High Burden of Sexual Dysfunction in Female Patients with Rheumatoid Arthritis: Results of a Cross-sectional Study.

OBJECTIVE: To evaluate the effect of rheumatoid arthritis (RA) on impairing women's sexuality regarding motivation, activity, and satisfaction, and to assess the correlation of disease-related physical impairment within sexual functioning. METHODS: An anonymous survey among women with RA and healthy controls (HC) using standardized questionnaires, predominantly the Changes in Sexual Functioning Questionnaire-short form (CSFQ-14). In addition, disease activity, depression, and disability were evaluated. RESULTS: There were 319 questionnaires distributed to patients and 306 to HC. Of these, 235 patient questionnaires (73.7%) and 180 HC questionnaires (58.8%) were returned, of which 203 and 169 were completed, respectively. Of the patients with RA, 47.8% had a total CSFQ-14 score of ≤ 41, indicating female sexual dysfunction (FSD), as compared to 14.2% of HC (p < 0.0001). The median CSFQ-14 score was lower in patients with RA [42 points, interquartile range (IQR) 36-48] than in HC (49 points, IQR 44-54; p < 0.0001), resulting in an OR of 5.53 (95% CI 3.19-9.57; p < 0.0001). After adjustment for confounders, given a higher mean age of patients (55.2 ± 11.3 yrs) than HC (47.4 ± 11.8 yrs; p < 0.0001), the OR for FSD in patients with RA was still 3.04 (95% CI 1.61-5.75; p = 0.001). Neither the Health Assessment Questionnaire-Disability Index nor the Clinical Disease Activity Index was associated with FSD after adjustment. CONCLUSION: FSD apparently is highly prevalent in female patients with RA, affects all subdomains of sexual function, and is most likely underestimated in daily clinical practice. Of note, FSD could not be linked to disability or RA disease activity.

Interface Management between General Practitioners and Rheumatologists-Results of a Survey Defining a Concept for Future Joint Recommendations.

OBJECTIVE: To measure the views of general practitioners (GPs) and rheumatologists in a nationwide evaluation, so as to optimise their cooperation in managing patients with inflammatory rheumatic diseases. METHODS: A questionnaire covering aspects of collaboration was sent, both by mail and/or by email, to all GPs and rheumatologists in Austria. Topics covered were (i) examinations and interventions to be performed before referral, (ii) the spectrum of diseases to be referred, and (iii) the role of GPs in follow-up and continuous management of patients. RESULTS: 1,229 GPs of the 4,016 GPs (31%) and 110 of the 180 rheumatologists (61%) responded to the questionnaire. In cases of suspected arthritis, 99% of the GPs and 92% of the rheumatologists recommended specific laboratory tests, and 92% and 70%, respectively, recommended X-rays of affected joints before referral. Rheumatoid arthritis and spondyloarthritis, psoriatic arthritis and connective tissue disease were unanimously seen as indications for referral to a rheumatologist. Only 12% of rheumatologists felt responsible for the treatment of hand osteoarthritis and fibromyalgia. 80% of GPs and 85% of rheumatologists were of the opinion that treatment with disease-modifying drugs should be initiated by a specialist. Subsequent drug prescription and administration by GPs was supported by a majority of GPs and rheumatologists, with a concomitant rheumatologist follow-up every three to six months. CONCLUSION: The considerable consensus between the two professional groups constitutes a solid base for future joint recommendations, with the aim to accelerate the diagnostic process and the initiation of adequate therapy.

Identification and monitoring of host cell proteins by mass spectrometry combined with high performance immunochemistry testing.

Biotherapeutics are often produced in non-human host cells like Escherichia coli, yeast, and various mammalian cell lines. A major focus of any therapeutic protein purification process is to reduce host cell proteins to an acceptable low level. In this study, various E. coli host cell proteins were identified at different purifications steps by HPLC fractionation, SDS-PAGE analysis, and tryptic peptide mapping combined with online liquid chromatography mass spectrometry (LC-MS). However, no host cell proteins could be verified by direct LC-MS analysis of final drug substance material. In contrast, the application of affinity enrichment chromatography prior to comprehensive LC-MS was adequate to identify several low abundant host cell proteins at the final drug substance level. Bacterial alkaline phosphatase (BAP) was identified as being the most abundant host cell protein at several purification steps. Thus, we firstly established two different assays for enzymatic and immunological BAP monitoring using the cobas® technology. By using this strategy we were able to demonstrate an almost complete removal of BAP enzymatic activity by the established therapeutic protein purification process. In summary, the impact of fermentation, purification, and formulation conditions on host cell protein removal and biological activity can be conducted by monitoring process-specific host cell proteins in a GMP-compatible and high-throughput (> 1000 samples/day) manner.

Very recent onset arthritis--clinical, laboratory, and radiological findings during the first year of disease.

OBJECTIVE: To describe clinical and radiological findings in patients with very early arthritis (< 3 months of symptoms) during one year of observation. METHODS: In an Austrian multicenter setting, patients were eligible if they had nontraumatic swelling or pain in at least one joint and laboratory signs of inflammation [elevated erythrocyte sedimentation rate, C-reactive protein, leukocytosis, or rheumatoid factor (RF)] within the last 3 months. Clinical and laboratory assessments were performed every 3 months. Radiographs of hands and feet were taken at entry and after one year. Treatment decisions were left to the discretion of the participating center. RESULTS: In total, 108 patients included between 1996 and 2000 had followup investigations during at least one year; 61.1% of these patients had rheumatoid arthritis (RA). Over 65% of RA diagnoses were made at the first visit. Lag time to referral was significantly longer in patients with RA than in patients with other inflammatory joint diseases (median 8 vs 4 weeks). Disease modifying antirheumatic drugs were started 19 +/- 10 (mean +/- SD) weeks after symptom onset in patients with RA. Patients with RA improved significantly (by American College of Rheumatology response criteria and the Disease Activity Score 28) during the first year. Erosions were present in 12.8% of RA patients' initial radiographs, compared to 27.6% after one year. Odds ratio to develop new erosions during the first year of RA was 9.7 (95% CI 1.05-89.93) in RF+ patients compared to RF- individuals (p < 0.05). CONCLUSION: When early referral of patients with arthritis is encouraged, RA can be diagnosed and treatment initiated early, with significant clinical response. Moreover, patients with RA tend to be referred later than patients with other inflammatory joint diseases; RA patients at this very early stage have low frequency of joint damage; and RF predicts erosions in the first year.