Baricitinib EUPAS25154 Non-interventional PASS Final Study Report Version 1.0 11 March 2020 Page 1 PASS Information Title Study I4V-MC-B010: Rheumatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant® (baricitinib) a JAK1/2 inhibitor Version identifier of the final study report Version 1.0 Date of last version of the final study report Not Applicable EU PAS register number EUPAS25154 Active substance Baricitinib ATC Code: L04AA37 Medicinal product(s): Baricitinib Product reference: EMEA/H/C/004085 Procedure number: Marketing authorisation holder(s) Eli Lilly Nederland B.V. Joint PASS Not Applicable Research question and objectives This study assessed: a) Rheumatologists’ understanding of the important safety information detailed in the Healthcare Professional Educational Material, that is, information relating to: - Pregnancy and breast feeding - Infections - Changes in lipid parameters b) Communication of the important safety information and mitigating actions to patients prescribed baricitinib for the first time c) Distribution of the Patient Alert Card (PAC) to patients prescribed baricitinib for the first time. Countries of study France, Germany, Sweden, and the United Kingdom. Author PPD PPD PPD Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285, USA Email: PPD Tel: PPD Signature of principal investigator PPD Signature on file/see approval date below Approval Date: 17-Mar-2020 GMT Page 1 of 154 Baricitinib EUPAS25154 Non-interventional PASS Final Study Report Version 1.0 11 March 2020 Page 2 Marketing Authorisation Holder Marketing authorisation holder (MAH) Eli Lilly Nederland B.V. (Lilly) Papendorpseweg 83 3528 BJ Utrecht The Netherlands MAH contact person PPD Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285, USA Email: PPD Tel: PPD Page 2 of 154 Baricitinib EUPAS25154 Non-interventional PASS Final Study Report Version 1.0 11 March 2020 Page 3 Table of Contents Section Page Table of Contents .............................................................................................................................3 List of Tables ...................................................................................................................................5 1. Abstract ....................................................................................................................................6 2. List of abbreviations ..............................................................................................................10 3. Investigators ..........................................................................................................................11 4. Other responsible parties .......................................................................................................12 5. Milestones ..............................................................................................................................13 6. Rationale and background .....................................................................................................14 7. Research question and objectives ..........................................................................................15 8. Amendments and updates ......................................................................................................16 9. Research methods ..................................................................................................................17 9.1. Study design .....................................................................................................................17 9.2. Setting ...............................................................................................................................17 9.3. Subjects.............................................................................................................................18 9.3.1. Inclusion criteria ......................................................................................................18 9.3.2. Exclusion criteria .....................................................................................................18 9.4. Variables ...........................................................................................................................18 9.5. Data sources ......................................................................................................................19 9.6. Bias ...................................................................................................................................20 9.7. Study size..........................................................................................................................20 9.8. Data transformation ..........................................................................................................21 9.9. Statistical methods ............................................................................................................22 9.9.1. Main summary measures .........................................................................................22 9.9.2. Main statistical methods ...........................................................................................22 9.9.3. Missing values ..........................................................................................................25 9.9.4. Sensitivity analyses ..................................................................................................25 9.9.5. Amendments to the Survey Analysis Plan ...............................................................25 9.10. Quality control ..................................................................................................................25 10. Results ...................................................................................................................................27 10.1. Participants .......................................................................................................................27 10.2. Descriptive data ................................................................................................................28 10.3. Main results ......................................................................................................................30 10.3.1. Individual questions about important safety information ........................................30 Page 3 of 154 Baricitinib EUPAS25154 Non-interventional PASS Final Study Report Version 1.0 11 March 2020 Page 4 10.3.2. Understanding of Key Risk Messages .....................................................................33 10.3.3. Communication of important safety information .....................................................35 10.3.4. Distribution of the Patient Alert Card ......................................................................35 10.4. Subgroup analyses ............................................................................................................36 10.4.1. Individual questions about important safety information and understanding of key risk messages .........................................................................36 10.4.2. Communication of important safety information .....................................................37 10.4.3. Distribution of the Patient Alert Card ......................................................................38 10.5. Adverse events/adverse reactions .....................................................................................38 11. Discussion ..............................................................................................................................39 11.1. Key results ........................................................................................................................39 11.2. Limitations ........................................................................................................................40 11.3. Interpretation ....................................................................................................................41 11.4. Generalisability.................................................................................................................42 12. Other information ..................................................................................................................43 13. Conclusions ...........................................................................................................................44 14. References .............................................................................................................................45 Annex 1. List of standalone documents ...................................................................................46 Annex 2. Additional information ...........................................................................................154 Page 4 of 154 Baricitinib EUPAS25154 Non-interventional PASS Final Study Report Version 1.0 11 March 2020 Page 5 List of Tables Table 9-1: Estimated Precision, by Sample Size and Proportion ..................................................21 Table 9-2: Key Risk Messages Informing Understanding of Important Safety Messages ............23 Table 10-1: Survey Administration Statistics ................................................................................27 Table 10-2: Survey Participant Eligibility Results ........................................................................28 Table 10-3: Description of Rheumatologists