PMID- 32533340
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Linking)
VI  - 40
IP  - 1
DP  - 2021 Jan
TI  - Biologic disease-modifying anti-rheumatic drugs and patient-reported outcomes in 
      axial SpA: a systematic review and a call for action.
PG  - 33-41
LID - 10.1007/s10067-020-05209-x [doi]
AB  - This paper is to assess the efficacy of different biologic DMARDs (bDMARDs) on 
      several patient-reported outcomes (PROs) in randomized controlled trials (RCT) in 
      axial spondyloarthritis (axSpA). A systematic literature review (SLR) was 
      performed. MEDLINE (May 1, 2018) was used with the filters "published in the last 
      10 years" and "humans." The PICO criteria used were Patients: adults with 
      radiographic axSpA (r-axSpA) or non-radiographic axSpA (nr-axSpA); Intervention: 
      any bDMARD; Compararator: placebo (PBO)/any different drug; Outcome: the Bath 
      Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing 
      Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life 
      (ASQoL), the EuroQol-5D (EQ-5D), the Short Form 36 Health Survey physical 
      component summary (SF36-PCS), the Short Form 36 Health Survey mental component 
      summary (SF36-MCS), and the Functional Assessment of Chronic Illness 
      Therapy-Fatigue (FACIT-F). After screening 84 initial references and manually 
      selecting other 9, 24 publications, assessing TNF inhibitors (TNFi) or IL17A 
      inhibitors (IL17Ai) were selected. Four RCTs quantified the minimal clinical 
      important difference (MCID) between treatment arms. Most of the RCTs compared the 
      mean difference of PROs between different timepoints. Overall, the treatment arm 
      was superior to the comparator. PROs were often underreported or highly 
      heterogeneously presented. MCID was seldom mentioned. There is a need to raise 
      the standard of care on SpA by aiming at remission and PRO associated 
      improvements. In order to achieve this goal, the target must be clearly defined, 
      reported, and tested.
FAU - Rodrigues-Manica, Santiago
AU  - Rodrigues-Manica S
AUID- ORCID: 0000-0002-7217-0469
AD  - CEDOC, NOVA Medical School, Lisbon, Portugal. santiagorodriguesma@gmail.com.
AD  - Rheumatology Department, Centro Hospitalar de Lisboa Ocidental, Hospital Egas 
      Moniz EPE, R. da Junqueira 126, 1349-019, Lisbon, Portugal. 
      santiagorodriguesma@gmail.com.
FAU - Silva, Joana
AU  - Silva J
AD  - Rheumatology Department, Unidade Local de Saude do Alto Minho, Ponte de Lima, 
      Portugal.
FAU - Cruz-Machado, Rita
AU  - Cruz-Machado R
AD  - Rheumatology Department, Centro Hospitalar de Lisboa Norte EPE, Hospital de Santa 
      Maria, R. da Junqueira 126, 1349-019, Lisbon, Portugal.
AD  - Rheumatology Research Unit, Instituto de Medicina Molecular, Lisbon Academic 
      Medical Centre, Lisbon, Portugal.
FAU - Coelho, Constanca
AU  - Coelho C
AD  - Genetics Laboratory, Environmental Health Institute, Lisbon Medical School, 
      University of Lisbon, Lisbon, Portugal.
FAU - Duarte, Joana
AU  - Duarte J
AD  - Medical Department, Novartis Pharma, Oeiras, Portugal.
FAU - Vieira-Sousa, Elsa
AU  - Vieira-Sousa E
AD  - Rheumatology Department, Centro Hospitalar de Lisboa Norte EPE, Hospital de Santa 
      Maria, R. da Junqueira 126, 1349-019, Lisbon, Portugal.
AD  - Rheumatology Research Unit, Instituto de Medicina Molecular, Lisbon Academic 
      Medical Centre, Lisbon, Portugal.
FAU - Tavares-Costa, Jose
AU  - Tavares-Costa J
AD  - Rheumatology Department, Unidade Local de Saude do Alto Minho, Ponte de Lima, 
      Portugal.
FAU - Pimentel-Santos, Fernando M
AU  - Pimentel-Santos FM
AD  - CEDOC, NOVA Medical School, Lisbon, Portugal.
AD  - Rheumatology Department, Centro Hospitalar de Lisboa Ocidental, Hospital Egas 
      Moniz EPE, R. da Junqueira 126, 1349-019, Lisbon, Portugal.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20200612
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biological Products)
SB  - IM
MH  - Adult
MH  - *Antirheumatic Agents/therapeutic use
MH  - *Biological Products/therapeutic use
MH  - Humans
MH  - Patient Reported Outcome Measures
MH  - *Spondylarthritis/drug therapy
MH  - *Spondylitis, Ankylosing/drug therapy
OTO - NOTNLM
OT  - PROs
OT  - Patient-reported outcomes
OT  - RCTs
OT  - Spondyloarthritis
OT  - bDMARDs
EDAT- 2020/06/14 06:00
MHDA- 2021/05/15 06:00
CRDT- 2020/06/14 06:00
PHST- 2020/04/02 00:00 [received]
PHST- 2020/05/28 00:00 [accepted]
PHST- 2020/05/26 00:00 [revised]
PHST- 2020/06/14 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/06/14 06:00 [entrez]
AID - 10.1007/s10067-020-05209-x [pii]
AID - 10.1007/s10067-020-05209-x [doi]
PST - ppublish
SO  - Clin Rheumatol. 2021 Jan;40(1):33-41. doi: 10.1007/s10067-020-05209-x. Epub 2020 
      Jun 12.