FREQUENTLY ASKED QUESTIONS ABOUT OPZELURA

Indication and Use

OPZELURA is indicated 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.

Limitation of Use:

Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.1

JAK=Janus kinase.

OPZELURA should be used in non-immunocompromised patients with mild to moderate AD 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1

For additional information on the patients that were studied, visit Trial Overview.

For examples of patients who may benefit from OPZELURA, visit Identifying Patients.

AD=atopic dermatitis.

How it works

OPZELURA is a topical JAK inhibitor designed to target signaling of key cytokines believed to be critical to the Th2 response in AD, which contribute to1-4:

  • Itch and inflammation: IL-4, IL-13, IL-31, and TSLP

The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1

To see how OPZELURA works, visit Mechanism of Action.

AD=atopic dermatitis; IL=interleukin; JAK=Janus kinase; TSLP=thymic stromal lymphopoietin.

JAKs are intracellular signaling enzymes that act downstream of many inflammatory cytokines involved in AD pathogenesis.2

AD=atopic dermatitis; JAK=Janus kinase.

> Targets key cytokine signals believed to contribute to itch and inflammation1,6

Relevance to therapeutic effectiveness is not currently known.

> Clear or almost clear skin (IGA 0/1)* in >50% of patients at week 8

(53.8% vs 15.1% and 51.3% vs 7.6% vehicle; P<0.0001)1,6

> Meaningful itch relief (Itch NRS4) in >50% of patients at week 8

(52.2% vs 15.4% and 50.7% vs 16.3% vehicle; P<0.0001)1,6‡

  • Itch NRS4 response seen as early as day 3

  • (18.4% vs 4.2% and 13.2% vs 0% vehicle)7

> Nonsteroidal, injection-free, can be used in sensitive skin areas

§For topical use only. Not for ophthalmic, oral, or intravaginal use. Stop using when signs and symptoms (eg, itch, rash, and redness) of AD resolve. If signs and symptoms do not improve within 8 weeks, patients should be reexamined by their healthcare provider.1

Learn more about the demonstrated Adverse Events Profile of OPZELURA.

*With a ≥2-grade improvement from baseline.1

In TRuE-AD1 and TRuE-AD2, respectively.1,6

≥4-point improvement in NRS among patients with a score of ≥4 at baseline.1

AD=atopic dermatitis; IGA=Investigator's Global Assessment; NRS=numeric rating scale.

How It Was Studied

OPZELURA was studied in 2 identically designed double-blind, randomized, vehicle-controlled trials (TRuE-AD1 and TRuE-AD2). The 2 studies included 1249 adult and adolescent patients ≥12 years of age with an affected BSA of 3%-20% and an IGA score of 2 or 3 on a severity scale of 0-4. Patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks.1,6

To see the results of these trials, visit Efficacy.

BSA=body surface area; IGA=Investigator's Global Assessment.

OPZELURA was studied in adults and adolescents 12 years and older with mild to moderate AD, with an affected BSA of 3%-20% (mean ~10%) and an IGA score of 2 or 3 on a severity scale of 0-4. In fact, 39% of patients had facial involvement at baseline.1

For additional information about how OPZELURA was studied, visit Trial Overview.

AD=atopic dermatitis; BSA=body surface area; IGA=Investigator's Global Assessment.

Efficacy

In the clinical trials, more than 50% of patients achieved IGA-TS as defined by clear to almost clear skin with at least a 2-point improvement from baseline at week 8.1

IGA-TS, or Investigator's Global Assessment Treatment Success, is defined as the achievement of clear (IGA 0) or almost clear (IGA 1) skin with at least a 2-point improvement from baseline.1

See visible results from the clinical trials by visiting Skin Clearance Data.

IGA=Investigator's Global Assessment.

In the clinical trials, more than 50% of patients with an Itch NRS score of at least 4 at baseline achieved a clinically meaningful ≥4-point improvement in daily itch (Itch NRS4) at week 8.1,6

See the impact OPZELURA had on itch by visiting Itch Results.

NRS=numeric rating scale.

Itch NRS4 response was seen as early as day 3 (18.4% vs 4.2% and 13.2% vs 0% vehicle*).7 

Patient-reported change in Itch NRS score was observed as early as day 1 and through day 56.6

See the impact OPZELURA had on itch by visiting Itch Results.

*In TRuE-AD1 and TRuE-AD2, respectively.1,6

NRS=numeric rating scale.

In the clinical trials, more than 60% of patients treated with OPZELURA achieved a ≥75% improvement in lesion extent and severity (EASI-75) by week 8.6

Mild was defined as EASI score 1.1-7.0.8

In TRuE-AD1 and TRuE-AD2, respectively, 46% and 50% of patients on OPZELURA vs 56% and 44% of patients on vehicle had a baseline EASI score of 1.1-7.0.7

See the impact OPZELURA had on disease area and extent by visiting EASI Results.

EASI=Eczema Area and Severity Index.

Safety

The most common adverse reactions (≥1%) were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea.1

Adverse reactions occurring in <1% for OPZELURA vs 0% for vehicle were: neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, staphylococcal infection, and acneiform dermatitis.1

Learn more about the demonstrated Adverse Events Profile of OPZELURA.

See the Important Safety Information below.

Dosing and Application

OPZELURA is applied as a thin layer twice daily to affected skin on up to 20% BSA (no more than 60 g per week).1

For topical use only. Not for ophthalmic, oral, or intravaginal use. Stop using when signs and symptoms (eg, itch, rash, and redness) of AD resolve. If signs and symptoms do not improve within 8 weeks, patients should be reexamined by their healthcare provider.1

Learn more about Dosing and Application.

AD=atopic dermatitis; BSA=body surface area.

OPZELURA is supplied as a 60-g tube.1

Learn more about Dosing and Application.

Patient Support

With the OPZELURA Copay Savings Card, eligible* patients may pay as little as $10 for their prescription.

*Eligibility required. For use only with commercial prescription insurance. The card may not be used if you are enrolled in a government-funded prescription insurance program or if you pay cash for your prescription. Individual out-of-pocket costs may vary. A maximum benefit per tube and per calendar year apply. Must be used for an FDA-approved indication. Additional Terms and Conditions apply.

Learn more about the OPZELURA Copay Savings Card.

We offer additional assistance and support for your patients during treatment.

For more information, contact IncyteCARES.

Our team is available Monday through Friday, 8 AM-8 PM ET. Call us at 1-800-932-1720.

Learn more about IncyteCARES.

References: 1. Opzelura. Prescribing Information. Incyte Corporation; 2021. 2. Kim BS, Howell MD, Sun K, et al. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2019;145(2):572-582. 3. Cevikbas F, Wang X, Akiyama T, et al. A sensory neuron-expressed IL-31 receptor mediates T helper cell-dependent itch: involvement of TRPV 1 and TRPA 1. J Allergy Clin Immunol. 2013;133(2):448-460. 4. Wilson SR, Thé L, Batia LM, et al. The epithelial cell-derived atopic dermatitis cytokine TSLP activates neurons to induce itch. Cell. 2013;155(2):285-295. 5. Smith P, Yao W, Shepard S, et al. Developing a JAK inhibitor for targeted local delivery: ruxolitinib cream. Pharmaceutics. 2021;13(7):1044. doi:10.3390/pharmaceutics13071044. 6. Papp K, Szepietowski JC, Kircik L, et al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021;85(4):863-872. doi:10.1016/j.jaad.2021.04.085. 7. Data on file. Incyte Corporation. 2021. 8. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353-1357.