The Food and Drug Administration has approved a new indication for ruxolitnib (Opzelura) for the topical treatment of nonsegmental vitiligo in children and adults ages 12 years and older. Nonsegmental vitiligo is a skin disorder characterized by a loss of pigmentation, or color, of the skin, mucosa, and hair. It is an acquired and progressive disease presumed to be caused by an autoimmune loss of melanocytes. It is frequently associated with other autoimmune diseases. With this disorder, there is a bilateral and symmetrical loss of pigmentation across the body's midline.
Previously, ruxolitnib, a Janus kinase inhibitor, was approved for short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised individuals ages 12 years and older if the condition was not controlled with other topical prescription therapies. Janus kinase inhibitors block the actions of cytokines associated with autoimmunity.
The safety and efficacy of ruxolitnib for the treatment of nonsegmental vitiligo were determined in two randomized, placebo-controlled clinical trials, in which a total of 674 adult and pediatric participants were randomized 2:1 to receive either the drug or placebo for 24 weeks. The primary efficacy end point was a 75% or greater improvement in the facial Vitiligo Area Scoring Index; 30% of those receiving ruxolitnib reached this level of improvement compared with 10% of those receiving placebo.
The most common adverse effects of treatment with ruxolitnib are application site acne, application site itching, common cold, headache, urinary tract infection, application site redness, and fever. Elevated cholesterol levels are also possible. Boxed warnings on ruxolitnib's labeling are associated with the Janus kinase inhibitor drug class and include
* serious infections leading to hospitalization or death, including tuberculosis (pulmonary or extrapulmonary), and bacterial, invasive fungal, viral, and other opportunistic infections.
* a higher rate of all-cause mortality, including sudden cardiovascular death.
* lymphoma and other malignancies.
* a higher rate of major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and stroke.
* thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, which can be fatal.
Nurses caring for patients receiving ruxolitnib should teach them or their caregivers to monitor for signs of infection; any evidence of infection requires prompt medical attention. Periodic skin examination should be performed during treatment to assess for potential skin cancers. Nurses should teach patients to report any signs or symptoms that could be thromboembolic events. Complete blood count monitoring is necessary to confirm that blood counts remain normal; patients should be told to return for these laboratory tests. Nurses should complete a thorough drug history prior to the start of ruxolitnib and throughout therapy, as the use of ruxolitnib in combination with other Janus kinase inhibitors or other potent immunosuppressants is not recommended. If therapy with these drugs is noted, a consultation with the prescriber is warranted.
For complete prescribing information for ruxolitnib, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf.