PMID- 34157132
OWN - NLM
STAT- MEDLINE
DCOM- 20220303
LR  - 20220721
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Print)
IS  - 0007-0963 (Linking)
VI  - 185
IP  - 6
DP  - 2021 Dec
TI  - Long-term efficacy and safety of risankizumab for the treatment of 
      moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless 
      open-label extension trial beyond 3 years of follow-up.
PG  - 1135-1145
LID - 10.1111/bjd.20595 [doi]
AB  - BACKGROUND: Psoriasis is a chronic inflammatory skin disease requiring prolonged 
      treatment. New biologic therapies require long-term evaluation to assess the 
      durability of their efficacy and safety profiles over time. OBJECTIVES: To 
      evaluate the long-term efficacy and safety of risankizumab (RZB) for the 
      treatment of psoriasis. METHODS: LIMMitless is an ongoing, phase III, open-label 
      extension study evaluating the long-term efficacy and safety of RZB in adults 
      with moderate-to-severe plaque psoriasis following multiple phase II/III studies. 
      This analysis assessed efficacy through 172 weeks of continuous RZB treatment by 
      examining the proportion of patients achieving >/= 90% or 100% improvement in 
      Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's 
      Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life 
      Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by 
      recording adverse events (AEs) through the data cutoff date. The study is 
      registered at ClinicalTrials.gov (identifier: NCT03047395). RESULTS: Of 955 
      patients randomized to RZB 150 mg in the base studies, 897 patients continued 
      into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the 
      time of data cutoff for this analysis. After 172 weeks of continuous RZB 
      treatment, 85.5% of patients achieved PASI 90, 54.4% achieved PASI 100, 85.2% 
      achieved sPGA 0/1, and 78.4% achieved DLQI 0/1 using modified nonresponder 
      imputation. Rates of AEs leading to discontinuation and AEs of safety interest 
      were low with long-term treatment and comparable with those identified in the 
      base studies. CONCLUSIONS: Overall, long-term continuous RZB was well tolerated 
      and showed high and durable efficacy over 172 weeks.
CI  - (c) 2021 AbbVie Inc. British Journal of Dermatology published by John Wiley & Sons 
      Ltd on behalf of British Association of Dermatologists.
FAU - Papp, K A
AU  - Papp KA
AUID- ORCID: 0000-0001-9557-3642
AD  - K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.
FAU - Lebwohl, M G
AU  - Lebwohl MG
AD  - Icahn School of Medicine at Mount Sinai, New York, NY, USA.
FAU - Puig, L
AU  - Puig L
AUID- ORCID: 0000-0001-6083-0952
AD  - Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
FAU - Ohtsuki, M
AU  - Ohtsuki M
AD  - Jichi Medical University, Tochigi, Japan.
FAU - Beissert, S
AU  - Beissert S
AD  - Department of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, 
      Dresden, Germany.
FAU - Zeng, J
AU  - Zeng J
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Rubant, S
AU  - Rubant S
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Sinvhal, R
AU  - Sinvhal R
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Zhao, Y
AU  - Zhao Y
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Soliman, A M
AU  - Soliman AM
AD  - AbbVie Inc., North Chicago, IL, USA.
FAU - Alperovich, G
AU  - Alperovich G
AD  - AbbVie Inc., Madrid, Spain.
FAU - Leonardi, C
AU  - Leonardi C
AD  - Central Dermatology, Richmond Heights, MO, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03047395
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210921
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Antibodies, Monoclonal)
RN  - 90ZX3Q3FR7 (risankizumab)
SB  - IM
CIN - Br J Dermatol. 2021 Dec;185(6):1086-1087. PMID: 34632571
MH  - Adult
MH  - Antibodies, Monoclonal
MH  - Double-Blind Method
MH  - Follow-Up Studies
MH  - Humans
MH  - *Psoriasis/drug therapy
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC9290992
EDAT- 2021/06/23 06:00
MHDA- 2022/03/04 06:00
PMCR- 2022/07/18
CRDT- 2021/06/22 17:23
PHST- 2021/06/17 00:00 [accepted]
PHST- 2021/06/23 06:00 [pubmed]
PHST- 2022/03/04 06:00 [medline]
PHST- 2021/06/22 17:23 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - BJD20595 [pii]
AID - 10.1111/bjd.20595 [doi]
PST - ppublish
SO  - Br J Dermatol. 2021 Dec;185(6):1135-1145. doi: 10.1111/bjd.20595. Epub 2021 Sep 
      21.