PMID- 32452352
OWN - NLM
STAT- MEDLINE
DCOM- 20201208
LR  - 20220531
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 38
IP  - 6
DP  - 2020 Nov-Dec
TI  - Clinically meaningful improvement in work productivity loss in active psoriatic 
      arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials.
PG  - 1227-1230
AB  - OBJECTIVES: To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 
      and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for 
      work productivity loss and activity impairment domains of Work Productivity and 
      Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire. METHODS: In 
      the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, 
      biologic-naive patients with active psoriatic arthritis (PsA) were randomised to 
      ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose 
      of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 
      enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were 
      randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind 
      treatment. In this post-hoc analysis, we investigated the proportion of patients 
      in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity 
      loss and 20% improvement in activity impairment domains of WPAI-SHP during 
      double- blind treatment period. RESULTS: In SPIRIT-P1, at Week 24, 57.1% and 
      55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID 
      estimates for work productivity loss compared to 25.6% of patients treated with 
      placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving 
      MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: 
      p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, 
      significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs 
      compared to placebo at Week 24. CONCLUSIONS: Treatment with ixekizumab was 
      associated with clinically meaningful improvements in WPAI-SHP domains in 
      biologic-naive and TNFi- experienced patients with active PsA.
FAU - Tillett, William
AU  - Tillett W
AD  - Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, 
      and Department of Pharmacy and Pharmacology, University of Bath, UK. 
      w.tillett@nhs.net.
FAU - Lin, Chen-Yen
AU  - Lin CY
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Trevelin Sprabery, Aubrey
AU  - Trevelin Sprabery A
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Birt, Julie A
AU  - Birt JA
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Kavanaugh, Arthur
AU  - Kavanaugh A
AD  - University of California, San Diego (UCSD) School of Medicine, Division of 
      Rheumatology, Allergy, and Immunology, San Diego, CA, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200511
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Dermatologic Agents)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/therapeutic use
MH  - *Antirheumatic Agents/therapeutic use
MH  - *Arthritis, Psoriatic/diagnosis/drug therapy
MH  - *Dermatologic Agents/therapeutic use
MH  - Double-Blind Method
MH  - Efficiency
MH  - Humans
MH  - Treatment Outcome
EDAT- 2020/05/27 06:00
MHDA- 2020/12/15 06:00
CRDT- 2020/05/27 06:00
PHST- 2019/11/08 00:00 [received]
PHST- 2020/04/20 00:00 [accepted]
PHST- 2020/05/27 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/05/27 06:00 [entrez]
AID - 14975 [pii]
PST - ppublish
SO  - Clin Exp Rheumatol. 2020 Nov-Dec;38(6):1227-1230. Epub 2020 May 11.