CIMZIA Prescriber Slide Kit GPSRC CZP-PRM

Transcription

1 CIMZIA Prescriber Slide Kit GPSRC CZP-PRM

2 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 2

3 Introduction The 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 3

4 Additional Educational Materials Tool Aim Prescriber Guide To optimise the use of CIMZIA Patient Alert Card Patient Medication Guide HCP Administration and Monitoring Guide 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. 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. To educate and remind HCPs and patients on the correct administration of CIMZIA 4

5 Rheumatoid Arthritis Rheumatoid 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) 5

6 Overview of CIMZIA Indications and Dose

7 CIMZIA Prescriber Slide Kit - Overview of CIMZIA 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 cellmediated cytotoxicity in vitro It does not induce apoptosis in vitro in human peripheral bloodderived monocytes or lymphocytes, or neutrophil degranulation 7

8 CIMZIA Prescriber Slide Kit - Overview of CIMZIA 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 8

9 CIMZIA Prescriber Slide Kit - Overview of CIMZIA 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 9

10 CIMZIA Prescriber Slide Kit - Overview of CIMZIA 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) 10

11 Administration of CIMZIA Injection Technique, Supply and Storage

12 CIMZIA Prescriber Slide Kit - Administration of CIMZIA 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 treatment of RA The HCP Administration and Monitoring Guide should be supplied to all HCPs administering CIMZIA After proper training in injection technique, patients may selfinject 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 12

13 CIMZIA Prescriber Slide Kit - Administration of CIMZIA 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 C The 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 13

14 CIMZIA Prescriber Slide Kit - Administration of CIMZIA Preparing for Injection For 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 14

15 CIMZIA Prescriber Slide Kit - Administration of CIMZIA 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 15

16 CIMZIA Prescriber Slide Kit - Administration of CIMZIA 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 16

17 CIMZIA Prescriber Slide Kit - Administration of CIMZIA 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 17

18 CIMZIA Prescriber Slide Kit - Administration of CIMZIA 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 18

19 Clinical Efficacy of CIMZIA

20 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA 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 Study number RAPID 1 (52 weeks) RAPID 2 (24 weeks) Patient numbers mtss: modified Total Sharp Score Dose regimen 982 CIMZIA 400 mg (0,2,4 weeks) with MTX CIMZIA 200 mg or 400 mg every 2 weeks with MTX 619 CIMZIA 400 mg (0,2,4 weeks) with MTX CIMZIA 200 mg or 400 mg every 2 weeks with MTX Study objectives 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 Evaluation for treatment of signs and symptoms and inhibition of structural damage. Primary endpoint: ACR 20 at Week 24. 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 Keystone E et al. Arthritis Rheum. 2008; 58(11): Smolen J et al. Ann Rheum Dis. 2009;68(6):

21 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA 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) Response RAPID 1 Methotrexate combination (24 and 52 weeks) Placebo + MTX N=199 CIMZIA 200 mg + MTX every 2 weeks N=393 RAPID 2 Methotrexate combination (24 weeks) Placebo + MTX N=127 CIMZIA 200 mg + MTX every 2 weeks N=246 ACR 20 Week 24 14% 59%** 9% 57%** Week 52 13% 53%** N/A N/A ACR 50 Week 24 8% 37%** 3% 33%** Week 52 8% 38%** N/A N/A ACR 70 Week 24 3% 21%** 1% 16%* Week 52 4% 21%** N/A N/A Major Clinical Response a. 1% 13%** CIMZIA vs. placebo: *p 0.01, ** p<0.001 a. Major clinical response is defined as achieving ACR 70 response at every assessment over a continuous 6- month period Keystone E et al. Arthritis Rheum. 2008; 58(11): Smolen J et al. Ann Rheum Dis. 2009;68(6):

22 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA 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% 22

23 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA 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 23

24 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA 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 24

25 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA 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 openlabel extension study) and had evaluable data at the 2-year timepoint 25

26 CIMZIA Prescriber Slide Kit Clinical Efficacy of CIMZIA Radiographic Change over 12 Months with CIMZIA mtss Placebo + MTX N=199 Mean (SD) CIMZIA 200 mg + MTX N=393 Mean (SD) CIMZIA 200 mg + MTX Placebo + MTX Mean Difference Week (7.8) 0.4 (5.7) -2.4 Erosion Score Week (4.3) 0.1 (2.5) -1.4 JSN Score Week (5.0) 0.4 (4.2) -1.0 p-values were < 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 26

27 CIMZIA - Use in Specific Patient Populations

28 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 28

29 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 incidence of 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 29

30 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations Pregnant Women 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 30

31 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 31

32 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 32

33 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations Patients with Hepatic Impairment CIMZIA has not been studied in this patient population No dose recommendations can be made 33

34 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations Patients Receiving Vaccinations No data are available on the response to vaccinations or the transmission of infection by live vaccines in patients receiving CIMZIA Live vaccines or attenuated vaccines should not be administered concurrently with CIMZIA 34

35 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 35

36 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 the combination of anakinra or abatacept and other TNF antagonists Therefore the use of CIMZIA in combination with anakinra or abatacept is not recommended 36

37 CIMZIA Prescriber Slide Kit CIMZIA Use in Specific Populations 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 results 37

38 CIMZIA - Important Safety Information For a Full List of Adverse Events Please See the Summary of Product Characteristics

39 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 infection Patients with underlying conditions which may predispose them to infection Patients who have been exposed to TB Patients 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 39

40 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 40

41 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 41

42 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 prior evidence 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 42

43 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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. 43

44 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 44

45 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 45

46 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 46

47 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information 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 47

48 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information Auto-immunity, Lupus and Lupuslike Illness Treatment with CIMZIA may result in the formation of autoantibodies and, uncommonly, in development of a lupuslike 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 48

49 CIMZIA Prescriber Slide Kit CIMZIA Important Safety Information Hypersensitivity Severe hypersensitivity reactions (including acute injectionrelated 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 49

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

51 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity 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:

52 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity 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 Felson D et al, Arthritis Rheum 1995;38:

53 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR Response Criteria How is it Measured? Tender joint count Swollen joint count An assessment of 28 or more joints Joints are classified as either swollen or not swollen Felson D et al, Arthritis Rheum 1995;38:

54 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR Response Criteria How is it Measured? 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 Felson D et al, Arthritis Rheum 1995;38:

55 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR Response Criteria How is it Measured? Tender joint count Swollen joint count Physician's global assessment of disease activity Patient'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 Felson D et al, Arthritis Rheum 1995;38:

56 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR Response Criteria How is it Measured? 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 Felson D et al, Arthritis Rheum 1995;38:

57 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR Response Criteria How is it Measured? 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 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 Felson D et al, Arthritis Rheum 1995;38: AIMS: Arthritis Impact Measurement Scales; HAQ: Health Assessment Questionnaire; MHIQ: McMaster Health Index Questionnaire; MACTAR: McMaster Toronto Arthritis Patient Preference Disability Questionnaire 57

58 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR Response Criteria How is it Measured? 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 Patient's assessment of physical function Acute-phase reactant value A Westergren erythrocyte sedimentation rate or a C-reactive protein level Felson D et al, Arthritis Rheum 1995;38:

59 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR20 Response 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) Felson D et al, Arthritis Rheum 1995;38:

60 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity ACR50, ACR70 and ACR 90 Responses 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 Felson D et al, Arthritis Rheum 1995;38:

61 Tools for Assessment of Disease Activity The Health Assessment Questionnaire (HAQ)

62 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity 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 62

63 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity The Health Assessment Questionnaire 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 63

64 CIMZIA Prescriber Slide Kit Tools for Assessment of Disease Activity The Health Assessment Questionnaire 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