Disease Analysis: Psoriatic Arthritis
Author: Pamela Spicer
Publisher: Datamonitor Healthcare
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Disease Overview
Psoriatic arthritis is grouped with spondyloarthritis and is characterized by inflammation in the spine (spondylitis) and/or joints (arthritis). It is often preceded by a diagnosis of psoriasis by about 10 years. The disease may be characterized by joint pain, swelling, or morning stiffness, and about 80–90% of psoriatic arthritis patients experience nail lesions, which include pitting (dents) and onycholysis (detachment). Around 30% of individuals with psoriasis develop psoriatic arthritis.
Latest key takeaways
- Psoriatic arthritis is often preceded by a diagnosis of psoriasis by about 10 years, with around 30% of individuals with psoriasis developing psoriatic arthritis. Characterized by inflammation in the spine and/or joints, the majority of patients also experience nail lesions.
- TNF-alpha inhibitors are usually recommended fairly quickly after first-line treatment with non-steroidal anti-inflammatory drugs or methotrexate. The choice of TNF inhibitor is driven more by formularies and access rather than by guidelines, which do not recommend one brand over another, with the exception of lending preference to monoclonal antibodies over Enbrel in patients with inflammatory bowel disease and uveitis.
- Approved to treat psoriatic arthritis in 2005, AbbVie’s Humira has long enjoyed status as the preferred first-line biologic due to its efficacy in joint manifestations, along with an ability to help clear the skin, and physicians’ extensive experience with the drug. Biosimilars of Humira have been approved but are not expected to be launched in the US until 2023. In Europe, biosimilar versions of adalimumab were first launched in 2018.
- There are relatively few drugs in the pipeline for psoriatic arthritis, with many labels for psoriatic arthritis being extensions from other indications, like psoriasis.
- AbbVie recently received supplemental approval for IL-23 inhibitor Skyrizi and JAK inhibitor Rinvoq in psoriatic arthritis. Although Skyrizi did not beat TNF inhibitors in musculoskeletal manifestations of psoriatic arthritis, improvement over placebo is enough to ensure that the momentum from psoriasis will spill over into psoriatic arthritis. Additionally, less frequent quarterly dosing coupled with AbbVie’s prominent physician outreach and marketing teams may give Skyrizi an edge over in-class competitors.
- While Rinvoq is not approved for psoriasis, the drug did show improvement in skin disease. In line with prior safety concerns associated with JAK inhibitors, one pulmonary embolism was reported, as was a non-fatal major adverse cardiovascular event.
- UCB’s bimekizumab neutralizes both IL-17A and IL-17F, and has a positive outlook in psoriasis, for which an FDA approval decision is pending. UCB has raised the bar in psoriatic arthritis by looking at ACR50 in the Phase III BE OPTIMAL and BE COMPLETE studies.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Disease definition
8 Diagnosis
9 Symptoms
9 Risk factors
9 Clinical subtypes
10 Patient segmentation
11 Juvenile psoriatic arthritis (JPsA)
12 TREATMENT
12 Topical treatments
12 NSAIDs
12 Corticosteroids
12 Light therapy
12 Traditional oral small molecules
13 Newer oral therapies
13 Biologics
13 Summary of treatment options
14 Guidelines for treatment
17 EPIDEMIOLOGY
17 Psoriatic arthritis prevalence
17 Psoriatic arthritis prevalence in patients with psoriasis
19 MARKETED DRUGS
28 PIPELINE DRUGS
32 KEY REGULATORY EVENTS
32 EMA Reviewing Cardiovascular & Cancer Risk From Five Janus Kinase Inhibitors
32 FDA Approves New Indication For Skyrizi
32 Coherus Promises ‘Compelling Value Proposition’ After US Adalimumab Approval
33 Rinvoq Gets FDA Nod For Active Psoriatic Arthritis
33 Samsung Bioepis Also Faces 2029 Wait For US Etanercept Biosimilar
33 Mochida And Ayumi Launch Unique Humira Biosimilar Formulation In Japan
33 AbbVie’s Skyrizi Wins Positive CHMP Opinion To Treat Active Psoriatic Arthritis
34 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
34 Scottish Funding Win For Janssen’s Tremfya
34 EU Decision Time On Broader Indication For AbbVie’s Skyrizi
35 JAK Inhibitor Extension Becomes Missed Goal Date
35 AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Hikma Adds Remsima SC To Celltrion MENA Collaboration
37 Xbrane Joins Forces With Contract Manufacturer For Cimzia Biosimilar
38 CLINICAL TRIAL LANDSCAPE
39 Sponsors by status
40 Sponsors by phase
41 Recent events
43 DRUG ASSESSMENT MODEL
43 Biologics
47 Oral small molecules
49 Juvenile psoriatic arthritis (JPsA)
50 MARKET DYNAMICS
51 FUTURE TRENDS
51 TNF inhibitors will remain dominant despite the availability of newer classes
51 Branded biologics make way for biosimilar prospects
51 More robust suppression of the IL-17 pathway holds promise
52 CONSENSUS FORECASTS
58 RECENT EVENTS AND ANALYST OPINION
58 Bimzelx for Psoriatic Arthritis (January 21, 2022)
59 Bimzelx for Psoriatic Arthritis (November 19, 2021)
60 Multiple Drugs for Psoriatic Arthritis (PA) (September 1, 2021)
61 Cosentyx for Psoriatic Arthritis (June 2, 2021)
63 Skyrizi for Psoriatic Arthritis (January 5, 2021)
65 BMS-986165 for Psoriatic Arthritis (November 5, 2020)
68 KEY UPCOMING EVENTS
69 KEY OPINION LEADER INSIGHTS
69 Dermatology KOLs present a mixed view on their role in treating co-morbid psoriatic arthritis
69 Biologic treatment selection for psoriasis patients with psoriatic arthritis is somewhat varied
69 Psoriatic arthritis is a primary co-morbidity considered by dermatologists when treating psoriasis
70 The evolution of dermatological conditions will affect the impact of psoriatic arthritis
71 UNMET NEEDS
71 Biomarkers for early detection, prognosis, and response to therapy are key
71 Data needed to inform best treatment strategies
71 Outcomes to optimize clinically relevant measures of disease clearance
72 BIBLIOGRAPHY
74 APPENDIX
LIST OF FIGURES
16 Figure 1: GRAPPA 2021 treatment recommendations by domain
16 Figure 2: EULAR 2019 treatment recommendations by domain
28 Figure 3: Overview of pipeline drugs for psoriatic arthritis in the US
28 Figure 4: Pipeline drugs for psoriatic arthritis, by company
29 Figure 5: Pipeline drugs for psoriatic arthritis, by drug type
29 Figure 6: Pipeline drugs for psoriatic arthritis, by classification
36 Figure 7: Probability of success in the psoriatic arthritis pipeline
38 Figure 8: Clinical trials in psoriatic arthritis
38 Figure 9: Top 10 drugs for clinical trials in psoriatic arthritis
39 Figure 10: Top 10 companies for clinical trials in psoriatic arthritis
39 Figure 11: Trial locations in psoriatic arthritis
40 Figure 12: Psoriatic arthritis trials status
41 Figure 13: Psoriatic arthritis trials sponsors, by phase
43 Figure 14: Datamonitor Healthcare’s drug assessment summary for psoriatic arthritis
50 Figure 15: Market dynamics in psoriatic arthritis
51 Figure 16: Future trends in psoriatic arthritis
60 Figure 17: Bimzelx for Psoriatic Arthritis (November 19, 2021): Phase III – BE OPTIMAL
63 Figure 18: Cosentyx for Psoriatic Arthritis (June 2, 2021): Phase III – JPsA and ERA
65 Figure 19: Skyrizi for Psoriatic Arthritis (January 5, 2021): Phase III – KEEPsAKE 1, KEEPsAKE 2
67 Figure 20: BMS-986165 for Psoriatic Arthritis (November 5, 2020): Phase II – IM011-084
68 Figure 21: Key upcoming events in psoriatic arthritis
LIST OF TABLES
9 Table 1: Differentiation among common forms of arthritis
14 Table 2: Summary of psoriatic arthritis treatment options
20 Table 3: Marketed drugs for psoriatic arthritis
30 Table 4: Pipeline drugs for psoriatic arthritis in the US
53 Table 5: Historical global sales, by drug ($m), 2016–20
56 Table 6: Forecasted global sales, by drug ($m), 2022–26
58 Table 7: Bimzelx for Psoriatic Arthritis (January 21, 2022)
59 Table 8: Bimzelx for Psoriatic Arthritis (November 19, 2021)
60 Table 9: Multiple Drugs for Psoriatic Arthritis (PA) (September 1, 2021)
62 Table 10: Cosentyx for Psoriatic Arthritis (June 2, 2021)
64 Table 11: Skyrizi for Psoriatic Arthritis (January 5, 2021)
66 Table 12: BMS-986165 for Psoriatic Arthritis (November 5, 2020)
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