***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The effect of hydroxychloroquine ( HCQ ) on dry eye has not been fully determined . This study aim ed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren 's syndrome ( pSS ) . A double-blind , r and omized control study was conducted in 39 pSS subjects from May 2011 through August 2013 . pSS was diagnosed based on the classification criteria of the American-European Consensus Group . Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline , 6 , and 12 weeks , with a re-visit at 16 weeks after drug discontinuance . The fluorescein staining score , Schirmer test score , tear film break-up time ( TBUT ) , and ocular surface disease index ( OSDI ) were measured , and tears and blood were collected for ESR , IL-6 , IL-17 , B-cell activating factor ( BAFF ) , and Th17 cell analysis . Color testing was performed and the fundus was examined to monitor HCQ complications . Twenty-six subjects completed the follow-up . The fluorescein staining score and Schirmer test score did not differ significantly . The OSDI improved with medication in the HCQ group but was not significantly different between the groups . TBUT , serum IL-6 , ESR , serum and tear BAFF , and the proportion of Th17 cells did not change in either group . HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS ( Clinical Trials.gov . NCT01601028 ) OBJECTIVE There is evidence to support a dominant role for B cells in the pathophysiology of primary Sjögren 's syndrome ( SS ) . Therefore , we evaluated the safety and efficacy of anti-CD20 monoclonal antibody . METHODS Sixteen patients who met the new American-European Consensus Group criteria for primary SS and scored > 50 on at least 2 of 4 visual analog scales ( VAS ; 100 mm ) evaluating global disease , pain , fatigue , and global dryness received infusions of low-dose rituximab ( 375 mg/m(2 ) ) at weeks 0 and 1 without steroid premedication . RESULTS Slow rituximab infusions ( 100 mg/hour ) were well tolerated , with only 1 patient experiencing serum sickness-like disease . There was a dramatic reduction in B cells of the blood and salivary gl and ( SG ) . At week 12 , VAS scores with respect to fatigue and dryness ( P < 0.05 ) , tender point count ( P < 0.035 ) , and quality of life as evaluated by the Short Form 36 question naire ( SF-36 ; P < 0.001 ) were significantly improved . At week 36 , significant improvements were noted in the 4 VAS scores ( P < 0.05 ) , tender joint count ( P = 0.017 ) , tender point count ( P = 0.027 ) , and SF-36 ( P < 0.03 ) . Pulmonary manifestations were ameliorated in 1 patient . Patients with improvements on at least 3 of the 4 VAS scores at any visit ( n = 11 ) had a shorter disease duration than the other patients ( n = 5 ; mean + /- SD duration 3.8 + /- 5.4 versus 30.1 + /- 29.5 years ; P = 0.02 ) . CONCLUSION Low-dose rituximab infusions were well tolerated without the benefit of steroids . Infusions induced a rapid depletion of B cells in the blood and SG and could improve primary SS . Controlled studies are needed The aim of this study was to evaluate the efficacy and safety of mycophenolate sodium ( MPS ) in patients with primary Sjögren syndrome ( pSS ) refractory to other immunosuppressive agents . Eleven patients with pSS were treated with MPS up to 1,440 mg daily for an observation period of 6 months in this single-center , open-label pilot trial . At baseline , after 3 months , and after 6 months , we examined the clinical status , including gl and ular function tests , as well as different laboratory parameters associated with pSS . In addition , subjective parameters were determined on the basis of different question naires . Treatment with MPS was well tolerated in 8 of 11 patients . Due to vertigo or gastrointestinal discomfort , two patients did not complete the trial . One patient developed pneumonia 2 weeks after treatment and was withdrawn . In the remaining patients , MPS treatment result ed in subjective improvement of ocular dryness on a visual analogue scale and a reduced dem and for artificial tear supplementations . However , no significant alterations of objective parameters for dryness of eyes and mouth were observed , although a substantial improvement of gl and ular functions occurred in two patients with short disease duration . In addition , treatment with MPS result ed in significant reduction of hypergammaglobulinemia and rheumatoid factors as well as an increase of complement levels and white blood cells .  MPS promises to be an additional therapeutic option for patients with pSS , at least in those with shorter disease duration . Further investigations about the efficacy and safety of MPS in pSS have to be performed in larger numbers of patients Objectives Fatigue is a major cause of disability in primary Sjögren 's syndrome ( pSS ) . Fatigue has similarities with sickness behaviour in animals ; the latter mediated by pro-inflammatory cytokines , in particular interleukin (IL)-1 , acting on neuronal brain cells . We hypothesised that IL-1 inhibition might improve fatigue in pSS patients ; thus , we examined the effects and safety of an IL-1 receptor antagonist ( anakinra ) on fatigue . Methods Twenty-six pSS patients participated in a double-blind , placebo-controlled parallel group study . Patients were r and omised to receive either anakinra or a placebo for four weeks . Fatigue was evaluated by a fatigue visual analogue scale and the Fatigue Severity Scale . The primary outcome measure was a group-wise comparison of the fatigue scores at week 4 , adjusted for baseline values . Secondary outcome measures included evaluation of laboratory results and safety . The proportion of patients in each group who experienced a 50 % reduction in fatigue was regarded as a post-hoc outcome . All outcomes were measured at week 4 . Results There was no significant difference between the groups in fatigue scores at week 4 compared to baseline after treatment with anakinra . However , six out of 12 patients on anakinra versus one out of 13 patients on the placebo reported a 50 % reduction in fatigue VAS ( p = 0.03 ) . There were two serious adverse events in each group . Conclusions This r and omised , double-blind , placebo-controlled trial of IL-1 blockade did not find a significant reduction in fatigue in pSS in its primary endpoint . A 50 % reduction in fatigue was analysed post-hoc , and significantly more patients on the active drug than on placebo reached this endpoint . Although not supported by the primary endpoint , this may indicate that IL-1 inhibition influences fatigue in patients with pSS . Trial registration Clinical Trials.gov BACKGROUND Primary Sjögren syndrome ( pSS ) is an autoimmune disorder characterized by ocular and oral dryness or systemic manifestations . OBJECTIVE To evaluate efficacy and harms of rituximab in adults with recent-onset or systemic pSS . DESIGN R and omized , placebo-controlled , parallel-group trial conducted between March 2008 and January 2011 . Study personnel ( except pharmacists ) , investigators , and patients were blinded to treatment group . ( Clinical Trials.gov : NCT00740948 ) . SETTING 14 university hospitals in France . PATIENTS 120 patients with scores of 50 mm or greater on at least 2 of 4 visual analogue scales ( VASs ) ( global disease , pain , fatigue , and dryness ) and recent-onset ( < 10 years ) biologically active or systemic pSS . INTERVENTION R and omization ( 1:1 ratio ) to rituximab ( 1 g at weeks 0 and 2 ) or placebo . MEASUREMENTS Primary end point was improvement of at least 30 mm in 2 of 4 VASs by week 24 . RESULTS No significant difference between groups in the primary end point was found ( difference , 1.0 % [ 95 % CI , -16.7 % to 18.7 % ] ) . The proportion of patients with at least 30-mm decreases in at least two of the four VAS scores was higher in the rituximab group at week 6 ( 22.4 % vs. 9.1 % ; P = 0.036 ) . An improvement of at least 30 mm in VAS fatigue score was more common with rituximab at weeks 6 ( P < 0.001 ) and 16 ( P = 0.012 ) , and improvement in fatigue from baseline to week 24 was greater with rituximab . Adverse events were similar between groups except for a higher rate of infusion reactions with rituximab . LIMITATION Low disease activity at baseline and a primary outcome that may have been insensitive to detect clinical ly important changes . CONCLUSION Rituximab did not alleviate symptoms or disease activity in patients with pSS at week 24 , although it alleviated some symptoms at earlier time points OBJECTIVE To study the efficacy and safety of B cell depletion with rituximab , a chimeric murine/human anti-CD20 monoclonal antibody , in patients with primary Sjögren 's syndrome ( SS ) in a double-blind , r and omized , placebo-controlled trial . METHODS Patients with active primary SS , as determined by the revised American-European Consensus Group criteria , and a rate of stimulated whole saliva secretion of > or = 0.15 ml/minute were treated with either rituximab ( 1,000 mg ) or placebo infusions on days 1 and 15 . Patients were assigned r and omly to a treatment group in a ratio of 2:1 ( rituximab : placebo ) . Followup was conducted at 5 , 12 , 24 , 36 , and 48 weeks . The primary end point was the stimulated whole saliva flow rate , while secondary end points included functional , laboratory , and subjective variables . RESULTS Thirty patients with primary SS ( 29 female ) were r and omly allocated to a treatment group . The mean + /- SD age of the patients receiving rituximab was 43 + /- 11 years and the disease duration was 63 + /- 50 months , while patients in the placebo group were age 43 + /- 17 years and had a disease duration of 67 + /- 63 months . In the rituximab group , significant improvements , in terms of the mean change from baseline compared with that in the placebo group , were found for the primary end point of the stimulated whole saliva flow rate ( P = 0.038 versus placebo ) and also for various laboratory parameters ( B cell and rheumatoid factor [ RF ] levels ) , subjective parameters ( Multidimensional Fatigue Inventory [ MFI ] scores and visual analog scale [ VAS ] scores for sicca symptoms ) , and extragl and ular manifestations . Moreover , in comparison with baseline values , rituximab treatment significantly improved the stimulated whole saliva flow rate ( P = 0.004 ) and several other variables ( e.g. , B cell and RF levels , unstimulated whole saliva flow rate , lacrimal gl and function on the lissamine green test , MFI scores , Short Form 36 health survey scores , and VAS scores for sicca symptoms ) . One patient in the rituximab group developed mild serum sickness-like disease . CONCLUSION These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS OBJECTIVE To report the efficacy and safety of long-term treatment of SS with belimumab , targeting the B-cell-activating factor . METHODS Patients with primary SS were included in the BELISS open-label phase II study , a 1-year open-label trial , if they were positive for anti-SSA or anti-SSB antibodies and had systemic complications or persistent salivary gl and enlargement or early disease or biomarkers of B-cell activation . They received belimumab , 10 mg/kg i.v . , at weeks 0 , 2 and 4 and then every 4 weeks ; if response was observed at week 28 , or if the clinician and the patient agreed to continue the study in the absence of side effects , treatment was continued for 1 year . Efficacy and safety were analysed during the 1-year period of treatment . RESULTS Among the 30 patients recruited , 28 were evaluated at week 28 as already reported . Nineteen terminated the 52-week study , 15 of them being responders and 4 non-responders at week 28 . Thirteen of the 15 responders at week 28 also responded at week 52 ( 86.7 % ) . The improvement in the EULAR Sjögren 's Syndrome Disease Activity Index and EULAR Sjögren 's Syndrome Patient Reported Index scores observed at week 28 showed a trend to further improvement at week 52 , and the amelioration of peculiar EULAR Sjögren 's Syndrome Disease Activity Index domains ( gl and ular , lymphadenopathy , articular ) appeared of particular relevance . The decrease in biomarkers of B-cell activation observed at week 28 persisted unchanged until week 52 , with RF decreasing further . Salivary flow , Schirmer 's test and the focus score of salivary biopsy did not change . Safety of treatment was good . CONCLUSION Long-term treatment with belimumab may be beneficial in SS . R and omized , double-blind , 
    Output:
    
Two Cochrane systematic literature review s ( SLRs ) have reported that topical treatments for dry mouth and dry eye are safe and effective .
RCTs using infliximab , anakinra and baminercept found no placebo-differences for the primary outcomes .
Conclusion The current evidence supporting the use of the main topical therapeutic options of primary SjS is solid , while limited data from RCTs are available to guide systemic therapies