Certolizumab Pegol (Monograph)
Brand name: Cimzia
Drug class: Tumor Necrosis Factor Inhibitors, Miscellaneous
Warning
- Serious Infections
-
Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death; tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections (may be disseminated), bacterial (e.g., legionellosis, listeriosis) and viral infections, and other opportunistic infections reported.1 6 24 (See Infectious Complications under Cautions.)
-
Carefully consider risks and benefits prior to initiating certolizumab pegol therapy in patients with chronic or recurring infections.1 24
-
Evaluate patients for latent tuberculosis infection prior to and periodically during certolizumab pegol therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating therapy.1 24
-
Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.1 6 24 Discontinue certolizumab pegol if serious infection occurs.1 6 Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.1 6 24
Introduction
Tumor necrosis factor (TNF) inhibitor and biologic disease-modifying antirheumatic drug (DMARD); a recombinant humanized Fab′ fragment of a monoclonal antibody.1 2 3 7 8 14 15 16
Uses for Certolizumab Pegol
Crohn Disease
Used to treat moderately to severely active Crohn disease in adults who have had an inadequate response to conventional therapies.1 2 3 47
Guidelines generally support use of TNF blocking agents for induction and maintenance therapy in adults with moderate to severe Crohn disease; however, other TNF blocking agents may be more effective than certolizumab pegol for induction of remission.2000 2001
Has been used in a limited number of patients with fistulizing Crohn disease† [off-label].48
Specific treatments for Crohn disease are selected according to the patient’s risk profile and disease severity.2000
Rheumatoid Arthritis
Used to manage moderately to severely active rheumatoid arthritis in adults.1 May be used alone or in combination with methotrexate or other nonbiologic DMARDs.1 17 18 19 49 50 51 52 53 54 55 56
Disease-modifying treatments for rheumatoid arthritis include conventional DMARDs (e.g., hydroxychloroquine, leflunomide, methotrexate, sulfasalazine), biologic DMARDs (e.g., TNF blocking agents, abatacept, tocilizumab, sarilumab, rituximab), and/or targeted synthetic DMARDs (e.g., Janus kinase inhibitors).2003
Guidelines generally support use of TNF blocking agents as add-on therapy to methotrexate in patients who do not meet treatment goals with methotrexate alone.2003
Specific agents for rheumatoid arthritis are selected according to current disease activity, prior therapies used, and presence of comorbidities.2003
Psoriatic Arthritis
Used to manage active psoriatic arthritis in adults.1 32 33 45 46
Disease-modifying treatments for psoriatic arthritis include oral small molecules (OSMs; e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide, apremilast), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab, ustekinumab, brodalumab, abatacept), and/or targeted synthetic DMARDs (e.g., tofacitinib).2005
Guidelines generally support use of TNF blocking agents as first-line treatment in patients with active psoriatic arthritis.2005
Ankylosing Spondylitis
Used to manage active ankylosing spondylitis in adults.1 31 36 37 38
Treatments for ankylosing spondylitis include NSAIAs, conventional DMARDs (e.g., methotrexate, sulfasalazine), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab), and/or targeted synthetic DMARDs (e.g., tofacitinib).2004
Guidelines generally support use of TNF blocking agents for treatment of ankylosing spondylitis in patients with active disease despite treatment with nonsteroidal anti-inflammatory agents (NSAIAs).2004
Recommendations for treatment selection in ankylosing spondylitis vary based the presence of certain comorbidities (e.g., iritis, inflammatory bowel disease).2004
Nonradiographic Axial Spondyloarthritis
Used to manage active nonradiographic axial spondyloarthritis in adults with objective signs of inflammation.1 31 35 36 37 38
Treatments for nonradiographic axial spondyloarthritis include NSAIAs, conventional DMARDs (e.g., methotrexate, sulfasalazine), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab), and/or targeted synthetic DMARDs (e.g., tofacitinib).2004 Continuous NSAIA treatment is typically considered first-line for active nonradiographic axial spondyloarthritis.2004
Guidelines generally support use of TNF blocking agents for treatment of nonradiographic axial spondyloarthritis in patients with active disease despite treatment with NSAIAs.2004
Specific agents for nonradiographic axial spondyloarthritis treatment are selected according to current disease activity and prior therapies used.2004
Plaque Psoriasis
Used to manage moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.1 39 40 41 42
Guidelines generally support use of TNF blocking agents in moderate to severe psoriasis, either as monotherapy or in combination with topical, oral, or phototherapy.2007 2009
Recommendations for use and selection of psoriasis therapies vary based on patient age, disease characteristics (e.g., severity, location, presence of psoriatic arthritis), and comorbidities (e.g., inflammatory bowel disease).2007 2008 2009 2010 2011 2012
Related/similar drugs
Entyvio, Otezla, Sotyktu, prednisone, naproxen, methotrexate, dexamethasone
Certolizumab Pegol Dosage and Administration
General
Pretreatment Screening
-
Evaluate all patients for active and inactive tuberculosis prior to initiating therapy using appropriate screening tests (e.g., tuberculin skin test, chest x-ray).1
-
Screen all patients for hepatitis B virus (HBV) infection before initiating therapy.1
-
Do not initiate therapy in patients with an active infection, including clinically important localized infections.1
Patient Monitoring
-
Monitor closely for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock) during and after treatment; monitor for possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy.1 24
-
Perform periodic dermatologic evaluations in all patients, particularly those with risk factors for skin cancer.1
-
Evaluate and monitor chronic carriers of HBV during treatment and for up to several months following treatment.1
Other General Considerations
-
May be used alone or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs); concomitant use with biologic DMARDs, including other TNF blocking agents, is not recommended.1
-
Corticosteroids, nonsteroidal anti-inflammatory agents (NSAIAs), and/or other analgesics may be continued in adults with rheumatoid arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, or psoriatic arthritis.1 17 18 19 31 32 35
-
Administered concomitantly with aminosalicylates, corticosteroids, azathioprine, mercaptopurine, methotrexate, or anti-infective agents in patients with Crohn disease.2 3
Administration
Sub-Q Administration
Administer by sub-Q injection into the thighs or abdomen using a 23-gauge needle.1 Rotate injection sites.1 Do not inject into areas where the skin is tender, bruised, red, or hard, or where there are scars or stretch marks.1
Commercially available as a lyophilized powder that must be reconstituted (see Reconstitution under Dosage and Administration) or a prefilled syringe.1 Allow reconstituted solution and prefilled syringes to sit at room temperature for 30 minutes prior to administration; do not leave at room temperature for more than 2 hours.1
When a 400-mg dose is required, 2 separate 200-mg doses should be administered at separate sites.1
Reconstituted solution intended for use under the guidance and supervision of a clinician.1 Certolizumab pegol solution supplied in prefilled syringes may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training.1
Reconstitution
Allow lyophilized powder kit (containing drug, diluent, syringes, needles) to sit at room temperature for 30 minutes prior to reconstitution.1
Reconstitute vial containing 200 mg of certolizumab pegol lyophilized powder by adding 1 mL of sterile water for injection (provided by manufacturer) to provide a solution containing approximately 200 mg/mL.1 Direct sterile water for injection at vial wall rather than directly onto powder.1
Gently swirl vial for about 1 minute to ensure all of the powder comes into contact with the diluent.1 Swirl as gently as possible to avoid foaming; do not shake.1 Full reconstitution may take as long as 30 minutes; swirl vial every 5 minutes as long as non-dissolved particles are observed.1
Dosage
Adults
Crohn Disease
Sub-Q
400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks (induction regimen); patients who respond may receive additional 400-mg doses every 4 weeks (maintenance regimen).1
Rheumatoid Arthritis
Sub-Q
400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks.1 For maintenance therapy, 400 mg every 4 weeks may be considered.1
Psoriatic Arthritis
Sub-Q
400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks.1 For maintenance therapy, 400 mg every 4 weeks may be considered.1
Ankylosing Spondylitis
Sub-Q
400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.1
Nonradiographic Axial Spondyloarthritis
Sub-Q
400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks or 400 mg every 4 weeks.1
Plaque Psoriasis
Sub-Q
400 mg (as two 200-mg injections at separate sites) every 2 weeks.1 For some patients with body weight ≤90 kg, the following can be considered: 400 mg (as two 200-mg injections at separate sites) at 0, 2, and 4 weeks, followed by 200 mg every 2 weeks.1
Special Populations
Hepatic Impairment
No specific dosage recommendations at this time.1
Renal Impairment
Insufficient data available to provide dosage recommendations for patients with moderate or severe renal impairment.1
Geriatric Patients
No specific dosage recommendations at this time.1
Cautions for Certolizumab Pegol
Contraindications
-
History of hypersensitivity to certolizumab pegol or to any of the excipients.1
Warnings/Precautions
Warnings
Infectious Complications
Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death.1 24 (See Boxed Warning.)
Opportunistic infections caused by bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens (e.g., aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, tuberculosis) reported, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids).1 2 3 6 24 Infections frequently are disseminated.1
Increased incidence of serious infections observed with concomitant use of a TNF blocking agent and anakinra or abatacept.1 5 Use of certolizumab pegol in combination with other biologic DMARDs not recommended.1
Patients >65 years of age, with comorbid conditions, and/or receiving concomitant therapy with immunosuppressive agents (e.g., corticosteroids, methotrexate) may be at increased risk of infection.1 24
Do not initiate therapy in patients with active infections, including clinically important localized infections.1 Consider potential risks and benefits prior to initiating therapy in patients with history of chronic, recurring, or opportunistic infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.1 24
Closely monitor patients during and after treatment for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock), including possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy.1 6 24
If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.1 6 Discontinue certolizumab pegol if serious infection or sepsis develops.1 6
Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.1 24 When indicated, initiate appropriate antimycobacterial regimen.1 Consider antimycobacterial therapy prior to initiating certolizumab pegol in patients with a history of latent or active tuberculosis for whom adequate antimycobacterial treatment is unconfirmed, and in patients with a negative tuberculin skin test who have risk factors for tuberculosis.1 Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.1
Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.1 Strongly consider tuberculosis in patients who develop new infections during therapy, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.1
Failure to recognize invasive fungal infections has led to delays in appropriate treatment.6 Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.1 6 24 Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.1 6
When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.6 Whenever feasible, consult specialist in fungal infections.6
Malignancies and Lymphoproliferative Disorders
Cases of lymphoma and other malignancies (some fatal) reported in children, adolescents, and adults receiving TNF blocking agents; patients receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly may be at increased risk.1 9 25 29 Malignancies included lymphomas (e.g., Hodgkin disease, non-Hodgkin lymphoma, hepatosplenic T-cell lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers, leiomyosarcoma, hepatic malignancies, renal cell carcinoma).1 9 (See Boxed Warning.)
FDA has concluded that there is an increased risk of malignancy with TNF blocking agents; however, the strength of the association is not fully characterized.9
Consider possibility of and monitor for occurrence of malignancies during and following treatment with TNF blocking agents.9 25
Carefully consider risks and benefits of TNF blocking agents, especially in adolescents and young adults and especially in the treatment of Crohn disease or ulcerative colitis.1 25
Periodic dermatologic evaluations recommended for all patients, particularly those with risk factors for skin cancer.1
Other Warnings/Precautions
Cardiovascular Effects
Worsening CHF and new-onset CHF reported in patients receiving TNF blocking agents; not studied in patients with CHF.1
If used in patients with CHF, caution and careful monitoring recommended.1
Sensitivity Reactions
Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria reported rarely, sometimes after the first dose.1
If allergic reaction occurs, discontinue certolizumab pegol and initiate appropriate treatment.1 Use caution if administering certolizumab pegol to patients who have experienced a severe hypersensitivity reaction to another TNF blocking agent.1
Needle shield inside the removable cap of the certolizumab pegol prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in latex-sensitive patients.1
HBV Reactivation
Increased risk of reactivation of HBV infection in patients who are chronic carriers of this virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]).1 5 Fatalities reported.1 Use of multiple immunosuppressive agents may contribute to HBV reactivation.1
Screen all patients for HBV infection prior to initiation of therapy.1 Consultation with an HBV infection specialist is recommended for those who test positive.1
Evaluate and monitor HBV carriers before, during, and for up to several months after therapy.1 Safety and efficacy of antiviral therapy for prevention of HBV reactivation not established.1 Discontinue certolizumab pegol and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.1 Not known whether certolizumab pegol can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.1
Nervous System Effects
New onset or exacerbation of central or peripheral nervous system demyelinating disorders (e.g., multiple sclerosis, Guillain-Barré syndrome) reported rarely.1 Exercise caution when considering certolizumab pegol therapy in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.1
Seizure disorder, optic neuritis, and peripheral neuropathy reported rarely.1
Hematologic Effects
Pancytopenia (including aplastic anemia),1 leukopenia, and thrombocytopenia reported rarely; causal relationship unclear.1
Use with caution in patients with a history of substantial hematologic abnormalities.1 Consider discontinuing therapy if substantial hematologic abnormalities occur.1
Immunologic Reactions and Antibody Formation
Possible formation of autoimmune antibodies.1 2 3 Lupus-like syndrome reported rarely.1 Discontinue therapy if manifestations suggestive of a lupus-like syndrome occur.1
Antibodies to certolizumab pegol may develop.1 Incidence of antibody formation lower in patients receiving concomitant therapy with other immunosuppressive agents (e.g., methotrexate).1
Antibody formation associated with lower plasma drug concentrations and reduced efficacy in patients with rheumatoid arthritis and psoriasis.1 In patients with nonradiographic axial spondyloarthritis, higher antibody titers associated with lower plasma drug concentrations.1 In patients with Crohn disease, antibody formation associated with lower plasma drug concentrations, but no apparent association between antibody development and efficacy or adverse events.1
Immunization
Avoid live vaccines.1
Immunosuppression
Safety and efficacy in immunosuppressed patients not evaluated.1
Psoriasis
New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents, including certolizumab pegol.1 9 Most patients experienced improvement following discontinuance of the TNF blocking agent.9 A change to a different subtype of plaque psoriasis (e.g., erythrodermic, pustular, guttate) rarely observed.1
Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.9
Specific Populations
Pregnancy
Limited data from an ongoing pregnancy registry insufficient to inform a risk of major birth defects or other adverse pregnancy outcomes.1 However, studies indicate that placental transfer of certolizumab pegol is negligible to low.1 No adverse developmental effects observed in animal reproduction studies.1
Data suggest increased disease activity in women with rheumatoid arthritis or inflammatory bowel disease is associated with increased risk of adverse pregnancy outcomes (e.g., fetal loss, preterm delivery, low birth weight, small size for gestational age at birth).1
In utero exposure to certolizumab pegol may affect immune responses of newborns and infants.1
Limited data suggest that certolizumab pegol may be eliminated at a slower rate in infants than in adults.1
Consider risks and benefits of administering live vaccines to infants exposed to the drug in utero; safety of live vaccines in such infants is unknown.1
Pregnancy registry at 877-311-8972 or [Web]/pregnancy-studies.1
Lactation
Distributes into human breast milk.1 No serious adverse reactions reported and not detected in plasma of breast-fed infants.1 No data on effects on milk production.1
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for certolizumab pegol and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.1
Pediatric Use
Safety and efficacy not established.1
Malignancies, some fatal, reported in children and adolescents who received TNF-blocking agents.1 9
Neonates and infants exposed to certolizumab pegol in utero may have impaired immune responses.1 Certolizumab pegol concentrations were negligible in most infants exposed to the drug in utero; clinical importance is unknown.1 The drug may be eliminated more slowly in infants than in adults.1 Consider risks and benefits of administering live vaccines to infants exposed to certolizumab pegol in utero; safety of live vaccines in these infants is unknown.1
Geriatric Use
No substantial differences in response relative to younger adults.1
Possible increased incidence of infections in geriatric patients; use with caution.1
Common Adverse Effects
Common adverse effects (7%) include upper respiratory tract infection, rash, and urinary tract infection.1
Drug Interactions
No formal drug interaction studies with oral corticosteroids, NSAIAs, analgesics, or immunosuppressants to date.1
Has been used concomitantly with corticosteroids, NSAIAs, and/or other analgesics in clinical studies;1 17 18 19 31 32 however, formal drug interaction studies with these agents not performed to date.1 Also has been used concomitantly with aminosalicylates, azathioprine, mercaptopurine, methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs), and/or anti-infective agents.1 2 3 17 18 31 32
Biologic Antirheumatic Agents
Concomitant use of certolizumab pegol and other biologic DMARDs not recommended.1
Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase the risk of infection.29
Vaccines
Avoid live vaccines.1 No data available on secondary transmission of infection by live vaccines in certolizumab pegol-treated patients.1
Specific Drugs and Laboratory Tests
Drug |
Interaction |
Comments |
---|---|---|
Abatacept |
Increased incidence of serious infection, without additional clinical benefit1 |
Concomitant use not recommended1 Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29 |
Anakinra |
Increased incidence of serious infections and neutropenia, without additional clinical benefit, reported with anakinra and etanercept (another TNF blocking agent) in rheumatoid arthritis; similar effects expected with certolizumab pegol and anakinra1 5 |
Concomitant use not recommended1 Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29 |
Corticosteroids, oral |
Increased risk of serious infection1 |
Used concomitantly in clinical studies1 |
Influenza virus vaccine |
Certolizumab pegol did not suppress immune response to concurrently administered influenza virus vaccine in patients with rheumatoid arthritis; concomitant methotrexate may reduce immune response to the vaccine, but clinical importance unknown 1 |
|
Methotrexate |
Increased risk of serious infection1 Possible decrease in rate of development of antibodies to certolizumab pegol in patients with rheumatoid arthritis; may result in sustained therapeutic plasma certolizumab pegol concentrations1 Concomitant use with certolizumab pegol may reduce immune response to influenza virus vaccine or pneumococcal polysaccharide vaccine, but clinical importance unknown1 Methotrexate pharmacokinetics not altered by certolizumab pegol in patients with rheumatoid arthritis; effect of methotrexate on certolizumab pharmacokinetics not determined1 |
|
Natalizumab |
Increased risk of serious infections1 |
Avoid concomitant use1 |
Pneumococcal polysaccharide vaccine |
Certolizumab pegol did not suppress immune response to concurrently administered pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis; however, those receiving concomitant methotrexate had reduced immune response, but clinical importance unknown 1 |
|
Rituximab |
Increased risk of serious infections1 |
Concomitant use not recommended1 Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29 |
Tests, coagulation |
May erroneously elevate aPTT; thrombin time and PT unaffected; no evidence of effect on in vivo coagulation1 |
Certolizumab Pegol Pharmacokinetics
Absorption
Bioavailability
Bioavailability is approximately 80% following sub-Q administration.1 Peak serum concentrations achieved in 54–171 hours.1
Distribution
Extent
Crosses the placenta in small amounts.1
Elimination
Metabolism
Not studied.1
Elimination Route
Not studied.1 Polyethylene glycol moiety excreted principally in urine.1
Half-life
Approximately 14 days.1
Special Populations
Pharmacokinetics of certolizumab pegol not formally studied in patients with renal impairment.1 However, pharmacokinetics of polyethylene glycol moiety dependent on renal function.1
Among adults, age does not appear to influence pharmacokinetics.1
Clearance of certolizumab pegol is higher with increasing body weight; however, no clinically important weight-related differences observed.1
In patients with certolizumab pegol antibodies, clearance of certolizumab is higher.1
No gender-related pharmacokinetic differences apparent.1
Stability
Storage
Sub-Q
Injection in Prefilled Syringes
2–8°C.1 Do not freeze.1 Protect from light; store in original carton until administration.1
Powder for Injection
2–8°C.1 Do not freeze.1 Protect from light; store in original carton until administration.1
May store reconstituted solution for up to 24 hours at 2–8°C.1 Do not freeze.1
Actions
-
Recombinant humanized Fab′ fragment of an anti-TNF monoclonal antibody conjugated to an approximately 40-kilodalton polyethylene glycol (PEG2MAL40K) in order to prolong the half-life.1 2 3 7 8
-
Binds with high affinity to TNF-α, a cytokine involved in the regulation of immune response.1 2 3 7 8
-
Does not contain a fragment crystallizable (Fc) region or induce complement activation, antibody-dependent cellular cytotoxicity, apoptosis, or neutrophil degranulation in vitro.1 2 3 7 8
Advice to Patients
-
Importance of advising patients about potential benefits and risks of certolizumab pegol.1 9 24 25 Importance of patients reading the manufacturer’s patient information (medication guide) prior to initiation of therapy and before each injection of the drug.1 24 25
-
Importance of instructing patient and/or caregiver regarding proper dosage and administration of certolizumab pegol, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined that the patient and/or caregiver is competent to safely administer the drug.1
-
Increased susceptibility to infection.1 Importance of informing clinicians promptly if any signs or symptoms suggestive of infection (e.g., persistent fever, sweating, cough, dyspnea, fatigue) occur.1 6 Importance of informing health care providers about any ongoing active infections.1
-
Risk of lymphoma, including hepatosplenic T-cell lymphoma, leukemia, and other malignancies with use of TNF blocking agents.1 9 25 Importance of informing patients and caregivers about the increased risk of cancer development in children, adolescents, and young adults, taking into account the clinical utility of TNF blocking agents, the relative risks and benefits of these and other immunosuppressive drugs, and the risks associated with untreated disease.9 25 Importance of promptly informing clinicians if signs and symptoms of malignancies (e.g., unexplained weight loss; fatigue; abdominal pain; persistent fever; night sweats; easy bruising or bleeding; swollen lymph nodes in the neck, underarm, or groin; hepatomegaly or splenomegaly) occur.9 25
-
Importance of informing clinician of any new or worsening medical conditions (e.g., heart failure, neurologic disease [e.g., demyelinating disorders], autoimmune disorders [e.g., lupus-like syndrome], cytopenias, psoriasis).1 9
-
Importance of informing latex-sensitive patients that the needle shield inside the removable cap of the certolizumab pegol prefilled syringe contains a derivative of natural rubber latex.1
-
Importance of promptly contacting a clinician if manifestations of an allergic reaction (e.g., urticaria, facial swelling, difficulty breathing) occur.1
-
Importance of taking the drug as prescribed and of not altering or discontinuing therapy without first consulting with a clinician.9 25
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or any history of cancer, tuberculosis, HBV infection, or other chronic or recurrent infections.1 6 24
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
-
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Parenteral |
For injection, for subcutaneous use |
200 mg |
Cimzia (available as single-dose vial) |
UCB |
Injection, for subcutaneous use |
200 mg/mL |
Cimzia (available as single-dose prefilled syringe) |
UCB |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions May 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
1. UCB, Inc. Cimzia (certolizumab pegol) prescribing information. Smyrna, GA; 2019 Sep.
2. Sandborn WJ, Feagan BG, Stoinov S et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med. 2007; 357:228-38. http://www.ncbi.nlm.nih.gov/pubmed/17634458?dopt=AbstractPlus
3. Schreiber S, Khaliq-Kareemi M, Lawrance IC et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007; 357:239-50. http://www.ncbi.nlm.nih.gov/pubmed/17634459?dopt=AbstractPlus
4. Best WR, Becktel JM, Singleton JW et al. Development of a Crohn’s disease activity index. National Cooperative Crohn’s Disease Study. Gastroenterology. 1976; 70:439-44. http://www.ncbi.nlm.nih.gov/pubmed/1248701?dopt=AbstractPlus
5. Amgen. Enbrel (etanercept) for subcutaneous injection prescribing information. Thousand Oaks, CA: 2021 Apr.
6. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Rockville MD: Food and Drug Administration; 2008 Sep 4. Available from FDA website. Accessed 2008 Sep 25. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124185.htm
7. Bourne T, Fossati G, Nesbitt A. A PEGylated Fab’ fragment against tumor necrosis factor for the treatment of Crohn disease: exploring a new mechanism of action. BioDrug. 2008; 22:331-7.
8. Nesbitt A, Fossati G, Bergin M et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor α agents. In flamm Bowel Dis. 2007; 13:1323-32.
9. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: Tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). FDA alert. Rockville MD; 2009 Aug 4. Available from FDA website (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm). Accessed 2009 Nov 3. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/UCM070725
10. UCB, Smyrna, GA: Personal communication.
14. Sebba A. Tocilizumab: the first interleukin-6-receptor inhibitor. Am J Health Syst Pharm. 2008; 65:1413-8. http://www.ncbi.nlm.nih.gov/pubmed/18653811?dopt=AbstractPlus
15. McCluggage LK, Scholtz JM. Golimumab: a tumor necrosis factor alpha inhibitor for the treatment of rheumatoid arthritis. Ann Pharmacother. 2010; 44:135-44. http://www.ncbi.nlm.nih.gov/pubmed/20118145?dopt=AbstractPlus
16. . Drugs for rheumatoid arthritis. Treat Guidel Med Lett. 2009; 7:37-46; quiz 47-8. http://www.ncbi.nlm.nih.gov/pubmed/19390497?dopt=AbstractPlus
17. Keystone E, Heijde D, Mason D et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008; 58:3319-29. http://www.ncbi.nlm.nih.gov/pubmed/18975346?dopt=AbstractPlus
18. Smolen J, Landewé RB, Mease P et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009; 68:797-804. http://www.ncbi.nlm.nih.gov/pubmed/19015207?dopt=AbstractPlus
19. Fleischmann R, Vencovsky J, van Vollenhoven RF et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009; 68:805-11. http://www.ncbi.nlm.nih.gov/pubmed/19015206?dopt=AbstractPlus
20. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. http://www.ncbi.nlm.nih.gov/pubmed/7779114?dopt=AbstractPlus
21. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36:729-40. http://www.ncbi.nlm.nih.gov/pubmed/8507213?dopt=AbstractPlus
22. Felson DT, Anderson JJ, Lange MLM et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent. Arthritis Rheum. 1998; 41:1564-70. http://www.ncbi.nlm.nih.gov/pubmed/9751088?dopt=AbstractPlus
24. US Food and Drug Administration. FDA drug safety communication: Drug labels for the tumor necrosis factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria. Rockville, MD; 2011 Sep 7. From FDA website. Accessed 2011 Oct 2. http://www.fda.gov/Drugs/DrugSafety/ucm270849.htm
25. US Food and Drug Administration. FDA drug safety communication: Safety review update on reports of hepatosplenic T-cell lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine. Rockville, MD; 2011 Apr 14. From FDA website. Accessed 2011 Jul 26. http://www.fda.gov/Drugs/DrugSafety/ucm250913.htm
29. Janssen Biotech, Inc. Remicade (infliximab) for IV injection prescribing information. Horsham, PA; 2020 May.
30. Sieper J, Rudwaleit M, Baraliakos X et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009; 68 Suppl 2:ii1-44. http://www.ncbi.nlm.nih.gov/pubmed/19433414?dopt=AbstractPlus
31. Landewé R, Braun J, Deodhar A et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014; 73:39-47. http://www.ncbi.nlm.nih.gov/pubmed/24013647?dopt=AbstractPlus
32. 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; 73:48-55. http://www.ncbi.nlm.nih.gov/pubmed/23942868?dopt=AbstractPlus
33. van der Heijde D, Fleischmann R, Wollenhaupt J et al. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis. 2014; 73:233-7. http://www.ncbi.nlm.nih.gov/pubmed/23942869?dopt=AbstractPlus
34. Smolen JS, Kay J, Doyle MK et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009; 374:210-21. http://www.ncbi.nlm.nih.gov/pubmed/19560810?dopt=AbstractPlus
35. Deodhar A, Gensler LS, Kay J et al. A Fifty-Two-Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019; 71:1101-1111. http://www.ncbi.nlm.nih.gov/pubmed/30848558?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC6619287&blobtype=pdf
36. Sieper J, Kivitz A, van Tubergen A et al. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015; 67:1475-80. http://www.ncbi.nlm.nih.gov/pubmed/25832312?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC5054930&blobtype=pdf
37. van der Heijde D, Dougados M, Landewé R et al. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017; 56:1498-1509. http://www.ncbi.nlm.nih.gov/pubmed/28498975?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC5850296&blobtype=pdf
38. van der Heijde D, Baraliakos X, Hermann KA et al. Limited radiographic progression and sustained reductions in MRI inflammation in patients with axial spondyloarthritis: 4-year imaging outcomes from the RAPID-axSpA phase III randomised trial. Ann Rheum Dis. 2018; 77:699-705. http://www.ncbi.nlm.nih.gov/pubmed/29343510?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC5909752&blobtype=pdf
39. Gottlieb AB, Blauvelt A, Thaçi 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). J Am Acad Dermatol. 2018; 79:302-314.e6. http://www.ncbi.nlm.nih.gov/pubmed/29660421?dopt=AbstractPlus
40. 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). J Am Acad Dermatol. 2018; 79:266-276.e5. http://www.ncbi.nlm.nih.gov/pubmed/29660425?dopt=AbstractPlus
41. Gordon KB, Warren RB, Gottlieb AB et al. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021; 184:652-662. http://www.ncbi.nlm.nih.gov/pubmed/32652544?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC8247431&blobtype=pdf
42. Warren RB, Lebwohl M, Sofen H et al. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021; 35:2398-2408. http://www.ncbi.nlm.nih.gov/pubmed/34192387?dopt=AbstractPlus
43. Gladman D, Fleischmann R, Coteur G et al. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res (Hoboken). 2014; 66:1085-92. http://www.ncbi.nlm.nih.gov/pubmed/24339179?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC4171746&blobtype=pdf
44. Kavanaugh A, Gladman D, van der Heijde D et al. Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study. Ann Rheum Dis. 2015; 74:44-51. http://www.ncbi.nlm.nih.gov/pubmed/24942382?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC4283690&blobtype=pdf
45. 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. http://www.ncbi.nlm.nih.gov/pubmed/29556416?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC5856919&blobtype=pdf
46. Walsh JA, Gottlieb AB, Hoepken B et al. Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial. Clin Rheumatol. 2018; 37:3285-3296. http://www.ncbi.nlm.nih.gov/pubmed/30191421?dopt=AbstractPlus
47. Sandborn WJ, Lee SD, Randall C et al. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014; 40:903-16. http://www.ncbi.nlm.nih.gov/pubmed/25146586?dopt=AbstractPlus
48. Schreiber S, Lawrance IC, Thomsen OØ et al. Randomised clinical trial: certolizumab pegol for fistulas in Crohn's disease - subgroup results from a placebo-controlled study. Aliment Pharmacol Ther. 2011; 33:185-93. http://www.ncbi.nlm.nih.gov/pubmed/21083671?dopt=AbstractPlus
49. Keystone E, Landewé R, van Vollenhoven R et al. Long-term safety and efficacy of certolizumab pegol in combination with methotrexate in the treatment of rheumatoid arthritis: 5-year results from the RAPID 1 trial and open-label extension. Ann Rheum Dis. 2014; 73:2094-100. http://www.ncbi.nlm.nih.gov/pubmed/23918037?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC4251202&blobtype=pdf
50. Smolen JS, van Vollenhoven R, Kavanaugh A et al. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015; 17:245. http://www.ncbi.nlm.nih.gov/pubmed/26353833?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC4565002&blobtype=pdf
51. Emery P, Bingham CO 3rd, Burmester GR et al. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017; 76:96-104. http://www.ncbi.nlm.nih.gov/pubmed/27165179?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC5264210&blobtype=pdf
52. Weinblatt ME, Fleischmann R, Huizinga TW et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012; 51:2204-14. http://www.ncbi.nlm.nih.gov/pubmed/22923753?dopt=AbstractPlus
53. Weinblatt ME, Fleischmann R, van Vollenhoven RF et al. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015; 17:325. http://www.ncbi.nlm.nih.gov/pubmed/26568428?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC4644627&blobtype=pdf
54. Smolen JS, Emery P, Ferraccioli GF et al. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis. 2015; 74:843-50. http://www.ncbi.nlm.nih.gov/pubmed/24431394?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC4392224&blobtype=pdf
55. Smolen JS, Burmester GR, Combe B et al. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016; 388:2763-2774. http://www.ncbi.nlm.nih.gov/pubmed/27863807?dopt=AbstractPlus
56. Hetland ML, Haavardsholm EA, Rudin A et al. Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial. BMJ. 2020; 371:m4328. http://www.ncbi.nlm.nih.gov/pubmed/33268527?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC7708829&blobtype=pdf
2000. Lichtenstein GR, Loftus EV, Isaacs KL et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018; 113:481-517. http://www.ncbi.nlm.nih.gov/pubmed/29610508?dopt=AbstractPlus
2001. Feuerstein JD, Ho EY, Shmidt E et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021; 160:2496-2508. http://www.ncbi.nlm.nih.gov/pubmed/34051983?dopt=AbstractPlus
2002. Nguyen GC, Loftus EV Jr, Hirano I et al. American Gastroenterological Association Institute Guideline on the Management of Crohn's Disease After Surgical Resection. Gastroenterology. 2017; 152:271-275. http://www.ncbi.nlm.nih.gov/pubmed/27840074?dopt=AbstractPlus
2003. Fraenkel L, Bathon JM, England BR et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021; 73:924-939. http://www.ncbi.nlm.nih.gov/pubmed/34101387?dopt=AbstractPlus
2004. Ward MM, Deodhar A, Gensler LS et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019; 71:1599-1613. http://www.ncbi.nlm.nih.gov/pubmed/31436036?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC6764882&blobtype=pdf
2005. Singh JA, Guyatt G, Ogdie A et al. Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019; 71:5-32. http://www.ncbi.nlm.nih.gov/pubmed/30499246?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=PMC8218333&blobtype=pdf
2006. Schoels MM, Aletaha D, Alasti F et al. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016; 75:811-8. http://www.ncbi.nlm.nih.gov/pubmed/26269398?dopt=AbstractPlus
2007. Menter A, Strober BE, Kaplan DH et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019; 80:1029-1072. http://www.ncbi.nlm.nih.gov/pubmed/30772098?dopt=AbstractPlus
2008. Elmets CA, Korman NJ, Prater EF et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021; 84:432-470. http://www.ncbi.nlm.nih.gov/pubmed/32738429?dopt=AbstractPlus
2009. Menter A, Gelfand JM, Connor C et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020; 82:1445-1486. http://www.ncbi.nlm.nih.gov/pubmed/32119894?dopt=AbstractPlus
2010. Menter A, Cordoro KM, Davis DMR et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020; 82:161-201. http://www.ncbi.nlm.nih.gov/pubmed/31703821?dopt=AbstractPlus
2011. Elmets CA, Leonardi CL, Davis DMR et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. J Am Acad Dermatol. 2019; 80:1073-1113. http://www.ncbi.nlm.nih.gov/pubmed/30772097?dopt=AbstractPlus
2012. Armstrong AW, Read C. Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: A Review. JAMA. 2020; 323:1945-1960. http://www.ncbi.nlm.nih.gov/pubmed/32427307?dopt=AbstractPlus
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