PMID- 34241691
OWN - NLM
STAT- MEDLINE
DCOM- 20230112
LR  - 20230112
IS  - 1435-1250 (Electronic)
IS  - 0340-1855 (Linking)
VI  - 82
IP  - Suppl 1
DP  - 2023 Jan
TI  - Placebo and nocebo responses in randomized controlled trials of non-tumor 
      necrosis factor biologics and Janus kinase inhibitors in patients with active 
      rheumatoid arthritis showing insufficient response to tumor necrosis factor 
      inhibitors: A meta-analysis.
PG  - 59-67
LID - 10.1007/s00393-021-01047-7 [doi]
AB  - OBJECTIVE: This study evaluated the frequency and magnitude of placebo and nocebo 
      responses in placebo-controlled RCTs of non-tumor necrosis factor (TNF) biologics 
      and Janus kinase (JAK) inhibitors in rheumatoid arthritis (RA) patients with 
      insufficient response to TNF inhibitors. METHODS: A meta-analysis on rates of 
      placebo response, adverse effects (AEs), severe AEs (SAEs), and withdrawal due to 
      AEs in placebo-controlled RCTs of non-TNF biologics and JAK inhibitors in 
      patients with RA and an insufficient response to TNF inhibitors was conducted. 
      RESULTS: In 9 RCTs containing 3442 patients the pooled incidence of ACR20 
      response rate in placebo-treated patients was 22.1 (95% CI 16.4-29.1%) and 27.9% 
      (95% CI 24.5-31.6%) in RCTs of non-TNF and JAK inhibitors, respectively. Strong 
      negative correlation was observed between ACR20 response and AE rates in the 
      placebo arm, indicating that the greater the placebo response, the weaker the 
      nocebo response (r = -0.762, P = 0.017). Strong positive correlation was observed 
      between ACR20 response in the placebo and active comparator arms, indicating that 
      the greater the placebo response, the greater the treatment response (r = 0.737, 
      P = 0.003). The pooled estimate in placebo-treated patients with >/=1 AE was 71.8 
      (95% CI 57.4-82.7%) and 58.7% (95% CI 52.8-64.3%) in RCTs of non-TNF and JAK 
      inhibitors, respectively. The pooled estimate in placebo-treated patients 
      withdrawing due to an AE was 3.8 (95% CI 2.7-5.3%) and 4.0% (95% CI 2.7-6.0%) in 
      RCTs of non-TNF and JAK inhibitors, respectively. Strong positive correlation was 
      observed between AE rates in the placebo and active arms, indicating that the 
      greater the nocebo response, the stronger the AE rate in the active arm 
      (r = 0.855, P = 0.003). CONCLUSION: There were higher placebo and less nocebo 
      effects of JAK vs. non-TNF inhibitors in RA patients with an insufficient 
      response to TNF inhibitors, and the greater the placebo response, the weaker the 
      nocebo response and the greater the efficacy.
CI  - (c) 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.
FAU - Sung, Yoon-Kyoung
AU  - Sung YK
AD  - Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 
      Seoul, Korea (Republic of).
FAU - Lee, Young Ho
AU  - Lee YH
AUID- ORCID: 0000-0003-4213-1909
AD  - Division of Rheumatology, Department of Internal Medicine, Korea University Anam 
      Hospital, Korea University College of Medicine, 73, Goryeodae-ro, 02841, 
      Seongbuk-gu, Seoul, Korea (Republic of). lyhcgh@korea.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
TT  - Ansprechen auf Placebo und Nocebo in randomisierten kontrollierten Studien zu 
      Non-Tumornekrosefaktor-Biologika und Januskinaseinhibitoren bei Patienten mit 
      aktiver rheumatoider Arthritis und insuffizienter Reaktion auf 
      Tumornekrosefaktorinhibitoren: Eine Metaanalyse.
DEP - 20210709
PL  - Germany
TA  - Z Rheumatol
JT  - Zeitschrift fur Rheumatologie
JID - 0414162
RN  - 0 (Janus Kinase Inhibitors)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 0 (Biological Products)
SB  - IM
MH  - Humans
MH  - *Janus Kinase Inhibitors/adverse effects
MH  - Tumor Necrosis Factor Inhibitors/therapeutic use
MH  - Nocebo Effect
MH  - *Biological Products/adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - *Arthritis, Rheumatoid/diagnosis/drug therapy
MH  - Necrosis/drug therapy
OTO - NOTNLM
OT  - Janus kinase inhibitor
OT  - Nocebo
OT  - Non-tumor necrosis factor biologic
OT  - Placebo
OT  - Rheumatoid arthritis
EDAT- 2021/07/10 06:00
MHDA- 2023/01/13 06:00
CRDT- 2021/07/09 12:20
PHST- 2021/06/14 00:00 [accepted]
PHST- 2021/07/10 06:00 [pubmed]
PHST- 2023/01/13 06:00 [medline]
PHST- 2021/07/09 12:20 [entrez]
AID - 10.1007/s00393-021-01047-7 [pii]
AID - 10.1007/s00393-021-01047-7 [doi]
PST - ppublish
SO  - Z Rheumatol. 2023 Jan;82(Suppl 1):59-67. doi: 10.1007/s00393-021-01047-7. Epub 
      2021 Jul 9.