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To investigate the expression levels of inflammatory cytokines in the conjunctival epithelium and correlations with clinical parameters in dry eye disease (DED).This study evaluated 28 patients with Sjögren syndrome (SS) DED, 28 patients with non-SS DED, and 10 controls. The messenger ribonucleic acid (mRNA) expression of inflammatory cytokines such as tumor necrosis factor-α, interleukin (IL)-1β, IL-6, interferon (IFN)-γ, IL-17, and matrix metalloproteinase 9 (MMP9) from conjunctival epithelium was investigated by real-time polymerase chain reaction. Protein expression was confirmed by immunofluorescence staining. Correlations were evaluated between the mRNA expression of inflammatory cytokines and clinical DED parameters such as ocular surface disease index score, Schirmer I value, tear film breakup time, and corneal and conjunctival staining scores.Patients with non-SS DED expressed significantly more IFN-γ, IL-6, and MMP9 genes in the conjunctival epithelium than the controls (P0.05), and all cytokine gene expression was significantly higher in patients with SS DED than in the controls (P0.01). Tumor necrosis factor-α, IL-1β, IL-6, and IL-17 gene expression was higher in patients with SS DED than in the non-SS DED group (P0.05). Immunofluorescence staining of conjunctival epithelium demonstrated that positive cells with IL-6 or MMP9 were significantly higher in non-SS DED than in controls (P0.01) and much higher in SS DED than in non-SS DED (P0.05). Conjunctival staining scores significantly correlated with the expression of IFN-γ, IL-6, IL-17, and MMP9 in both DED groups (P0.05 in non-SS DED and P0.01 in SS-DED). Interestingly, correlation coefficients of all cytokines were much higher in SS DED compared to non-SS DED. Corneal staining scores showed positive correlations with IFN-γ, IL-17, and MMP9 (P0.05), and correlation coefficients were lower than those of conjunctival staining scores.Conjunctival staining scores may be useful to measure ocular surface inflammation in SS and non-SS DED.

PURPOSE To evaluate the efficacy and safety of autologous serum (AS) eye drops combined with punctal plugs (PPs) in patients with Sjogren syndrome (SS)-related dry eye. METHODS A retrospective clinical study was performed in patients with dry eye caused by SS. We evaluated the Schirmer test value, tear breakup time (tBUT), and fluorescein and Rose Bengal (RB) staining scores at baseline, 3 months, 6 months, 1 year, and >1 year after treatment. The dry eye indexes were also evaluated in 2 subgroups, which determined by the using of PPs, including the AS + PP group and AS only group. RESULTS A total of 56 eyes of 28 patients were investigated with a mean follow-up of 42.3 ± 26.1 months. After the application of AS eye drops, the Schirmer test showed no significant changes. The tBUT (2.7 ± 1.9 seconds) was significantly improved at each time point (3.9 ± 3.1, 4.5 ± 3.1, 3.7 ± 2.5, and 5.1 ± 4.0; P < 0.01), fluorescein staining (4.3 ± 2.8) was significantly improved at each time point (2.2 ± 2.2, 1.9 ± 1.9, 1.8 ± 1.6, and 1.8 ± 1.8; P < 0.01), and RB (2.6 ± 3.0) staining was significantly improved from 6-month treatment (1.5 ± 1.9, 1.9 ± 1.9, and 1.4 ± 1.8; P < 0.05, 0.01, and 0.01, respectively). When combined with PPs, the tBUT and RB staining scores were found to be significantly improved in the AS + PP group compared with those of the AS only group. CONCLUSIONS Long-term application of AS eye drops was found to be an effective and apparently safe treatment for SS dry eye. Furthermore, PPs in combination with AS eye drops were considered to have an additive effect on SS dry eye.

PURPOSE To comparatively evaluate the efficacy of a bandage contact lens (BCL) and autologous serum (AS) eye drops in the management of severe dry eye caused by Sjogren syndrome (SS). METHODS In this prospective randomized study, 40 patients with SS were enrolled. Patients were divided into 2 treatment groups: BCL and AS. RESULTS A total of 37 patients were included, 18 patients (35 eyes) in the AS group and 19 patients (36 eyes) in the BCL group. At the end of 6 weeks, the best-corrected visual acuity improved significantly in the BCL group (0.5 ± 0.3 vs. 0.3 ± 0.2, P = 0.003) but not in the AS group (0.4 ± 0.3 vs. 0.3 ± 0.3, P = 0.11). The best-corrected visual acuity remained stable up to 6 weeks after discontinuation of the BCL (0.5 ± 0.3 vs. 0.4 ± 0.2, P = 0.03). Although the Ocular Surface Disease Index scores decreased significantly after treatment in both groups, patients in the BCL group had lower Ocular Surface Disease Index scores than those in the AS group (53.4 vs. 41.8 at week 3, 47.1 vs. 31.0 at week 6, 52.7 vs. 32.0 at week 12; P = 0.014

The aim of this study was to investigate the efficacy of 2% rebamipide suspension in treatment of keratoconjunctivitis sicca (KCS) in patients with Sjögren syndrome (SS) with or without punctal occlusions.Thirty patients with SS, diagnosed based on the presence of autoantibodies and/or focus score1 on lip biopsies, with corneal fluorescein staining scores (FSS)3, and conjunctival lissamine green-staining scores (LSS)3, were treated 4 times daily for 4 weeks with 2% rebamipide ocular suspension. Ocular examinations were performed before treatment and 2 and 4 weeks after treatment to evaluate FSS (0-9), LSS (0-6), and tear film break-up time (BUT). Hyaluronate and/or artificial tears were not discontinued. The patients were interviewed regarding the 5 major KCS symptoms, foreign body sensation, dry eye sensation, photophobia, ocular pain, and blurred vision, with each graded from none (0) to very severe (4).Of the 30 patients, 3 failed to attend all sessions, leaving 27 (25 females, 2 males, mean age 62.5 ± 10.8 years) to be studied. FSS and LSS showed improvement at week 2, but BUT showed improvement later, at week 4. All 5 symptoms improved significantly. When the patients were divided into 3 groups according to the presence of punctal occlusions, FSS and LSS were found to improve in all groups, but BUT improved only in patients with both puncta occluded at week 4.Rebamipide ophthalmic suspension was effective in treating KCS of patients with SS, probably by increasing mucins and suppressing inflammatory cytokines. Punctal occlusions resulted in sufficient retention of tear fluid to enhance the activities of rebamipide and improve BUT.

PURPOSE To evaluate tear meniscus changes in patients with Sjogren syndrome (SS) receiving oral pilocarpine with Visante optical coherence tomography (OCT). METHODS Eight patients with primary SS were recruited in this prospective interventional case series study. Patients received pilocarpine tablets twice a day for 3 months. Visual analog scale assessment for dry eye and dry mouth symptoms was carried out. Patients underwent OCT and slit-lamp microscopy graticule scale tear meniscus height (TMH) measurements, strip meniscometry testing, tear film breakup time measurement, fluorescein and Rose Bengal staining, and the Schirmer 1 test. The data were analyzed 1 week, 1 month, and 3 months after treatment. Mann-Whitney test was performed. RESULTS Visual analog scale assessment showed a significant time-wise improvement (P < 0.05). OCT and graticule scale TMH measurements significantly improved after 1 week (P < 0.05), 1 month, and 3 months of treatment (P < 0.001). Strip meniscometry, mean tear film stability, and fluorescein and Rose Bengal scores remained improved 3 months after treatment (P < 0.001), whereas Schirmer 1 test values tended to improve without statistical significance. CONCLUSIONS Visante OCT was effective in monitoring tear meniscus changes during the course of treatment noninvasively and quickly. Oral pilocarpine seemed to be effective in improving TMH, and the signs and symptoms of dryness in patients with SS.

PURPOSE We have previously reported that mouse kallikrein (KLK) 22 in the lacrimal and salivary glands is an autoantigen that can induce primary Sjogren syndrome (SS) in rats. In this study, we determine whether the production of antibodies against tissue KLK is specific for SS and whether the antibody can be used as a biomarker for the diagnosis in humans. METHODS Sera from 11 patients diagnosed with SS, 8 patients with dry eye disease (DED), and 8 normal age/sex-matched controls (NL) were collected for detecting antibodies against tissue KLK1, KLK11, KLK12, and KLK13 by capture enzyme-linked immunosorbent assay. RESULTS Anti-KLK11 antibody was significantly higher in the SS than in the DED (P = 0.05) and NL (P < 0.01) groups, with no difference in the level of this antibody between the DED and NL groups. In addition, receiver operating characteristic analysis revealed that, at or above an optical density cutoff point of 0.2695, anti-KLK11 antibody has a sensitivity of 82% and a specificity of 94% to distinguish the SS group from the other groups. CONCLUSIONS Our results suggest that anti-KLK11 might be a novel biomarker for SS in humans. Further investigation is required to confirm this finding and to establish the exact role of KLK11 in the pathogenesis of SS.

PURPOSE: We standardized quality-controlled cord blood serum (CBS)-based eye drops and evaluated the efficacy of 1-month CBS treatment in the healing of diseased corneal epithelium in severe dry eye (DE) patients. METHODS: Seventeen graft-versus-host disease (GVHD) and 13 Sjogren syndrome patients with severe persistent corneal defects were enrolled in the framework of a registered clinical trial (ClinicalTrials.gov NCT01234623). Sterile CBS eye drops were prepared to supply 0.15 ng per eye per day epithelial growth factor and administered for 1 month in a 1-day dose dispensing. The extent of epithelial defect was evaluated in square millimeters area, and subjective symptom score (Ocular Surface Disease Index score), Schirmer test I, break-up time, tear osmolarity, corneal esthesiometry (Cochet-Bonnet esthesiometer), conjunctival scraping, and imprint cytology with goblet cell count were performed at baseline (V0) and after 15 (V1) and 30 (V2, endpoint) days of treatment. Satisfaction and tolerability questionnaires were evaluated at V1 and V2. RESULTS: A significant reduction was shown at the endpoint versus baseline in corneal epithelial damage (mean ± SD, 16.1 ± 13.7 vs. 40.9 ± 30 mm²/area, respectively), discomfort symptoms (Ocular Surface Disease Index score, 22.3 ± 10.3 vs. 39.3 ± 16.9), scraping cytology score (3.8 ± 1.2 vs. 6.6 ± 2.1), and tear osmolarity (312.5 ± 7 vs. 322 ± 9.1 mOsm/L), whereas a significant improvement was shown in corneal esthesiometry (48.2 ± 2.1 vs. 49.7 ± 2.1 nylon/mm/length, P < 0.05). All patients reported a high degree of satisfaction upon drop instillation. CONCLUSIONS: Heterologous CBS-based eye drops represent a promising therapeutic approach in the healing of severely injured corneal epithelium and in subjective symptom relief. These drops can be obtained as readily available and quality-controlled blood derivative from cord blood banks on a routine basis.

Purpose To describe a case of keratoconjunctivitis sicca treated with punctal plug placement with the first reported complication of subsequent plug erosion through the canaliculus and extrusion through the lid. Methods Punctal plugs were placed in a patient with Sjogren syndrome for treatment of keratoconjunctivitis sicca. More than 12 years later, the plug was noted to have eroded through the canaliculus and extruded through the conjunctiva and lid. Results The extruded plug was removed, and punctal cautery was performed on 2 other puncta with improved symptom control. Conclusions Plug extrusion through the conjunctiva and lid is a possible consequence of punctal plug placement.

The purpose of this case series was to report the detection of early markers for Sjögren syndrome (SS) in 3 patients with chronic dry eye who previously tested negative for classic SS autoantibodies.Cases of 3 patients with a history of dry eye are described. Current assessments in a cornea/ocular surface specialist clinical setting and an ocular medical history review are presented in conjunction with laboratory testing for the presence of novel autoantibody markers linked to the early stages of SS.All 3 dry eye patients described in this case series tested negative for the classic autoantibody markers [Sjögren syndrome type A (SS-A) and Sjögren syndrome type B (SS-B)]. However, autoantibodies were detected in these patients indicating a likely diagnosis of early-stage SS. All patients were referred to a rheumatologist for further evaluation and treatment.Patients with a history of dry eye signs/symptoms that persist despite treatment (male and female patients) may benefit from a serological evaluation for SS that is capable of detecting not only the traditional SS-A and SS-B markers, but also the recently identified autoantibodies.

To evaluate the rate of Sjögren syndrome (SS) in a cohort of patients with dry eye syndrome.Medical records of patients with a primary diagnosis of dry eye syndrome (International Classification of Diseases [ICD] code 375.15 or 370.33) were reviewed retrospectively. Patients who had 2 or more visits to a single dry eye center during a 2-year period (January 2004 to January 2006) were considered.Two hundred twenty patients with dry eye syndrome were identified. A total of 57 patients (25.9%) had an underlying rheumatic condition: 25 patients (11.4%) had rheumatoid arthritis and 24 (10.9%) had primary Sjögren syndrome (PSS). Majority of the patients with rheumatoid arthritis (96%) carried the diagnosis at the time of presentation. Of all patients with PSS, only 33.3% (8/24) carried the diagnosis at the time of presentation. Fifty percent (12/24) were diagnosed as a result of the initial evaluation. Among those, only 66.6% (8/12) tested SSA (anti-Ro antibodies) or SSB (anti-La antibodies) positive. One third of patients (4/12) tested only antinuclear antibody positive at a titer of1/320 and required minor salivary gland biopsy for definitive diagnosis. Additional 16.7% (4/24), who were initially serologically negative, eventually underwent minor salivary gland biopsy and became diagnosed with SS.PSS seems to be underdiagnosed in patients with dry eye syndrome and should be the focus of diagnostic evaluations. A minor salivary gland biopsy might be required for a definitive diagnosis in a significant proportion of the patients with SS.

Purpose: A controlled uniocular study to evaluate the short-term efficacy of lacrimal punctum occlusion in the treatment of severe dry eye caused by Sjogren syndrome. Methods: Uniocular punctum occlusion by punctum plug in the upper and lower puncta in 1 eye was performed in 20 patients with severe keratoconjunctivitis Sicca caused by Sjogren syndrome. To overcome possible interindividual variability between patients, the other eye, in the same patient, was not occluded and served as a control eye. The eye to be occluded was randomly selected. The patients were instructed to continue using their dry eye medications. Tear function tests (Schirmer test, rose Bengal test, and debris in de cul-de-sac) were performed in both eyes. Subjective complaints (discomfort) were registered for both eyes. All the above-mentioned data were collected before starting the treatment and at least 6 weeks later. The above-mentioned parameters were compared and statistically analyzed in both eyes. Results: Of the 20 patients, 7 patients dropped out. The remaining 13 patients completed the final analysis. In the occluded eye, we found a significant improvement in both the subjective complaints and the rose Bengal score, but the Schirmer test and the tear mucus score did not change. Conclusion: Punctum occlusion therapy in a short-term study improved the rose Bengal score and discomfort score in our patients and thus may be helpful in the treatment of severe dry eye caused by Sjogren syndrome.

Purpose: A controlled uniocular study to evaluate the short-term efficacy of lacrimal punctum occlusion in the treatment of severe dry eye caused by Sjogren syndrome.Methods: Uniocular punctum occlusion by punctum plug in the upper and lower puncta in 1 eye was performed in 20 patients with severe keratoconjunctivitis Sicca caused by Sjogren syndrome. To overcome possible interindividual variability between patients, the other eye, in the same patient, was not occluded and served as a control eye. The eye to be occluded was randomly selected. The patients were instructed to continue using their dry eye medications. Tear function tests (Schirmer test, rose Bengal test, and debris in de cul-de-sac) were performed in both eyes. Subjective complaints (discomfort) were registered for both eyes. All the above-mentioned data were collected before starting the treatment and at least 6 weeks later. The above-mentioned parameters were compared and statistically analyzed in both eyes.Results: Of the 20 patients, 7 patients dropped out. The remaining 13 patients completed the final analysis. In the occluded eye, we found a significant improvement in both the subjective complaints and the rose Bengal score, but the Schirmer test and the tear mucus score did not change.Conclusion: Punctum occlusion therapy in a short-term study improved the rose Bengal score and discomfort score in our patients and thus may be helpful in the treatment of severe dry eye caused by Sjogren syndrome.

PURPOSE To evaluate the clinical efficacy of anti-inflammatory therapy in the management of primary Sjogren syndrome. METHODS Thirty-eight patients with primary Sjogren syndrome were included in this study. The diagnosis of Sjogren syndrome was made on the basis of the classification criteria of the American-European Consensus Group. Fluorescein staining score, rose-bengal staining score, Schirmer test score, tear film breakup time, and functional parameters including ocular surface disease index (OSDI) and visual analog scale (VAS) score were measured at the first visit. Anti-inflammatory therapy included topical corticosteroids, topical autologous serum, and topical cyclosporin A. The clinical efficacy of anti-inflammatory treatment was evaluated in terms of subjective symptoms and objective signs (including Schirmer-1 test, breakup time, rose-bengal score, and fluorescein score). RESULTS Patients with Sjogren syndrome had higher rose-bengal scores than patients with non-Sjogren dry eye (P < 0.05). The OSDI score showed better correlation with fluorescein score than with VAS score. Subjective symptoms improved with anti-inflammatory treatment in 70% of patients with primary Sjogren syndrome. Anti-inflammatory treatment provided significant improvement in visual acuity and fluorescein score but did not affect Schirmer score, tear breakup time, or rose-bengal score. CONCLUSIONS Anti-inflammatory therapy in primary Sjogren syndrome significantly improved subjective symptoms and objective ocular signs; however, we did not find evidence that anti-inflammatory treatment increases tear production in patients with Sjogren syndrome.

To report a complication, not previously described, of the Medennium SmartPLUG, which is a new punctal plug with a novel design.Two case reports are detailed, including clinical and pathologic photographs.Case 1 is a 58-year-old woman with Sjögren syndrome. Nearly 2 years following placement of a SmartPLUG in her right lower canaliculus, the patient presented with an erythematous, papillomatous growth overlying her punctum. Biopsy demonstrated pyogenic granuloma. Case 2 is a 62-year-old woman with dry eye. Exactly 2 years after a SmartPLUG was place in her right lower canaliculus, she also developed a pyogenic granuloma. After irrigation to remove the plug, the growth decreased in size.Pyogenic granuloma can develop as a late complication of the Medennium SmartPLUG punctum plug.

To evaluate tear osmolarity with the recently introduced TearLab system (TearLab Corporation, San Diego, CA) in patients with non-Sjögren syndrome dry eye (NSSDE) and Sjögren syndrome dry eye (SSDE), and in healthy subjects, and to compare the results with those from classical dry eye tests.Thirty-nine eyes of 21 patients with NSSDE, 39 eyes of 20 patients with SSDE, and 44 eyes of 22 healthy individuals were included in the study. Tear osmolarity was measured with the TearLab system, lid-parallel conjunctival folds score was examined with the slit lamp, and then the classical diagnostic tests such as Schirmer I test, tear film break-up time, and corneal staining were carried out, followed by the examination of meibomian glands and corneal transparency.Mean tear osmolarity was 296.77 ± 16.48 mOsm/L in NSSDE (15% abnormal), 303.36 ± 17.22 mOsm/L in SSDE (23% abnormal), and 303.52 ± 12.92 mOsm/L in the control group (16% abnormal; P = 0.018, Kruskal-Wallis). Schirmer test, corneal staining, tear film break-up time, and meibomian gland status were significantly different in the 2 patient groups when compared with those in the control group (P0.0001). In the control and SSDE groups, no significant correlation was disclosed between tear osmolarity and any of the dry eye tests performed.Tear hyperosmolarity is considered a key factor that leads to dry eye symptoms and to the progression of clinical signs. Osmolarity measurements with the TearLab system disclosed no ability to distinguish between healthy individuals and patients with dry eye. This suggests that the TearLab device should not be used alone but in combination with classical dry eye tests.

To report the clinical outcome of the treatment of dry eyes using 0.03% tacrolimus eye drops (olive oil + tacrolimus 0.03%) (Ophthalmos, Sao Paulo, Brazil).Sixteen eyes of 8 patients with Sjögren syndrome dry eyes (age, 51.13 ± 9.45 years) were enrolled in this study (prospective noncontrolled interventional case series). Patients were instructed to use topical 0.03% tacrolimus eye drops twice a day (every 12 hours) in the lower conjunctival sac. Schirmer I test, break-up time, corneal fluorescein, and rose bengal staining score were performed in all patients 1 day before, and 14, 28, and 90 days after treatment with 0.03% tacrolimus eye drops.The average fluorescein staining and rose bengal staining scores improved statistically significantly after 14 days of treatment and improved even more after 28 and 90 days. The average Schirmer I test did not improve statistically significantly after 28 days of treatment, although we did observe a significant improvement after 90 days of treatment with 0.03% tacrolimus eye drops. The average break-up time did not improve statistically after 14 days of treatment, although we observed a significant improvement after 28 and 90 days of treatment with 0.03% tacrolimus eye drops.Topical 0.03% tacrolimus eye drops successfully improved tear stability and ocular surface status in patients with dry eyes.

Objective To assess the results of 1-minute and 5-minute Schirmer test (ST) when eyes are open (STo) and closed (STc) in normal subjects and patients with dry eye disease. Methods In a comparative, observational case series study, 34 normal volunteers (group 1) and 34 patients with dry eye disease (DED) associated with Sjogren syndrome (group 2) were included in the study. STo and STc for 1 minute and 5 minutes were performed separately for all subjects with an interval of at least 24 hours using Whatman No. 41 (5 × 60 mm) with bended end of the paper inserted into the lateral side of the lower conjunctival fornix. Results In group 1, there were 19 females and 15 males with a mean age of 20.8 years (range 18 to 23 years). In group 2, there were 29 females and 5 males with a mean age of 53.7 years (range 35 to 75 years). Mean value of STc was significantly less than STo in both 1 minute and 5 minutes in both groups. One-minute STo and STc showed significantly less wetting than the 5-minute test in both healthy and patients with DED. Normal distribution was observed for all the values. A significant correlation between 1-minute and 5-minute tests in both STo and STc were found in the two groups. Therefore, two equations were proposed to calculate the 5-minute from 1-minute ST in each group. Statistical analysis did not provide a reliable equation for calculating the standard ST (5-minute STo) from the most comfortable state (1-minute STc). Conclusion Faster and more comfortable ST (1-minute) is a reliable test to calculate the 5-minute ST in both open and closed eyes, using the provided equations. The 1-minute STc is not a reliable test to calculate the 5-minute STo.

Lichen planus is a chronic inflammatory disease that can affect both the skin and mucosa. Although more commonly affecting the oral and genital mucosa, it can also affect the conjunctiva, causing cicatrization in rare cases. It has been reported previously to be associated with hepatitis C infection, paraneoplastic conditions,1 systemic lupus erythematosus, Sjogren syndrome,2 and ocular cicatricial pemphigoid.3 It can be present in the mucosa as a reticulated network of white streaks or an erosive plaque-like process with multiple, recurrent, discrete lesions.4 We present a case of conjunctival lichen planus in a patient with a history of herpes simplex virus keratitis without cicatrization.

Objective: To compare the efficacy, retention rates, and complications of two types of silicone lacrimal punctal plugs in patients with or without Sjogren syndrome. Methods: We studied 36 patients with keratoconjunctivitis sicca (KCS) including 17 cases with Sjogren syndrome (SS) and 19 without SS. The fluorescein and rose bengal staining scores and the Schirmer values with and without nasal stimulation were evaluated before and after insertion of the Eagle Plugs and the punctal plugs (FCI Punctal Plugs). The retention rates and complications of these plugs were also investigated. Results: The staining scores were significantly improved after the insertion of the plugs, but the Schirmer values did not increase significantly in either SS or non-SS patients. A spontaneous loss of the plugs was observed in 29% of all plugs within 1 month after insertion. The Eagle Plugs were lost more frequently, and plugs in the upper punctum were lost more often for the Eagle Plugs. There was one case of granulomatous proliferation and two cases of punctal infection with the FCI Punctal Plugs. Conclusions: Both types of punctal plugs led to an improvement of the fluorescein and rose bengal staining scores in eyes with KCS. The difference in the retention rate and complications between the two types of plugs was probably caused by the differences in the material and the design of the plugs. Close monitoring is necessary to check for loss of plugs and to prevent complications.

To review recent experimental evidence on the involvement of autoantigens and autoantibodies in the pathogenesis of organ-specific autoimmunity in Sjögren syndrome (SS).Among candidate autoantigens in SS, we investigated the role of alpha-fodrin in the lacrimal gland using a mouse model and a lacrimal gland cell line established in p53 knockout mice. We also tried to identify a novel organ-specific autoantigen by screening the human salivary gland cell line (HSG) against sera from SS patients. The specificity and sensitivity of this autoantigen to SS patient sera, its cellular localization, and the gene encoding the protein were analyzed.In addition to the previously identified 120-kd alpha-fodrin in the salivary gland, a shorter fragment was detected, indicating that there may be a distinct apoptosis-related protease that cleaves alpha-fodrin in the lacrimal gland. A novel salivary gland-specific autoantibody was detected in 50.9% of sera from SS patients. The antigen recognized by this antibody may be a 45-kd nucleus protein not recognized in its native form.The precise roles of autoantigens in organ-specific autoimmunity are still unclear, although accumulated evidence suggests that they may be associated with disease progression. Further studies of alpha-fodrin and the 45-kd antigen may contribute to the understanding of the pathogenesis of SS and may provide a new strategy for organ-specific therapy, such as vaccination with analogue peptides.