| Study characteristics |
| Methods |
RCT, active‐controlled, double‐blind trial
Date of study: February 2016 ‐ December 2017
Location: world‐wide |
| Participants |
Randomised: 443 participants
Inclusion criteria
Men or women ≥ 18 years old with a clinical diagnosis of stable moderate‐to‐severe plaque psoriasis (defined by PASI score ≥ 12, PGA score ≥ 3, and ≥ 10% of body surface area affected at Screening and Baseline [Day 1 of Week 1]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque‐type psoriasis despite topical therapy Participants must not have received more than 1 biologic therapy Other protocol‐defined inclusion criteria could apply
Exclusion criteria
People were excluded if they have erythrodermic, pustular, guttate, or medication‐induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration People was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis [TB]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex Other protocol‐defined exclusion criteria could apply
Dropouts and withdrawals
Biosimilar group (9), Humira group (19)
Not treated: Biosimilar group (1), Humira group (1) Participant decision: Biosimilar group (1), Humira group (4) Lost to follow‐up: Biosimilar group (1), Humira group (2) Lack of efficacy: Biosimilar group (0), Humira group (2) Protocol violation: Biosimilar group (3), Humira group (1) AEs: Biosimilar group (2), Humira group (9) Others: Biosimilar group (1), Humira group (0)
|
| Interventions |
Intervention
A. Biological: MSB11022, S/C, Biosimilar adalimumab week 0: 80 mg, week 1: 40 mg, then 40 mg EOW, n = 222
Control Intervention
B. Biological: adalimumab (Humira) week 0: 80mg, week 1: 40 mg, then 40 mg EOW, n = 221 |
| Outcomes |
At 16 weeks
Primary outcome
Secondary outcomes
PASI 90 and PASI 75 after 2, 4, 8, 12, 24, 48 and 52 weeks Quality of life at 16 weeks
|
| Notes |
Funding:
Quote (ClinicalTrials.gov): EMD Serono Research and Development Institute, Inc.
Conflict of interest: not stated |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote (ClinicalTrials.gov): "Allocation: randomized"
Comment: no description of the method used to guarantee random sequence generation |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: no description of the method used to guarantee allocation concealment |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote (ClinicalTrials.gov): "Double (Participant, Investigator)"
Comment: probably done |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote (ClinicalTrials.gov): "Double (Participant, Investigator)"
Comment: probably done |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Dealing with missing data: not stated
Results posted on ClinicalTrials.gov: Per protocol analyses (non‐inferiority trial) |
| Selective reporting (reporting bias) |
Low risk |
Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02660580)
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported |
