PMID- 28862513
OWN - NLM
STAT- MEDLINE
DCOM- 20180402
LR  - 20220408
IS  - 1502-7732 (Electronic)
IS  - 0300-9742 (Linking)
VI  - 47
IP  - 2
DP  - 2018 Mar
TI  - Relationship between glucocorticoid dose and adverse events in systemic lupus 
      erythematosus: data from a randomized clinical trial.
PG  - 131-140
LID - 10.1080/03009742.2017.1336570 [doi]
AB  - OBJECTIVE: The aim was to obtain a better understanding of the relationship 
      between exposure to glucocorticoids (GCs) and adverse events (AEs) reported in a 
      randomized controlled trial (RCT) in systemic lupus erythematosus (SLE) patients. 
      METHOD: We used data from the BLISS-76 trial on belimumab. The data were accessed 
      through an agreement under the SHARE mechanism. AEs were grouped according to 
      medical relevance, i.e. based on similarity of symptoms and pathophysiology. We 
      studied the relationship between AEs and exposure to GCs at baseline and at any 
      time-point, and compared the frequencies of each AE and groups of AEs between 
      tertiles of cumulative GC dose. RESULTS: In total, 991 AEs were reported in the 
      819 patients of the trial. The frequencies of anaemia, pyrexia, oral herpes, and 
      malaise were significantly higher (p < 0.05) in patients who were on GCs at 
      baseline than in those who were not. The frequencies of several other AEs, 
      including nausea, seasonal allergy, bacterial sinusitis, and viral upper 
      respiratory infection, were significantly higher in patients without GCs. For 
      cumulative GCs, tachycardia and proteinuria were significantly more frequent in 
      the highest tertile than in the lowest tertile, but other AEs and groups of AEs 
      were significantly more frequent in the lowest tertile. CONCLUSION: This study 
      highlights the feasibility of post-hoc analyses of RCTs using the SHARE mechanism 
      and demonstrates the association of GCs with various AEs. Contrary to 
      expectations, there were also associations between lower cumulative GC dose and 
      several other AEs.
FAU - Emamikia, S
AU  - Emamikia S
AD  - a Department of Medicine (ClinTRID), Solna , Karolinska Institutet, Karolinska 
      University Hospital , Stockholm , Sweden.
FAU - Gentline, C
AU  - Gentline C
AD  - a Department of Medicine (ClinTRID), Solna , Karolinska Institutet, Karolinska 
      University Hospital , Stockholm , Sweden.
FAU - Chatzidionysiou, K
AU  - Chatzidionysiou K
AD  - a Department of Medicine (ClinTRID), Solna , Karolinska Institutet, Karolinska 
      University Hospital , Stockholm , Sweden.
FAU - Arnaud, L
AU  - Arnaud L
AD  - b Department of Rheumatology , Strasbourg University Hospital , Strasbourg , 
      France.
FAU - van Vollenhoven, R
AU  - van Vollenhoven R
AD  - a Department of Medicine (ClinTRID), Solna , Karolinska Institutet, Karolinska 
      University Hospital , Stockholm , Sweden.
AD  - c Academic Medical Center , Amsterdam Rheumatology and Immunology Center , 
      Amsterdam , The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170901
PL  - England
TA  - Scand J Rheumatol
JT  - Scandinavian journal of rheumatology
JID - 0321213
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Glucocorticoids)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Glucocorticoids/*administration & dosage/adverse effects
MH  - Humans
MH  - Immunosuppressive Agents/therapeutic use
MH  - Lupus Erythematosus, Systemic/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2017/09/02 06:00
MHDA- 2018/04/03 06:00
CRDT- 2017/09/02 06:00
PHST- 2017/09/02 06:00 [pubmed]
PHST- 2018/04/03 06:00 [medline]
PHST- 2017/09/02 06:00 [entrez]
AID - 10.1080/03009742.2017.1336570 [doi]
PST - ppublish
SO  - Scand J Rheumatol. 2018 Mar;47(2):131-140. doi: 10.1080/03009742.2017.1336570. 
      Epub 2017 Sep 1.