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Help her get all she can from anti-TNFs with CIMZIA

Clinical response was 63% (n=215) for CIMZIA patients with moderate-to-severe CD vs. 36% (n=210) for placebo patients, based on a 26-week study in which all patients received CIMZIA 400 mg at 0, 2, and 4 weeks, and Week 6 responders were randomized to CIMZIA 400 mg or placebo every 4 weeks.1

CD: Crohn’s disease; TNF: tumor necrosis factor.

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PEGylated Fab

CIMZIA inhibits TNF-alpha at low concentrations with a high affinity.1

PEGylation changes the physical and chemical properties of the biochemical molecule.4

  • Increases bioavailability of CIMZIA5,6
  • Extends half-life of antigen-binding fragment1,7
  • Increases drug stability and retention time, thereby allowing a reduced dosing frequency4,7

Clinical relevance of in vitro and in vivo data is unknown.

The only Fc-free, PEGylated, monoclonal antibody fragment for patients with CD2,3,7,8

 Fc-free, PEGylated
Chimeric human/mouse antibody imageFull human antibody image

The visual images do not imply comparable safety, efficacy, or indication.

Clinical relevance of in vitro findings is unknown.

CD: Crohn’s disease; Fab: fragment antigen binding; Fc: fragment crystallizable; IgG1: immunoglobulin G1; PEG: polyethylene glycol; TNF: tumor necrosis factor.

Choose CIMZIA when response or remission is a goal1,9

Clinical response in Week 6 responders at Week 26 (ITT-NRI)1,9*†

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Clinical response in Week 6 responders at Week 26 (ITT-NRI)1,10*†

Clinical remission in Week 6 responders at Week 26 (ITT-NRI)1,9*†

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Clinical remission in Week 6 responders at Week 26 (ITT-NRI)1,10*†
  • Clinical response was defined as a ≥100-point reduction in CDAI
  • Clinical remission was defined as an absolute CDAI score ≤150
IMPORTANT SAFETY INFORMATION

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. 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.

* Overall clinical response (decrease in CDAI ≥100 from baseline) and remission (CDAI ≤150) at Week 26 were prespecified secondary end points in PRECiSE 2.91,9
All patients received open-label CIMZIA 400 mg at Weeks 0, 2, and 4.1,9

CIMZIA produced clinical responses in bio-naïve and bio-experienced patients9‡

The result of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocol.

Among Week 6 responders9

Bio-naïve

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69% vs. 40% circles image

Bio-experienced

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  • Patients with severe hypersensitivity or anaphylactic reaction and patients who were primary failures to previous anti-TNF therapy were excluded from PRECiSE 29
Clinical response was defined as a ≥100-point reduction in CDAI score.9

CDAI: Crohn’s Disease Activity Index; ITT-NRI: intent-to-treat non-responder imputation; Q4W: once every 4 weeks; TNF: tumor necrosis factor.

Diagnosed with moderate-to-severe CD:

3 years ago at age 22

Started corticosteroids:

1 year ago

Top priority:

Work

(without worrying about symptoms)

Chloe's clinical and treatment history

Diagnosis

  • Diagnosed with moderate-to-severe CD 3 years ago at age 22
  • CD was interfering with finishing her senior year of college and with her active social life

Presenting signs
and symptoms

  • 5 to 6 liquid or soft stools per day, despite antidiarrheals
  • Mild-to-moderate abdominal pain weekly
  • Poor well-being: daily fevers, mucosal lesions, pain, and tenderness
  • Impacting quality of life and ability to work

Clinical workup

  • Blood test revealed anemia
  • Fecal test positive for blood
  • C. difficile negative
  • Colonoscopy revealed several mucosal lesions in ileum

Treatment history

  • Started on a course of corticosteriods, which initially improved her symptoms 
  • Repeat courses over 1 year were not sufficient to sustain remission

The patient presented in this case example represents a patient profile and not an actual patient.

Therapeutic goals for supporting Chloe’s future

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Rapid relief and durable improvement in signs and symptoms

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Achievement of clinical remission/mucosal response

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Ability to return to active lifestyle to focus on her career

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Potential for controlling CD as she and her fiancé plan for their future together

Choose CIMZIA when response or remission is a goal1,9

Clinical response in Week 6 responders at Week 26 (ITT-NRI)1,9*†

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Clinical response in Week 6 responders at Week 26 (ITT-NRI)9

Clinical remission in Week 6 responders at Week 26 (ITT-NRI)1,9*†

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Clinical remission in Week 6 responders at Week 26 (ITT-NRI)9
  • Clinical response was defined as a ≥100-point reduction in CDAI1,9
  • Clinical remission was defined as an absolute CDAI score ≤1501,9
IMPORTANT SAFETY INFORMATION

Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including children, adolescents, and young adults. Acute and chronic cases of leukemia have also been reported. 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. 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.

* Overall clinical response (decrease in CDAI ≥100 from baseline) and remission (CDAI ≤150) at Week 26 were prespecified secondary end points in PRECiSE 2.9
All patients received open-label CIMZIA 400 mg at Weeks 0, 2, and 4.1,9

Bio-naïve response among Week 6 responders9

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The result of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocol.

The loading dose is key to quickly reaching therapeutic drug levels

PRECiSE 2 open-label loading dose9

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PRECiSE 2 study chart 

percent

of all patients (N=668) achieved clinical response by Week 6

  • All patients received CIMZIA 400 mg at Weeks 0, 2, and 49
  • Clinical response was defined as a ≥100-point reduction in CDAI9
  • These results should be interpreted with caution as there is a limited ability to evaluate treatment effect due to the open-label, single-arm study design that lacked a placebo control or active comparator during induction
  • Patients were evaluated for clinical response at Week 6, and responders were then randomized to CIMZIA treatment or placebo9
IMPORTANT SAFETY INFORMATION

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.

Symptom relief in CIMZIA patients at Week 610

Post hoc analysis of PRECiSE 2

CDAI subscore improvement after the initial loading dose among Week 6 clinical responders (n=425)10

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CDAI subscore improvement after the initial loading dose among Week 6 clinical responders (n=425)11

chart

The results of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocol

  • CDAI is a weighted, composite index of 8 items: stool frequency, severity of abdominal pain, degree of well-being, presence or absence of extraintestinal manifestations or fistula, use/nonuse of antidiarrheal agents, presence/absence of an abdominal mass, hematocrit, and body weight11
  • Total mean CDAI reduction at 6 weeks was 57%10

CD: Crohn’s disease; CDAI: Crohn’s Disease Activity Index; ITT-NRI: intent-to-treat non-responder imputation; Q4W: every 4 weeks.

While on anti-TNF therapy,

Eliza lost response

Therapeutic status:

Bio-experienced

Top priority:

Response and remission, with the convenience of at-home dosing

Eliza lost response to her first-line anti-TNF therapy

Eliza previously responded to infliximab

CIMZIA produced significant clinical response at Week 26 among Week 6 responders in the overall population of PRECiSE 2.9*

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Bio-Naïve9

69% of CIMZIA patients (n=163) vs. 40% of placebo patients (n=150) produced significant clinical response at Week 26 among bio-naïve Week 6 responders in PRECiSE 2 (P<0.001).

BIO-EXPERIENCED9

44% of CIMZIA patients (n=52) vs. 25% of placebo patients (n=51) produced significant clinical response at Week 26 among bio-experienced Week 6 responders in PRECiSE 2 (P=0.02).

  • Patients with severe hypersensitivity or anaphylactic reaction and patients who were primary failures to previous anti-TNF therapy were excluded from PRECiSE 29

The result of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocol.

*Clinical response was defined as a ≥100-point reduction in CDAI score. 

CIMZIA has the ability to provide a response in bio-experienced patients previously on infliximab12

WELCOME open-label study—clinical response and remission over time

Clinical response and remission with CIMZIA in patients who lost
response and/or experienced hypersensitivity to infliximab (N=539)12†‡

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WELCOME study chart 

CIMZIA may offer a clinical response by Week 612

CIMZIA may offer a clinical response by Week 613

  • In the WELCOME study, all patients who had a clinical response (≥100-point decrease in CDAI score) to CIMZIA had a previous clinical response to anti-TNF therapy, but were no longer adequately responding and/or had developed hypersensitivity12
  • The results of the WELCOME study should be interpreted with caution as there is a limited ability to evaluate treatment effect due to the open-label, single-arm study design that lacked a placebo control or active comparator during induction

Clinical response defined as decrease from baseline in CDAI score ≥100. Primary end point was clinical response at Week 6. The same patients may not have responded at each time point.12

Clinical remission defined as CDAI score ≤150.12

Important Safety Information

Anaphylaxis or serious allergic reactions may occur. Some of these reactions occurred after the first administration of CIMZIA. Hypersensitivity reactions have been reported rarely following CIMZIA administration. 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.

WELCOME study design12:

WELCOME was a Phase 3b, multicenter, open-label induction and randomized, double-blind, maintenance-phase, active control clinical study in 539 adult patients with active CD, defined as a CDAI score of 220 to 450, who were no longer adequately responding or had developed hypersensitivity to infliximab. All patients received CIMZIA 400 mg administered at Weeks 0, 2, and 4. Patients with a clinical response at Week 6 (CDAI score reduction by ≥100 points from baseline) were randomized to either CIMZIA 400 mg every 4 weeks or 400 mg every 2 weeks until Week 26. If patients in either treatment group experienced a loss of response, they were permitted to receive open-label treatment with CIMZIA 400 mg every 2 weeks. The primary end point was clinical response at Week 6, defined as a reduction of ≥100 points in CDAI score.

CD: Crohn’s disease; CDAI: Crohn’s Disease Activity Index; TNF: tumor necrosis factor.

CIMZIA improved CDEIS score by Week 1013

MUSIC (open-label study): Mean CDEIS score in a subpopulation with endoscopic assessment at Week 10 (n=78)13

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MUSIC (open-label study chart)
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MUSIC (open-label study chart)

The results of the MUSIC trial should be interpreted with caution as there is a limited ability to evaluate treatment effect due to the open-label, single-arm study design that lacked a placebo control or active comparator during induction.

CDEIS is an instrument developed to evaluate changes in endoscopic severity based on characteristics of the ileocolonic mucosa.13

  • 5 segments of the bowel (ileum, right colon, transverse colon, combined sigmoid and left colon, and rectum) were evaluated by presence of deep ulcerations, presence of superficial ulcerations, surface of ulcerations, surface of lesions, and presence of stenosis13
  • CDEIS scores ranged from 0-44, with higher scores indicating greater endoscopic severity13

IMPORTANT SAFETY INFORMATION

Use of TNF blockers, including CIMZIA, has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal.

Mucosal responses were achieved with CIMZIA

Subpopulation of CIMZIA patients with active CD and endoscopic assessment at Week 10 (n=78)13

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CIMZIA assessment at Week 10 chart

percent

percent

Mean (SD) CDEIS scores evaluated at Week 10 (n=78)13:

  • Baseline: 14.7 (5.3)
  • Week 10: 8.3 (6.0)

Rates of endoscopic response, remission, and complete remission at Week 10 were secondary end points of the MUSIC study.13

MUSIC study design13:

MUSIC was a Phase 3b, multicenter, open-label, single-arm clinical trial in 89 adult patients with moderate-to-severe ileocolonic CD. Patients had ulceration in ≥2 intestinal segments with a CDEIS score ≥8 points and active CD for ≥3 months. All patients received CIMZIA 400 mg administered at Weeks 0, 2, and 4, and then every 4 weeks until Week 52. At Week 10, patients who did not achieve a clinical response or remission increased their CIMZIA dose frequency to 400 mg every 2 weeks. In addition, patients who lost clinical response after Week 10 switched to CIMZIA 400 mg every 2 weeks. The primary end point was mean change in CDEIS score from baseline to Week 10.

CD: Crohn’s disease; CDEIS: Crohn’s Disease Endoscopic Index of Severity; SD: standard deviation.

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13 years

Over >937K patient-years of cumulative market experience worldwide10*

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Studied in humans for over 20 years

* Patient exposure was estimated using the available sales data from 01 Sept 2007 to 28 Feb 2019 for the cumulative time interval. The exposure of certolizumab pegol was calculated using the following formula: Patient-years = ([total mg of product distributed]/[monthly maintenance dose])/12 months in year.

6 FDA-approved indications1

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Evaluated in more than 80 clinical trials across indications

Includes approved indications for RA, CD, PsA, AS, PSO and nr-axSpA, as well as other completed and ongoing research.

6 FDA-approved indications1

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CIMZIA Multiple Indications

Supporting patients worldwide for over a decade across 6 indications1

PRECiSE 2 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial in 668 adult patients with active CD defined as a CDAI score of 220 to 450. All patients received CIMZIA 400 mg administered at Weeks 0, 2, and 4. Patients with a clinical response at Week 6 (CDAI score reduction of ≥100 points from baseline) were randomized to receive either CIMZIA 400 mg or placebo every 4 weeks to Week 24 with a follow-up visit scheduled for Week 26. Clinical remission was defined as a CDAI score of ≤150. The primary end point was a clinical response at Week 26 in patients with a baseline CRP level of ≥10 mg/dL.9

AS: ankylosing spondylitis; CD: Crohn’s disease; CDAI: Crohn’s Disease Activity Index; nr-axSpA: non-radiographic axial spondyloarthritis; PsA: psoriatic arthritis; PSO: plaque psoriasis; RA: rheumatoid arthritis.

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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.