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. They include topical corticosteroids and topical calcineurin inhibitors.
- 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) has enjoyed its status as the first and only biologic approved for the condition in the US since 2017.
- Janus kinase (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 JAK inhibitors to target several key cytokines in the pathogenesis.
- 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 decisions for the class of JAK inhibitors in atopic dermatitis, including Rinvoq, Olumiant, abrocitinib, and topical ruxolitinib cream. 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 9.8%, and the average probability a drug advances from Phase III is 70%. Drugs, on average, take 7.3 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
12 Adjunctive treatment
14 EPIDEMIOLOGY
14 Prevalence and disease burden
15 MARKETED DRUGS
19 PIPELINE DRUGS
29 KEY REGULATORY EVENTS
29 JAK Inhibitor Safety Concerns vs Rebates: Which Will Impact Atopic Dermatitis Drug Access More?
29 EU Thumbs Up Signals First-Ever Approval For Leo’s Tralokinumab
29 JAK-Inhibitor Review Delays Spur Talk Of US FDA Panel Meeting On Class Safety
30 AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs
30 Pfizer Secures Early Patient Access In UK For Eczema Drug Abrocitinib
30 AbbVie’s Rinvoq Advances Along Aggressive Growth Plan
30 EU Firsts Beckon For Olumiant In Dermatitis & Orfadin For AKU
31 Pfizer Readies Abrocitinib To Take On Dupixent In Eczema
32 PROBABILITY OF SUCCESS
33 LICENSING AND ASSET ACQUISITION DEALS
33 Sanofi Hits M&A Trail Again To Buy UK’s KyMab
33 Allergy Therapeutics Takes First Steps Into Broader Vaccine Field
34 CLINICAL TRIAL LANDSCAPE
35 Sponsors by status
36 Sponsors by phase
37 Recent events
39 DRUG ASSESSMENT MODEL
39 Biologics
41 Janus kinase inhibitors
43 Topical PDE4 inhibitors
45 MARKET DYNAMICS
46 FUTURE TRENDS
46 Despite increasing competition, Dupixent will remain dominant
46 Systemic JAK inhibitors regarded with mixed reviews but increasing excitement
46 Excitement mounts for non-steroidal topical treatment alternatives
48 CONSENSUS FORECASTS
51 RECENT EVENTS AND ANALYST OPINION
51 Lebrikizumab for Atopic Dermatitis (August 16, 2021)
51 RPT193 for Atopic Dermatitis (June 14, 2021)
52 ATI-1777 for Atopic Dermatitis (June 8, 2021)
54 Dupixent for Atopic Dermatitis (March 1, 2021)
56 Dupixent for Atopic Dermatitis (February 27, 2021)
57 Abrocitinib for Atopic Dermatitis (February 26, 2021)
59 Abrocitinib for Atopic Dermatitis (February 26, 2021)
60 Dupixent for Atopic Dermatitis (February 26, 2021)
62 AMG 451 for Atopic Dermatitis (February 18, 2021)
64 Rinvoq for Atopic Dermatitis (December 10, 2020)
66 Abrocitinib for Atopic Dermatitis (November 11, 2020)
68 Etrasimod for Atopic Dermatitis (November 9, 2020)
69 SAR445229 for Atopic Dermatitis (August 11, 2020)
71 Rinvoq for Atopic Dermatitis (July 28, 2020)
72 Rinvoq for Atopic Dermatitis (July 21, 2020)
74 B-244 for Atopic Dermatitis (June 30, 2020)
76 Rinvoq for Atopic Dermatitis (June 18, 2020)
78 Abrocitinib for Atopic Dermatitis (June 10, 2020)
79 Abrocitinib for Atopic Dermatitis (June 3, 2020)
81 ASN002 for Atopic Dermatitis (June 2, 2020)
83 OPA-15406 for Atopic Dermatitis (March 26, 2020)
84 BTX-1204 for Atopic Dermatitis (March 25, 2020)
86 ASN002 for Atopic Dermatitis (March 10, 2020)
89 KEY UPCOMING EVENTS
90 UNMET NEEDS
90 More treatment options
90 Topical nonsteroidals that are more potent
90 Safe and effective oral therapy
90 Effective treatment for younger patients
90 Predictive markers of treatment success
91 BIBLIOGRAPHY
93 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
32 Figure 5: Probability of success in the atopic dermatitis pipeline
34 Figure 6: Clinical trials in atopic dermatitis
34 Figure 7: Top 10 drugs for clinical trials in atopic dermatitis
35 Figure 8: Top 10 companies for clinical trials in atopic dermatitis
35 Figure 9: Trial locations in atopic dermatitis
36 Figure 10: Atopic dermatitis trials sponsors by status
37 Figure 11: Atopic dermatitis trials sponsors by phase
39 Figure 12: Datamonitor Healthcare’s drug assessment summary for atopic dermatitis
45 Figure 13: Market dynamics in atopic dermatitis
46 Figure 14: Future trends in atopic dermatitis
54 Figure 15: ATI-1777 for Atopic Dermatitis (June 8, 2021): Phase IIa – Moderate/Severe AD
57 Figure 16: Dupixent for Atopic Dermatitis (February 27, 2021): Phase III – R668-AD-1652 (≥6 to <12 years old)
62 Figure 17: Dupixent for Atopic Dermatitis (February 26, 2021): Phase III – R668-AD-1652 (≥6 to <12 years old)
64 Figure 18: AMG 451 for Atopic Dermatitis (February 18, 2021): Phase II – 4083-006
66 Figure 19: Rinvoq for Atopic Dermatitis (December 10, 2020): Phase IIIb – Heads Up (vs. Dupilumab)
68 Figure 20: Abrocitinib for Atopic Dermatitis (November 11, 2020): Phase III – JADE REGIMEN
72 Figure 21: Rinvoq for Atopic Dermatitis (July 28, 2020): Phase III – AD-UP (w/Corticosteroids)
74 Figure 22: Rinvoq for Atopic Dermatitis (July 21, 2020): Phase III – MEASURE UP 2
76 Figure 23: B-244 for Atopic Dermatitis (June 30, 2020): Phase II – 001
77 Figure 24: Rinvoq for Atopic Dermatitis (June 18, 2020): Phase III – MEASURE UP 1
79 Figure 25: Abrocitinib for Atopic Dermatitis (June 10, 2020): Phase III – JADE TEEN
81 Figure 26: Abrocitinib for Atopic Dermatitis (June 3, 2020): Phase III – JADE Mono-2
83 Figure 27: ASN002 for Atopic Dermatitis (June 2, 2020): Phase II – Severe Chronic Hand Eczema
84 Figure 28: OPA-15406 for Atopic Dermatitis (March 26, 2020): Phase III – Adults (Japan), Phase III – Pediatric (Japan)
86 Figure 29: BTX-1204 for Atopic Dermatitis (March 25, 2020): Phase II – 1204 Study
88 Figure 30: ASN002 for Atopic Dermatitis (March 10, 2020): Phase IIb – RADIANT
89 Figure 31: 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
48 Table 3: Historical global sales, by drug ($m), 2016–20
49 Table 4: Forecasted global sales, by drug ($m), 2021–25
51 Table 5: Lebrikizumab for Atopic Dermatitis (August 16, 2021)
52 Table 6: RPT193 for Atopic Dermatitis (June 14, 2021)
53 Table 7: ATI-1777 for Atopic Dermatitis (June 8, 2021)
55 Table 8: Dupixent for Atopic Dermatitis (March 1, 2021)
56 Table 9: Dupixent for Atopic Dermatitis (February 27, 2021)
58 Table 10: Abrocitinib for Atopic Dermatitis (February 26, 2021)
59 Table 11: Abrocitinib for Atopic Dermatitis (February 26, 2021)
61 Table 12: Dupixent for Atopic Dermatitis (February 26, 2021)
62 Table 13: AMG 451 for Atopic Dermatitis (February 18, 2021)
65 Table 14: Rinvoq for Atopic Dermatitis (December 10, 2020)
67 Table 15: Abrocitinib for Atopic Dermatitis (November 11, 2020)
68 Table 16: Etrasimod for Atopic Dermatitis (November 9, 2020)
70 Table 17: SAR445229 for Atopic Dermatitis (August 11, 2020)
71 Table 18: Rinvoq for Atopic Dermatitis (July 28, 2020)
73 Table 19: Rinvoq for Atopic Dermatitis (July 21, 2020)
75 Table 20: B-244 for Atopic Dermatitis (June 30, 2020)
76 Table 21: Rinvoq for Atopic Dermatitis (June 18, 2020)
78 Table 22: Abrocitinib for Atopic Dermatitis (June 10, 2020)
80 Table 23: Abrocitinib for Atopic Dermatitis (June 3, 2020)
82 Table 24: ASN002 for Atopic Dermatitis (June 2, 2020)
83 Table 25: OPA-15406 for Atopic Dermatitis (March 26, 2020)
85 Table 26: BTX-1204 for Atopic Dermatitis (March 25, 2020)
87 Table 27: ASN002 for Atopic Dermatitis (March 10, 2020)
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