(BPT) - At first glance, psoriasis may appear to be only a surface-level condition that affects one’s skin and outward appearance. What many people do not realize is this common, chronic inflammatory disease may lead to the development of psoriatic arthritis in a third of patients. Psoriasis sufferers also may experience an increased risk of diabetes, heart disease or depression.1,2 While there have been many advances in the treatment of psoriasis in the past decade, it is important to call attention to the significant unmet needs of the 125 million people worldwide living with psoriasis.2
Psoriasis is an autoimmune disease that causes rapid build-up of extra skin cells that form thick, silvery scales and itchy, dry red patches.3 But psoriasis is more than a skin disease and can have a negative impact on the psychological and social well-being of those living with psoriatic diseases. This is particularly true for women, as a recent study found that psoriasis can negatively affect women more than men.4 While treatments are continuing to advance, moderate-to-severe psoriasis patients still have unmet needs.
“Research continues to identify the special unmet needs of this patient population and treatments like Cimzia (certolizumab pegol) provide the dermatology community with another effective and durable option for aiding in skin clearance. Because of its efficacy and durability, Cimzia may offer clearer skin that can last,” said Dr. Scott Drew, practicing dermatologist, Dermatology Associates of Mid-Ohio.
Cimzia is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and adults with active psoriatic arthritis. The adverse event profile for all three psoriasis pivotal trials appears consistent with the safety profile for Cimzia in other approved indications. Adverse reactions seen in these trials included upper respiratory tract infections, headache, injection site reactions, cough, and herpes infections.
Patients unable to achieve skin clearance may experience a negative impact on their quality of life.1,2 Psoriasis patients may be 30% or more likely to suffer from depression and often feel self-conscious, helpless, embarrassed, angry, and frustrated about their disease.6,1 Cimzia has been shown to improve quality of life in patients with chronic plaque psoriasis.7
Drew expresses the importance of patients connecting with dermatology teams and supportive communities to help manage their disease. “The needs of patients often go beyond skin clearance. Advocating for oneself and for others can help ease the social burden they often experience and gives one a much-needed sense of community. I encourage my patients to join support groups as well as have open conversations with their dermatologists about their concerns and experiences to help develop a treatment plan that is best for them,” continues Drew.
More information on psoriasis and treatment with Cimzia is available at cimzia.com.
Important Safety Information about CIMZIA® in the US
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.
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.
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.
- Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Exercise caution and monitor carefully.
- 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.
- 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.
- 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.
- Do not use CIMZIA in combination with other biological DMARDS.
- 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.
- Patients on CIMZIA should not receive live or live-attenuated vaccines.
- The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).
For full prescribing information, please visit https://ucb-usa.com/_up/ucb_usa_com_kopie/documents/Cimzia_PI.pdf
1 Choi J, Koo J. Quality of Life Issues in Psoriasis. J AM Acad Dermatol. 2003;49(2):57-61.
2 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause// Accessed August 2019.
3 Mayo Clinic. Psoriasis Overview. Available at: https://www.mayoclinic.org/diseases-conditions/psoriasis/symptoms-causes/syc-20355840 Accessed August 2019.
4 Wu J, et al. The risk of depression, suicidal ideation and suicide attempt in patients with psoriasis, psoriatic arthritis or ankylosing spondylitis. J Eur Acad Dermatol Venereol. 2017;31(7):1168-1175.
5 Feldman SR, et al. Dermatology Online Journal. 2014;20(8).
6 Weiss SC, et al. Quantifying the harmful effect of psoriasis on health-related quality of life. J Am Acad Dermatol. 2002;47:512-51810.
7 Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from two phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314.e6.
CIMZIA® is a registered trademark of the UCB Group of Companies. ©2019 UCB, Inc., Smyrna, GA 30080. All rights reserved.