IMMerge 2021.

Study characteristics
Methods	RCT, active‐controlled, single‐blind study (outcomes assessor) Date of study: March 2018 ‐ March 2020 Location: worldwide (64 sites) Phase 3
Participants	Randomised: 327 participants Inclusion criteria Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the baseline visit Stable moderate‐to‐severe chronic plaque psoriasis with or without psoriatic arthritis Must be a candidate for systemic therapy as assessed by the investigator Must be an acceptable candidate to receive secukinumab according to the local label for this compound Exclusion criteria History of erythrodermic psoriasis, generalised or localised pustular psoriasis, medication‐induced or medication‐exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/or active tuberculosis. People with a positive QuantiFERON®‐TB /PPD) test result may participate in the study if further work‐up (according to local practice/guidelines) establishes conclusively that the person has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines Active systemic infection during the last 2 weeks prior to baseline visit (exception: common cold) History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully‐treated non‐melanoma skin cancer (NMSC) or localised carcinoma in situ of the cervix Previous exposure to risankizumab Previous exposure to secukinumab Baseline characteristics N = 327, mean age of 47 years and 65% men Dropouts and withdrawals 46/327 (14%): Risankizumab group (15), Secukinumab group (31) Protocol deviation: Risankizumab group (1), Secukinumab group (3) Lack of efficacy: Risankizumab group (1), Secukinumab group (8) Lost to follow‐up: Risankizumab group (6), Secukinumab group (8) Adverse event: Risankizumab group (2), Secukinumab group (8) Withdrew with consent: Risankizumab group (5), Secukinumab group (2) Other: Risankizumab group (0), Secukinumab group (3)
Interventions	Intervention A. Risankizumab (2 SC injections of 75 mg (150 mg total) at weeks 0 and 4, and every 12 weeks thereafter until the last dose at week 40, except for participants in France, who received additional doses at weeks 52 and 64 to allow for continuous treatment until it was commercially available for patients in France), n = 164 Control interventions B. Secukinumab (2 SC injections of 150 mg (300 mg total) at weeks 0, 1, 2, 3 and 4,and every 4 weeks thereafter until the last dose at week 48), n = 163
Outcomes	At week 16 Primary outcome PASI 90 Secondary outcomes PASI 90 at 52 weeks PGA 0/1 at 52 weeks PASI 75 at 52 weeks PASI 100 at 52 weeks
Notes	Funding Quote (p 1): "AbbVie Inc. funded this study, and participated inthe study design, research, analysis, data collection, interpretation of data, reviewing and approval ofthe publication. All authors had access to the data and participated in the development, review, critique and approval of the manuscript throughoutthe editorial process, and approved the final manuscript draft submitted for publication. All authors agree to be accountable for all aspects of the work, ensuring the accuracy and integrity of the publication. Medical writing support was paid for by AbbVie) Conflicts of interest Quote (appendix 1): "R.B.W. has received research grants from and leads clinical trials for AbbVie, Almirall, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer and UCB Pharma; and has received consulting fees from AbbVie, Almirall, Amgen, Arena Pharmaceuticals, Avillion, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Janssen, LEO Pharma, Eli, Lilly, Novartis, Pfizer, Sanofi and UCB Pharma. A.B. has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Pharmaceuticals, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, Forte, Galderma, Janssen, LEO, Novartis, Ortho, Pfizer, Rapt, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma and UCB Pharma; and as a paid speaker for AbbVie. Y.P. has received grant funding and honoraria for services as an investigator, speaker and member of advisory boards from AbbVie, Amgen, Bausch, Janssen‐Ortho and UCB Pharma; and has received grant funding as an investigator from Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Incyte, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Sanofi, Serono and Takeda. C.P. has received grants from and has been a consultant for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sandoz and UCB Pharma. S.B., M.K., T.W. and Z.G. are full‐time employees of AbbVie Inc. and may hold AbbVie stock and/or stock options."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 1) : "IMMerge was a phase III, international, multicentre, randomized, ... randomized in a 1: 1 ratio via a centralized Interactive Response Technology system to open‐label treatment with risankizumab or secukinumab for up to 64 weeks" Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 1) : "IMMerge was a phase III, international, multicentre, randomized.....randomized in a 1: 1 ratio via a centralized Interactive Response Technology system to open‐label treatment with risankizumab or secukinumab for up to 64 weeks" Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (p 1) : open‐label, efficacy–assessor‐blinded, active‐comparator study Comment: no blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 3) : "Efficacy assessments were performed by a qualified physician or designee at each study site at all appropriate study visits.The efficacy assessor was fully trained on the protocol and could not perform efficacy assessments prior to having completed all necessary training. The efficacy assessor remained blinded to each patient’s treatment and clinical laboratory results, and all safety data during the course of the study. The efficacy assessor was instructed to document the dermatological assessments on paper worksheets and was not allowedaccess to patient electronic case report forms" Comment: clearly defined
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dealing with missing data Quote (p 4 ): "Missing efficacy data were accounted for using nonresponder imputation, whereby any patient who had a missing valueat a study visit was categorized as a nonresponder for that visit, unless the patient was a responder both before and after a specific visit window. Safety analyses were performed on all intent‐to‐treat patients who received at least one dose of study drug (safety population)." Randomised 327, analysed 327
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT03478787) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported No results were posted on ClinicalTrials.gov on the 21 September 2020