CIMPASI‐1 2018.

Study characteristics
Methods	RCT, active/placebo‐controlled, double‐blind trial Date of study: December 2014 ‐ October 2016 Location: World‐wide Phase 3
Participants	Randomised: 234 participants Inclusion criteria Provided informed consent Adult men or women ≥ 18 years Chronic plaque psoriasis for ≥ 6 months Baseline PASE ≥ 12 and BSA ≥ 10% and PGA score ≥ 3 Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy Other protocol‐defined inclusion criteria may apply Exclusion criteria Erythrodermic, guttate, generalised pustular form of psoriasis History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol Congestive heart failure History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease History of other malignancy concurrent malignancy as described in the protocol History of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis) Breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following last dose of study drug. Men who are planning a partner pregnancy during the study or within 10 weeks following the last dose Any other condition which, in the Investigator's judgement, would make the person unsuitable for participation in the study Other protocol‐defined exclusion criteria may apply Dropouts and withdrawals 9/234 (3.8%); Certolizumab 400 (1), Certolizumab 200 (3), placebo group (5) Adverse events: Certolizumab 400 (1), Certolizumab 200 (0), placebo group (0) Lack of efficacy: Certolizumab 400 (0), Certolizumab 200 (0), placebo group (1) Withdrawal: Certolizumab 400 (0), Certolizumab 200 (2), placebo group (3) Lost to follow‐up: Certolizumab 400 (0), Certolizumab 200 (1), placebo group (1) Other reason:Certolizumab 400 (2), Certolizumab 200 (0), placebo group (0)
Interventions	Intervention A. Certolizumab pegol (400 mg at weeks 0, 2, 4, followed by certolizumab pegol 200 mg every 2 weeks from week 6 to week 14) (n = 95) Control intervention B. Certolizumab pegol (certolizumab pegol 400 mg every 2 weeks through week 14) (n = 88) C. Placebo (n = 51)
Outcomes	At week 16 Primary composite outcome PASI 75 PGA 0/1 Secondary outcomes PASI 90 DLQI
Notes	Funding source Quote (p 302): "Supported by Dermira Inc and UCB Inc." Conflicts of interest Quote (p 302): "Dr Gottlieb has consulted and/or received other fees from Janssen Inc, Celgene Corp, Bristol‐Myers Squibb Co, Beiersdorf Inc, AbbVie, UCB, Novartis, Incyte, Eli Lilly, Reddy Labs, Valeant, Dermira Inc, Allergan, and Sun Pharmaceutical Industries; and has received research or educational grants (paid to TuftsMedical Center) from Janssen Incyte, Lilly, Novartis, Allergan, and LEO Pharma. Dr Blauvelt has received honoraria or fees for consulting, being a clinical investigator, and/or speaker for AbbVie, Aclaris, Allergan, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira Inc, Eli Lilly, Genentech/Roche, GlaxoSmith‐Kline, Janssen, LEO Pharma,Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac. Dr Leonardi has received fees or honoraria for consulting, speaking, or serving on the advisory board for AbbVie, Actavis, Amgen, Boehringer Ingelheim Pharma, Celgene, Coherus, Corrona, Dermira Inc, Eli Lilly, Galderma, Glenmark, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel, UCB Pharma, Vitae, and Wyeth. Dr Poulin has received research grants as an investigator for AbbVie, Baxter, Boehringer Ingelheim Pharma, Celgene, Centocor/Janssen, Eli Lilly, EMD Serono, GlaxoSmithKline, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Takeda, and UCB Pharma; and has received honoraria speaking for AbbVie, Celgene, Janssen, Eli Lilly, LEO Pharma, Novartis, Regeneron, and Sanofi Genzyme. Dr Reich has received speaker’s fees or honoraria from and/or served on the advisory board for AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen‐Cilag, LEO Pharma, Eli Lilly, Medac, Merck Sharp & Dohme, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Dr Thac¸has received research support from AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Dignity, Eli Lilly, Forward‐Pharma, GlaxoSmithKline, LEO Pharma, Janssen‐Cilag, Maruho, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfizer, Roche, Regeneron, and Sandoz; received honoraria from AbbVie, Biogen, Celgene, Janssen, LEO Pharma, Pfizer, Roche‐Possay, Novartis, and Mundipharma; served as a consultant for AbbVie, Biogen, Celgene, Dignity, Galapagos, Maruho, Mitsubishi, Novartis, Pfizer, and Xenoport; and sat on the scientific advisory boards for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, GlaxoSmithKline, LEO Pharma, Pfizer, Novartis, Janssen, Mundipharma, and Sandoz. Ms Drew and Dr Burge have received stock options fromDermira Inc. Mr Peterson owns stock in UCB Inc. Dr Arendt owns stock in and has received stock options from UCB Inc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (pp 303‐4): " CIMPASI‐1 (NCT02326298) and CIMPASI‐2 (NCT02326272) are ongoing, replicate, phase 3, randomized, double‐blinded, multicenter... At the baseline visit, an interactive voice web response system was used to assign patients to... according to the randomization schedule produced by an independent biostatistician (2:2:1, stratified by site)." Comment: Probably done
Allocation concealment (selection bias)	Low risk	Quote (pp 303‐4): " CIMPASI‐1 (NCT02326298) and CIMPASI‐2 (NCT02326272) are ongoing, replicate, phase 3, randomized, double‐blinded, multicenter... At the baseline visit, an interactive voice web response system was used to assign patients to... according to the randomization schedule produced by an independent biostatistician (2:2:1, stratified by site)." Comment: Probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (pp 303‐4): " CIMPASI‐1 (NCT02326298) and CIMPASI‐2 (NCT02326272) are ongoing, replicate, phase 3, randomized, double‐blinded, multicenter... to assign patients to subcutaneous treatment with CZP 400 mg every 2 weeks, CZP 200 mg every 2 weeks (after loading dose of CZP 400 mg at weeks 0, 2, and 4), or placebo every 2 weeks until week 16 (initial treatment period)" Comment: Probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (pp 303‐4): " CIMPASI‐1 (NCT02326298) and CIMPASI‐2 (NCT02326272) are ongoing, replicate, phase 3, randomized, double‐blinded, multicenter... to assign patients to subcutaneous treatment with CZP 400 mg every 2 weeks, CZP 200 mg every 2 weeks (after loading dose of CZP 400 mg at weeks 0, 2, and 4), or placebo every 2 weeks until week 16 (initial treatment period)" Comment: Probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 234 Management of missing data: Quote (p 308): "Efficacy analyses were performed on the randomized set (all randomized patients)...The Markov chain Monte Carlo method for multiple imputation was used to account for missing data." Table 2: 234 analysed participants Comment: done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02326298) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported Results are posted on ClinicalTrials.gov