A multicentre, double-blind, randomised, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (123 patients, 100 mg twice daily) in comparison to piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with osteoarthritis of the knee. The treatment period of two months was preceded by a washout period of one week duration. On completion of the study, patients in both aceclofenac and piroxicam-treated groups exhibited significant improvement in pain intensity and functional capacity of the affected knee, as represented by the Osteoarthritis Severity Index (OSI) (p < 0.0001 and p < 0.001 respectively). This was further substantiated following the patient's assessment of pain intensity using the Visual Analogue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p < 0.001). Although both treatment groups showed a significant improvement in all investigator's clinical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between the groups. There was, however, a more rapid improvement in knee flexion in the aceclofenac group after 15 days of treatment. Both aceclofenac and piroxicam were well tolerated by patients, the most commonly reported adverse events being gastrointestinal, although their incidence was low. Only 24 patients on aceclofenac, as opposed to 33 on piroxicam complained of dyspepsia, epigastralgia and pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patient with piroxicam was withdrawn because of severe upper gastrointestinal bleeding. Twice as many reports of fecal blood loss were made in the piroxicam group in comparison to the aceclofenac group. In summary, this study confirms the therapeutic efficacy of aceclofenac and suggests that it is a well-tolerated alternative NSAID to piroxicam in the treatment of osteoarthritis.

Eighty-five men with 92 vascular grafts placed for peripheral vascular disease of the lower extremity underwent a total of 264 examinations with duplex Doppler over a 2.5-year period. In 64 patients who underwent more than one examination, the total follow-up encompassed 740 months. In 220 native femoral arteries (96.0%) the peak systolic velocity (PSV) was higher than that in the graft. Arteriovenous shunting was associated with a normal PSV and a markedly elevated diastolic component at spectral analysis. Focal fluid collections were common initially near the graft and usually disappeared uneventfully. An average PSV of 32 cm/sec or less was always associated with impending occlusion. The sensitivity of an average PSV of 40 cm/sec or less to indicate impending graft occlusion by the next visit was only 33%; the specificity, 94%. At initial examination, stenoses were associated with high PSV focally in the graft or low PSV with absent diastolic flow.

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Background:Biosimilar drugs has supposed a huge savings in our health systems and there are data that conclude that they work as original molecules when we making these switchings. There are limited studies that analize these patients across the time (1-3).Objectives:Long term follow up of patients after switching from original etanercept to biosimilar drug.Methods:We reviewed 187 patients who started Etanercept original in Rheumatology department at Navarra Hospital Complex and their switch to Etanercept biosimilar with a follow-up of 18 months.Results:The switch was performed in 176 patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA).At 18 months of follow-up 26,1% discontinued treatment; 13% at 6 months, 9,1% at 12 months and 4% patients at 18 months. The median time in etanercept original drug before switching was 52 months.There were 46 withdrawal patients with etanercept biosimilar: 34 inefficacy, 3 skin reaction, 2 malignancies (lymphoma and GIST), 1 injection site reaction, 1 headache, 1 diarrhea, 1 recurrent urinary infection, 1 heart failure and 2 deaths. 25 patients returned to Etanercept original but 3 did not achieve good response; all of them in RA group.Conclusion:In our series 50 % of withdrawal happened at 6 months of follow-up. 73,9% had a good response with etanercept biosimilar at 18 months. The main reason to stop biosimilar drug was inefficacy.Longer-term follow-up and greater number of patients are necessary to ratify these data.References:[1]Selmi C, et al. BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis. Clin Exp Rheumatol. 2020 Jun 30. Epub ahead of print.[2]Glintborg B, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019 Feb;78(2):192-200.[3]Tweehuysen L, et al. Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study. Arthritis Rheumatol. 2018 Sep;70(9):1408-1418.Table 1.WITHDRAWAL (months)BACK TO ENBREL (n)CONTINUEENBREL (n)TIME TO SWITCH (months)REASON FOR WITHDRAWALInefficacyA.event*CancerDeathRA2211853 14521PsA166653,515001SpA888455300TOTAL4625225234822*Infections (1), Heart failure (1), skin reaction (3), injection point reaction (1)RA: rheumatoid arthritis; PsA: psoriatic artrhritis; SpA: spondyloarthritisDisclosure of Interests:None declared