The US Food and Drug Administration (FDA) approved several drugs in January 2022 relevant to conditions treated by nurse practitioners and PAs. Approvals include treatments for psoriatic arthritis, atopic dermatitis, insomnia, and seasonal allergic rhinitis.
Skyrizi® for Psoriatic Arthritis
Skyrizi® (risankizumab-rzaa) was approved by the FDA for treatment of psoriatic arthritis (PsA) in adults. Skyrizi has also been approved for treatment of moderate to severe plaque psoriasis.
The approval was based on data from 2 randomized, double-blind, placebo-controlled phase 3 studies that evaluated the safety and efficacy of the interleukin-23 antagonist in patients with PsA who had an inadequate response or were intolerant to biologic therapy and/or nonbiologic disease-modifying antirheumatic drugs.
Results from KEEPsAKE-1 and KEEPsAKE-2 showed that 57.3% and 51.3% of patients, respectively, treated with risankizumab 150 mg achieved American College of Rheumatology (ACR) 20 response at week 24 compared with 34% and 27% of patients who received placebo (P <.001). Risankizumab was also associated with improvements in ACR50 and ACR70 responses at week 24 vs placebo.
The most common adverse reactions reported include upper respiratory infections, headache, fatigue, reactions at the injection site, and tinea infections.
Skyrizi is supplied in a 150 mg/mL single dose pen, 150 mg/mL single-dose prefilled syringe, and 75 mg/0.83 mL single-dose prefilled syringe.
Rinvoq® for Atopic Dermatitis
The FDA has approved oral Rinvoq® (upadacitinib) for treatment of refractory, moderate to severe atopic dermatitis in patients 12 years and older. The approval was based on data collected from 3 randomized, double-blind, phase 3 trials that assessed the safety and efficacy of once daily upadacitinib (15 mg and 30 mg) in 2584 patients.
Efficacy data showed that 60% to 70% of patients treated with upadacitinib 15 mg and 73% to 80% of those treated with upadacitinib 30 mg achieved the coprimary endpoint of 75% improvement in the Eczema Area Severity Index (EASI 75), A significantly higher proportion of patients treated with upadacitinib met key secondary endpoints including EASI 90, EASI 100, and at least a 4-point improvement in the Worst Pruritus Numerical Rating Scale (NRS) at week 16. Patients treated with upadacitinib reported a clinically meaningful reduction in itch as early as day 2.
The most common adverse reactions reported include upper respiratory tract infections, herpes simplex, acne, headache, cough, increased blood creatine phosphokinase, fatigue, myalgia, increased weight, and herpes zoster.
Rinvoq label also includes warnings about the risk of cardiovascular-related events, malignancy, thrombosis, and death. Rinvoq is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Quviviq™ for Insomnia
For adults with insomnia characterized by difficulties with sleep onset or sleep maintenance, Quviviq™ (daridorexant) was approved by the FDA. Quviviq is a dual orexin receptor antagonist that suppresses wake drive by blocking binding of the wake-promoting neuropeptides orexin A and orexin B to its receptors.
The approval was based on data from 2 pivotal phase 3 studies that compared the safety and efficacy of Quviviq to placebo in 1854 patients 18 years and older who experienced insomnia for 3 months. Quviviq use was associated with statistically significant improvements in sleep onset, sleep maintenance, and total sleep time. Reduction in daytime sleepiness was also reported.
The most common adverse reactions reported were headache and fatigue. Quviviq is supplied in 25-mg and 50-mg tablets in 30-count bottles.
Ryaltris™ for Seasonal Allergic Rhinitis
Ryaltris™ (olopatadine hydrochloride, mometasone furoate) was approved by the FDA for the treatment of symptoms associated with seasonal allergic rhinitis in patients 12 years and older. Ryaltris is a prescription nasal spray that delivers 665 µg of olopatadine hydrochloride, an antihistamine, and 25 µg of mometasone furoate corticosteroid in each spray.
Approval was based on data from 2 randomized, double-blind, placebo- and active-controlled phase 3 studies that assessed the safety and efficacy of Ryaltris in 2352 patients.
Patients were randomly assigned to receive 1 of 4 treatments: Ryaltris, olopatadine hydrochloride nasal spray, mometasone furoate nasal spray, or placebo for 2 weeks. The primary endpoint for both studies was the change from baseline in average morning and evening patient-reported 12-hour reflective total nasal symptom score (rTNSS) over the 14-day treatment period.
Ryaltris therapy resulted in statistically significant improvement in rTNSS compared with olopatadine hydrochloride, mometasone furoate, and placebo. However, a statistically significant difference was not observed when Ryaltris was compared with mometasone furoate in Study 1.
The most common adverse reactions reported were dysgeusia, epistaxis, and nasal discomfort. Ryaltris is supplied in a bottle containing 240 metered sprays in addition to 6 initial priming sprays.
Nucala® for Severe Eosinophilic Asthma in Children
The FDA has approved a prefilled syringe of Nucala® (mepolizumab, 40 mg/ 0.4 mL) as add-on maintenance treatment for children aged 6 to 11 years with severe eosinophilic asthma. The new syringe can be used to administer the drug to children every 4 weeks at home or in a physician’s office.
Previously, Nucala was administered only in a physician’s office; caregivers may administer the subcutaneous injection at home if cleared by a clinician.
Nucala is also supplied in 100-mg single-dose vials; for patients aged 12 years and older, 100-mg/mL single-dose prefilled autoinjections and prefilled syringes are available.
1. Skyrizi. Prescribing information. AbbVie; 2022. Accessed January 26, 2022. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf
2. Rinvoq. Prescribing information. AbbVie; 2022. Accessed January 26, 2022. https://www.rxabbvie.com/pdf/rinvoq_pi.pdf
3. Quviviq. Prescribing information. Idorsia Pharmaceuticals Ltd; 2022. Accessed January 26, 2022. https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf
4. Ryaltris. Prescribing information. Glenmark Specialty SA; 2022. Accessed January 26, 2022. https://labeling.seqirus.com/PI/AU/Ryaltris/EN/Ryaltris-Product-Information.pdf
5. Nucala. Prescribing information. GlaxoSmithKline plc; 2022. Accessed January 26, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF