Summary of clinical experience was revised to remove the explanation regarding the last day and the first day of the study. Overview of study design was revised to include the explanation that once participants complete treatment and follow-up in the study, signed the informed consent form (ICF), and met all study eligibility criteria, they may be enrolled in this OLE study. Estimated duration of participant's participation and treatment regimen sections in the study were revised to reduce the duration of the study to 2 years. Rationale for study design was updated to remove the reference to participants at least 18 years of age. Inclusion criteria clarified use of adequate contraception for females and males, clarified to state that participants must be willing to forgo other forms of experimental treatment. Withdrawal criteria was clarified for procedures following permanent discontinuation of study drug. Monitoring of dose administration was updated to remove the reference that temperature should be taken orally. Schedule of study procedures for the treatment period and for 85-day follow-up period were revised and updated. Removal of Clinical Evaluation Questionnaire for adverse event of special interest (AESI), addition of procedures for an unscheduled study visit, collection of biomarker samples was made optional, addition of statement that non-serious and serious AESIs should be recorded.

Addition of Health-related quality of life impact as exploratory objective and addition of SF-36v2 assessments and analyses to relevant sections, clarification of management of oral corticosteroid (OCS) treatment, addition of hepatitis B virus DNA polymerase chain reaction, QuantiFERON-TB Gold In-tube systemic lupus erythematosus test, immunology profile, urinalysis, urine β human chorionic gonadotropin, and investigator flare question(s) to visit 27, clarification regarding recording of serious and non-serious events of hepatic abnormality as well as AESIs (new or reactivated TB infection, herpes zoster infection, malignancy, infusion, hypersensitivity or anaphylactic reactions, and vasculitis).

Duration of IV infusion updated to approximately 60 minutes, updated that for OCS medication taken >40 mg/day of prednisone (or equivalent) for greater than 14 days, dosing with study medication must be withheld until OCS medication can be tapered to ≤40 mg/day, changes in instructions of dose preparation and monitoring of dose administration, modification in schedule of study procedures to state that if Day 1 of the study occurred on Day 422 of study 1013, many of the procedures/assessments only needed to be collected once. If >28-day window elapsed after Day 422, the Day 1 procedures needed to be conducted, serum sample collection of proteomics/biomarkers made optional, guidance for participant who have had recent contact or show signs and symptoms of active tuberculosis (TB), discontinuation of participants due to active TB or noncompliance with latent TB treatment, guidance for pregnancy testing requirements updated.

Exemption of participants from requirement of study 1013 completion in regions of Ukraine, interim analysis of study 1013 updated after completion and resulted change in: dose from 1000 mg to 300 mg, infusion time from approximately 60 minutes to at least 30 minutes, and infusion volume based on dose reduction, change in duration of study drug administration from 2 to 3 years, total number of participants randomized in study 1013 (n=307) updated, clarification of permitted study medications and dosing regimens for OCS, clarification that vital signs were to be measured until stable and participant judged by investigator ready for discharge, modification of multiple procedures in the schedule of study assessment, clarification of methodology for multiple study assessments, correction of definition of grade 4 adverse event severity, addition of appendix providing guidance for abnormal liver function test management.