TY - JOUR
T1 - Safety of treatments for primary Sjogren's syndrome
AU - van Nimwegen, Jolien F.
AU - Moerman, R. V.
AU - Smitt, Nicole Sillevis
AU - Brouwer, Elisabeth
AU - Bootsma, Hendrika
AU - Vissink, Arjan
PY - 2016/4/2
Y1 - 2016/4/2
N2 - Introduction: Primary Sjogren's syndrome (pSS) is a disabling auto-immune disease, affecting exocrine glands and several organs.Areas covered: In this review we analyze the safety of therapies used in pSS. Symptomatic treatment is widely applied due to the good supportive effect and good safety profile. Systemic stimulation of tears and saliva can be successful in pSS. However, cumbersome adverse events can influence the tolerability of this therapy. Evidence for the effectiveness of synthetic DMARDs therapies in pSS is limited, while there is a risk of adverse events. Several studies on biologic DMARD treatment of pSS patients have shown promising efficacy and safety results.Expert opinion: The safety of symptomatic treatment of pSS is very good. However, systemic therapy is necessary to achieve long-term relieve and prevention of organ-damage. Synthetic DMARDs have not shown much efficacy in earlier studies, and their benefits do not weigh up to the possible harms, while biologic DMARDs show promising results regarding efficacy and cause mostly mild adverse events. Many questions remain unanswered regarding safety of DMARDs in pSS. There is a need for well designed studies, in which safety should be evaluated in a uniform manner to be able to compare the results between studies.
AB - Introduction: Primary Sjogren's syndrome (pSS) is a disabling auto-immune disease, affecting exocrine glands and several organs.Areas covered: In this review we analyze the safety of therapies used in pSS. Symptomatic treatment is widely applied due to the good supportive effect and good safety profile. Systemic stimulation of tears and saliva can be successful in pSS. However, cumbersome adverse events can influence the tolerability of this therapy. Evidence for the effectiveness of synthetic DMARDs therapies in pSS is limited, while there is a risk of adverse events. Several studies on biologic DMARD treatment of pSS patients have shown promising efficacy and safety results.Expert opinion: The safety of symptomatic treatment of pSS is very good. However, systemic therapy is necessary to achieve long-term relieve and prevention of organ-damage. Synthetic DMARDs have not shown much efficacy in earlier studies, and their benefits do not weigh up to the possible harms, while biologic DMARDs show promising results regarding efficacy and cause mostly mild adverse events. Many questions remain unanswered regarding safety of DMARDs in pSS. There is a need for well designed studies, in which safety should be evaluated in a uniform manner to be able to compare the results between studies.
KW - Primary Sjogren's syndrome
KW - drug safety
KW - topical treatment
KW - synthetic DMARDs
KW - biologic DMARDs
KW - SYSTEMIC-LUPUS-ERYTHEMATOSUS
KW - PLACEBO-CONTROLLED TRIAL
KW - PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
KW - AUTOLOGOUS SERUM APPLICATION
KW - DYSFUNCTIONAL TEAR SYNDROME
KW - CONNECTIVE-TISSUE DISEASES
KW - RANDOMIZED-CLINICAL-TRIAL
KW - INTERSTITIAL LUNG-DISEASE
KW - GOBLET CELL-DENSITY
KW - DRY EYE SYMPTOMS
U2 - 10.1517/14740338.2016.1146676
DO - 10.1517/14740338.2016.1146676
M3 - Review article
C2 - 26809028
SN - 1474-0338
VL - 15
SP - 513
EP - 524
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
IS - 4
ER -