BRUSSELS, May 29, 2018 /PRNewswire/ --
- The U.S. Food and Drug Administration's (FDA) approval of CIMZIA® (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry of UCB into immuno-dermatology
- CIMZIA Phase 3 psoriasis studies demonstrated significant and clinically meaningful improvements in biologic-naïve patients and those previously treated with biologics, with clinical benefit maintained through 48 weeks and the flexibility of two dose regimens that allow for tailored treatment1
UCB announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for CIMZIA® (certolizumab pegol) to include a new indication in adults with moderate-to-severe plaque psoriasis. CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. The approval makes CIMZIA the first Fc-free, PEGylated anti-TNF treatment option for this indication and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists. The approval also follows a recent FDA label update for CIMZIA in pregnancy and breastfeeding that provides essential information to healthcare professionals and women.
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"The Phase 3 clinical development program for CIMZIA in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16. A clinically meaningful response was maintained up to week 48. This compelling body of evidence is especially significant for a disease like psoriasis, which often has significant emotional and social burdens in addition to the more widely recognized physical symptoms," Alice Gottlieb, M.D., Ph.D., Professor of Dermatology at New York Medical College and lead investigator. "Today's approval provides patients and their healthcare professionals with a robust new biologic option that provides durable disease control. The two dose regimens of CIMZIA also allow for patient-tailored treatment. CIMZIA also demonstrated similar efficacy in both biologic-naïve patients and those previously treated with other biologics."
"CIMZIA is the first Fc-free biologic of its kind approved by the FDA to treat this challenging skin condition, building on 10 years of market experience with demonstrated efficacy and established safety across multiple inflammatory diseases. This approval reflects our heritage of making a difference for specific patient populations with unmet needs, and we are especially gratified to welcome immuno-dermatology patients for the first time to our community of support," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB. "The approval of CIMZIA for psoriasis and the recent CIMZIA label update regarding pregnancy and breastfeeding in women with chronic inflammatory diseases are important treatment advances.UCB is committed to improving care for psoriasis patients and is also investigating bimekizumab, a therapy with significant potential for psoriasis patients."
This FDA approval is based on data from a Phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials enrolled over 1,000 patients, of whom nearly one third had prior biologic exposure, and confirmed the durable efficacy up to 48 weeks and safety of CIMZIA in the treatment of adults with moderate-to-severe plaque psoriasis.1 Each of the three studies included an assessment of the percentage of patients who achieved at least 75% and 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90, respectively) compared to placebo; within 16 weeks in CIMPASI-1 and CIMPASI-2, and within 12 weeks in CIMPACT. CIMPASI-1, CIMPASI-2 and CIMPACT also assessed the percentage of patients who achieved at least a two-point improvement on a five-point Physician's Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. In all three trials, CIMZIA demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses, and the clinical benefit was maintained through to week 48.1 These findings and the new approval in psoriasis that they support are significant because they build on four years of efficacy and safety data in psoriatic arthritis (PsA).2
According to the updated label, the recommended dose of CIMZIA for adults with moderate-to-severe plaque psoriasis is 400 mg (given as two subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤ 90 kg), CIMZIA 400 mg (given as two subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week can be considered.
"Due to the unique nature of psoriasis, it is critical for dermatologists to have as many options as possible to find the right treatment for each patient, said Michael Siegel, Ph.D., Senior Vice President of Research and Clinical Affairs, National Psoriasis Foundation. "It's a great day when new psoriasis treatments come to market, as both dermatologists and patients are given hope that this could be the treatment that will work for them."
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.3
Psoriasis affects nearly three percent of the population, or approximately 125 million people worldwide.3 Symptoms vary from person to person, but for those who are more severely affected, psoriasis can have a major impact on their quality of life.4 As many as 42% of patients with psoriasis will develop psoriatic arthritis,5,6 33% will develop metabolic syndrome,7 and approximately 46% are often or always depressed because of their psoriasis.8 Despite drug development advances in the past decade, patient survey data suggest that moderate-to-severe psoriasis is being undertreated.9
About the CIMPASI-1, CIMPASI-2 and CIMPACT Studies1
CIMPASI-1, CIMPASI-2 and CIMPACT Phase 3 trials each evaluated the efficacy and safety of CIMZIA (certolizumab pegol, CZP) in adults with moderate-to-severe plaque psoriasis. The three trials enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products.
In CIMPASI-1 and CIMPASI-2, at week 16, the response rate for patients who achieved a PASI 75 response was 75% and 82% for patients receiving CZP 400 mg every two weeks (Q2W) and 65% and 81% for patients receiving CZP 200 mg every two weeks (Q2W), compared to 7% and 13% for patients receiving placebo, respectively. The response rate for patients who achieved a PASI 90 response was 44% and 52% for patients receiving CZP 400 mg every Q2W and 36% and 50% for patients receiving CZP 200 mg Q2W, comparted to 0% and 5% for patients receiving placebo, respectively. In addition, the response rates for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale (PGA 0/1) at week 16 was 55% and 65% for CZP 400 Q2W dose-treated subjects, and 45% and 61% for CZP 200 mg Q2W dose-treated patients, compared to 4% and 3% for subjects receiving placebo, respectively. Week 16 PASI 75 responders maintained a PASI 75 response to week 48 in 94% and 81% of patients receiving CZP 400mg Q2W, and 81% and 74% for patients receiving CZP 200 mg Q2W, respectively.
In CIMPACT, the response rate for patients who achieved a PASI 75 response at week 16 was 69% and 75% among patients receiving CZP 400 mg Q2W and CZP 200 mg Q2W, compared to 4% for patients receiving placebo, respectively. The response rate for patients who achieved a PASI 90 at week 16 was 49% and 40% among patients receiving CZP 400 mg Q2W and CZP 200 mg Q2W, compared to 0% for patients receiving placebo. In patients who received CZP 400 mg Q2W and were PASI 75 responders at week 16, 98% maintained their response at week 48. In addition, 80% of patients who received CZP 200 mg Q2W from week 16 maintained their response at week 48.
In all three trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at all treatment doses, and the clinical benefit was maintained through to 48 weeks. The adverse event profile across all three trials appears consistent with the safety profile for CIMZIA in other approved indications. In the placebo-controlled portions of the clinical trials in psoriasis patients, elevated liver enzymes were reported more frequently in the CIMZIA-treated patients than in placebo-treated patients, 4.3% in the 200mg group, 2.3% in the 400mg group, and 2.5% in placebo. Additionally, cases of other psoriasis subtypes were reported (including erythrodermic, pustular, and guttate) in <1% of CIMZIA-treated patients.
About the CRIB Study10
CRIB was a pharmacokinetic study assessing the potential level of placental transfer of certolizumab pegol (CZP) from pregnant women to their infants. The study followed 16 women (≥ 30 weeks gestation) who were already receiving CZP at approved doses. In the US, CIMZIA is not indicated for axial spondylitis (axSpA).
The study found that CZP levels were below the lower limit of quantification (LLOQ = 0.032 micrograms/ML) in 13 out of 15 infant blood samples at birth, and in all samples at weeks four and eight. One infant had a minimal CZP level of 0.042ug/ML, which was 0.09% of the mother's plasma concentration at birth. In a second infant, delivered by emergency Caesarean section, the concentration was 0.485 mcg/mL, which was 4.49% of the mother's plasma concentration at birth. At Week 4 and Week 8, all 15 infants had no measurable concentrations. No anti-CZP antibodies were detected in mothers, umbilical cords, or infants. Among 16 exposed infants, one serious adverse reaction was reported in a neonate who was treated empirically with intravenous antibiotics due to an increased white blood cell count; blood cultures were negative. These data indicate negligible to low placental transfer of CZP from mothers to infants, suggesting minimal in-utero fetal exposure during the third trimester.
About the CRADLE Study4
The primary objectives of the CRADLE pharmacokinetic study were to determine the concentration of CZP in human breast milk and the average daily infant dose, an estimation of the daily dose of maternal CZP ingested by the breastfeeding infant.
Among 137 breast milk samples from 17 mothers, 56% had no measurable CZP; the remaining samples showed minimal levels of CZP. The median of the estimated average daily infant doses was 0.0035 mg/kg/day (range: 0 to 0.01 mg/kg/day). The percentage of the maternal dose (200 mg CIMZIA dosed once every 2 weeks), that reaches an infant ranged from 0.56% to 4.25% based on samples with measurable certolizumab pegol concentration.
In CRADLE, no serious adverse reactions were noted in the 17 infants in the study. Adverse events in mothers exposed to CZP were consistent with the known safety profile of CZP.
About CIMZIA® in the US
CIMZIA® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
CIMZIA® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS).
In addition, it 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. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
IMPORTANT SAFETY INFORMATION
CIMZIA® (certolizumab pegol) is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria.
Risk of Serious Infections and Malignancy
Patients treated with CIMZIA are at an 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. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated 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. Empiric anti-fungal therapy should be considered 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.
The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating 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.
Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.
Treatment with CIMZIA should not be initiated in patients with an active infection, including clinically important localized infections. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with CIMZIA should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.
During controlled and open-labeled portions of CIMZIA studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. During CIMZIA studies of psoriasis, malignancies (excluding non-melanoma skin cancer) were observed corresponding to an incidence rate of 0.5 (0.2, 1.0) per 100 subject-years among a total of 995 subjects who received CIMZIA. In studies of CIMZIA for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA-treated patients and one case of Hodgkin's lymphoma among 1,319 placebo-treated patients. In CIMZIA RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. In the CIMZIA PsO clinical trials (placebo-controlled and open label) there was one case of Hodgkin's lymphoma. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤18 years of age), of which CIMZIA is a member. Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.
Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with CIMZIA, especially in these patient types.
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. CIMZIA has not been formally studied in patients with CHF. Exercise caution when using CIMZIA in patients who have heart failure and monitor them carefully.
Symptoms compatible with hypersensitivity reactions, including angioedema, anaphylactoid reaction, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA administration. Some of these reactions occurred after the first administration of CIMZIA. If such reactions occur, discontinue further administration of CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains 7% of a plastic derived from natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.
Hepatitis B Reactivation
Use of TNF blockers, including CIMZIA, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with CIMZIA. Exercise caution in prescribing CIMZIA for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue CIMZIA and initiate effective anti-viral therapy with appropriate supportive treatment.
Use of TNF blockers, including CIMZIA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA. Exercise caution in considering the use of CIMZIA in patients with these disorders.
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with CIMZIA. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on CIMZIA. Consider discontinuation of CIMZIA therapy in patients with confirmed significant hematologic abnormalities.
An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of CIMZIA in these combinations. Therefore, the combination of CIMZIA with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with CIMZIA. There is no evidence that CIMZIA therapy has an effect on in vivo coagulation. CIMZIA may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.
Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.
Do not administer live vaccines or live-attenuated vaccines concurrently with CIMZIA.
In controlled Crohn's clinical trials, the most common adverse events that occurred in ≥5% of CIMZIA patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA and 7% for placebo.
In controlled RA clinical trials, the most common adverse events that occurred in ≥3% of patients taking CIMZIA 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo), hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo), back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo), pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute bronchitis (3% CIMZIA, 1% placebo), fatigue (3% CIMZIA, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving CIMZIA 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA and 2.5% for placebo.
The safety profile for patients with Psoriatic Arthritis (PsA) treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with CIMZIA.
The safety profile for AS patients treated with CIMZIA was similar to the safety profile seen in patients with RA
The safety profile for PSO patients treated with CIMZIA was similar to the safety profile seen in patients for other approved indications. In the placebo-controlled portions of the clinical trials in psoriasis patients, elevated liver enzymes were reported more frequently in the CIMZIA-treated patients than in placebo-treated patients, 4.3% in the 200mg group, 2.3% in the 400mg group, and 2.5% in placebo. Additionally, cases of other psoriasis subtypes were reported (including erythrodermic, pustular, and guttate) in <1% of CIMZIA-treated patients.
For full prescribing information, please visit www.ucb-usa.com11
CIMZIA® is a registered trademark of the UCB Group of Companies.
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UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology or neurology. With more than 7 500 people in approximately 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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1 UCB data on file.
2 Oliveira Rocha B, et al. Psoriasis: classical and emerging comorbidities. An Bras Dermatol. 2015;90(1):9–20.
3 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause// Last accessed 22 February 2018.
4 Clowse ME, Förger F, Hawng C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76:1890–1896.
5 Mease PJ and Armstrong AW. Managing Patients with Psoriatic Disease: The Diagnosis and Pharmacologic Treatment of Psoriatic Arthritis in Patients with Psoriasis. Drugs. 2014;74(4):423-41.
6 Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64 Suppl 2:ii14-7.
7 Danielsen K, Wilsgaard T, Olsen AO, et al. Elevated odds of metabolic syndrome in psoriasis: a population-based study of age and sex differences*. British Journal of Dermatology. 2015;172:419–427.
8 Weiss SC, Kimball AB, Liewehr DJ, et al. Quantifying the harmful effect of psoriasis on health-related quality of life. J Am Acad Dermatol. 2002;47:512-518.
9 Lebwohl MG, Bachelez H, Barker J, et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol. 2014;70(5):871-881.
10 Mariette X, Förger F, Abraham B, et al. Lack of Placental Transfer of Certolizumab Pegol During Pregnancy: Results from CRIB, a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study. Ann Rheum Dis. 2018:77(2):228-233
11 CIMZIA U.S. Prescribing Information. Available at https://www.ucb-usa.com/_up/ucb_usa_com_kopie/documents/Cimzia_PI.pdf or https://www.cimzia.com/. Accessed May 2018.