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. 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 (adalimumab) has long enjoyed status as the preferred first-line biologic for use in psoriatic arthritis 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 (risankizumab) 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 expected in October 2021. UCB has raised the bar, looking at ACR50 in the Phase III BE OPTIMAL and BE COMPLETE studies in psoriatic arthritis, each expected to complete in the second half of 2021.
- In early 2021, AbbVie’s selective JAK inhibitor, Rinvoq (upadacitinib), 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 segments
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 among patients with psoriasis
19 MARKETED DRUGS
26 PIPELINE DRUGS
30 KEY REGULATORY EVENTS
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
30 Merck Matches Sandoz With Canadian Etanercept Indications
31 Cadila Pharma Adds To Indian Biosimilars With Adalimumab
31 Extra Indications Approved For Celltrion’s Remsima SC
31 FDA Approves Mylan’s Humira Biosimilar
31 J&J Bids To Strengthen Simponi’s Pediatric Labeling
33 PROBABILITY OF SUCCESS
34 LICENSING AND ASSET ACQUISITION DEALS
34 Lupin And Mylan Launch Etanercept in Germany
34 Bio-Thera Out-Licenses Golimumab To Russia And CIS
35 CLINICAL TRIAL LANDSCAPE
36 Sponsors by status
37 Sponsors by phase
38 Recent events
39 DRUG ASSESSMENT MODEL
39 Biologics
43 Oral small molecules
44 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
48 CONSENSUS FORECASTS
55 RECENT EVENTS AND ANALYST OPINION
55 Cosentyx for Psoriatic Arthritis (June 2, 2021)
56 Skyrizi for Psoriatic Arthritis (January 5, 2021)
58 BMS-986165 for Psoriatic Arthritis (November 5, 2020)
60 Rinvoq for Psoriatic Arthritis (February 5, 2020)
63 KEY UPCOMING EVENTS
64 UNMET NEEDS
64 Biomarkers for early detection, prognosis, and response to therapy are key
64 Data to inform best treatment strategies are needed
64 Outcomes to optimize clinically relevant measures of disease clearance
65 BIBLIOGRAPHY
67 APPENDIX
LIST OF FIGURES
16 Figure 1: GRAPPA 2021 treatment recommendations by domain
16 Figure 2: EULAR 2019 treatment recommendations by domain
26 Figure 3: Overview of pipeline drugs for psoriatic arthritis in the US
26 Figure 4: Pipeline drugs for psoriatic arthritis, by company
27 Figure 5: Pipeline drugs for psoriatic arthritis, by drug type
27 Figure 6: Pipeline drugs for psoriatic arthritis, by classification
33 Figure 7: Probability of success in the psoriatic arthritis pipeline
35 Figure 8: Clinical trials in psoriatic arthritis
35 Figure 9: Top 10 drugs for clinical trials in psoriatic arthritis
36 Figure 10: Top 10 companies for clinical trials in psoriatic arthritis
36 Figure 11: Trial locations in psoriatic arthritis
37 Figure 12: Psoriatic arthritis trials status
38 Figure 13: Psoriatic arthritis trials sponsors, by phase
39 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
56 Figure 17: Cosentyx for Psoriatic Arthritis (June 2, 2021): Phase III – JPsA and ERA
58 Figure 18: Skyrizi for Psoriatic Arthritis (January 5, 2021): Phase III – KEEPsAKE 1, KEEPsAKE 2
60 Figure 19: BMS-986165 for Psoriatic Arthritis (November 5, 2020): Phase II – IM011-084
62 Figure 20: Rinvoq for Psoriatic Arthritis (February 5, 2020): Phase III – SELECT-PsA-1
63 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
28 Table 4: Pipeline drugs for psoriatic arthritis in the US
49 Table 5: Historical global sales, by drug ($m), 2016–20
52 Table 6: Forecasted global sales, by drug ($m), 2021–25
55 Table 7: Cosentyx for Psoriatic Arthritis (June 2, 2021)
57 Table 8: Skyrizi for Psoriatic Arthritis (January 5, 2021)
59 Table 9: BMS-986165 for Psoriatic Arthritis (November 5, 2020)
60 Table 10: Rinvoq for Psoriatic Arthritis (February 5, 2020)
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