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RealWorld Dynamix™: Biologic and Apremilast New Starts in Client Database Variables

Patient Audit Select the most recent patients with Psoriasis whom you have initiated on their first biologic or apremilast (Otezla). Selected patients must meet the following criteria: ● At least 18 years old ● Not enrolled in a clinical trial for a disease modifying therapy (biologic or small molecule) ● Initiated for the first time on a biologic or apremilast within the past three months

Specify the initiated agent o (Humira) o Apremilast (Otezla) o (Siliq) o Etanercept (Enbrel) o (Tremfya) o (Remicade, biosimilar Infliximab or biosimilar Renflexis) o (Taltz) o (Cosentyx) o (Stelara)

Key Dates ● Number of months since first visit with physician ● Number of months since prior visit with physician ● Number of months until next scheduled visit with physician ● Number of months since diagnosis of PsO ● Number of months since first treatment with a biologic or Otezla ● Total visits in the past 12 months ● Most recent visit routine follow-up, non-routine, or first visit

History and Physical ● Gender ● Age ● Height ● Weight ● Ethnicity ● Employment status ● Primary insurance type ● Patient participation in assistance program (if applicable) ● Quality of life o Pain o Fatigue o Activities of daily living o Work/school performance o Social, leisure, or family activities o Sleep quality 2

o Sexual activity

● Overall health status ● Patient lifestyle—sedentary to active ● Patient adherence to psoriasis regimen

Severity ● Current psoriasis severity: mild, moderate, severe ● Areas of the body affected by psoriasis and severity in each area (not present, mild, moderate, severe) ○ Face, scalp, hands, fingernails, feet, trunk, legs, arms, genitals, back ● Values at: first referral and biologic/Otezla initiation ○ Body surface area ○ Total PASI score ○ CRP ○ ESR ○ Uric acid ○ Fungal testing ○ Presence of joint involvement (none, mild, moderate, severe)

Co-morbidities/Risk Factors ● Co-morbidities ○ Anemia, anorexia/bulimia, chronic fatigue syndrome, depression, other mental health comorbidity, diabetes, heart failure, hypertension, cancer (past or present), hyperlipidemia/dyslipidemia, obesity, renal impairment, liver impairment, ocular comorbidities ● Other Autoimmune conditions ○ Ulcerative colitis, Crohn’s disease, multiple sclerosis, , , non-radiographic axial spondylitis, SLE, rheumatoid arthritis, uveitis, other ● Notable histories of ○ Allergies, history of myocardial infarction, recent infection, history of VTE, history of or current smoker, clinically relevant alcohol consumption, family history of psoriasis ● Cardiovascular risk profile ● Risk for developing a malignancy ● Plans for starting family/having more children

Co-management/Referrals ● Co-management with rheumatologists if joint involvement ● Level of involvement of rheumatologist if comanaged ● Future plans of rheumatology referral ● Specialty of patient’s first referral ● If dermatology referred, reason for referral

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Concomitant Treatments ● History of psoriasis treatment: Currently prescribed, immediately prior to current biologic/Otezla, previously treated but not immediately prior, never ○ Topical steroids, systemic steroids, Soriatane, Methotrexate, Cyclosporine, Other oral systemics, Dovonox, Taclonex, Tazorac, Vectical, Zithronal-RR, Phototherapy ● If currently on systemic steroids what is the dose and frequency ● Number of times short-course steroids prescribed ● If currently on MTX- dose, administration and frequency ● If not on MRX, reason why

Insurance ● If a prior authorization was required ● What was needed for prior authorization approval

Patient Involvement and Decision to Initiate Therapy ● Number of months physician and patient discussed biologic/apremilast therapy prior to initiation ● Timeliness of biologic/apremilast therapy initiation in patient’s course of disease ● Patients mental/emotional view on beginning biologic/apremilast therapy ● Overall patient role in selecting current brand ● Clinical rationale when patient was a primary driver in brand selection

Current Treatment ● Maintenance dose, frequency, administration type, if received loading dose of current agent ● Reason for choice of current brand; primary reason and all reasons ○ Desire for specific MOA ○ Desire for dosing interval ○ Desire for oral ○ Desire for SC ○ Desire of IV administration ○ Insurance mandate, reimbursement issue ○ Lowest out of pocket cost to patient ○ Access to drug through a patient assistance program ○ Family planning considerations ○ Speed of onset of action ○ Patient requested ○ I have the most comfort with it ○ The drug’s safety profile ○ The drug’s efficacy profile for skin clearance ○ Efficacy in skin and joints ○ The manufacturer is very supportive of our patients and practice ○ Specific patient co-morbidities 4

○ Which specific comorbidities ○ Other ○ Specify ● Level of patient involvement in brand selection ● Impact of managed care on brand selection ● If managed care access/OOP costs not an issue, what brand would have been prescribed ● If current brand were not available, what would have been prescribed/back-up agent ● Reason current agent was chosen over back-up agents ● How long physician will keep patient on current agent to assess response ● If current agent is unsuccessful, what is the next likely brand you will switch to ● Candidacy for products in development ○ , (BI 655066), Cimzia (certolizumab), Bimekizumab ● If all products in development were commercially available, which one would be most considered for this patient ○ Tildrakizumab, risankizumab (BI 655066), Cimzia (certolizumab), Bimekizumab

Physician Questionnaire This market research study is intended for US based Rheumatologists treating Psoriasis (“PsO”) patients treated with a biologic agent or Otezla who have recently had a switch in their biologic agent / Otezla treatment. ● Geographic region of practice ● Specialty (must be dermatology) ● Years in clinical practice (must be between 2 and 35) ● Age groups of PsO patients treated (under 18 must be less than 30% of patients) ● Number of patients with certain conditions (must treat at least 50 with Psoriasis) ● Percentage of professional time spent in clinical practice (must be at least 50%) ● Percent of patient visits related to dermatology conditions (cosmetic dermatology must be less than 30%) ● Number of patients being treated with biologic agents or Otezla ● Number of new and returning PsO seen in the last month ● Description of practice setting—office, academic hospital, community hospital, HMO, other ● Services offered in physician’s practice: ● Products in which they offer infusion services for (if applicable) ● Description of relationship with pharmaceutical representatives ● Presence of Biological coordinator ● Percent of biological coordinator’s time devoted to this task (if applicable) ● Any changes in past 6 months in the way they are managing PsO patients ● Percent of patients with: ○ Mild, moderate, severe PsO ● Percent of psoriasis patients in the following severity categories who also have psoriatic arthritis: ○ Mild, moderate, severe ● Percent of psoriasis patients in the following severity categories who also see a rheumatologist: 5

○ Mild, moderate, severe ● Percent of physician’s PsO patients that are: ○ Not clinical candidates for biologic therapy ○ Clinical candidates for biologic therapy but are not prescribed these agents ○ Currently prescribed biologics ● Changes in physician’s use of biologics to treat PsO in the last year ● Reasons for increased use of biologics to treat PsO (if applicable) ● Percent of (a) mild (b) moderate and (c) severe PsO patients currently receiving prescription drug therapy following the regimens listed: ○ Prescription topical agents ○ Conventional systemic agents ○ Otezla ○ Biologics ● Percent of PsO patients on the following brands who are currently treated with biologic agents: ○ Cosentyx, Enbrel, Humira, Inflectra (infliximab biosimilar), Remicade, Stelara, Taltz, Siliq, Tremfya, Other biologics not currently approved for PsO ● Brand satisfaction: ○ Cosentyx, Enbrel, Humira, Inflectra (infliximab biosimilar), Otezla, Remicade, Renflexis (infliximab biosimilar), Stelara, Taltz, Siliq, Tremfya ● Percent of Otezla patients prescribed Otezla prior to biologics, after 1 biologic, or after 2 or more biologics ● Percent of PsO patients: ○ On their first, second, or third line biologic agent ● First-line biologic brand share o Cosentyx, Enbrel, Humira, Infliximab (Remicade or biosimilar), Stelara, Taltz, Siliq, Tremfya, Other biologics not currently approved for PsO ● Percent of first-line biologic patients (initiated in the last year) who A) Started at an appropriate time in their disease B) Should have been initiated on biologic earlier C) Could have waited a little longer before initiating treatment ● Categorize first-line biologic PsO patients (initiated in the past year) o Reluctant to initiate biologic therapy o Resigned to the fact that biologic therapy was necessary o Relieved that they were able to initiate biologic therapy o Excited/Motivated to begin biologic therapy o Anxious about initiating biologic therapy o Other (specify) ● Initiation origin of biologic therapy discussion for first-line biologic PsO patients initiated in the past year (physician vs. patient) ● Level of agreement with specified statements o DTC advertising drives patient requests for PsO brands o In general, DTC advertising for biologics and Otezla sets appropriate expectations for patients o When a patient requests a particular brand, I generally approve that request o Given the choice, most patients would choose an oral agent over one that would be administered subcutaneously ● Company which physician feels provides the best support for practice 6

● Company which physician feels provides the best support for PsO patients ● Level of agreement with specified statements ○ The SC TNF agents are interchangeable in PsO ○ The IL-17 inhibitors (Cosentyx, Taltz and Siliq) are interchangeable in PsO ○ DTC advertising drives patient requests for PsO brands ○ In general, DTC advertising for biologics and Otezla sets appropriate expectations for patients ○ After a primary TNF failure in PsO, I usually move to an alternate mechanism of action ○ When a patient requests a particular brand, I generally approve that request ○ Given the choice, most patients would choose an oral agent over one that would be administered subcutaneously ○ I have full confidence that the quality, safety and efficacy of infliximab biosimilars is equivalent to that of branded Remicade ○ Payers are significantly restricting my use of biologics ○ I like the convenience and safety associated with Otezla in PsO ○ I think that Otezla is generally an efficacious option for PsO ○ I prefer to try Otezla as a PsO treatment prior to biologics ○ I anticipate decreasing my use of TNF-inhibitors and increasing my use of alternative MOAs for the treatment of PsO in the near future ○ I will exhaust all topical and systemic treatment options before introducing a biologic or small molecule ○ I would be more comfortable prescribing a drug that was newly approved for PsO but had post-marketing experience in another indication than I would be prescribing a completely novel MOA drug ○ I am excited about the approval of Janssen’s Tremfya (guselkumab) ● Preferred anti-TNF ● Preferred alternate MOA biologic ● Preferred IL-17 inhibitor ● Barriers to increased Otezla use in patients with psoriasis ● Percent of PsO patients treated with biologics that are (a) well managed on current treatment (b) improving but not optimal and (c) not having a great response ● Percent of PsO patients treated with Otezla that are (a) well managed on current treatment (b) improving but not optimal and (c) not having a great response ● Familiarity with products in development for RA: ○ Tildrakizumab, risankizumab (BI 655066), Cimzia (certolizumab), bimekizumab ● Preferred pipeline agent to gain approval ○ Tildrakizumab, risankizumab (BI 655066), Cimzia (certolizumab), bimekizumab