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ID PMID Title PublicationDate abstract
25707965 Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, imm 2015 Mar Immune-mediated inflammatory diseases encompass a variety of different clinical syndromes, manifesting as either common diseases such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis, or rare diseases such as cryopyrin-associated periodic syndromes. The therapy for these diseases often involves the use of a wide range of drugs including nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, immunomodulators, and biologic therapies. Due to the abundance of relevant clinical data, this article provides a general overview on the clinical impact of the concomitant use of immunomodulators and biologic therapies, with a focus on anti-tumor necrosis factor-α agents (anti-TNFα), for the treatment of RA and Crohn's disease (CD). Compared to biologic monotherapy, concomitant use of immunomodulators (methotrexate, azathioprine, and 6-mercaptopurine) often increases the systemic exposure of the anti-TNFα agent and decreases the formation of antibodies to the anti-TNFα agent, consequently enhancing clinical efficacy. Nevertheless, long-term combination therapy with immunomodulators and anti-TNFα agents may be associated with increased risks of serious infections and malignancies. Therefore, the determination whether combination therapy is suitable for a patient should always be based on an individualized benefit-risk evaluation. More research should be undertaken to identify and validate prognostic markers for predicting patients who would benefit the most and those who are at greater risk from combination therapy with immunomodulators and anti-TNFα agents.
26980987 Surgical options for the young patient with glenohumeral arthritis. 2016 Jan Young patients with glenohumeral arthritis are an ongoing treatment challenge. They typically have high demands of their shoulders, require long-term durability due to their young age, and often have altered local anatomy, through their disease process (instability arthropathy, juvenile rheumatoid arthritis, etc.) or from previous surgery (capsulorraphy arthropathy, chondrolysis, etc.). Workup to evaluate underlying causes of early arthritis, and to exclude infectious causes are necessary. When nonoperative management fails, arthroscopic debridement, hemiarthroplasty (isolated, with glenoid reaming, or with biological interposition), and total shoulder arthroplasty are treatment options available to the treating surgeon. Debridement or hemiarthroplasty can provide pain relief for a subset of patients, but results have not been reproducible across the literature and have not been durable over time. Total shoulder arthroplasty provides the most reliable pain relief, but long-term glenoid loosening and wear continue to lead to high revision rates in this patient population.
27747836 Claims Data Analysis of Tumor Necrosis Factor Inhibitor Treatment Dosing Among Patients wi 2016 Sep BACKGROUND: With tumor necrosis factor inhibitors, changes of dosing, switching between drugs, insufficient adherence, and persistence are frequent in rheumatoid arthritis. Because this is often associated with decreased efficiency and increased costs, dosage analyses based on claims data are of increasing interest for healthcare providers and payers. Nevertheless, no standardized methods exist to ensure high-quality research. OBJECTIVE: In this review, we compare and discuss applied methods in claims data-based dosage analyses of tumor necrosis factor inhibitor prescriptions in patients with rheumatoid arthritis. METHODS: A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The dosage analysis methods performed within the selected studies were classified into switching, persistence, adherence, and dosage-change analyses, and were then compared and finally discussed. RESULTS: A total of 45 studies were found to be relevant. In most studies, a change in dose or persistence was evaluated, followed by switching and adherence analyses. Analyses of changed dose exhibit the most extensive variation of methods. We divided them into three principal methods, where a specified reference dose is compared with (1) the last dose, (2) any dose, or (3) all doses. CONCLUSION: The systematic review identified a high variation of methods. Our results may be helpful for choosing appropriate methods in future studies. The results also demonstrate the need for evidence-based recommendations of methods used in claims data research.
26403380 Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first appro 2016 Jan The introduction of targeted biological therapies has revolutionised the management of immune-mediated inflammatory diseases (IMIDs) such as rheumatoid arthritis, ankylosing spondylitis, psoriasis and inflammatory bowel disease. Following treatment with these therapies, many patients experience significant improvements in different aspects of their disease, including symptoms, work productivity and other outcomes relevant for individuals and society. However, due to the complexity of biological drug development and manufacturing processes, the costs of these therapies are relatively high. Indeed, the financial burden on healthcare systems due to biological therapies is considerable and lack of patient access to effective treatment remains a concern in many parts of the world. As many reference biological therapies have now reached or are near to patent expiry, a number of 'biosimilar' drugs have been developed for use in various clinical settings, and some of these drugs are already in use in several countries. While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the 'switchability' and relative immunogenicity of biosimilars and their reference drugs. In this review, these issues will be discussed with reference to CT-P13, a biosimilar of the anti-tumour necrosis factor monoclonal antibody infliximab, which is approved in Europe and elsewhere for the treatment of various IMIDs. Other important issues, including those related to data collection during nonclinical and clinical development of biosimilars, are also discussed.
26545293 Survey of rheumatologists on the use of the Philippine Guidelines on the Screening for Tub 2016 Nov BACKGROUND: The use of biologic agents has become an important option in treating patients with rheumatoid arthritis. However, these drugs have been associated with an increased risk of tuberculosis (TB) reactivation. Local guidelines for TB screening prior to the use of biologic agents were developed to address this issue. AIM: This study is a survey describing the compliance of Filipino rheumatologists to these guidelines. METHOD: Eighty-seven rheumatologists in the Philippines were given the questionnaire and responses from 61 rheumatologists were included in the analysis. RESULTS: All respondents agree that patients should be screened prior to giving the biologic agents. Local guidelines recommend screening with tuberculin skin test (TST) and chest radiograph. However, cut-off values considered for a positive TST and timing of initiation of biologic agents after starting TB prophylaxis and treatment varied among respondents. In addition, screening of close household contacts were only performed by 41 (69.5%) respondents. There were 11 respondents who reported 16 patients developing TB during or after receiving biologic agents, despite adherence to the guidelines. CONCLUSION: This survey describes the compliance rate of Filipino rheumatologists in applying current local recommendations for TB screening prior to initiating biologic agents. The incidence of new TB cases despite the current guidelines emphasizes the importance of compliance and the need to revise the guidelines based on updated existing literature.
27824546 Citrullination in Rheumatoid Arthritis-A Process Promoted by Neutrophil Lysis? 2016 Oct 31 Anti-citrullinated protein antibodies (ACPAs) are highly specific serologic markers for rheumatoid arthritis (RA) and can pre-date clinical disease onset by up to 10 years, also predicting erosive disease. The process of citrullination, the post-translational conversion of arginine to citrulline residues, is mediated by peptidylarginine deiminase (PAD) enzymes present in polymorphonuclear cells (PMNs). Calcium ions (Ca(2+)) are required for PAD activation, but the intracellular Ca(2+) concentration in normal cells is much lower than the optimal Ca(2+) concentration needed for PAD activation. For this reason, it has been proposed that PAD activation, and thus citrullination, occurs only during PMN cell death when PAD enzymes leak out of the cells into the extracellular matrix, or extracellular Ca(2+) enters the cells, with the high Ca(2+) concentration activating PAD. Recently, using artificial in vitro systems to corroborate their hypothesis, Romero et al. demonstrated that "hypercitrullination," citrullination of multiple intracellular proteins, occurs within synovial fluid (SF) cells of RA patients, and that only modes of death leading to membranolysis such as perforin-granzyme pathway or complement membrane attack complex activation cause hypercitrullination. In order for Romero's hypothesis to hold, it is reasonable to surmise that PMN-directed lysis should occur in the rheumatoid joint or the circulation of RA patients. Research conducted thus far has shown that immunoglobulin G (IgG) targeting PMNs are present in RA SF and mediate PMN activation. However, the role of anti-PMN IgG in mediating complement activation and subsequent PMN lysis and hypercitrullination has not been fully evaluated.
26915082 Segmentation of joint and musculoskeletal tissue in the study of arthritis. 2016 Apr As the most frequent cause of physical disability, musculoskeletal diseases such as arthritis and osteoporosis have a great social and economical impact. Quantitative magnetic resonance imaging (MRI) biomarkers are important tools that allow clinicians to better characterize, monitor, and even predict musculoskeletal disease progression. Post-processing pipelines often include image segmentation. Manually identifying the border of the region of interest (ROI) is a difficult and time-consuming task. Manual segmentation is also affected by inter- and intrauser variability, thus limiting standardization. Fully automatic or semi-automatic methods that minimize the user interaction are highly desirable. Unfortunately, an ultimate, highly reliable and extensively evaluated solution for joint and musculoskeletal tissue segmentation has not yet been proposed, and many clinical studies still adopt fully manual procedures. Moreover, the clinical translation of several promising quantitative MRI techniques is highly affected by the lack of an established, fast, and accurate segmentation method. The goal of this review is to present some of the techniques proposed in recent literature that have been adopted in clinical studies for joint and musculoskeletal tissue analyses in arthritis patients. The most widely used MRI sequences and image processing algorithms employed to accomplish segmentation challenges will be discussed in this paper.
27383742 Three subgroups of pain profiles identified in 227 women with arthritis: a latent class an 2017 Mar The objectives were to identify subgroups of women with arthritis based upon the multi-dimensional nature of their pain experience and to compare health and socio-demographic variables between subgroups. A latent class analysis of 227 women with self-reported arthritis was used to identify clusters of women based upon the sensory, affective, and cognitive dimensions of the pain experience. Multivariate multinomial logistic regression analysis was used to determine the relationship between cluster membership and health and sociodemographic characteristics. A three-class cluster model was most parsimonious. 39.5 % of women had a unidimensional pain profile; 38.6 % of women had moderate multidimensional pain profile that included additional pain symptomatology such as sensory qualities and pain catastrophizing; and 21.9 % of women had severe multidimensional pain profile that included prominent pain symptomatology such as sensory and affective qualities of pain, pain catastrophizing, and neuropathic pain. Women with severe multidimensional pain profile have a 30.5 % higher risk of poorer quality of life and a 7.3 % higher risk of suffering depression, and women with moderate multidimensional pain profile have a 6.4 % higher risk of poorer quality of life when compared to women with unidimensional pain. This study identified three distinct subgroups of pain profiles in older women with arthritis. Women had very different experiences of pain, and cluster membership impacted significantly on health-related quality of life. These preliminary findings provide a stronger understanding of profiles of pain and may contribute to the development of tailored treatment options in arthritis.
26769128 Antiarthritis Effect of Morin is Associated with Inhibition of Synovial Angiogensis. 2015 Dec Morin, a flavonoid isolated from Morus alba L. (Moraceae), possesses anti-inflammatory, antiangiogenic among other biological activities. This study investigated its effect on type II collagen-induced arthritis (CIA) in rats and explored the underlying mechanisms in view of synovial angiogenesis. Morin administered po attenuated arthritic progression as indicated by reduction of arthritis scores and paw swelling. It also markedly reduced serum levels of the proinflammatory cytokines, tumor necrosis factor alpha (TNF-α) and interleukin-6 (IL-6), but increased the level of anti-inflammatory cytokine interleukin-10, and ameliorated histopathological changes of joints. Morin markedly inhibited expression of CD31, vascular endothelial growth factor (VEGF), and basic fibroblast growth factor in synovial membrane tissues, and decreased serum levels of VEGF in CIA rats. In vitro, morin markedly inhibited VEGF-induced migration and tube formation in human umbilical vein endothelial cells. These results indicate that morin had antirheumatoid potential, and its mechanism might be associated with inhibition of synovial angiogenesis.
27760487 Primary Sjögren's syndrome impact on smell, taste, sexuality and quality of life in femal 2017 Jul OBJECTIVES: The aim of this study is to assess the impact of dryness caused by primary Sjögren's Syndrome (pSS) on smell, taste and sexual function in female patients, and its influence on quality of life. METHODS: Electronic databases including MEDLINE via Ovid, Web of Science, SCOUPUS, EMBASE and COCHRANE LIBRARY were searched until April 2016. Studies that assessed the function of smell, taste and sexuality in pSS patients, defined by the American European Consensus Group (AECG) criteria. Standardized mean differences (SMD) for individual studies using random-effects meta-analysis were feasible. RESULTS: Five studies incorporated 378 participants were included in the quantitative synthesis. The impact of pSS vs. healthy controls was: smell SMD -0.78 (95% CI -1.29 to -0.27); taste SMD -1.01 (95% CI -1.54 to -0.49); total sexual function SMD -0.93 (95% CI -1.22 to -0.64); physical and mental component of the quality of life SMD -1.28 (95% CI -1.65 to -0.90) and SMD -0.83 (95% CI -1.27 to -0.40) respectively; anxiety and depression SMD 0.61 (95% CI 0.02, 1.20) and SMD 0.79 (95% CI 0.43 to 1.15), respectively. CONCLUSION: pSS has a negative impact on smell, taste, sexual function and quality of life in women.
26786867 Characterization and Comparison of Patient Subgroups Suspicious for IgG4-Related Disease a 2016 Jul Differential diagnosis of patients with Sjögren's syndrome (SS), IgG4-related disease (IgG4-RD) and SS patients having high risk for lymphoma (LHR) can be challenging. Some patients with IgG4-RD might be misdiagnosed as having SS. There are special symptoms of SS that raise the possibility of IgG4-RD whereas other symptoms identify patients as having LHR. The purpose of this study was to characterize and compare patients with SS, possible IgG4-RD and SS patients with LHR. Sixty-five SS patients were divided into 4 subgroups according to having possible IgG4-RD (n = 15), LHR (n = 16), eligible for both aforementioned groups (n = 20) and not eligible for either group (n = 14), respectively. Four patients fulfilled the diagnostic criteria for IgG4-RD. The serum levels of IgG4 were significantly higher in patients suspicious for IgG4-RD compared to that of LHR patients (0.46 g/l vs. 0.12 g/l, p = 0.032). Shared features of the patient groups (salivary gland swelling (SGS) and lymphadenopathy), were separately analysed: SGS patients had higher IgG4/IgG ratio (p = 0.036), lymphadenopathic patients had higher IgG4 levels (p = 0.042). Some patients may be "hidden" under the diagnosis of SS. Although patients with LHR and patients with possible IgG4-RD share some symptoms, they differ significantly regarding IgG4 levels and IgG4/IgG ratio.
26312681 Scleredema associated with Sjögren's syndrome. 2015 May Scleredema adultorum of Buschke is a rare disorder characterized by diffuse swelling and non-pitting induration of the skin usually involving the face, neck, arms and upper trunk. It has been associated with previous infectious diseases, diabetes, paraproteinemia and, more rarely, malignant neoplasms or autoimmune disorders. We report the case of a 30-year-old man who presented with a 2-year history of scleredema. Further investigation led to the diagnosis of primary Sjögren's syndrome. The association between scleredema and autoimmune disorders has been rarely seen. To our knowledge, there are no other reports describing the association between primary Sjögren's syndrome and scleredema adultorum of Buschke.
25582994 Assessment of fatigue and dryness in primary Sjögren's syndrome: Brazilian version of "Pr 2015 Mar OBJECTIVE: To perform a cross-cultural adaptation and validation of the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory (short form) (PROFAD-SSI-SF) questionnaire assessing the subjective aspects of the symptoms of primary Sjögren syndrome (pSS), for the Brazilian Portuguese language. METHOD: Conceptual, of the item, semantic and operational equivalences were evaluated. The Brazilian version of PROFAD-SSI-SF was administered to 62 women with pSS according to the European-American consensus 2002 to assess measurement equivalence. α-Cronbach was used for internal consistency; intraclass correlation coefficient (ICC) for intraobserver reproducibility; and Spearman correlation coefficient for validity by comparing with Patient Global Assessment (PaGA), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-F) and EuroQOL (EQ-5D). RESULTS: The internal consistency of PROFAD, SSI and total score was 0.80; 0.78; and 0.87, respectively. The intraobserver reproducibility of total PROFAD was 0.89; of total SSI of 0.86; and total score of 0.89. In terms of validity, PROFAD correlated significantly with PaGA (r = 0.50), FACIT-F (r = 0.59), ESSPRI (r = 0.58) and all domains of EQ-5D, with the exception of Mobility. On the other hand, SSI correlated significantly with PaGA (r = 0.43), FACIT-F (r = 0.57), ESSPRI (r = 0.55) and most areas of EQ-5D. The total score of PROFAD-SSI-SF had a non-statistically significant correlation only with Mobility domain and with 1-100 range of EQ-5D. CONCLUSION: The Portuguese version of PROFAD-SSI-SF proved to be an adaptable, reproducible and valid tool for the Brazilian Portuguese language.
25480887 Defining disease activity states and clinically meaningful improvement in primary Sjögren 2016 Feb OBJECTIVES: To define disease activity levels, minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) with the primary Sjögren's syndrome (SS) disease activity indexes: European League Against Rheumatism (EULAR) SS disease activity index (ESSDAI) and EULAR SS patient-reported index (ESSPRI). METHODS: For 790 patients from two large prospective cohorts, ESSDAI, physician evaluation of disease activity, ESSPRI and patients' satisfaction with their current health status were recorded. Receiver operating characteristic curve analyses and anchoring methods were used to estimate disease activity levels of ESSDAI and the PASS of ESSPRI. At follow-up visit, patients and physicians assessed, respectively, whether symptoms and disease activity have improved or not. An anchoring method based on this evaluation was used to estimate MCII of ESSDAI and ESSPRI. RESULTS: Low-activity (ESSDAI<5), moderate-activity (5≤ESSDAI≤13) and high-activity (ESSDAI≥14) levels were defined. MCII of ESSDAI was defined as an improvement of at least three points. The PASS estimate was defined as an ESSPRI<5 points and MCII as a decrease of at least one point or 15%. CONCLUSIONS: This study determined disease activity levels, PASS and MCII of ESSDAI and ESSPRI. These results will help designing future clinical trials in SS. For evaluating systemic complications, the proposal is to include patients with moderate activity (ESSDAI≥5) and define response to treatment as an improvement of ESSDAI at least three points. For addressing patient-reported outcomes, inclusion of patients with unsatisfactory symptom state (ESSPRI≥5) and defining response as an improvement of ESSPRI at least one point or 15% seems reasonable.
27541181 Epidemiology of sporadic inclusion body myositis. 2016 Nov PURPOSE OF REVIEW: In this review, we describe recent progress in the clinical epidemiology of sporadic inclusion body myositis (IBM). RECENT FINDINGS: In a population-based, retrospective study from Norway, performed with a denominator population of 2.6 million; and with cases defined by the 1997 and/or 2011 European Neuro-Muscular Centre Research Diagnostic criteria, the estimated point prevalence of IBM was 3.3/100 000. Mean time from symptom onset to diagnosis was 5.6 years, longer than in earlier studies. The male to female ratio was 3 : 2, and the mean age at diagnosis 67 years, very similar to figures reported this year from a nationwide, Dutch myopathy registry. Coexisting rheumatic diseases were recorded in 25% of Norwegian IBM cases, with Sjøgren's syndrome as the most commonly encountered. Mortality was increased in IBM, with a standardized mortality rate of 1.7, but there was no indication of increased cancer risk. SUMMARY: Population-based data indicate that the prevalence of IBM in Europe is higher than expected from previous studies. Diagnostic delay appears to be a persisting problem in IBM; a major challenge with promising new therapies on the horizon.
26212053 Aging and Immunopathology in Primary Sjögren's Syndrome. 2015 Sicca complaints (sensation of dry mouth and/or eyes) are present in about a quarter of the individuals above the age of 65 years old and are mainly due to medication. However, physiological changes that occur during aging might also lead to a diminished glandular function. These age-related changes are, at least in part, to be the consequence of decreased androgen levels. In addition to these physiological effects that occur during normal aging, sicca complaints can also be caused by Sjögren's syndrome (SS): a systemic auto-inflammatory disorder mainly affecting exocrine glands. Genetic factors, lowered levels of gonadal hormones and (viral) infections appear to contribute to the etiology of the syndrome. The incidence of SS is higher among aged individuals, which might be due to earlier diagnosis, as the onset of SS in an individual with age-related exocrine gland dysfunction lowers the threshold for sicca complaints. On the other hand, physiological aging might be considered as a risk factor for development of SS, resulting in a faster development of the syndrome. Differentiating physiological sicca complaints from SS in the elderly can be challenging, since apparently healthy individuals might present with auto-antibodies and lymphocytic infiltrates in salivary glands might be present as well. The drop in the level of androgens and estrogens upon aging, immunosenescence and pro-inflammatory features of the aging immune system may all contribute to the etiology of pSS in the elderly. In this review, we describe the physiological effects of aging and the influence of SS on exocrine gland morphology and function.
27666115 The design of clinical trials to support the switching and alternation of biosimilars. 2016 Dec Loss of exclusivity for biological therapeutics opens the door for biosimilar development. Biosimilars must demonstrate structural, functional, and clinical similarity with a currently approved biological originator product. A therapeutic alternative for biologic-naive patients, a single switch from an originator to biosimilar has also been studied in clinically stable patients; further, switching therapy multiple times (alternating) between an originator and a biosimilar has been investigated. Because biosimilars are not identical to originators and no robust clinical data have convincingly demonstrated that switching or alternating therapy of stable patients is safe and efficacious, there is an imperative need to understand the characteristics of well-designed clinical trials to support these practices. Areas covered: Clinical trials of biosimilars are reviewed, with an emphasis on trial designs that incorporate therapy switching, including the NOR-SWITCH study as an example. Expert opinion: As currently designed, biosimilar clinical trials provide insufficient information to support switching or alternating between originator products and their biosimilars. Lack of regulatory guidance contributes to this void. More robust data are required to inform the safety and efficacy of switching or alternating therapies, particularly regarding immunogenicity risks. Studies that also include alternations of therapy are needed to address these knowledge gaps.
27939798 Diplopia and Sjogren's disease: A rare case report. 2017 Jan 15 Sjogren's syndrome is a chronic autoimmune disorder which affects the exocrine glands with lymphocytic infiltration, and occasionally involves central nervous system. It is usually rare and manifests as a lesion in the trigeminal nerve. Our case discusses the involvement of the oculomotor and abducens nerves along with the prevalence of such cases as seen on literature review. We describe a case of a middle aged woman who presented with ophthalmoplegic symptoms. The symptoms resolved in response to steroid therapy and serum analysis was positive for anti SSA antibodies. Increasing use of imaging modalities has enabled identifying cranial nerve enhancements easily. Correlating this to serum analysis, as in our case; has helped identify more cases of third and sixth cranial nerve involvement than was previously known to occur with primary Sjogren's syndrome.
26466709 Two cases of adult-onset Still's disease with orbital inflammatory lesions originating fro 2015 Orbital inflammation has been rarely associated with adult-onset Still's disease (AOSD). We herein describe two AOSD patients who developed lacrimal gland enlargement with inflammation spreading to the contiguous tissues in the orbit. Case 1 was a 26-year-old woman who developed bilateral eyelid swelling while taking prednisolone (22.5 mg/day) for AOSD. The swelling of the eyelid worsened after other symptoms emerged, such as a fever, a rash, and arthritis. The laboratory findings, including leukocytosis, liver dysfunction, and ferritin elevation, also suggested an AOSD flare-up. Case 2 was a 62-year-old woman who presented with left eyelid swelling. She was diagnosed with AOSD at 45 years of age but sustained remission. During admission, she subsequently developed a fever, a rash, arthritis, lymphadenopathy, and ocular hyperemia. AOSD was suspected from the clinical course. We speculate that dacryoadenitis and orbital inflammation are manifestations of AOSD.
26194149 Risk of Sjögren's syndrome in Taiwanese female adults with irregular menstrual cycles: a 2016 Jan Primary Sjögren's syndrome (pSS) is a progressive systemic autoimmune disorder with a strong female predominance. Hormonal influences are thought to play a role in the development of pSS. However, no studies have specifically evaluated the association between irregular menstrual cycles and pSS. Therefore, using a health claims database, this study investigated the risk of pSS in women with irregular menstrual cycles. We conducted a case-control study using the Taiwan's National Health Insurance Research Database. A total of 360 patients diagnosed with pSS (International Classification of Diseases, ninth revision, clinical modification, ICD-9-CM code 710.2) between 2001 and 2012 were identified. Controls were frequency-matched at a rate of 5:1 to the cases by five-year age interval and index year. Both cases and controls were retrospectively traced back until 2001 for the diagnosis of irregular menstrual cycles (ICD-9-CM code 626.4). The risk of pSS was assessed using multivariate logistic regression analyses. Irregular menstrual cycles were significantly associated with pSS [adjusted odds ratio, (AOR) = 1.38, p = 0.027], after adjusted for insured amount, urbanization level, and thyroid disorder. In addition, when the data were stratified by three age categories, only the patients in the age category of 45-55 years showed significant association between irregular menstrual cycles and pSS (AOR = 1.74, p = 0.005). In this nationwide, population-based case-control study, we found a significant increased risk of pSS in female patients with irregular menstrual cycles, particularly those in their mid-forties to mid-fifties.