Background: Little is known about effectiveness of certolizumab (CTZ) in clinical practice, especially in patients with inadequate response to prior biologics. Objectives: To estimate the survival rate of CTZ in RA, PsA or SpA cohorts from the registry BIOPURE. Secondary endpoint was the changes of clinical outcomes from baseline at 6 and 12 months for each disease. Methods: We analyzed longitudinal data of consecutive patients, affected with RA, PsA or SpA starting a treatment with CTZ recorded into the web-based Apulian registry BIOPURE. Demographic and disease related characteristics were collected at baseline, 6 and 12 months. Drug survival was evaluated by Kaplan-Meier life table analysis. Estimates hazard ratios (HRs, 95% confidence intervals (CI)) of drug discontinuation adjusted for patient’s demographics, disease characteristics and prior biologic treatments were computed by Cox-regression models. Differences of DAS28, DAPSA and BASDAI among baseline, 6 and 12 months were estimated by T-test. Results: 506 patients were included in this analysis (table 1). Global mean survival time (95% CI) was 58 (52-64) months. Drug survival rate was significantly higher in RA (71.1%) than in PsA (63.5%, p=0.001), while SpA showed 67.5% (Figure 1). Naïve-CTZ patients showed higher survival rates than biologic-inadequate responder (Bio-IR) patients in PsA (naïve 78.4% vs 56.9%, p=0.02), but not in RA (76.9% vs 64.1%, p=0.08), or SpA (73.7% vs 64.8%, p=0.84). The only weak predictor of drug discontinuation was age at baseline for SpA patients (HR 1.04 (95% CI:1.005-1.007) p=0.02) (Figure 1). No baseline covariate, including sex, cDMARDs co-therapy and biologic-naïve status, was found to be associated with CTZ discontinuation for RA and PsA cohorts. A significant improvement of clinical outcomes from baseline was seen at 6 and 12 months, regardless prior biologic therapies. In RA DAS28 dropped from 3.95 ±1.5 to 2.77 ±1.3 at 6 months (p=0.0001) and 2.55 ±1.3 at 12 months (p= 0.0001). In PsA DAPSA decreased from 19.1 ±10 to 10.8 ±8 at 6 months (p=0.0001) and 9.6 ±7 at 12 months (p=0.0001). In SpA DAS28 reduced from 3.66 ±1.4 to 2.85 ±1.3 at 6 months (p=0.0001) and 2.55 ±1.1 at 12 months (p=0.0001). Additionally, in SpA BASDAI dropped from 5.3 ±1.6 to 3.8 ±2.3 at 6 months (p=0.0001) and 2.8 ±1.8 at 12 months (p=0.0001). Conclusion: In real-life settings CTZ has shown a good effectiveness also in Bio-IR patients. Unlike other TNF-inhibitors, the clinical response and the survival rate were also meaningful in RA patients. Table: RA (nr. 180) PsA (nr.189) SpA (nr.137) Age (mean ± SD) 54.5 ±12 50.6 ±12 52.0 ±11 Female 82.9 % 74.6 % 56.3 % BMI (mean) 25.9 ± 5 28.4 ± 5 26.7 ± 5 Dis Durat months (mean ± SD) 46 ± 14 106 ± 82 97 ± 92 Naive 53.9 % 32.8 % 28.5 % Prior biologics 52.9 % 75.0 % 71.1 % Glucocorticoids 55.9 % 39.7 % 39.4 % DMARDs 72.4 % 52.4 % 43.8 % DAS28 (mean ± SD) 4.8 ± 1.5 3.6 ± 1.2 3.7 ± 1.3 BASDAI (mean ± SD) 5.2 ± 2 DAPSA (mean ± SD) 19.7 ±10 HAQ (mean ± SD) 1.2 ± 0.7 1.1 ± 0.6 1.2 ± 0.7 RF/ACPA + 72.4 % Disclosure of Interests: Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Nicola Maruotti Speakers bureau: Pfizer, Angelo Semeraro Speakers bureau: Sanofi, Roche, AbbVie, BMS, MSD, Novartis, Romano Bucci Speakers bureau: Pfizer, Sanofi, MSD, BMS, Giorgio Carlino Speakers bureau: Pfizer, Janssen, AbbVie, MSD, BMS., Leonardo Santo Consultant of: AbbVie, MSD, Novartis UCB outside this work, Speakers bureau: AbbVie, MSD, Novartis UCB outside this work, Laura Quarta: None declared, Carmelo Zuccaro Consultant of: MSD, AbbVie, Novartis, Pfizer, Janssen outside this work, Speakers bureau: MSD, AbbVie, Novartis, Pfizer, Janssen outside this work, Giuseppina Santacesaria: None declared, Marco Fornaro: None declared, Francesco Paolo Cantatore: None declared

We studied the case of a male patient aged 43 affected by post-traumatic chronic osteomyelitis with frequent relapses. Having supposed an insufficiency of the arterial and venous microcirculation in perilesional bone and soft tissue we decided for a therapy with iloprost and antibacterial drugs. After 15 months of treatment the patient hasn’t showed any clinically evident relapsing episodes and we have not reported any side effects related to the therapy.

Steroid therapy is the third most common cause of osteoporosis, after loss of gonad function and senescence. The aim of the present study was to evaluate the protective action of clodronate on bone mass loss induced by steroid therapy. Sixty patients with bronchial asthma receiving either fluticasone (250 mg x 4/day) or beclomethasone (250 mg x 4/day) inhaled corticosteroid treatment were enrolled. Half the patients received combination treatment with clodronate (100 mg i.m./14 days), for a total period of 12 months. All patients were evaluated at baseline and at the end of treatment for bone mineral density (BMD) and calcium/phosphor metabolism parameters (kalemia, kaluria, phosphoremia, phosphaturia, alkaline phosphatase and hydroxyprolinuria over a 24-h period). The results of this preliminary study confirm the protective influence of clodronate on bone mass loss, as documented by the increment in mean values in BMD reported at the end of treatment compared with baseline values.

Gastrointestinal inflammation or infection can be associated with various forms of arthritis, such as, acute reactive arthritis triggered by enteritis due to gram-negative bacteria or ankylosing spondylitis and peripheral arthritis in relation to Crohn's disease and ulcerative colitis. Using colonoscopy, we have found a high prevalence of clinically silent inflammatory lesions in 38 patients (24 males and 14 females) affected by undifferentiated spondyloarthropathies (SpA). Microscopic inflammatory lesions were present in all the patients. Three patterns of nonspecific chronic inflammatory alterations were observed. No difference was noted between patients taking or not taking nonsteroidal anti-inflammatory drugs. Direct immunofluorescence demonstrated the presence of IgG, IgA, IgM, C3, C4 and fibrinogen in 75% of the specimens examined. The finding of chronic inflammatory gut lesions hypothesizes that a local activation of the immune system depending on the persistence of intestinal microbial antigens or toxins, due to impaired elimination or increased exposition, may have a part in the pathogenesis of SpA.