care nurse at Dr Moopen’s WIMS Medical college (ASTER) in Kerala soon after graduation for a total of three years. She then progressed to serve as a medical surgical nurse at Aspel health care in 2020 for 12 months after which she moved to Dubai, where she started working for two years at One call Doctor Home Health Care in Al Qusais as a registered nurse and medical director. In November 2023, Mrs Reshma joined our team at the Al Rubaie Dermatology Center as registered nurse, and she has done fantastically well in her first year with great feedback from many patients.

Mrs Cruz is one of the most experienced members of our staff with more than 25 years of experience, working in the field of nursing. She is a graduate of St. Paul University Dumaguete in 1997, with a degree of Bachelor of Science in Nursing (BSc Nursing). Soon after graduation, Mrs Cruz took up a post as a junior nurse in the Provincial Hospital located in Dumaguete. She relocated to Dubai in 1999, where she started working at Gulf Medical Center for 3 years and then took up a post at Dr Salah Al-Rubaie Dermatology and Venereology Clinic (now known as Al Rubaie Dermatology Center) in 2003. She is a licensed LASER technician and operates many machines unsupervised including IPL Quantum by Lumenis, Splendor X by Lumenis and Radiofrequency microneedling. Her areas of interest include LASER hair removal, cosmetic and aesthetic dermatology. She is well familiar with all treatments provided at our Center including biological medications used to treat atopic dermatitis, psoriasis and alopecia areata. She is also responsible for provided phototherapy to our patients including through Ultraviolet A, Ultraviolet B and Excimer.

Originally, a dentist by trade, Dr Abeer completed his Bachelor of Dental Surgery (BDS) at the University of Alexandria, Egypt in 1973 before being awarded with the Doctor of Philosophy (PhD) degree in fixed dental prostheses and bridge procedures in 1987. He is the man behind the scenes, ensuring that our services are running up to the standards required and that everyone attending our healthcare facility is leaving with a smile on their face. Dr Abeer has played an important role in developing our new clinic in Jumeirah, as he has applied the final touches to the general design of the facility as well as being instrumental in securing our partnership deals with Esaad and Avène.
Dr Al-Rubaye finished his medical training at the well-known Royal College of Surgeons of Ireland (RCSI-MUB) University in 2015. He has since completed an IHO year at Dubai Health Authority and then started working as a Senior House Officer in core medical specialties at the Royal Wolverhampton NHS Trust where he completed 2 years before achieving Membership of the Royal College of Physicians of the United Kingdom (MRCP-London). He has then served 4 years as a dermatology registrar rotating in New Cross Hospital, Walsall Manor Hospital and Cannock Chase Hospital in the West Midlands during which he completed the Specialty Certificate Examination in Dermatology. Dr Al-Rubaye worked as a senior specialist dermatologist at Health Harmonie Group – Birmingham, regularly doing medical dermatology and surgical dermatology clinics in Birmingham, Stoke and Shrewsbury. He holds a post graduate diploma in clinical dermatology (PGDip-Clinical Dermatology) with Merit from Queens Mary University in London and he has a master’s in clinical dermatology (MSc Clinical Dermatology) with distinction from Cardiff University during which he finished as one of the top students in his class. Dr Al-Rubaye holds the American Board of Aesthetic Medicine and is an expert in LASER treatments, Radiofrequency, BOTOX and non-surgical lip enhancements and facial contouring. He has published more than 15 review articles in international and peer reviewed journals. Dr Al-Rubaye is a regular attender of national and international conferences, and he is a regular presenter at the Dubai World Dermatology and LASER Conference & Exhibition (DUBAI DERMA).

Dr Salah is one of the most distinguished and famous dermatologists in Dubai and highly regarded as the go to skin specialist for complicated cases in this city. He has served as a consultant dermatologist at Rashid Hospital for 20 years during which he trained hundreds of aspiring physicians and dermatologists, many of which continued their careers successfully in the country and internationally. A University of Baghdad graduate originally, Dr Salah continued his career in Egypt where he achieved a diploma in clinical dermatology with distinction followed by a masters in dermatology and an MD Doctorate in dermatology at Cairo University (Kasr Al-Ainy) School of Medicine. He then continued his medical career in New York where he completed a fellowship in dermatopathology at the world renown New York University (NYU) and affiliated hospital. He has published more than 70 different clinical research papers both locally and internationally, as well as hundreds of oral presentations in the United Arab Emirates, France, China, Italy, and the United Kingdom. His areas of interest include biological medications in the treatment of Atopic Dermatitis, Psoriasis and Alopecia Areata. His oral presentations and talks have covered many different topics including LASER’s and genodermatosis as well as chronic dermatological diseases such as Acne vulgaris, Atopic dermatitis, Hair loss, and Psoriasis. Dr Salah has been recognised on an international level and he has been chosen as the “Man of the Year” by the Marquis Who’s Who in the World in 1999 and “Man of the Year” by the Marquis Who’s Who in Science and Engineering from 2000-2001. Dr Al-Rubaie opened the doors to his private practice in Dubai in 2003 and has relocated in 2023 to Jumeirah. He is an active member of the American Academy of Dermatology from 1985 – present and his 3 decades of membership have been valued and rewarded as he is a fellow of the American Academy of Dermatology (FAAD). He has also been a member of the European Academy of Dermatology and Venereology (EADV) for almost 3 decades.