EVALUATION OF USE OF BELIMUMAB IN CLINICAL PRACTICE SETTINGS PATIENT CASE RECORD FORM PHASE II, MONTH PATIENT FOLLOW-UP

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Roderick Derek Austin
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1 EVALUATION OF USE OF BELIMUMAB IN CLINICAL PRACTICE SETTINGS PATIENT CASE RECORD FORM PHASE II, MONTH PATIENT FOLLOW-UP NOTE: Important Definition of Study Treatment Period Please provide patient information only for the period between month 18 and month 24 post belimumab therapy initiation. Based on data previously submitted in Phase I, the post-belimumab therapy initiation followup time period of months 18 to 24 for this patient is: FROM: TO: MD OFFICE ID #: (MDA ASSIGNED) PATIENT ID #: PATIENT GENDER: PATIENT ETHNICITY: BELIMUMAB START DATE: Did this patient experience any adverse event(s) related to belimumab between and? 2 No 1 Yes If Yes, please provide a description of the adverse experience(s) including the date of the event, belimumab dose at the time of event, and if the event was resolved / unresolved. If the patient died, please include cause of death and all relative details. Adverse Event 1: Date of event #1: M D Y Belimumab dose at the time of the event: Was this adverse event resolved? Yes 1 No 2 Did this patient die? No 2 Yes 1 Continue below If this patient died, what was the cause of death: If this patient died, what was the date of death: M D Y Adverse Event 2: Date of event #2: M D Y Belimumab dose at the time of the event: Was this adverse event resolved? Yes 1 No 2 Did this patient die? No 2 Yes 1 Continue below If this patient died, what was the cause of death: If this patient died, what was the date of death: M D Y SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 1

2 SECTION I: PATIENT PROFILE 1. Current weight: _ 1 lbs 2 kg SECTION II: CURRENT BELIMUMAB THERAPY 2. Is this patient still on belimumab therapy? 1 Yes Skip to Q3 2 No / / _ Answer below: If belimumab therapy ended, specify reasons for ending therapy [ x all that apply]: 1 Disease progression 4 Patient request 2 Medication not effective 5 Loss of insurance or reimbursement 3 Lack of compliance 6 Lost to follow-up or death x Adverse Event (SPECIFY): x Other (SPECIFY): 3. Specify the LAST or MOST RECENT DOSE of belimumab (at 24 months post-initiation or at time of discontinuation): mg/kg 4. Any CHANGES to the belimumab dose between and or date of discontinuation? 2 No Skip to Q5 1 Yes # of dose changes? Please indicate the date, dose, and reason for each dose change below: Date: 1 st : / / New Dose: _mg/kg Reason (SPECIFY): Date: 2 nd : / / New Dose: _mg/kg Reason (SPECIFY): Date: 3 rd : / / New Dose: _mg/kg Reason (SPECIFY): 5. What is your overall clinical assessment of disease severity of this patient at the end of month 18 (as of ) post belimumab therapy initiation? ( X one only) 0 Not documented SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 2

3 SECTION III: SLE CLINICAL MANIFESTATIONS, SEVERITY, AND IMPROVEMENT ASSESSMENT BETWEEN MONTHS 18 AND 24 POST BELIMUMAB THERAPY INITIATION 6. Complete table below based on the period of months following the start of belimumab therapy on:. PLEASE NOTE: This section pertains only to the 6-month period between and ; NOT from initiation to current. CLINICAL ASSESSMENT BETWEEN MONTH 18 AND MONTH 24 POST BELIMUMAB THERAPY INITIATION SLE Clinical Manifestations at Start of month 18 (Use # Codes In Legend Sheet. Use one row for each clinical manifestation) Code #: Code #: Code #: Code #: Code #: Code #: Other (SPECIFY): Severity of Clinical Manifestation at start of month 18 ( X one only for each) % Improvement in Individual Clinical Manifestations from months 18 to 24 (or date of ( X one only for each manifestation ) OVERALL CLINICAL RESPONSE to belimumab: during months 18 to 24 (or to Clinician impression of overall clinical manifestations observed: ( X one only) 1 Deteriorated 2 No Improvement 3 <20% Improvement % Improvement % Improvement 6 >80% Improvement SECTION IV: SLE DISEASE ACTIVITY ASSESSMENT BETWEEN MONTHS 18 AND 24 POST BELIMUMAB THERAPY INITIATION 7. Did you use any of the disease activity assessment tools listed below for this patient to be able to provide assessments at end of month 24 (as of, or date of post belimumab therapy initiation? ( X one only) 1 Yes Complete table below 2 No Skip to Q8 Q7b. Assessment at the end of month 24 post belimumab initiation (or at date of YES, tool used ( X box below) Score Physician Global Assessment Scale Specify range of scale used: to 1 _ Patient Global Assessment Scale Specify range of scale used: to 2 _ SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index SELENA Modification) / SLEDAI) 3 _ BILAG (British Isles Lupus Assessment Group Index) 4 _ SLAM (Systemic Lupus Activity Measure) 5 _ ECLAM (European Consensus Lupus Activity Measurement Index) 6 _ Other (SPECIFY): _ x _ 8. Did you use any other assessment tools for this patient at the end of month 24 (as of ) post belimumab therapy initiation? ( X one only) SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 3

4 1 Yes Complete table below 2 No Skip to Q9 Q8b. Assessment at the end of month 24 post belimumab initiation (or at date of Fatigue Severity Scale Please normalize the scale/score to a range of and provide your assessment YES, tool used ( X box below) 1 Score Other (SPECIFY): _ x SECTION V: OTHER SLE THERAPIES PRESCRIBED/USED BETWEEN MONTHS 18 & 24 POST BELIMUMAB THERAPY INITIATION 9. Was this patient prescribed other SLE medications, other than belimumab, between months 18 & 24 post belimumab therapy initiation? ( X one only) 1 Yes Complete table below 2 No Skip to Q10 Q.9a SLE medications [CONTINUED FROM PREVIOUS TREATMENT PERIOD used between and. Medication (use Legend # codes) Medication (use Legend # codes) Dose per Administration Medication (use Legend # codes) Medication (use Legend # codes) Route of Administration Frequency x Other: x Other: x Other: x Other: SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 4

5 Q.9b SLE medications [NEWLY STARTED] between and. Dose per Administration Route of Administration Frequency Medication (use Legend # codes) At the time of medication start 4 Once a week 5 Every 2 weeks x Other: 1 Daily 2 BID 4 Once a week 3 TID 5 Every 2 weeks Medication (use Legend # codes) At the time of medication start Medication (use Legend # codes) At the time of medication start x Other: x Other: x Other: 4 Once a week 5 Every 2 weeks x Other: x Other: SECTION VI: SLE-RELATED RESOURCE UTILIZATION 10. How many scheduled and unscheduled SLE-related office visits did this patient have between and or the date of belimumab discontinuation? (Record below) SLE RELATED PATIENT VISITS TO YOUR OFFICE # of Scheduled SLE-related visits to your office: # of Unscheduled SLE-related visits to your office: Between months 18 & 24 (or date of post belimumab therapy initiation (ENTER 0 IF NONE DOCUMENTED) SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 5

6 11. Between and (or the date of, which other physician specialties, if any, did this patient see for SLE-related reasons? Complete the number of visits for each specialty seen in table below. SPECIALISTS VISITED FOR SLE-RELATED REASONS [ X all that apply] 1 Another Rheumatologist 2 Allergist 3 Cardiologist 4 Dermatologist 5 Gastroenterologist 6 Internist 7 Nephrologist 8 Neurologist 9 Ophthalmologist 10 Psychologist 11 Radiologist x Other (Please Specify): Between months 18 & 24 (or date of post belimumab therapy initiation (ENTER 0 IF NONE DOCUMENTED) 12. Has this patient had at least one Emergency Room (ER) visit related to SLE between and or the date of belimumab discontinuation? ( X one only) 1 Yes Complete table below 2 No Skip to Q13 Q18b ER visits related to SLE Between months 18 & 24 (or date of belimumab discontinuation) post belimumab therapy initiation (ENTER 0 IF NONE DOCUMENTED) # of ER visits: 13. Has this patient had at least one SLE-related hospitalization between and or the date of belimumab discontinuation? ( X one only) 1 Yes Complete table below 2 No Skip to Q14 Q13b Hospitalization # 1 Hospitalization # 2 Hospitalization # 3 Hospitalization # 4 Admission date Mo Day Yr Mo Day Yr Mo Day Yr Mo Day Yr ICD-9 Code Related to belimumab? 1 Yes 1 Yes 1 Yes 1 Yes # Hospital days # # # # Admitted to ICU SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 6

7 14. Did this patient receive any SLE-related ancillary care between and or the date of belimumab discontinuation? ( X one only) 1 Yes Complete table below Q14b SLE-RELATED ANCILLARY CARE Physical therapy Occupational therapy Home health care services Other (Specify): 2 No Skip to Q15 Between months 18 & 24 (or date of post belimumab therapy initiation 15. Did this patient s primary or secondary medical or prescription drug insurance coverage change between months 18 and 24 post belimumab initiation? If yes, please indicate the patient s major medical insurance (Column A) and prescription drug insurance coverage (Column B) in the table below, at the end of month 24 (as of ) post belimumab initiation, or at the date of belimumab discontinuation. ( X one only) 1 Yes Complete table below 2 No Please complete the remaining Patient CRFs. INSURANCE COVERAGE CHANGE between and Column A: Medical Insurance Coverage Column B: Drug Insurance Coverage Primary Secondary Primary Secondary Medicare (including office injection) Medicaid State Funded Program Traditional Fee For Service/Indemnity Insurance HMO PPO Self Pay Indigent / No Pay VA None Don t Know / Not documented END OF THIS PATIENT CRF. PLEASE COMPLETE THE REMAINING PATIENT CRFs. SLE PATIENT CRF v8 August 15, 2012 PHASE II_FU Page 7

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