Disease Analysis Atopic Dermatitis
Author: Pammy Spicer
Publisher: Datamonitor Healthcare
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Disease Overview
Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic, relapsing inflammator dermatological condition. The condition usually begins during early infancy and childhood, but can persist into, or start during, adulthood. AD usually fluctuates between periods of relative flares and quiescence; however, some individuals have chronically active disease.
Latest key takeaways
- The Global Burden of Disease study estimated that in 2019 there were approximately 171.2 million prevalent cases of atopic dermatitis worldwide, however, the exact definition used to arrive at this estimate was not clear.
- Topical agents are considered as a primary treatment for mild-to-moderate atopic dermatitis. Most commonly, they comprise topical corticosteroids and topical calcineurin inhibitors. Branded options also include the topical PDE4 inhibitor Eucrisa, while topical Janus kinase (JAK) inhibitor Opzelura represents a newer therapy.
- The Th2 immune axis has been identified as a major pathway in the pathogenesis of atopic dermatitis. Sanofi and Regeneron’s IL-4 receptor alpha antagonist Dupixent (dupilumab) enjoyed its status as the first and only biologic approved for the condition in the US from 2017 until the end of 2021, when Adbry (tralokinumab), an antibody that targets the IL-13 cytokine, also gained approval. However, stronger efficacy and familiarity will ensure that Dupixent remains the first-line biologic of choice for atopic dermatitis.
- JAK inhibitors are regarded with cautious optimism by dermatologists for the treatment of atopic dermatitis due to the heterogenous nature of the disease and the ability for these drugs to target several key cytokines in the pathogenesis. However, safety concerns will relegate these convenient oral therapies to later lines of treatment, where they will be used after an inadequate response to gold-standard Dupixent.
- Results from the Heads Up study showed that Rinvoq achieved superiority to Dupixent on the primary endpoint – the proportion of patients with at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 16 – in adults with moderate-to-severe atopic dermatitis.
- High-impact upcoming events include the delayed FDA decision for Olumiant. Looking further ahead, Arcutis expects topline data from the pivotal INTEGUMENT-1 and -2 studies of ARQ-151 in the second half of 2022.
- The overall likelihood of approval of a Phase I atopic dermatitis asset is 12.5%, and the average probability a drug advances from Phase III is 70%. Drugs, on average, take 9.0 years from Phase I to approval in the atopic dermatitis space.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Disease definition
9 Patient segmentation
9 Symptoms
9 Risk factors
9 Diagnosis
10 Variation in clinical characteristics by age and geography
11 TREATMENT
11 Non-pharmacologic interventions
11 Medications
12 Systemic treatment
12 Biologic therapy
12 Phototherapy treatment
13 Adjunctive treatment
14 EPIDEMIOLOGY
14 Prevalence and disease burden
15 MARKETED DRUGS
19 PIPELINE DRUGS
30 KEY REGULATORY EVENTS
30 EMA Reviewing Cardiovascular & Cancer Risk From Five Janus Kinase Inhibitors
30 Lilly Says Safety Not A Factor In Issues With Atopic Dermatitis Filing In US
30 Scottish Medicines Consortium OKs Leo Pharma’s Adtralza
30 Pfizer And AbbVie JAKs Finally Join Dupixent In US Atopic Dermatitis Space
31 FDA Approves LEO Pharma’s Adbry
31 Cibinqo Receives Positive CHMP Opinion
31 Incyte Plays Down Ruxolitinib Cream Label Worries Following Atopic Dermatitis Approval
32 JAK Inhibitor Safety Concerns vs Rebates: Which Will Impact Atopic Dermatitis Drug Access More?
32 EU Thumbs Up Signals First-Ever Approval For Leo’s Tralokinumab
33 JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety
33 AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs
34 PROBABILITY OF SUCCESS
35 LICENSING AND ASSET ACQUISITION DEALS
35 Pfizer Buys Arena For $6.7bn In Bid To Diversify In Inflammation & Immunology
35 KoBioLabs, SPH Sine Ink $107.25m Microbiome Therapeutics Deal
35 Union Inks China Deal For Promising Skin Drug Orismilast
36 CLINICAL TRIAL LANDSCAPE
37 Sponsors by status
38 Sponsors by phase
39 Recent events
43 DRUG ASSESSMENT MODEL
43 Biologics
45 Janus kinase inhibitors
47 Topical PDE4 inhibitors
49 MARKET DYNAMICS
50 FUTURE TRENDS
50 Despite increasing competition, Dupixent will remain dominant
50 Systemic JAK inhibitors regarded with mixed reviews but increasing excitement
50 Excitement mounts for non-steroidal topical treatment alternatives
52 CONSENSUS FORECASTS
55 RECENT EVENTS AND ANALYST OPINION
55 Lebrikizumab for Atopic Dermatitis (March 26, 2022)
56 B-244 for Atopic Dermatitis (February 22, 2022)
57 Olumiant for Atopic Dermatitis (January 28, 2022)
59 CBP-201 for Atopic Dermatitis (November 18, 2021)
60 ASLAN004 for Atopic Dermatitis (September 27, 2021)
62 Multiple Drugs for Atopic Dermatitis (September 1, 2021)
63 Lebrikizumab for Atopic Dermatitis (August 16, 2021)
64 RPT193 for Atopic Dermatitis (June 14, 2021)
65 ATI-1777 for Atopic Dermatitis (June 8, 2021)
67 Oral Difelikefalin for Atopic Dermatitis (April 29, 2021)
69 Dupixent for Atopic Dermatitis (March 1, 2021)
70 Dupixent for Atopic Dermatitis (February 27, 2021)
72 Abrocitinib for Atopic Dermatitis (February 26, 2021)
73 Abrocitinib for Atopic Dermatitis (February 26, 2021)
75 Dupixent for Atopic Dermatitis (February 26, 2021)
76 AMG 451 for Atopic Dermatitis (February 18, 2021)
78 Rinvoq for Atopic Dermatitis (December 10, 2020)
79 Abrocitinib for Atopic Dermatitis (November 11, 2020)
81 Etrasimod for Atopic Dermatitis (November 9, 2020)
83 KEY UPCOMING EVENTS
84 KEY OPINION LEADER INSIGHTS
86 UNMET NEEDS
86 More treatment options
86 Topical nonsteroidals that are more potent
86 Safe and effective oral therapy
86 Effective treatment for younger patients
86 Predictive markers of treatment success
87 BIBLIOGRAPHY
89 APPENDIX
LIST OF FIGURES
19 Figure 1: Overview of pipeline drugs for atopic dermatitis in the US
19 Figure 2: Pipeline drugs for atopic dermatitis, by company
20 Figure 3: Pipeline drugs for atopic dermatitis, by drug type
20 Figure 4: Pipeline drugs for atopic dermatitis, by classification
34 Figure 5: Probability of success in the atopic dermatitis pipeline
36 Figure 6: Clinical trials in atopic dermatitis
36 Figure 7: Top 10 drugs for clinical trials in atopic dermatitis
37 Figure 8: Top 10 companies for clinical trials in atopic dermatitis
37 Figure 9: Trial locations in atopic dermatitis
38 Figure 10: Atopic dermatitis trials status
39 Figure 11: Atopic dermatitis trials sponsors, by phase
43 Figure 12: Datamonitor Healthcare’s drug assessment summary for atopic dermatitis
49 Figure 13: Market dynamics in atopic dermatitis
50 Figure 14: Future trends in atopic dermatitis
56 Figure 15: Lebrikizumab for Atopic Dermatitis (March 26, 2022): Phase III – ADvocate1, Phase III – ADvocate2
60 Figure 16: CBP-201 for Atopic Dermatitis (November 18, 2021): Phase IIb – CBP-201-WW001
62 Figure 17: ASLAN004 for Atopic Dermatitis (September 27, 2021): Phase I – SAD/MAD (Singapore, Australia, and U.S.)
67 Figure 18: ATI-1777 for Atopic Dermatitis (June 8, 2021): Phase IIa – Moderate/Severe AD
69 Figure 19: Oral Difelikefalin for Atopic Dermatitis (April 29, 2021): Phase II – KARE
72 Figure 20: Dupixent for Atopic Dermatitis (February 27, 2021): Phase III – R668-AD-1652 (≥6 to <12 years old)
76 Figure 21: Dupixent for Atopic Dermatitis (February 26, 2021): Phase III – R668-AD-1652 (≥6 to <12 years old)
78 Figure 22: AMG 451 for Atopic Dermatitis (February 18, 2021): Phase II – 4083-006
79 Figure 23: Rinvoq for Atopic Dermatitis (December 10, 2020): Phase IIIb – Heads Up (vs. Dupilumab)
81 Figure 24: Abrocitinib for Atopic Dermatitis (November 11, 2020): Phase III – JADE REGIMEN
83 Figure 25: Key upcoming events in atopic dermatitis
LIST OF TABLES
16 Table 1: Marketed drugs for atopic dermatitis
21 Table 2: Pipeline drugs for atopic dermatitis in the US
52 Table 3: Historical global sales, by drug ($m), 2016–20
53 Table 4: Forecasted global sales, by drug ($m), 2022–26
55 Table 5: Lebrikizumab for Atopic Dermatitis (March 26, 2022)
57 Table 6: B-244 for Atopic Dermatitis (February 22, 2022)
58 Table 7: Olumiant for Atopic Dermatitis (January 28, 2022)
59 Table 8: CBP-201 for Atopic Dermatitis (November 18, 2021)
60 Table 9: ASLAN004 for Atopic Dermatitis (September 27, 2021)
62 Table 10: Multiple Drugs for Atopic Dermatitis (September 1, 2021)
64 Table 11: Lebrikizumab for Atopic Dermatitis (August 16, 2021)
65 Table 12: RPT193 for Atopic Dermatitis (June 14, 2021)
66 Table 13: ATI-1777 for Atopic Dermatitis (June 8, 2021)
68 Table 14: Oral Difelikefalin for Atopic Dermatitis (April 29, 2021)
70 Table 15: Dupixent for Atopic Dermatitis (March 1, 2021)
71 Table 16: Dupixent for Atopic Dermatitis (February 27, 2021)
72 Table 17: Abrocitinib for Atopic Dermatitis (February 26, 2021)
74 Table 18: Abrocitinib for Atopic Dermatitis (February 26, 2021)
75 Table 19: Dupixent for Atopic Dermatitis (February 26, 2021)
76 Table 20: AMG 451 for Atopic Dermatitis (February 18, 2021)
78 Table 21: Rinvoq for Atopic Dermatitis (December 10, 2020)
80 Table 22: Abrocitinib for Atopic Dermatitis (November 11, 2020)
81 Table 23: Etrasimod for Atopic Dermatitis (November 9, 2020)
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