Prescriber Slide Kit Approved [Read-Only] - ucb.com Slide Kit... · as sepsis or opportunistic infections •Patients with moderate to severe heart failure (NHYA classes III/IV) CIMZIA

CIMZIA® Prescriber Slide Kit

GPSRC CZP-PRM- 005437

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Outline of Content•Introduction to the Prescriber Slide Kit.....................Slide 3

•Overview of CIMZIA®...............................................Slide 6

•Administration of CIMZIA®......................................Slide 11

•Clinical Efficacy of CIMZIA®...................................Slide 19

•Use of CIMZIA® in Specific Patient Population.......Slide 27

•CIMZIA® - Important Safety Information.................Slide 38

•Tools for Assessment of Disease Activity ...............Slide 50

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IntroductionThe Prescriber Slide Kit is designed to optimise the use of CIMZIA ®

in the treatment of Rheumatoid Arthritis (RA)

The Prescriber Slide Kit is one component of a full set of educational materials. Also available are:

•Prescriber Guide•Healthcare Professional (HCP) Administration & Monitoring Guide•Patient Medication Guide•Patient Alert Card

The educational materials can be obtained in the following ways:

•From a UCB Medical Scientific Liaison (MSL)•By completion of the accompanying order form•Online at www.cimzia.eu

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Additional Educational MaterialsTool Aim

Prescriber Guide To optimise the use of CIMZIA®

Patient Alert Card To provide critical advice to patients and caregivers about CIMZIA® and its adverse events, alerting them to seek medical advice if necessary. This alert card will be supplied to patients by the prescribing physician.

Patient Medication Guide

To provide user-friendly advice to educate both the patient and the care-giver about CIMZIA® and its side effects. This guide will be supplied to patients by the prescribing physician.

HCP Administration and Monitoring Guide

To educate and remind HCPs and patients on the correct administration of CIMZIA®

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Rheumatoid ArthritisRheumatoid arthritis (RA) is a chronic systemic inflammatory disease associated with significant morbidity and mortality

The disease is characterised by:

•Inflammation of the synovial joints, resulting in• Pain• Swelling• Joint damage with secondary deformity and progressive

disability

•Chronic fatigue•Impairment of patient physical function•Impairment of health-related quality of life (HRQoL)

Overview of CIMZIA®

Indications and Dose

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Overview of CIMZIA®

CIMZIA® (certolizumab pegol) is a recombinant, humanised antibody Fab' fragment conjugated to polyethylene glycol (PEG)

CIMZIA® is a tumour necrosis factor alpha (TNFα) inhibitor with high affinity for human TNFα (a key pro-inflammatory cytokine with a central role in inflammatory processes)

CIMZIA® does not contain a fragment crystallisable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro

It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, or neutrophil degranulationC

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CIMZIA® Summary of Product Characteristics 2009

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Indication for CIMZIA®

CIMZIA®, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate

CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate

CIMZIA® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX

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Dose of CIMZIA®

• The recommended starting dose of CIMZIA® for adult patients with RA is 400 mg (as 2 injections of 200 mg each on one day) at weeks 0, 2 and 4

• This is followed by a maintenance dose of 200 mg every 2 weeks

• MTX should be continued during treatment with CIMZIA®

where appropriate• Available data suggest that clinical response is usually

achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment

Patients who miss a dose should be advised to inject the next dose of CIMZIA® as soon as they remember and then inject the subsequent doses every 2 weeks as originally instructed

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Contra-Indications for CIMZIA®

CIMZIA® is contraindicated in:

•Patients with hypersensitivity to the active substance or to any of the excipients•Patients with active tuberculosis or other severe infections such as sepsis or opportunistic infections•Patients with moderate to severe heart failure (NHYA classes III/IV)

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Administration of CIMZIA®

Injection Technique, Supply and Storage

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Method of Administration of CIMZIA®

CIMZIA® must be administered subcutaneously.•CIMZIA® treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatmentof RA•The HCP Administration and Monitoring Guide should be supplied to all HCPs administering CIMZIA®

•After proper training in injection technique, patients may self-inject with CIMZIA® if their physician determines that it is appropriate and with medical follow-up as necessary

• A separate guide has been developed for patients that want to be trained in self-injection technique

•Any administration errors with CIMZIA® should be reported to the local representative of the Marketing Authorisation Holder or to the Pharmacovigilance Department of the Health Authority

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Supply and Storage of CIMZIA®

CIMZIA® is supplied as a prefilled syringe package

In each prefilled syringe package there is:•2 single-use glass prefilled syringes of CIMZIA®

•2 alcohol swabs

Each prefilled syringe contains 200 mg of CIMZIA®

•Each 200 mg dose requires 1 subcutaneous 1 ml injection •Each 400 mg dose requires 2 subcutaneous 1 ml injection

Refrigerate CIMZIA® at 2 to 8 °CThe shelf-life for CIMZIA® is 18 months

•Do not freeze CIMZIA®

•Do not use beyond expiry date on container•Keep the pre-filled syringe in the outer carton in order to protect it from light

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Preparing for InjectionFor each 200-mg injection, you will use:•1 prefilled syringe of CIMZIA® with needle•1 alcohol swab

CIMZIA® may be injected into the patient’s abdomen or thigh area

If administering more than one injection, each injection should be given at a different injection site, in the abdomen and thigh

Let the medicine in the syringe come to room temperature before injection - This will take about 30 minutes

Do not shake the prefilled syringe prior to use

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Choosing and Preparing Injection Site• Choose a different site on the abdomen

and/or thigh each time

• Never inject into areas where the skin is tender, bruised, red, or hard or where the patient has scars or stretch marks

• Be sure to alternate the injection site between the patient’s thighs and abdomen to avoid infection

• Once the injection site has been selected, use an alcohol swab to wipe the site and the area around it - Be sure not to touch this area again until you’re ready to inject

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Injecting• Remove the needle cover by pulling straight

up on the plastic ring• Take care not to touch the needle and do

not allow the needle to touch any surface

• Hold the syringe so the needle is pointing up and lightly tap the syringe to force any air bubbles to the top

• Press the plunger slowly until you expel any air

• Stop when a small drop appears at the tip of the needle

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Injecting• Gently grasp the cleaned area of skin with one

hand and hold firmly• With the other hand, gently pinch a fold of the

patient’s cleaned skin and insert the needle subcutaneously at about a 45-degree angle, with a one quick, short motion

• Push plunger to inject solution - It can take up to 10 seconds to empty the syringe

• When the syringe is empty, carefully remove the needle from the skin at the same angle at which it was inserted

• Release the skin with the first hand• Use a piece of gauze, apply pressure over the

injection site for a few seconds. • Do not rub the injection site - You may cover

the injection site with a small adhesive bandage, if necessary

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Disposal of the Needle

• Do NOT re-use the syringe or re-cap the needle• Throw away the used prefilled syringe and needle in a special

puncture-proof container

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Clinical Efficacy of CIMZIA®

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CIMZIA® Clinical Trial Descriptions• Two randomised, placebo-controlled, double-blind trials in patients

aged 18 years of age and over, with active RA diagnosed according to American College of Rheumatology (ACR) criteria: RAPID 1 and RAPID 2• Patients had ≥ 9 swollen and tender joints each and had active

RA for at least 6 months prior to baseline

• CIMZIA® was administered subcutaneously in combination with oral MTX. Patients were required to have received MTX for a minimum of 6 months at a stable dose of at least 10 mg weekly for 2 months prior to inclusion in both trials

Study number

Patient numbers

Dose regimen Study objectives

RAPID 1(52 weeks)

982 CIMZIA® 400 mg (0,2,4 weeks) with MTXCIMZIA® 200 mg or 400 mg every 2 weeks with MTX

Evaluation for treatment of signs and symptoms and inhibition of structural damage. Co-primary endpoints: ACR 20 at Week 24 and change from baseline in mTSS at Week 52

RAPID 2(24 weeks)

619 CIMZIA® 400 mg (0,2,4 weeks) with MTXCIMZIA® 200 mg or 400 mg every 2 weeks with MTX

Evaluation for treatment of signs and symptoms and inhibition of structural damage.Primary endpoint: ACR 20 at Week 24.

mTSS: modified Total Sharp Score

Keystone E et al. Arthritis Rheum. 2008; 58(11): 3319-29Smolen J et al. Ann Rheum Dis. 2009;68(6):797-804

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ACR Response• A statistically significantly greater ACR 20 response was achieved

from Week 1 in both clinical trials compared to placebo. ACR 50 response was statistically significantly greater from Week 2 • Responses were maintained through Weeks 52 (RAPID 1) and

24 (RAPID 2) RAPID 1

Methotrexate combination(24 and 52 weeks)

RAPID 2Methotrexate combination

(24 weeks)Response Placebo + MTX

N=199CIMZIA®

200 mg + MTX every 2 weeksN=393

Placebo + MTXN=127

CIMZIA®

200 mg + MTX every 2 weeksN=246

ACR 20Week 24 14% 59%** 9% 57%**Week 52 13% 53%** N/A N/AACR 50Week 24 8% 37%** 3% 33%**Week 52 8% 38%** N/A N/AACR 70Week 24 3% 21%** 1% 16%*Week 52 4% 21%** N/A N/AMajor Clinical Responsea.

1% 13%**

CIMZIA® vs. placebo: *p≤0.01, ** p<0.001a.Major clinical response is defined as achieving ACR 70 response at every assessment over a continuous 6-

month period

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Keystone E et al. Arthritis Rheum. 2008; 58(11): 3319-29Smolen J et al. Ann Rheum Dis. 2009;68(6):797-804

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ACR Response• Of the 783 patients initially randomised to active treatment in RAPID 1,

508 completed 52 weeks of placebo-controlled treatment and entered the open-label extension study:

• Of these, 427 completed 2 years of open-label follow-up and thus had a total exposure to CIMZIA® of 148 weeks overall

• The observed ACR20 response rate at this time point was 91%

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Fatigue and Physical Function• In RAPID 1 and RAPID 2:

• CIMZIA® -treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) as early as Week 1 through to the end of the study (Week 52, RAPID 1; Week 24, RAPID 2) compared to placebo. Improvements in physical function were maintained to at least 2 years in the open-label extension to RAPID 1

• CIMZIA® -treated patients reported significant improvements in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as early as Week 1 through to the end of the study (Week 52, RAPID 1; Week 24, RAPID 2) compared to placebo

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Quality of Life and Productivity• In both clinical trials, CIMZIA® -treated patients reported

significantly greater improvements in the SF-36 Physical and Mental Component Summaries (PCS and MCS) and all domain scores indicating better health-related quality of life (HRQoL)• Improvements in HRQoL were maintained to at least 2

years in the open-label extension to RAPID 1

• CIMZIA® -treated patients reported statistically significant improvements in the Work Productivity Survey compared to placebo

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Radiographic Response• In RAPID 1, structural joint damage was assessed

radiographically and expressed as change in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at Week 52, compared to baseline:• CIMZIA® patients demonstrated significantly less

radiographic progression than patients receiving placebo at Week 24 and Week 52

• In the placebo group, 52% of patients experienced no radiographic progression (mTSS ≤0.0) at Week 52 compared to 69% in the CIMZIA® 200 mg treatment group

• Sustained inhibition of progression of structural damage was demonstrated in a subset of 449 patients who completed at least 2 years of treatment with CIMZIA® (RAPID 1 and open-label extension study) and had evaluable data at the 2-year timepointC

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Radiographic Change over 12 Months with CIMZIA®

Placebo + MTXN=199

Mean (SD)

CIMZIA® 200 mg + MTX

N=393Mean (SD)

CIMZIA® 200 mg + MTX –

Placebo + MTXMean Difference

mTSSWeek 52 2.8 (7.8) 0.4 (5.7) -2.4Erosion ScoreWeek 52 1.5 (4.3) 0.1 (2.5) -1.4JSN ScoreWeek 52 1.4 (5.0) 0.4 (4.2) -1.0

p-values were < 0.001 for both mTSS and erosion score and ≤0.01 for JSN score. An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate

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CIMZIA® - Use in Specific Patient Populations

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Paediatric Population • CIMZIA® is not recommended for use in children and

adolescents below age 18 due to a lack of data on efficacy and safety

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Elderly Population • No dose adjustment of CIMZIA® is required in the elderly (≥65

years old)• Population pharmacokinetic analyses showed no effect of age

• In the clinical trials, there was an apparently higher incidenceof infections among subjects ≥65 years of age, compared to younger subjects, although experience is limited• Caution should be exercised when treating the elderly,

and particular attention paid with respect to occurrence of infections

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• There are no adequate data from the use of CIMZIA® in pregnant women

• Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the fetus. • However, these are insufficient with respect to human

reproductive toxicity• Due to its inhibition of TNFα, CIMZIA® administered

during pregnancy could affect normal immune response in the newborn

• Therefore, CIMZIA® should not be used in pregnancy

• Women of childbearing potential should use adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last CIMZIA® administration

Pregnant Women

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Nursing Mothers• There is insufficient information on the excretion of CIMZIA®

in human or animal breast milk• Since immunoglobulins are excreted into human breast

milk, a risk to the nursing child cannot be excluded

• A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CIMZIA® should be made taking into account the benefit of breast-feeding to the child and the benefit of CIMZIA® therapy to the woman

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Patients with Renal Impairment• Specific clinical trials have not been performed to assess the

effect of renal impairment on the pharmacokinetics of CIMZIA® or its PEG fraction

• However, population pharmacokinetic analysis based on subjects with mild renal impairment showed no effect of creatinine clearance.

• There are insufficient data to provide a dosing recommendation in moderate and severe renal impairment

• The pharmacokinetics of the PEG fraction of CIMZIA® are expected to be dependent on renal function but have not been assessed in patients with renal impairment

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Patients with Hepatic Impairment• CIMZIA® has not been studied in this patient population• No dose recommendations can be made

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Patients Receiving Vaccinations• No data are available on the response to vaccinations or the

transmission of infection by live vaccines in patients receivingCIMZIA®

• Live vaccines or attenuated vaccines should not be administered concurrently with CIMZIA®

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Patients Requiring Surgery• There is limited safety experience with surgical procedures in

patients treated with CIMZIA®

• The 14-day half-life of CIMZIA® should be taken into consideration if a surgical procedure is planned

• A patient who requires surgery while on CIMZIA® should be closely monitored for infections, and appropriate actions should be taken

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Patients with Concomitant Use of Other Biologics• Severe infections and neutropenia were reported in clinical

studies with concurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28 modulator) and another TNF antagonist, etanercept, with no added benefit compared to TNF antagonist therapy alone

• Because of the nature of the adverse events seen with the combination of another TNF antagonist with either abatacept or anakinra therapy, similar toxicities may also result from thecombination of anakinra or abatacept and other TNF antagonists

• Therefore the use of CIMZIA® in combination with anakinra or abatacept is not recommended

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Patients Requiring Coagulation Assays• There is no evidence that CIMZIA® therapy has an effect on

blood clotting (in vivo coagulation)• However, interference with certain tests of blood clotting

(coagulation assays) has been detected in patients treated with CIMZIA®. CIMZIA® may cause erroneously elevated activated partial thromboplastin time (aPTT) assay results in patients without coagulation abnormalities

• This effect has been observed with:• PTT-Lupus Anticoagulant (LA) test from Diagnostica Stago• Standard Target Activated Partial Thromboplastin time (STA-PTT)

Automate tests from Diagnostica Stago • HemosIL APTT-SP liquid test from Instrumentation Laboratories• HemosIL APTT lyophilized silica tests from Instrumentation

Laboratories.• Other aPTT assays may be affected as well. Interference

with thrombin time (TT) and prothrombin time (PT) assays have not been observed

• After patients receive CIMZIA® careful attention should be given to interpretation of abnormal coagulation resultsC

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CIMZIA® - Important Safety InformationFor a Full List of Adverse Events Please See the Summary of Product Characteristics

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Serious Infections• Serious infections (bacterial, fungal and viral), including

sepsis, and tuberculosis (TB) and opportunistic infections have been reported in patients receiving TNF antagonists including CIMZIA®

• Do not start CIMZIA® in patients with an active infection, including localised infections. Exercise caution in:

Patients with chronic or recurrent infectionPatients with underlying conditions which may predispose them to infectionPatients who have been exposed to TBPatients who have resided or travelled in regions where TB or mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, are endemic

• CIMZIA® should be discontinued if a patient develops a serious infection or sepsis

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Tuberculosis• Before initiating therapy, all patients should be evaluated for

both active or inactive (latent) TB infection. This should include:• A detailed medical history • A tuberculin skin test - this should be recorded on the

patient alert card• Chest X-ray - this should be recorded on the patient alert

card• Relevant immunological tests and/or polymerase chain

reaction techniques to exclude TB infection

• If active tuberculosis is diagnosed prior or during treatment, CIMZIA® therapy must not be initiated or must be discontinued


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Tuberculosis• Patients should be instructed to seek medical advice if

signs/symptoms suggestive of TB occur during or after therapy with CIMZIA®. These include:• Persistent cough• Low grade fever• Wasting/weight loss• Listlessness

• Patients should be instructed to seek medical advice in the following circumstances:• Family or other contact history of persons with TB• Vaccination history for TB • Positive PPD test• Recent foreign travel


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Hepatitis B• TNF inhibitors, including CIMZIA® have been associated with

reactivation of hepatitis B virus (HBV) in patients who are chronic carriers - Some cases were fatal

• Patients at risk for HBV infection should be evaluated for priorevidence of HBV infection before initiating CIMZIA®

• Exercise caution when prescribing CIMZIA® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with CIMZIA®

• Discontinue CIMZIA® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment• Exercise caution when considering resumption of

CIMZIA® and monitor patients closely


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Malignancies (including Lymphoma and Leukaemia)• The potential role of TNF antagonist therapy in the

development of malignancies is not known• In clinical trials with CIMZIA® and other TNF antagonists,

more cases of lymphoma and other malignancies have been reported among patients receiving TNF antagonists than in control patients receiving placebo

• Caution should be exercised when considering TNF antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy

• Caution should be exercised when using any TNF antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.


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Malignancies (including Lymphoma and Leukaemia) • There is an increased background lymphoma risk in RA

patients with long-standing, highly active, inflammatory disease

• With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded

• Patients should be monitored for symptoms of lymphoma including:• Swollen lymph nodes in the neck, underarms, groin, or

other areas • Excessive sweating, especially while sleeping at night • Fever • Severe itchiness • Unintentional weight loss


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Congestive Heart Failure• Worsening congestive heart failure and increased mortality

due to congestive heart failure have been observed with another TNF antagonist. Cases of congestive heart failure have also been reported with CIMZIA®

• Patients should be monitored for symptoms of CHF including:• Cough • Shortness of breath• Swelling of feet and ankles • Weight gain

• CIMZIA® is contra-indicated in patients with moderate to severe heart failure

• CIMZIA® should be used with caution in patients with mild heart failure

• Treatment with CIMZIA® must be discontinued in patients who develop new or worsening symptoms of CHF


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Neurological Events• TNF-blocking agents, including CIMZIA ®, have been

associated with rare cases of new onset or exacerbation of demyelinating disease including multiple sclerosis. Exercise caution when considering CIMZIA® for patients with these disorders

• Patients should be monitored for symptoms of demyelinating disease, especially multiple sclerosis including:• Dizziness• Numbness or tingling• Problems with vision• Weakness in the arms and legs


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Haematological Reactions• Reports of pancytopaenia, including aplastic anaemia, have

been rare with TNF antagonists. Adverse reactions of the haematologic system, including medically significant cytopaenia (e.g. leukopaenia, pancytopaenia, thrombocytopaenia) have been reported with CIMZIA®.

• All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection while on CIMZIA® including:• Persistent fever• Bruising• Bleeding• Pallor

• Discontinuation of CIMZIA® therapy should be considered in patients with confirmed significant haematological abnormalities


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Auto-immunity, Lupus and Lupus-like Illness• Treatment with CIMZIA® may result in the formation of

autoantibodies and, uncommonly, in development of a lupus-like syndrome

• The impact of long-term treatment with CIMZIA® on the development of auto-immune diseases is unknown

• Discontinue treatment if symptoms of lupus-like syndrome develop


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Hypersensitivity• Severe hypersensitivity reactions (including acute injection-

related and delayed systemic) have been reported rarely following CIMZIA® administration in trials

• If severe reactions occur, administration of CIMZIA® should be discontinued immediately and appropriate therapy instituted


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Tools for Assessment of Disease ActivityAmerican College for Rheumatology Response Criteria (ACR20, ACR50, ACR70, ACR90)

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ACR Response Criteria - What is Measured?

• Number of tender joints

• Number of swollen joints

• Global assessment of disease activity by physician

• Global assessment of disease activity by patient

• Patient's assessment of pain

• Patient's assessment of physical function (e.g. HAQ)

• Acute-phase response (e.g. ESR or CRP)

HAQ: Health Assessment Questionnaire; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein

Felson D et al, Arthritis Rheum 1995;38:727-35

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ACR Response Criteria – How is it Measured?

Tender joint count• An assessment of 28 or more joints

• The joint count should be done by scoring several different aspects of tenderness, as assessed by pressure and joint manipulation on physical examination

• The information on various types of tenderness should then be collapsed into a single tender-versus-non-tender dichotomy


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Tender joint count

Swollen joint count• An assessment of 28 or more joints

• Joints are classified as either swollen or not swollen

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Tender joint count

Swollen joint count

Physician's global assessment of disease activity• A horizontal visual analog scale (usually 10 cm) or Likert scale

measure of the physician's assessment of the patient's current disease activity


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Tender joint countSwollen joint countPhysician's global assessment of disease activityPatient's global assessment of disease activity

• Patient's overall assessment of how the arthritis is doing• One acceptable method for determining this is the question

from the Arthritis Impact Measurement Scale (AIMS) instrument: "Considering the ways your arthritis affects you, mark 'X' on the scale for how well you are doing"

• An anchored, horizontal, visual analog scale (usually 10 cm) should be provided

• A Likert scale response is also acceptable


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Tender joint count

Swollen joint count

Physician's global assessment of disease activity

Patient's global assessment of disease activity

Patient's assessment of pain• A horizontal visual analog scale (usually 10 cm) or Likert scale

assessment of the patient's current level of pain


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Tender joint count

Swollen joint count



Patient's assessment of pain

Patient's assessment of physical function• Any patient self-assessment instrument which has been validated, has

reliability, has been proven in RA trials to be sensitive to change, and which measures physical function in RA patients is acceptable

• Instruments which have been demonstrated to be sensitive in RA trials include the AIMS, the HAQ, the Quality (or Index) of Well Being, the MHIQ, and the MACTAR


AIMS: Arthritis Impact Measurement Scales; HAQ: Health Assessment Questionnaire; MHIQ: McMaster Health Index Questionnaire; MACTAR: McMaster Toronto Arthritis Patient Preference Disability Questionnaire

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Tender joint count

Swollen joint count



Patient's assessment of pain

Patient's assessment of physical function

Acute-phase reactant value• A Westergren erythrocyte sedimentation rate or a C-reactive

protein level


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To achieve an ACR20 response:• A 20% improvement in the score for tender joints

and

• A 20% improvement in the score for swollen joints

and

• A 20% improvement in at least 3 of the following is necessary:► Global assessment of disease activity by physician

► Global assessment of disease activity by patient

► Patient's assessment of pain

► Patient's assessment of physical function (e.g. HAQ)

► Acute-phase response (e.g. ESR or CRP)

ACR20 Response

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To achieve an ACR20 response• A 20% improvement in the score for tender joints and a 20%

improvement in swollen joints is necessary, and 20% improvement in at least 3 of the following:► Global assessment of disease activity by physician

► Global assessment of disease activity by patient

► Patient's assessment of pain

► Patient's assessment of physical function (e.g. HAQ)

► Acute-phase response (e.g. ESR or CRP)

Responses may also be defined as ACR50 (50%), ACR70 (70%), or ACR90 (90%) depending on the degree of benefit

ACR50, ACR70 and ACR 90 Responses

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Tools for Assessment of Disease ActivityThe Health Assessment Questionnaire (HAQ)

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The Health Assessment Questionnaire

Measures functional capacity

Consists of 2 or 3 questions in 8 categories:• Dressing and grooming

• Rising

• Eating

• Walking

• Hygiene

• Reaching

• Grip

• Activities

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http://aramis.stanford.edu/HAQ.html

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Consists of 2 or 3 questions in 8 categories:

• Dressing and grooming– Dress yourself, including doing shoelaces, and shampoo your hair

• Rising– From an armless chair and in and out of bed

• Eating– Being able to cut meat, lift a full cup or glass to the mouth, and open a new

carton of milk• Walking

– Outdoors on flat ground and climb five steps• Hygiene

– Wash and dry entire body, take a bath, get on and off the toilet• Reaching

– Reach and get down a 5-lb object, bend down and pick up clothing• Grip

– Open car doors, open previously unopened jars, turn taps on and off• Activities

– Run errands and shop, get in and out of car, do chores

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Each category is scored• 0 (without any difficulty)

• 1 (with some difficulty)

• 2 (with much difficulty)

or

• 3 (unable to do)

The maximum score in each of the 8 categories is added to give a maximum possible score of 24

This total score may be divided by 8 to give an average value in the range 0-3

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