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ID PMID Title PublicationDate abstract
11296948 Enhanced in vitro induced production of interleukin 10 by peripheral blood mononuclear cel 2001 Mar OBJECTIVE: To investigate the effect of in vivo treatment with methotrexate (MTX) on the regulation of ex vivo interleukin 10 (IL-10) production by peripheral blood mononuclear cells (PBMC) derived from patients with rheumatoid arthritis (RA). METHODS: Spontaneous as well as lipopolysaccharide (LPS) and phytohemagglutinin (PHA) induced IL-10 release was assessed by a specific immunoassay in culture supernatants of PBMC derived from 32 patients with active RA before and 6, 12, and 24 weeks after MTX treatment. IL- 10 production was correlated to the clinical response. As a control, IL-10 release from PBMC of 7 healthy blood donors was determined. RESULTS: PBMC of patients with RA showing > 50% improvement of the Paulus index after 3 and 6 months of MTX treatment (responders; n = 18) exhibited significantly enhanced IL-10 production after in vitro stimulation with LPS, whereas constitutively released IL-10 was below the detection limit of the immunoassay in all patients and controls. In contrast, IL-10 release from LPS stimulated PBMC of RA patients who showed < 20% improvement by Paulus index (nonresponders; n = 14) or who even deteriorated compared to baseline disease activity was markedly downregulated during MTX treatment in vivo. PHA-induced IL-10 release from PBMC in vitro was not significantly affected by MTX in vivo whether RA patients responded or not to MTX. CONCLUSION: Enhanced ex vivo LPS induced IL-10 production by PBMC of patients with RA is associated with a favorable therapeutic response to MTX treatment, whereas reduced production coincides more closely with disease deterioration or insufficient response. This may reflect both disease outcome upon treatment and/or the mode of the antiinflammatory action of MTX in RA. Because the LPS--but not the PHA--induced ex vivo IL-10 production by PBMC was stimulated by MTX in vivo, monocytes seem to be the prominent target cells for this drug mediated antiinflammatory cytokine regulation.
10733482 Response to methotrexate in early rheumatoid arthritis is associated with a decrease of T 2000 Apr OBJECTIVE: This study was performed to assess whether there is any change in the T cell cytokine pattern in early rheumatoid arthritis (RA) patients treated with methotrexate (MTX) and whether the lymphocytic cytokine pattern correlates with disease activity. METHODS: Eight patients with RA (disease duration < six months) were studied serially before, after three, and after six to nine months of treatment with MTX for the cytokines tumour necrosis factor alpha (TNFalpha), interferon gamma (IFNgamma), interleukin 4 (IL4) and interleukin 10 (IL10) by intracellular staining of T cells derived from peripheral blood. Response to treatment was assessed by the modified disease activitiy score. RESULTS: The clincial response was accompanied by a significant decrease of TNFalpha positive CD4(+) T cells from a median of 8.53% (interquartile range 5.83-10.91%) before treatment to 6.17% (2.15-6.81%) after six to nine months of treatment (p=0.021). Inversely, IL10 positive T cells increased from a median of 0.65% (interquartile range 0.6-0.93%) to a median of 1. 3% (1.22%-1.58%) after six to nine months of treatment (p=0.009). No significant change in the percentage of INFgamma positive T cells and a small decrease of IL4 positive T cells during treatment were observed. The percentage of IL4 positive CD4(+) T cells before treatment correlated with disease activity after six to nine months (r= -0.7066; p=0.05). CONCLUSIONS: During treatment of RA with MTX the percentage of TNFalpha producing T cells decreases whereas that of IL10 producing T cells increases. This may affect macrophage activation and, therefore, may represent a regulatory mechanism relevant to disease remission. Furthermore, the percentage of IL4 positive CD4(+) T cells at disease onset may be a useful prognostic marker.
10589357 Combination treatment of rheumatoid arthritis with cyclosporine and methotrexate. 1999 Nov In patients with rheumatoid arthritis (RA) not controlled on methotrexate (MTX) alone, clinical trials have shown that combination therapy with cyclosporine (CSA) and MTX is effective and relatively well tolerated over 12 months. Information regarding the long-term benefits, toxicities and tolerability of this combination therapy in clinical practice, and comparisons with alternative strategies, will determine the utility of the MTX plus CSA combination regimen in patients with RA not controlled with a single drug.
9121027 [Coronary artery bypass grafting using arterial grafts in a patient with rheumatoid arthri 1997 Mar We report a 58-year-old man with rheumatoid arthritis (RA) who underwent successful coronary artery bypass grafting (CABG) for stable angina after myocardial infarction. He had been receiving prednisolone for 9 years. Selective coronary angiography revealed 99% stenosis in the left anterior descending branch (LAD; seg. 6). Before going on cardiopulmonary bypass, the inferior epigastric artery (IEA) was anastomosed to the left internal thoracic artery (LITA) in end-to-side fashion. The LITA was anastomosed to LAD (seg. 7) and the IEA was anastomosed to the first diagonal branch (seg. 9). The postoperative course was uneventful and postoperative angiography showed both grafts were well patent. He is now doing well with no angina attack. The stumps of the LITA and IEA were examined pathologically with the atherosclerotic changes of both grafts relatively mild. We consider the arterial grafts are useful for CABG even in the patient with RA requiring steroid therapy.
10855302 Extensor digiti minimi tendon "rerouting" transfer in permanent abduction of the little fi 1998 Permanent abduction of the little finger is a bothersome deformity which usually occurs in the context of sequelae of ulnar nerve palsy (Wartenberg's sign), but also in rheumatoid arthritis. The authors report an original technique for correction of this deformity. The extensor digiti minimi tendon is sectioned at its distal insertion and transferred in the wrist through the extensor retinaculum. The "rerouted" tendon is finally resutured distally on the radial aspect of the interosseous muscle. Side-to-side suture of the transferred tendon to the extensor digitorum tendon of the little finger further reinforces the solidity of the procedure. The distal insertion of the extensor digiti minimi tendon is consequently radialized. Its new direction eliminates the abduction component, and the tendon then behaves as an active adductor of the little finger. Five cases (2 cases of ulnar nerve palsy, 3 cases of rheumatoid arthritis) are reported with a mean follow-up of 19 months. All patients have complete active adduction of the little finger in extension, with a persistent capacity for abduction. The other correction techniques published in the literature are discussed.
11036834 Antibodies to AB blood group antigens mimic anti-salivary duct autoantibodies in patients 2000 Oct OBJECTIVE: We evaluated the clinical relevance and pathogenic significance of anti-salivary duct autoantibodies (ASDA) in Sjögren's syndrome (SS) and rheumatoid arthritis (RA) by examining (1) their frequency in healthy controls, patients with sicca symptoms, and patients with various autoimmune and infective disorders; (2) their localization by confocal microscopy; and (3) their tissue distribution and cross reactivity with blood group antigens. METHODS: Indirect immunofluorescence (IF) was performed on commercial cryostat sections of monkey parotid salivary gland. Sections were examined by fluorescence and confocal laser scanning microscopy. Sera giving positive staining on the ducts were tested by IF on a range of monkey tissues and salivary glands from several mammalian species. Blocking experiments were performed with human erythrocytes of different ABO blood groups and AB antigens. RESULTS: We identified 2 distinct ductal staining patterns. The first resembled ASDA described in earlier studies and showed patchy bright staining of the apical (luminal) surfaces of the ducts and staining of apical cytoplasmic vesicles. The other was only observed with anti-mitochondrial antibody positive sera and stained the mitochondrial-rich ductal epithelium in a distinctive punctate pattern. Antibodies staining the apical surface of ducts were detected rarely in patients with antiRo/La autoantibody-positive primary SS (1/76) and RA (1/36) and were found in only 1115 with RA and secondary SS. ASDA were detected in sera from 13/51 (25.5%) of patients referred to our clinic with limited sicca symptoms who were anti-Ro/La antibody-negative and had no typical clinical or laboratory features of classical primary SS. The apical ductal staining pattern was not observed with sera from 63 healthy controls without sicca symptoms or in patients with autoimmune and infective disorders. Twelve of the 13 patients whose sera gave ASDA-like staining were blood group O and one group A. Ductal staining was abolished in all sera after absorption with blood group AB erythrocytes or AB antigen. In 5 patients ductal staining was removed by absorption with B erythrocytes but not with A erythrocytes; in the remainder ductal reactivity was abolished by both A and B erythrocytes. CONCLUSION: ASDA seem to occur rarely in patients with primary SS and RA. However, isotype-switched IgG AB blood group antibodies cross react with primate salivary ducts and may produce false positive ASDA staining. Detection of ASDA may be of value in identifying a subset of patients who present with mild sicca symptoms without other autoimmune features.
9820101 [The Groningen Activity Restriction Scale (GARS) in the evaluation of severity of rheumato 1998 Apr BACKGROUND: The functional ability of the patient in chronic diseases reflects the severity of the pathological process and the success of treatment. OBJECTIVE: Evaluation of the functional ability of patients with RA and assessment of the influence of the pathological process on the performance of simple everyday tasks. METHODS: Physical capacity and functional ability were examined using the Groningen activity restriction scale (GARS) and Health Assessment Quesionnaire (HAQ). RESULTS: The authors examined 160 patients with RA (135 women and 25 men), mean age 48.3 +/- 12.13 years and a duration of the disease of 21.32 +/- 15.61 months. The mean value of the functional ability according to GARS was 32.67 +/- 11.61. Women had a poorer score (33.36 +/- 11.91) than men (28.96 +/- 9.44), the difference was however not statistically significant. The mean value of functional ability according to HAQ/FDI of the patients was 1.079 +/- 0.65. Women had a poorer score (1.156 +/- 0.625) than men (0.722 +/- 0.936), the difference being significant (P < 0.01). The authors found a significant correlation (P < 0.001) between HAQ and GARS as well as a significant relationship with parameters assessing the inflammatory activity. In GARS a relationship with the duration of the disease was found (P < 0.05), but not with HAQ. There was no significant relationship between GARS or HAQ with the patients age. In investigations of the restriction of functional ability during common everyday activities it was revealed that the greatest problem of patients is care of feet and nails, climbing stairs and personal hygiene. As to household activities the highest score was recorded for "strenuous house work" (scrubbing floors, cleaning windows and vacuum cleaning), shopping ironing and bedmaking. CONCLUSION: GARS is a reliable practical and simple scale of functional ability of patients with RA which can be used for the accurate description of the severity and for evaluation of the degree of functional ability.
10380255 Long-term cyclosporin continuation rates in rheumatoid arthritis patients. 1999 May OBJECTIVE: To evaluate the continuation rate of cyclosporin therapy in rheumatoid arthritis patients followed for at least three years. METHODS: Retrospective medical chart review of rheumatoid arthritis patients on cyclosporin. Treatment efficacy was assessed based on a visual analog scale pain score, Ritchie's articular index, and Lee's functional index. Nonparametric Kaplan-Meier survival curves were used to evaluate continuation rates. RESULTS: 24 cyclosporin-treated patients with a mean age of 58 years and a mean disease duration of ten years were included in the study; 87% had received three second-line drugs prior to cyclosporin. Mean cyclosporin treatment duration was 28 months (range, 1-103 months). Overall cyclosporin continuation rates were 75% after four months and 50% after 36 months. Toxicity and inefficacy caused 33% and 13% of cyclosporin discontinuations, respectively. CONCLUSION: The continuation rate of cyclosporin was satisfactory and similar to that reported for other second-line drugs.
11129489 Minimax D-optimal designs for the logistic model. 2000 Dec We propose an algorithm for constructing minimax D-optimal designs for the logistic model when only the ranges of the values for both parameters are assumed known. Properties of these designs are studied and compared with optimal Bayesian designs and Sitter's (1992, Biometrics, 48, 1145-1155) minimax D-optimal kk-designs. Examples of minimax D-optimal designs are presented for the logistic and power logistic models, including a dose-response design for rheumatoid arthritis patients.
11299054 Future of adenoviruses in the gene therapy of arthritis. 2001 Recombinant adenoviruses are straightforward to produce at high titres, have a promiscuous host-range, and, because of their ability to infect nondividing cells, lend themselves to in vivo gene delivery. Such advantages have led to their widespread and successful use in preclinical studies of arthritis gene therapy. While adenoviral vectors are well suited to 'proof of principle' experiments in laboratory animals, there are several barriers to their use in human studies at this time. Transient transgene expression limits their application to strategies, such as synovial ablation, which do not require extended periods of gene expression. Moreover, there are strong immunological barriers to repeat dosing. In addition, safety concerns predicate local, rather than systemic, delivery of the virus. Continued engineering of the adenoviral genome is producing vectors with improved properties, which may eventually overcome these issues. Promising avenues include the development of 'gutted' vectors encoding no endogenous viral genes and of adenovirus-AAV chimeras. Whether these will offer advantages over existing vectors, which may already provide safe, long-term gene expression following in vivo delivery, remains to be seen.
9260157 Multiple mechanisms support oligoclonal T cell expansion in rheumatoid synovitis. 1997 Jul BACKGROUND: The synovial T cell infiltrate in rheumatoid arthritis (RA) is diverse but contains clonally expanded CD4+ populations. Recent reports have emphasized that RA patients have a tendency to develop CD4+ T cell oligoclonality which also manifests in the peripheral blood. Clonal dominance in the tissue may thus result from antigen specific stimulation in the synovial membrane or may reflect the infiltration of expanded clonotypes present throughout the lymphoid system. We have explored to what extent clonal populations amongst tissue CD4+ T cells display joint specificity as defined by their restriction to the joint, their persistence over time, and their expression of markers indicative for local activation. MATERIALS AND METHODS: Matched samples of peripheral blood and synovial fluid or synovial tissue were collected from 14 patients with active RA and CD4+ IL-2R+ and CD4+ IL-2R- T cells from both compartments were purified. Clonal populations of CD4+ T cells were detected by RT-PCR amplification of T cell receptor (TCR) transcripts with BV and BJ specific primers followed by size fractionation and direct sequencing of dominant size classes of TCR transcripts. RESULTS: Clonal CD4+ T cells were detected in the synovial fluid and synovial tissue of all patients. All patients carried synovial clonotypes that were undetectable in the blood but were present in independent joints or at several non-adjacent areas of the same joint. These joint restricted CD4+ clonotypes were generally small in size, were preferentially found in the IL-2R+ subpopulation, and persisted over time. A second type of clonogenic T cells in the synovial infiltrate had an unrestricted tissue distribution and was present at similar frequencies amongst activated and nonactivated T cells in the blood and affected joints. Ubiquitous clonotypes isolated from two different patients expressed sequence homologies of the TCR beta chain. CONCLUSIONS: Two types of expanded CD4+ clonotypes contribute to the T cell infiltrate in rheumatoid synovitis. Differences in the distribution pattern and in molecular features suggest that distinct mechanisms are supporting the clonal outgrowth of these two groups of clonotypes. Clonally expanded T cells restricted to the joint but present in several independent joints appear to respond to locally residing antigens. Clonogenic cells with an unrestricted distribution pattern and widespread activation in the blood and tissue may react to a different class of antigens which appear to be shared by multiple patients. T cell recognition in RA may be involved at several different levels and may be related to more than one pathomechanism.
10917158 There is no disease-specific role for streptococci-responsive synovial T lymphocytes in th 2000 Jun The initiation or exacerbation of psoriasis vulgaris is associated with infections by group A streptococci. T lymphocytes specific for streptococcal antigens or expressing a restricted, for streptococcal superantigens typical T cell receptor Vbeta chain repertoire have been described in psoriatic skin lesions. The aim of our study was, therefore, to clarify whether streptococci-reactive T lymphocytes played a role in the pathogenesis of psoriatic arthritis (PsA), and by which antigens they might be stimulated. Synovial membrane mononuclear cells from patients with PsA and other arthropathies, separated by collagenase digestion, were expanded in interleukin-2-supplemented medium and subsequently cloned in a representative cloning procedure. The T cell lines and about 30% of the T cell clones proliferated in response to preparations of group A streptococci but not to other bacteria as tested by [3H]thymidine incorporation assays. Interestingly, they did not proliferate in response to exotoxin-negative streptococci, but did so in response to the streptococcal pyrogenic exotoxins A and C, which are known to be superantigens. Accordingly, no HLA-DR restriction was seen for the proliferative response. The remaining 70% of the established T cell clones did not react to an antigen of group A streptococci. Our results show that in patients with PsA, osteoarthritis or rheumatoid arthritis a significant number of synovial T lymphocytes were responsive to streptococcal superantigens, but not to conventional streptococcal antigens. A disease-specific role of streptococci-reactive T lymphocytes in the pathogenesis of PsA is, therefore, unlikely.
10332971 Longterm outcome of total joint arthroplasty in nonambulatory patients with rheumatoid art 1999 May OBJECTIVE: To assess the outcome of minimum 10 year followup of total joint arthroplasty (TJA) in nonambulatory patients with rheumatoid arthritis (RA). METHODS: TJA was performed in 40 nonambulatory patients with RA who satisfied the following criteria: (1) strong motivation; (2) good relationship with our medical staff; (3) no marked cervical cord lesion: (4) absence of severe systemic complications. These included 38 women and 2 men whose average age at the initiation of TJA was 58.8 years. The duration of time between loss of walking ability and surgery was 2 months to 5 years. Average hospitalization time was 4.5 months. Followup after the last surgery was 10 to 18 years. RESULTS: One year after the last surgery, 28 of the 40 patients could walk outdoors again, 11 indoors, and one was still unable to walk. By 5 years after surgery, 9 patients had died of diseases unrelated to surgery. Of the remaining 31 patients, 19 could walk outdoors, 10 indoors, and 2 could not walk. Deterioration of walking was observed in 13 patients (41.9%) compared with one year after surgery. By 10 years after surgery, 32 patients had died of diseases unrelated to surgery, 4 could walk outdoors, 4 indoors. Of these, 4 patients (50%) had worsened in walking ability compared with one or 5 years after surgery. Major complications of TJA were observed in 12 patients. These were femoral neck fractures in 3, supracondylar femoral fractures in 3, loosening of the acetabulum socket in 4, loosening of the femoral hip prosthesis in 2. CONCLUSION: TJA should be a useful treatment for restoration of walking in nonambulatory patients with RA. However, even after TJA, walking ability deteriorated in about half of the patients as the duration of followup observations exceeded 5 years.
11884114 The value of crossed intrinsic transfer after metacarpophalangeal silastic arthroplasty: a 2001 Dec Seventy three hands in patients with rheumatoid arthritis undergoing primary index to small finger metacarpophalangeal joint replacements were studied retrospectively. In twenty eight hands a crossed intrinsic transfer was performed and in forty five hands it was not. A similar splintage and rehabilitation programme was followed in each group. The two treatment groups had similar preoperative ulnar drift (crossed intrinsic transfer group mean 27 degrees, comparative group 29 degrees). At a mean follow up of 50 months the crossed intrinsic transfer group had statistically less ulnar drift (crossed intrinsic transfer group mean 6 degrees, comparative group mean 14 degrees, P=0.01). There were no other significant differences at follow up.
9779299 Serum matrix metalloproteinase-3 and fibrin degradation product levels correlate with clin 1998 Sep OBJECTIVE: Plasmin and matrix metalloproteinase-3 (MMP-3) have been linked to articular destruction in rheumatoid arthritis (RA). We compared circulating levels of plasmin-mediated fibrin degradation product (FDP D-dimer) and MMP-3 with traditional parameters of disease activity in RA to determine their clinical utility. MATERIALS AND METHODS: Serum levels of MMP-3 and D-dimer were determined by enzyme-linked immunoassays in 60 patients with RA. Twenty healthy females and 21 patients with systemic lupus erythematosus (SLE) served as controls. RESULTS: MMP-3 (436.8 +/- 474.2 ng/ml) and D-dimer levels (351.2 +/- 296.3 ng/ml) were markedly elevated in the sera from RA patients as compared with healthy controls (43.9 +/- 15.2 ng/ml and 63.0 +/- 64.1 ng/ml, p < 0.0001, respectively). Both levels strongly correlated with each other (r = 0.627, p < 0.0001) and were closely associated with various clinical parameters for the disease activity of RA, including the erythrocyte sedimentation rate (ESR) and the Lansbury's activity index (p < 0.0001). MMP-3 levels were more highly correlated with articular parameters such as the swollen and painful joint counts (r = 0.454, p = 0.0002), whereas D-dimer levels correlated well with C-reactive protein (CRP) levels (r = 0.581, p < 0.0001). In SLE patients, MMP-3 (239.1 +/- 199.6 ng/ml, p < 0.0001) and D-dimer levels (86.9 +/- 85.2 ng/ml, p = 0.0278) were also higher than in healthy controls. Both levels correlated with each other (r = 0.612, p = 0.0025), and were associated with ESR and CRP levels, as was observed in RA patients, but not with most of the other clinical indicators for SLE. CONCLUSIONS: Serum levels of MMP-3 and D-dimer are clinically useful indicators for disease activity in RA. Our results further support the hypothesis that MMP-3 and plasmin may interact in the inflammatory synovial tissues, and thus augment the articular destruction seen in RA. In SLE patients, however, MMP-3 producing cells could be different from in RA patients, and further studies will be required to clarify the pathogenetic mechanism underlying the raised serum levels of MMP-3 and/or D-dimer.
11095266 NGF, a useful tool in the treatment of chronic vasculitic ulcers in rheumatoid arthritis. 2000 Nov 18 Vasculitic necrosis and ulceration of the skin are frequent complications of connective tissue diseases and are very difficult to heal. We treated chronic vasculitic leg ulcers in rheumatoid arthritis and systemic sclerosis by topical application of nerve growth factor (NGF). In all patients with rheumatoid arthritis, NGF led to rapid healing, whereas less striking results were obtained in patients with systemic sclerosis. The efficacy of NGF could be due to its promoting activity on keratinocytes proliferation and vascular neoangiogenesis. We suggest that topical application of NGF could represent a powerful pharmacological tool for the treatment of vasculitic ulcers.
9832618 Regulation of interleukin-1beta-induced interleukin-6 gene expression in human fibroblast- 1998 Dec 1 Involvement of interleukin-6 (IL-6) in the pathogenesis of rheumatoid arthritis (RA) has recently been demonstrated. In the present study, the regulation of IL-6 gene expression by glucocorticoids and IL-1beta in fibroblast-like synoviocytes (FLSs) was investigated. Both synthetic and natural glucocorticoids, i.e., dexamethasone (DEX) and hydrocortisone (HC), respectively, concentration-dependently inhibited protein production and gene expression of IL-6 by human FLSs. The effect of DEX was dependent on de novo protein synthesis. DEX significantly reduced the rate of IL-6 gene transcription without affecting the stability of IL-6 mRNA. The IkappaBalpha pathway seemed not to be involved in DEX-mediated inhibition of IL-6 gene expression in IL-1beta-stimulated human FLSs. These findings suggest that glucocorticoids suppress IL-6 gene transcription by an as yet undefined mechanism.
11826735 Peripheral analgesic and antiinflammatory effects of opioids. 2001 Dec Traditionally, opioids were considered the prototype of centrally acting analgesics. In the past decade a substantial literature has emerged demonstrating that opioids can produce potent and clinically measurable analgesia by activation of opioid receptors on peripheral terminals of primary sensory neurons. In addition, endogenous ligands of these peripheral receptors were discovered in immune cells. Major recent findings in peripheral opioid analgesia include the relative lack of tolerance under inflammatory conditions, tetrapeptides as novel peripherally restricted compounds, the potent antiinflammatory activity of mu- and kappa-agonists and the identification of selectins as important molecules governing the homing of opioid cells to injured tissue. In addition to the extensively documented efficacy of locally applied morphine in post-surgical pain, clinical studies have now moved into the field of chronic arthritic pain.
9170374 Arthroplasty for rheumatoid forefoot deformities by a shortening oblique osteotomy. 1997 May Seventy-five feet in 47 patients (46 women, 1 man) who had rheumatoid arthritis were observed for an average of 6 years (range, 4-11 years) after an operation on the forefoot that included a shortening oblique osteotomy of the metatarsal neck of the lateral toes. In addition, patients underwent either flexible hinge toe implant arthroplasty or Mitchell's osteotomy in the first metatarsophalangeal joint. Forty-two feet (56%) looked normal with no valgus or dorsal displacement of the toes. Recurrence of callosities occurred in 9 feet (12%) with moderate pain in 3 feet. Thirty-nine (83%) patients were satisfied with the outcome after surgery. Resection arthroplasty often is recommended for management of forefoot deformities. However, as shown in this series, the improvement in deformities, function, and cosmesis of metatarsophalangeal joint preservation may be better with an osteotomy of the metatarsal neck than with a resection arthroplasty. Because of the development of combined drug therapy, the benefits of synovectomy, osteotomy, and shortening in length should be reconsidered. The authors' studies suggest that the shortening oblique osteotomy should be considered 1 of the surgical reconstruction options for patients with rheumatoid arthritis who have forefoot deformities.
11072596 Oral type II collagen in the treatment of rheumatoid arthritis. A six-month double blind p 2000 Sep OBJECTIVE: To evaluate the efficacy of oral chicken type II collagen (CII) in the treatment of rheumatoid arthritis (RA). METHODS: Sixty patients with clinically active RA of long duration (mean 7.2 +/- 5.5 years) were treated for 6 months with oral chicken CII at 0.25 mg/day (n = 31) or with placebo (n = 29) in a double-blind randomized study. RESULTS: The response rate to treatment of the collagen-treated group, based on the ACR 20% criteria, was higher than that of the control group but this difference was not statistically significant at any time. Intention-to-treat (ITT) analysis did not show statistically significant improvement in any of the several secondary outcome measures over the 6 months of the study in the collagen-treated patients in comparison with the placebo-treated group. However, in 2 collagen-treated patients we observed a clinical remission according to the criteria of the American Rheumatism Association. CONCLUSION: Our study seems to show that the oral treatment of RA patients with chicken CII is ineffective and results in only small and inconsistent benefits. Furthermore, our results raise the possibility that in a sub-group of patients oral collagen administration, usually considered devoid of harmful effects, may actually induce disease flares.