Table 1

Objectives and endpoints

Objectives	Endpoints
Primary objective	Primary endpoint
To compare the change in generic HRQoL from baseline to 24 weeks	Change in mean SF-36 PCS from baseline to 24 weeks
Key secondary objectives	Key secondary endpoints
To compare the change in generic PROs from baseline to 24 Weeks	Proportion of subjects achieving MCID in SF-36 PCS at week 24 Change in mean SF-36 MCS from baseline to 24 weeks Change in mean Facit-Fatigue score from baseline to 24 weeks Change in mean WPAI score from baseline to 24 weeks Change in mean General Self-Efficacy scale scores from baseline to 24 weeks Change in mean HADS-A from baseline to 24 weeks Change in mean HADS-D from baseline to 24 Weeks
Additional secondary objectives
To compare the change in disease-specific PROs from baseline to 24 weeks	Change in mean DLQI from baseline to 24 weeks Change in mean HAQ from baseline to 24 weeks Change in mean BASDAI from baseline to 24 weeks Change in mean BASFI from baseline to 24 weeks Change in mean SIBDQ from baseline to 24 weeks
To compare the change in cardiovascular and metabolic risk factors	Change in body weight from baseline to 24 weeks# BMI response (5% BMI reduction) at 24 weeks# Change in waist-hip ratio from baseline to 24 weeks# Percent change in LDL-C, TC, TG and HDL-C at 24 weeks## Change in proportion of subjects receiving lipid-lowering agents from baseline to 24 weeks
To compare changes in signs and symptoms of inflammatory disease from baseline to follow-up	PASI remission PASI≤3 at week 24 PASI 75, 90 and 100 response at 24 weeks* Change in PASI, psoriasis BSA and number of psoriatic nails from baseline at 24 weeks* ASDAS remission at 24 weeks (remission <1.3/ not in ASDAS remission >1.3) ASAS 20 and 40 response at 24 weeks ACR 20, 50 and 70 at week 24* Change from baseline in DAPSA* Change from baseline in MDA* HBI remission (HBI <4) at 24 weeks SCCAI score <2 (remission) at 24 weeks* Proportion of patients with Hidradenitis Suppurativa Clinical Response (HiSCR) at 24 weeks****
To assess the change in generic and disease-specific HRQoL from baseline to all other applicable timepoints To assess whether changes in clinical endpoints is associated with changes in HRQoL

Among patients with *Psoriasis at baseline, **AxSpA/AS at baseline, ***Psoriatic Arthritis at baseline, ****Crohn’s disease at baseline, *****Ulcerative colitis at baseline, ******Hidradenitis Suppurativa at baseline, #BMI≥35 at baseline, ##LDL-C ≥3.0 mmol/L at baseline.
ACR, American College of Rheumatology; ASAS, Assessment of SpondyloArthritis international society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Function Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BMI, Body Mass Index; BSA, body surface area; DAPSA, Disease Activity in PSoriatic Arthritis; DLQI, Dermatology Life Quality Index; HADS, Hospital Anxiety and Depression Scale; HADS-A, Hospital Anxiety and Depression Scale-Anxiety; HADS-D, Hospital Anxiety and Depression Scale-Depression; HAQ-DI, Health Assessment Questionnaire Disability Index; HBI, Harvey-Bradshaw Index; HDL-C, Cholesterol High Density Lipoprotein; HiSCR, Hidradenitis Suppurativa Clinical Response; HRQoL, Health-Related Quality of Life; IGA, Investigators Global Assesment Scale; LDL-C, Cholesterol Low Density Lipoprotein; MCID, Minimal Clinical Important Difference; MCS, Mental Component Score ; MDA, Minimal Disease Activity; PASI, Psoriasis Area Severity Index; PCS, Physical Component Score; PGA, Physician’s Global Assessment; PRO, Patient Reported Outcome; SCCAI, Simple Clinical Colitis Activity Index; SF-36, Short Form Health Survey; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; SJC, Swollen Joint Count; SPARCC, Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system; TC, Total Cholesterol; TG, Triglycerid; TJC, Tender Joint Count; WPAI, Work Productivity and Activity Impairment Questionnaire.