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, many patients also experience nail lesions.
- Approved drugs in the psoriatic arthritis space focus on a wide variety of targets, with both biologics and oral small molecules integrated into guidelines.
- 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 the 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. In April 2021, Boehringer Ingelheim reported positive topline results from the VOLTAIRE-X study, showing no difference in switching psoriasis patients between its adalimumab biosimilar (Cyltezo) and Humira. Pfizer is also assessing the interchangeability of its Humira biosimilar in rheumatoid arthritis patients.
- Therapies in development for psoriatic arthritis focus on targets such as IL-23, IL-17, selectins, JAK, and TYK2.
- AbbVie has submitted a supplemental filing for IL-23 inhibitor Skyrizi in psoriatic arthritis. Although not beating 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.
- 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, looking at ACR50 in the Phase III BE OPTIMAL and BE COMPLETE studies in psoriatic arthritis.
- In early 2021, AbbVie’s selective JAK inhibitor Rinvoq gained approval for psoriatic arthritis in Europe, while US approval is pending. Comparatively, results seem to position once-daily Rinvoq as more efficacious than twice-daily pan-JAK inhibitor Xeljanz. Importantly, the higher Rinvoq dose achieved superiority to Humira and both doses achieved non-inferiority. Although 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.
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
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
25 PIPELINE DRUGS
29 KEY REGULATORY EVENTS
29 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
29 Scottish Funding Win For Janssen’s Tremfya
29 EU Decision Time On Broader Indication For AbbVie’s Skyrizi
29 JAK Inhibitor Extension Becomes Missed Goal Date
30 AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs
30 Janssen’s Tremfya Gains Psoriatic Arthritis Indication In EU
30 Johnson & Johnson’s Simponi Aria Extends Its Rheumatology Footprint
31 Merck Matches Sandoz With Canadian Etanercept Indications
31 Cadila Pharma Adds To Indian Biosimilars With Adalimumab
32 PROBABILITY OF SUCCESS
33 CLINICAL TRIAL LANDSCAPE
34 Sponsors by status
35 Sponsors by phase
36 Recent events
38 DRUG ASSESSMENT MODEL
38 Biologics
42 Oral small molecules
43 Juvenile psoriatic arthritis
45 MARKET DYNAMICS
46 FUTURE TRENDS
46 TNF inhibitors will remain dominant despite availability of newer classes
46 Branded biologics make way for biosimilar prospects
46 More robust suppression of the IL-17 pathway holds promise
47 CONSENSUS FORECASTS
52 RECENT EVENTS AND ANALYST OPINION
52 Multiple Drugs for Psoriatic Arthritis (PA) (September 1, 2021)
53 Cosentyx for Psoriatic Arthritis (June 2, 2021)
55 Skyrizi for Psoriatic Arthritis (January 5, 2021)
57 BMS-986165 for Psoriatic Arthritis (November 5, 2020)
60 KEY UPCOMING EVENTS
61 UNMET NEEDS
61 Biomarkers for early detection, prognosis, and response to therapy are key
61 Data needed to inform best treatment strategies
61 Outcomes to optimize clinically relevant measures of disease clearance
62 BIBLIOGRAPHY
64 APPENDIX
LIST OF FIGURES
16 Figure 1: GRAPPA 2021 treatment recommendations by domain
16 Figure 2: EULAR 2019 treatment recommendations by domain
25 Figure 3: Overview of pipeline drugs for psoriatic arthritis in the US
25 Figure 4: Pipeline drugs for psoriatic arthritis, by company
26 Figure 5: Pipeline drugs for psoriatic arthritis, by drug type
26 Figure 6: Pipeline drugs for psoriatic arthritis, by classification
32 Figure 7: Probability of success in the psoriatic arthritis pipeline
33 Figure 8: Clinical trials in psoriatic arthritis
33 Figure 9: Top 10 drugs for clinical trials in psoriatic arthritis
34 Figure 10: Top 10 companies for clinical trials in psoriatic arthritis
34 Figure 11: Trial locations in psoriatic arthritis
35 Figure 12: Psoriatic arthritis trials status
36 Figure 13: Psoriatic arthritis trials sponsors, by phase
38 Figure 14: Datamonitor Healthcare’s drug assessment summary for psoriatic arthritis
45 Figure 15: Market dynamics in psoriatic arthritis
46 Figure 16: Future trends in psoriatic arthritis
55 Figure 17: Cosentyx for Psoriatic Arthritis (June 2, 2021): Phase III – JPsA and ERA
57 Figure 18: Skyrizi for Psoriatic Arthritis (January 5, 2021): Phase III – KEEPsAKE 1, KEEPsAKE 2
59 Figure 19: BMS-986165 for Psoriatic Arthritis (November 5, 2020): Phase II – IM011-084
60 Figure 20: 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
27 Table 4: Pipeline drugs for psoriatic arthritis in the US
48 Table 5: Historical global sales, by drug ($m), 2016–20
50 Table 6: Forecasted global sales, by drug ($m), 2021–25
52 Table 7: Multiple Drugs for Psoriatic Arthritis (PA) (September 1, 2021)
54 Table 8: Cosentyx for Psoriatic Arthritis (June 2, 2021)
56 Table 9: Skyrizi for Psoriatic Arthritis (January 5, 2021)
58 Table 10: BMS-986165 for Psoriatic Arthritis (November 5, 2020)
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