BackgroundPure red cell aplasia is a severe, non-regenerative form of anaemia, with selective erythroid aplasia of the bone marrow. Although there are congenital forms, most cases are adquired by toxic, radiation or drugs and 50% are idiopathic.PurposeOur objective is to describe the probable relationship between the occurrence of pure red cell aplasia and the treatment with adalimumab in a patient diagnosed with Crohn´s disease.Material and methods22 years old woman who was admitted to hospital because of probably central origin anaemia secondary to adalimumab administration, over base severe iron deficiency. The variables analysed were: haemoglobin (g/dl), hematocrit (%), erythrocytes (×109/l), leukocytes (×109/l), platelets (×109/l), serum iron (μg/dl), transferrin (mg/dl) and transferrin saturation index (%).ResultsThe patient started treatment with adalimumab in November 2013 with an induction dose of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every other week. Baseline haemoglobin, erythrocytes and hematocrit were 11, 1 (norm. 12–15), 4, 18 (4–5) and 33, 8 (37–47), respectively. Concerning to iron study, baseline values of serum iron, transferrin and transferring saturation index were 22,4 (50–70), 217 (200–360) and 8, 13 (16–50), respectively. Platelets and leukocytes were in the normal range. After 5 months of treatment with adalimumab, the patient was admitted to hospital because of severe anaemia (haemoglobin = 4, 1, hematocrit = 14, 1 and erythtocytes = 2, 33), requiring stopping treatment and the administration of intravenous iron, 3 packed red blood cells and subcutaneous erythropoietin 40.000 once a week. After 5 weeks, the patient had haemoglobin values of 10.2 g/dl, showing a partial marrow recovery.ConclusionThere have been rare cases of aplastic anaemia associated with the use of tumour necrosis factor antagonists, so that, although their relationship is unclear, patients with confirmed significant hematologic abnormalities should be considered to discontinue the treatment.ReferenceKurvilla J, Leitch HA, Vickars LM, et al. Aplastic anemia following administration of a tumor necrosis factor-alfa-inhibitor. Eur J Haematol 2003;71:396–8No conflict of interest.

Background The length of treatment with triple therapy against hepatitis C virus genotype 1 (HCV-1), which comprises telaprevir, ribavirin and peginterferon α-2b, is variable, depending on the patient to be treated. Purpose To evaluate the use and effectiveness of telaprevir in HCV-1 patients according to the SPC guidelines. Materials and methods Retrospective observational study of HCV-1 mono-infected patients who started treatment with telaprevir, ribavirin and peginterferon α -2b. The follow-up period was 48 weeks. The variables analysed were: type of patient (treatment-naïve, relapsed, partial responder and non-responder), viral load (VL) at baseline, at 4, 12, 24, 36 and 48 weeks (IU/ml) and duration of treatment. For treatment-naïve and relapsed patients in which VL was undetectable at week 4 and 12, the treatment lasted 24 weeks, extending up to 48 weeks in patients with detectable VL. In the case of partial responders or non-responders, it is always 48 weeks. Furthermore, criteria for considering discontinuation were: VL >1000 (IU/ml) at weeks 4 or 12, and detectable VL at weeks 24 or 36, since it was unlikely that these patients would obtain a sustained viral response. Results A total of 17 patients were included. Of the treatment-naïve and relapsed patients (14), the treatment of 2 of them did not follow the SPC. Although both had undetectable VL at 4 and 12 weeks the treatment continued for 48 weeks. Among partial responder and non-responder patients (3), 1 did not follow SPC recommendations; treatment was suspended after 24 weeks, but VL was detectable again at week 48. Premature suspension in this case was not due to toxicity reasons. Viral load remained undetectable at week 48 in 14 of the remaining patients. Conclusions The treatment in our study did not follow SPC recommendations in 18% (3/17) of patients. Triple therapy was not effective in 1 of 3 patients who stopped at week 24 (shorter than recommended). We advise establishing a cutoff point at week 24, and evaluating the patient type (treatment-naïve/relapsed or partial responder/non-responder) before deciding to suspend treatment early, as well as determining VL at weeks 4 and 12 for correct adjustment of treatment duration. No conflict of interest.

BackgroundNivolumab is a human monoclonal antibody against the programmed death-1 receptor (PD-1) that prevents inactivation of T lymphocytes.PurposeTo assess the efficacy and safety of nivolumab in squamous non-small cell lung cancer (NSCLC).Material and methodsThis was a retrospective descriptive study of patients with squamous NSCLC who were treated with nivolumab from November 2015 to August 2016. The dose of nivolumab administered was 3 mg/kg as an intravenous infusion every 2 weeks and all patients were premedicated with granisetron 1 mg intravenously. Overall survival (OS) was considered as a measure of efficacy, obtained by the Kaplan–Meier method and defined as the time elapsed from the start of the treatment until the patient died, excluding those patients who had not died at the end of the study.Results8 patients (6 men and 2 women) were included, all with stages IIIa-b and IV, who were ex-smokers, except for 1 patient who still smoked 4 cigarettes/day. Only 1 patient had brain metastases at baseline. Mean age was 64±12 years and mean pre-nivolumab lines of chemotherapy were 2.12±1.35. Regarding the functional status of patients, 4 had an ECOG of 2 and the remaining 4 patients had an ECOG of 0 or 1. 2 patients died during the study period. Brain metastases were evidenced in 1 patient due to nivolumab progression. The other 5 patients remained stable. Median OS was 5 months (95% CI 3.56–6.43). Regarding safety profile, most patients reported asthenia, muscle weakness, loss of appetite and/or cough. However, in none of the cases did this result in suspension or delay of treatment.ConclusionThe median OS obtained in our study was lower than that published in the CheckMate 017 study (5 vs 9.2 months), with an acceptable safety profile. However, it should be considered that in our case, 4 patients had an ECOG of 2, whereas in the CheckMate 017 study all patients had an ECOG of 0 or 1 (20% and 79%, respectively) which, together with the small sample size, can justify the results obtained.References and/or acknowledgementsBrahmer J, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 2015;0:1–13.No conflict of interest

Background The addition of telaprevir to standard treatment considerably improves response rates and allows the duration of treatment to be reduced in a significant number of patients. Purpose To assess the efficacy and safety of telaprevir in combination with peginterferon alfa-2b and ribavirin (RBV) in patients with hepatitis C virus genotype 1 (HCV). Materials and Methods Retrospective observational study of patients mono-infected with HCV genotype 1, treatment-naive and pretreated, who started treatment with telaprevir. The follow-up period was 24 weeks. Relapsed patients were defined as those with undetectable viral load at the end of treatment but detectable at 24 weeks’ follow-up, partial responders as ≥2log10 decline in viral RNA at week 12 but without undetectable viral load at week 24 and null responders as <2log10 decline in viral RNA at week 12. Some of the variables were: degree of fibrosis, basal viral load, at week 4 and at week 12 (IU/ml), duration of treatment (weeks), basal dose of RBV (mg/day), basal haemoglobin at week 4 and at week 12 (mg/dl), need for blood transfusions and support with erythropoietin and skin toxicity (mild/moderate/severe). Results We included 16 patients (81.3% men and 18.8% women). 15 patients presented undetectable viral load at weeks 4 and 12, reducing the duration of treatment to 24 weeks. RBV dose was reduced in 6 patients and 2 patients started with a dose of 600 mg, in both cases without compromising treatment success. 7 patients had anaemia, of whom 2 required transfusions and erythropoietin. 12 cases had skin toxicity (8 mild, 3 moderate and 1 severe with subsequent interruption of treatment at week 4). Conclusions The data confirm those reported in the ILLUMINATE study, with high rates of rapid virological response and reduction of treatment from 48 to 24 weeks, but with a higher rate of skin toxicity although mostly mild to moderate. No conflict of interest.

(median 20 per centre). The composite indexes of physical and mental well being were correlated with each other (R=0.826; p<0.001) according to a direct proportionality, and both had an inverse correlation with the degree of EDSS disability (R=À0.511, p<0.001 and R=0.344, p<0.001, respectively). Although there was no correlation between QoL and route of administration of the drug, we found significantly lower scores for patients treated with teriflunomide compared with other oral drugs (54.24 points vs 67.64 for fingolimod and 78.25 for dimethyl-fumarate; p=0.002). Conclusion and relevance The study achieved primary and secondary endpoints and indicated a relevant decrease in QoL related to physical health associated with teriflunomide, which deserves further investigations. We also demonstrated that joint action by a scientific society and a student association was a valuable method to perform a no profit, multicentre, observational study in real practice.