Assessing the Relationship between Psoriasis and Psoriatic Arthritis

Dr. Braulio Gomez is Head of Dermatology Medical Affairs at UCB, a global biopharmaceutical company. In this Q&A, we discuss with Dr. Gomez the connection between psoriasis and psoriatic arthritis, and learn how UCB aims to optimize treatment options for people living with these diseases.

Please see Important Safety Information including Boxed Warning and full Prescribing Information or visit www.Cimziahcp.com.

What is the relationship between psoriasis and psoriatic arthritis—why are the two often related?

Psoriasis is one of the most common inflammatory diseases; an estimated 125 million people globally live with this condition.¹ Psoriasis is a chronic skin condition with hereditary and autoimmune pathogenesis factors. Although there are a variety of clinical manifestations, 90% of psoriasis cases are psoriasis vulgaris, or plaque psoriasis, which typically presents as chronic plaques on the trunk, extremities, or scalp.² An estimated 40% of patients with psoriasis will develop psoriatic arthritis.³ Early psoriatic arthritis detection and treatment are critical for improving long-term patient outcomes.⁴

While most people are familiar with the externally visible component of psoriasis, the impact of this disease is more than skin deep. Psoriasis is known to have a negative effect on cardiovascular health,⁵ gastrointestinal health,⁶ mental health, and quality of life due to its social impacts, and it can lead to the development of psoriatic arthritis.⁷

Psoriatic arthritis is a chronic inflammatory and musculoskeletal condition that has a range of manifestations—including spondylitis, peripheral arthritis, inflammation of tendons, or inflammation of a whole digit. Symptoms that may occur outside of the joints include uveitis and inflammatory bowel disease.⁸ Some people with psoriatic arthritis may have symptoms of fatigue, limitations in their physical function, and sleep disturbances. They may also experience reduced work capacity and social participation. Additionally, psoriatic arthritis is associated with several chronic comorbidities, including obesity, metabolic diseases, cardiovascular disease, hypertension, and mental health conditions, which can impact treatment decisions.^5,9

Why is early treatment of psoriatic arthritis so important?

In most patients who develop psoriatic arthritis, the skin lesions associated with psoriasis appear prior to or concurrently with the musculoskeletal symptoms of PsA.^6,10 However, the severity of skin disease does not have a strong correlation with the severity of the articular disease.¹⁰ Patients diagnosed with psoriatic arthritis who began treatment early have been shown to fare better in their disease course.¹¹ Early intervention with systemic therapy is the best approach for achieving the major targets of treating psoriatic arthritis, including the reduction of pain, improvement of function, inhibition of joint damage, and maintenance of quality of life.¹² Increasing awareness of the risks of psoriatic arthritis among psoriasis patients may help increase surveillance for this condition, allowing for earlier treatment and potentially reducing symptom burden for patients who have psoriatic arthritis or will progress to having it.⁶

How are psoriasis and psoriatic arthritis currently managed?

Fortunately, several treatments are available for psoriasis and psoriatic arthritis. Psoriasis therapies include non-pharmacological management, over-the-counter and prescription topicals, phototherapy, biologics, and biosimilars.¹³ Therapies for psoriatic arthritis include non-pharmacological management, oral small molecules (MTX, sulfasalazine, cyclosporine, leflunomide, apremilast), TNF inhibitors including CIMZIA^® (certolizumab pegol), IL-23/23 inhibitors, IL-17A inhibitors, JAK/STAT inhibitors, symptomatic therapies, and psoriasis therapies (including topical and other oral therapies).^5,14

CIMZIA is approved for six indications, including the treatment of adult patients with active psoriatic arthritis and the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Current treatment guidelines recommend a “treat to target” approach for psoriatic arthritis, in which an objective outcome is followed at each patient visit and therapeutic treatment is adjusted as needed to achieve a state of low disease activity or remission.⁵ However, a healthcare provider’s treatment determination can be complicated by individual factors, such as non-response to some therapies and heterogeneous presentations of the disease.¹⁰ Caring for psoriatic arthritis is complex, requiring practitioners to estimate which of the approved therapies will benefit their patient the most.⁶

How do we optimize treatment for people with psoriasis and psoriatic arthritis?

Many treatments for the skin lesions of psoriasis may not be adequate in treating the joint involvement of PsA. Anti-TNF treatment, including CIMZIA, may be effective in treating either condition.^9,15 CIMZIA is an anti-TNF that works differently – providing skin improvement while also providing sustained joint symptom relief.^16,17,18 For patients with psoriasis, CIMZIA has been shown to deliver rapid skin clearance improvement that lasts, regardless of prior biologic treatment.^{16, 17,18}

The CIMPASI-1 and CIMPASI-2 Phase 3 multicenter, randomized, double-blinded, placebo-controlled trials studied CIMZIA for the treatment of chronic plaque psoriasis. The co-primary end points at Week 16 in the CIMPASI-1 and CIMPASI-2 studies were PASI 75 and PGA 0 or 1, with >70% of patients responding at Week 16 vs. 7.5% of placebo patients.^17,18 The primary end point in CIMPACT – a 48-week Phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study – was PASI 75 at Week 12. CIMZIA 400 mg Q2W demonstrated numerically higher efficacy results for psoriasis patients than CIMZIA 200 mg Q2W.¹⁷ The PASI 75 analysis is a prespecified pooled efficacy analysis of the CIMPASI-1, CIMPASI-2, and CIMPACT trials. ^17,18 The results of the biologic-experienced PASI 90 data were prespecified in the integrated summary of efficacy analysis but not adjusted for multiplicity. ^17,18

CIMZIA has also been shown to help prevent the progression of joint damage in patients with psoriatic arthritis and provide powerful relief from joint pain and swelling.¹⁶ The primary endpoint of the RAPID-PsA trial was ACR20 at Week 12. The endpoint was achieved in 58% of patients receiving CIMZIA vs 24% of patients receiving placebo (randomized set nonresponder imputation, P<0.001 vs placebo. Imputation is NRI for the primary end point).¹⁶ Weeks 48 through 216 were an open-label extension (OLE) phase of the study.¹⁶ As with any long-term, uncontrolled OLE, there were several limitations with this portion of the study. In the RAPID-PsA trial, 80% of patients assessed radiographically experienced no progression of joint damage over 4 years (CIMZIA 200 mg Q2W; n=98). ¹⁶ The remainder experienced minimal progression. The radiographic primary end point was change from baseline in mTSS at Week 24 (–0.02 with CIMZIA 200 mg Q2W [n=138] vs 0.18 with placebo [n=136] P<0.05).^14,19 Patients treated with CIMZIA 400 mg Q4W did not demonstrate greater inhibition of radiographic progression compared with placebo-treated patients at Week 24.¹⁶

Visit https://www.cimziahcp.com/dermatology/psoriatic-arthritis to learn more about how CIMZIA can provide relief to patients experiencing psoriasis and psoriatic arthritis.

References

1. Griffiths C, van der Walt J, Ashcroft D, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4–e7.
2. Rendon A, Schäkel K. Psoriasis Pathogenesis and Treatment. International Journal of Molecular Sciences. 2019; 20(6):1475. https://doi.org/10.3390/ijms20061475.
3. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423-441. doi:10.1007/s40265-014-0191-y.
4. Gottlieb A, et al. Psoriatic arthritis for dermatologists. J Dermatolog Treat. 2020:31(7):662-679.
5. Ogdie A, et al. Ann Rheum Dis. 2015;74(2):326-332.
6. Fu Y, et al. JAMA Dermatol. 2018;154(12):1417-1423.
7. Zill, J. M., Dirmaier, J., Augustin, M., Dwinger, S., Christalle, E., Härter, M., & Mrowietz, U. (2018). Psychosocial Distress of Patients with Psoriasis: Protocol for an Assessment of Care Needs and the Development of a Supportive Intervention. JMIR research protocols, 7(2), e22. https://doi.org/10.2196/resprot.8490.
8. Ogdie A, Coates LC, Gladman DD. Treatment guidelines in PsA. Rheumatology (Oxford). 2020;59(Suppl 1):i37-i46. doi:10.1093/rheumatology/kez383.
9. Ritchlin CT, Kavanaugh A, Gladman DD, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis. 2009;68(9):1387-1394. doi:10.1136/ard.2008.094946.
10. Tiwari V, Brent LH. PsA. [Updated 2022 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547710/.
11. Olivieri I, D’Angelo S, Palazzi C, Padula A. Advantages in early recognition and treatment of PsA. International Journal of Clinical Rheumatology. 2010;5(4):461-473. doi:10.2217/ijr.10.40.
12. Cunha JS, Qureshi AA, Reginato AM. Management of psoriasis and PsA in a multidisciplinary rheumatology/dermatology clinic. Fed Pract. 2015;32(Suppl 12):14S-20S.
13. Treatments for Psoriatic Disease. National Psoriasis Foundation. https://www.psoriasis.org/treatments-for-psoriatic-disease/. Accessed February 2023.
14. CIMZIA package insert. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125160s270lbl.pdf. Accessed January 2023.
15. Rutkowski D, Chinoy H, Warren RB. The Potential Benefits of Certolizumab Pegol in Patients with Concurrent Psoriatic Arthritis and Chronic Plaque Psoriasis: A Case Series and Review of the Literature. Dermatol Ther (Heidelb). 2019;9(2):373-381. doi:10.1007/s13555-019-0290-5.
16. van der Heijde D, Deodhar A, FitzGerald O, et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4:e000582. doi: 10.1136/rmdopen-2017-000582.
17. Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). Journal of the American Academy of Dermatology. 2018; 10.1016/j.jaad.2018.04.013
18. Gottlieb AB, Blauvelt A, Thaci D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo controlled studies (CIMPASI-1 and CIMPASI-2). Journal of the American Academy of Dermatology. 2018;10.1016/j.jaad.2018.04.012
19. Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73(1):48-55.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

INDICATIONS

CIMZIA is indicated for:

• Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
• Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
• Treatment of adult patients with active psoriatic arthritis (PsA)
• Treatment of adults with active ankylosing spondylitis (AS)
• Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
• Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

IMPORTANT SAFETY INFORMATION (CONT)

CONTRAINDICATIONS

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

SERIOUS INFECTIONS

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

• Do not start CIMZIA during an active infection, including localized infections.
• Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
• If an infection develops, monitor carefully and initiate appropriate therapy.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

• Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
• In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
• In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
• Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
• Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
• Cases of acute and chronic leukemia were reported with TNF blocker use.

HEART FAILURE

• Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

HYPERSENSITIVITY

• Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

HEPATITIS B VIRUS REACTIVATION

• Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
• Test patients for HBV infection before initiating treatment with CIMZIA.
• Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
• Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

NEUROLOGIC REACTIONS

• TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

HEMATOLOGIC REACTIONS

• Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
• Consider stopping CIMZIA if significant hematologic abnormalities occur.

DRUG INTERACTIONS

• Do not use CIMZIA in combination with other biological DMARDs.

AUTOIMMUNITY

• Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

• Patients on CIMZIA should not receive live or live-attenuated vaccines.

ADVERSE REACTIONS

• The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

Please refer to full Prescribing Information.

CIMZIA^® is a registered trademark of the UCB Group of Companies. All other trademarks are the property of their respective holders.

©2023 UCB, Inc., Smyrna, GA 30080.

All rights reserved.

US-P-CZ-PSO-2300051