J Hinojosa

Publications (57)132.9 Total impact

• Article: Joint position statement by Spanish Society of Gastroenterology and Spanish Society of Pharmacology on biosimilar therapy for inflammatory bowel disease.

  F Argüelles-Arias, M Barreiro-de-Acosta, F Carballo, J Hinojosa, T Tejerina
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  ABSTRACT: Biological drugs or biopharmaceutical products, manufactured with or from living organisms using biotechnology, have represented a therapeutic revolution for the control of inflammatory bowel disease (IBD). At present, in this indication and in our country, only two biological are approved, infliximab (IFX) and adalimumab (ADA), both of them monoclonal antibodies against tumor necrosis factor alpha. Effectiveness data are strong for both therapies, with maximum levels of scientific evidence.The upcoming expiry date for these biologicals´ patents has allowed the potential marketing of so-called biosimilar agents for the IBD indication. While biosimilars are conceptually for biological what generics are for chemical drugs, the structural complexity of biosimilars and their biological and manufacturing variability lead to consider validation processes for these two types in humans as highly differential. Thus, in our setting, under the coverage of "Agencia Española del Medicamento y Productos Sanitarios (AEMPS)" (Spanish Agency of Medicines and Medical Devices), guidelines issued by the European Medicines Agency (EMA) are to be applied, which states that a number of stages or steps must be overcome in order to obtain approval for a biosimilar agent.However, despite the presence of these recommendations by EMA, which must be met by a biosimilar in order to be licensed in our marketplace, relevant uncertainties persist that only future decisions by EMA and AEMPS may clarify. The present stance by our task force is that biosimilar development should be undertaken according to established regulations, thus certifying their efficacy and safety. Similarly, this task force considers that results obtained from studies in rheumatoid arthritis (RA) should not be extrapolated to IBD since the biological variability of these complex structures will not ensure a lack of noticeable changes in efficacy and safety.
  Revista espanola de enfermedades digestivas: organo oficial de la Sociedad Espanola de Patologia Digestiva 01/2013; 105(1):37-43. · 1.55 Impact Factor
• Article: Adherence of gastroenterologists to European Crohn's and Colitis Organisation consensus on Crohn's disease: a real-life survey in Spain.

  J Hinojosa, J P Gisbert, F Gomollón, A López San Román
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  ABSTRACT: There is no information as to the extent by which Spanish gastroenterologists adhere to Crohn's disease (CD) management guidelines. The objective of this study was to evaluate the degree of adherence of Spanish gastroenterologists to the European Crohn's and Colitis Organisation (ECCO) guidelines and to determine whether differences in adherence exist between gastroenterologists specialized in inflammatory bowel diseases (GSIBDs) and general gastroenterologists (GGs). This was a prospective, nation-wide, questionnaire-based survey covering aspects related to diagnosis, treatment, follow-up, and safety considered by the physicians in their daily management of CD, as well as demographic traits seen in clinical practice. The overall degree of adherence to guidelines by both GSIBDs and GGs was high. However, the use of imaging techniques in diagnosis, follow-up, and in relapsed patients differed between the two groups. In the diagnosis of perianal disease, GSIBDs used magnetic resonance and surgical exploration under anesthesia more frequently than GGs. In terms of therapeutic choices, the adherence to guidelines was good in both groups. However, GSIBDs showed significantly higher adherence in some areas: thiopurines were used less in refractory cases and methotrexate was used more commonly in corticoid-dependent, azathioprine-intolerant patients, and in patients under biological treatment. Request for infection studies and vaccinations at diagnosis or prior to treatment was more common among GSIBDs. Guideline adherence among Spanish gastroenterologists is high. However, there are significant differences between IBD-specialized (more adherent in general) and non-specialized gastroenterologists.
  Journal of Crohn s and Colitis 01/2012; 6(7):763-70. · 2.57 Impact Factor
• Article: Infliximab salvage therapy after failure of ciclosporin in corticosteroid-refractory ulcerative colitis: a multicentre study.

  M Chaparro, P Burgueño, E Iglesias, J Panés, F Muñoz, G Bastida, L Castro, C Jiménez, J L Mendoza, M Barreiro-de Acosta, S Gómez Senent, F Gomollón, X Calvet, E García-Planella, M Gómez, V Hernández, J Hinojosa, M Mañosa, O Pérez Nyssen, J P Gisbert
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  ABSTRACT: Ciclosporin has proven to be effective in patients with corticosteroid-refractory ulcerative colitis (UC). When therapy with this drug fails, infliximab can be considered to avoid colectomy. The efficacy and safety of this sequential approach remain unknown. To assess the efficacy and safety profile of treatment with infliximab after failure of ciclosporin in patients with a corticosteroid-refractory flare of UC. Retrospective review of medical records of patients with a corticosteroid-refractory flare of UC who did not respond to ciclosporin and received salvage therapy with infliximab within a month of discontinuing ciclosporin. The severity of the flare and response to the treatment were graded using the Lichtiger index. Cumulative rates of colectomy were calculated using Kaplan-Meier analysis. Cox regression analysis was performed to identify predictors of colectomy. To evaluate the safety profile of this treatment strategy, any adverse event occurring after the first infusion of infliximab was considered. The study population comprised 47 patients with corticosteroid-refractory UC treated with infliximab after failure of ciclosporin. The median baseline Lichtiger index was 13. The mean time from the last ciclosporin dose to the first infliximab infusion was 6 days. After the first infliximab infusion, 13% of patients achieved remission, and 74% partial response. Of the 35 patients who received the third infliximab infusion, 60% achieved remission, and 37% partial response. Fourteen patients (30%) underwent colectomy. The rate of adverse events was 23%. One death occurred in a 40-year-old man who failed ciclosporin and infliximab and underwent surgery 10 days after the first infliximab infusion; he died of nosocomial pneumonia. Treatment with infliximab makes it possible to avoid colectomy in two-thirds of corticosteroid-refractory UC patients in whom ciclosporin fails. However, the rates of adverse events and mortality mean that the decision to administer sequential therapy (ciclosporin-infliximab) should be taken on an individual basis.
  Alimentary Pharmacology & Therapeutics 12/2011; 35(2):275-83. · 3.77 Impact Factor
• Article: Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry.

  J L Cabriada, E Domènech, N Ibargoyen, V Hernández, J Clofent, D Ginard, I Gutiérrez-Ibarluzea, J Hinojosa
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  ABSTRACT: Several small, prospective, open studies suggest that leukocytapheresis might be efficient in patients with steroid-dependent ulcerative colitis (UC). To evaluate the short- and long-term effectiveness of leukocytapheresis for the management of steroid-dependent UC in clinical practice. A Web-based, nationwide database specifically designed to record the efficacy and safety data of leukocytapheresis therapy in UC was available from September 2007 in Spain. Clinical data were collected at treatment baseline, 1 month after the last apheresis session (initial efficacy), and 6 and 12 months thereafter (long-term efficacy). Remission was defined as a Mayo Clinic index ≤2 together with complete steroid withdrawal and response as a decrease of ≥3 from the baseline score. A total of 142 steroid-dependent UC patients were included in the registry, most of them treated with the Adacolumn™ system. In 69% of patients thiopurine therapy failed to achieve steroid-free clinical remission. Initial clinical remission was obtained in 37% of cases. The initial corticosteroid dose, the number and frequency of apheresis sessions, or the previous failure of thiopurines and/or infliximab did not influence the initial remission rate, but a greater decrease in CRP levels was associated with a higher probability to obtain initial remission. At 6 and 12 months, 41 and 36% of patients were in clinical remission, respectively. Only one serious adverse effect was recorded. In clinical practice, apheresis allows long-term steroid-free clinical remission in up to one third of steroid-dependent UC patients, even in those with prior failure of thiopurines.
  Journal of Gastroenterology 11/2011; 47(4):359-65. · 4.16 Impact Factor
• Article: Long-term durability of response to adalimumab in Crohn's disease.

  M Chaparro, J Panés, V García, O Merino, P Nos, E Domènech, M Peñalva, E García-Planella, M Esteve, J Hinojosa, [......], J L Mendoza, J Barrio, M Barreiro-de, I Vera, P Vilar, J L Cabriada, M A Montoro, X Aldeguer, C Saro, J P Gisbert
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  ABSTRACT: Adalimumab is an effective treatment for Crohn's disease (CD), but may also be associated with loss of response. Few reports provide insight into the durability of treatment of CD with adalimumab for periods longer than 12 months in clinical practice. Aims: To evaluate the long-term durability of adalimumab maintenance treatment and to identify predictive factors associated with loss of response. CD patients who initially responded to adalimumab were evaluated in a historical cohort study. Maintenance of long-term response was estimated using Kaplan-Meier analysis. Cox regression analysis was performed to identify potential predictive factors for loss of efficacy. In all, 380 CD patients were included (mean age, 38 years; 52% female). Of these, 43% had ileocolic CD, 50% inflammatory CD, and 41% perianal CD. Median follow-up with adalimumab was 8 months (range, 4-75 months). The annual risk of loss of response to adalimumab was 18% per patient-year of follow-up. Twenty-eight percent of patients were anti-TNF-naïve and 72% anti-TNF-experienced. The loss of efficacy was 8% per patient-year of follow-up in the anti-TNF-naïve patients and 22% in the anti-TNF-experienced group (P < 0.01). In the multivariate analysis, the presence of extraintestinal manifestations (hazard ratio [HR] = 1.7; 95% confidence interval [CI] = 1.02-2.9) and previous experience with other anti-TNF agents (HR = 2.5,95% CI = 1.2-5.3) were associated with higher risk of loss of efficacy. A relevant proportion of CD patients on long-term adalimumab lost response. The risk of loss of response was higher (more than 2-fold) in anti-TNF-experienced than in anti-TNF-naïve patients (22% vs. 8% per patient-year of treatment). Having extraintestinal manifestations seems to increase the risk of loss of efficacy.
  Inflammatory Bowel Diseases 05/2011; 18(4):685-90. · 4.86 Impact Factor
• Article: Adherence of gastroenterologists to European Crohn's and Colitis Organisation consensus on ulcerative colitis: a real-life survey in Spain.

  J P Gisbert, F Gomollón, J Hinojosa, A López San Román
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  ABSTRACT: A European consensus on the management of ulcerative colitis (UC) was recently published; however, there is no adequate evidence about adherence to such guidelines among gastroenterologists. This knowledge would allow the local evaluation of the situation and the adoption of actions to reduce the existent clinical variability. A cross-sectional survey was conducted in Spain to assess the adherence to the European Crohn's and Colitis Organisation (ECCO) guidelines on mild to moderate UC. We surveyed 700 gastroenterologists, and finally a total of 530 gastroenterologists specialised in inflammatory bowel disease (GSIBDs) and general gastroenterologists (GGs), responded to the survey (76%). Agreement with the guidelines was high; discrepancies included that only 25% of the GGs used the combination of oral and topical 5-aminosalycilic acid (5-ASA) for treating extensive UC vs 45% of the GISBDs. In addition, topical rectal steroids were considered as effective as topical mesalazine by 48% of the GGs vs 31% of the GSIBDs, indefinite treatment with 5-ASA was prescribed by only 26% of the GGs vs 41% of the GSIBDs, and the once daily dosing of 5-ASA was generally used by 46% of the GGs vs 51% of the GSIBDs. The questionnaire showed a high degree of agreement between GGs and GSIBDs. Nevertheless, the GSIBD group showed closer agreement with the ECCO guidelines. Furthermore, some shortcomings were found in the GG group, in which increased maintenance treatment with 5-ASA, the use of a single daily dose of 5-ASA, and the use of combined oral and topical treatment for distal colitis should be advised.
  Journal of Crohn s and Colitis 11/2010; 4(5):567-74. · 2.57 Impact Factor
• Article: Treatment cost of ulcerative colitis is apheresis with Adacolumn cost-effective?

  J Panés, M Guilera, D Ginard, J Hinojosa, P González-Carro, V González-Lara, V Varea, E Domènech, X Badia
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  ABSTRACT: Scarce data are available in Europe on the cost of treatment for ulcerative colitis (UC). To assess the cost of illness of moderate-to-severe UC in two scenarios: traditional treatment versus alternative treatment incorporating granulocyte, monocyte adsorption - apheresis (GMA-Apheresis; Adacolumn). To determine the relative cost-effectiveness of both options in steroid-dependent patients. One-year cost-of-illness and cost-effectiveness analysis from the third-payer perspective using a decision tree model was carried out. Probabilities of each event were derived from the literature and an expert panel. Direct medical costs were obtained from official sources (euro2004). Effectiveness was measured by the proportion of patients achieving clinical remission. The average annual cost per patient treated with traditional treatment was estimated to be euro6740; with GMA-Apheresis, the cost was estimated to be euro6959. In steroid-dependent patients, the average annual cost was euro6059 and euro11,436, respectively. The proportion of patients achieving clinical remission with GMA-Apheresis was 22.5% higher. As second- and third-line therapy, a new course of corticosteroids and surgery was avoided in 18.5 and 4% of patients, respectively. Incorporating GMA-Apheresis (Adacolumn) in the therapeutic management of moderate-to-severe UC patients is cost-effective and implies savings related to the reduction of adverse effects derived from corticosteroid use and to the decreased number of surgical interventions.
  Digestive and Liver Disease 08/2007; 39(7):617-25. · 3.05 Impact Factor
• Article: Efficacy and safety of short-term adalimumab treatment in patients with active Crohn's disease who lost response or showed intolerance to infliximab: a prospective, open-label, multicentre trial.

  J Hinojosa, F Gomollón, S García, G Bastida, J L Cabriada, C Saro, D Ceballos, M Peñate, M A Gassull
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  ABSTRACT: The use of tumour necrosis factor antagonists has changed the therapeutic approach to Crohn's disease. To determine response and remission rates associated with the 4-week induction phase of adalimumab treatment in patients with luminal and/or fistulizing Crohn's disease, who have lost response to or become intolerant of infliximab. In this multicentre, prospective, open-label, observational, 52-week study, 50 adults received an induction dose of adalimumab (160 mg at baseline followed by 80 mg at week 2). Of the 36 patients with luminal Crohn's disease, 83% achieved clinical response [> or =70-point reduction in the Crohn's Disease Activity Index (CDAI) score] and 42% achieved clinical remission (CDAI score <150) at week 4. Of the 22 patients with fistulizing disease, five (23%) experienced fistula remission (complete closure of all fistulas that were draining at baseline), and nine (41%) experienced fistula improvement (> or =50% decrease in the number of fistulas that were draining at baseline) at week 4. Of the 19 adverse events, most [13 (68%)] were mild, and no serious or infectious adverse events occurred. Adalimumab may be an effective alternative in patients with luminal and/or fistulizing Crohn's disease who have lost response to or become intolerant of infliximab.
  Alimentary Pharmacology & Therapeutics 02/2007; 25(4):409-18. · 3.77 Impact Factor
• Article: [Consensus document on the use of granulocytapheresis in patients with inflammatory bowel disease].

  J L Cabriada, E Doménech, F Gomollón, P González-Carro, V González-Lara, J Hinojosa, C E Jiménez-López, P Nos, A Obrador, J Panès, C Saro, V Varea, R Lafuente, M Guilera
  Gastroenterología y Hepatología 03/2006; 29(2):85-92. · 0.73 Impact Factor
• Article: [Cyclosporine in ulcerative colitis flares].

  P Nos, J Hinojosa
  Gastroenterología y Hepatología 01/2006; 28(10):629-31. · 0.73 Impact Factor
• Article: Clinical evolution of luminal and perianal Crohn's disease after inducing remission with infliximab: how long should patients be treated?

  E Domènech, J Hinojosa, P Nos, E Garcia-Planella, E Cabré, I Bernal, M A Gassull
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  ABSTRACT: Few data are available regarding the evolution of Crohn's disease after discontinuing a successful course of infliximab. To evaluate clinical outcome of Crohn's disease after induction of remission with three infliximab infusions (luminal disease) and after maintenance of remission with 1-year course of infliximab every 8 weeks (luminal and perianal). Twenty-three patients with active luminal Crohn's disease who responded to three infusions of infliximab (0, 2, and 6 weeks), and 23 patients with sustained response to infliximab every 8 weeks during 1 year, were included. Patients were followed-up until relapse or for at least 6 months after infliximab discontinuation. Clinical outcomes and factors associated to relapse were evaluated. In luminal Crohn's disease, a three-infusion infliximab regimen achieved a sustained response in most patients, especially if a complete response occurred at the time of the third infusion. In patients treated for 1-year, infliximab discontinuation was also successful, with a cumulative probability of being free of relapse of 69% at 12 months. In perianal disease, early relapse was the rule after stopping infliximab treatment, with only 34% of patient maintaining remission at 1 year. Short regimens of infliximab might be evaluated in patients with luminal Crohn's disease. However, infliximab discontinuation is not recommended in perianal Crohn's disease, because of a high rate of early relapse.
  Alimentary Pharmacology & Therapeutics 01/2006; 22(11-12):1107-13. · 3.77 Impact Factor
• Article: [GETECCU-2005 recommendations for the use of infliximab (Remicade) in inflammatory bowel disease].

  E Domènech, M Esteve, F Gomollón, J Hinojosa, J Panés, A Obrador, M A Gassull
  Gastroenterología y Hepatología 04/2005; 28(3):126-34. · 0.73 Impact Factor
• Article: Granulocyteaphaeresis in steroid-dependent inflammatory bowel disease: a prospective, open, pilot study.

  E Domènech, J Hinojosa, M Esteve-Comas, F Gomollón, J M Herrera, G Bastida, A Obrador, R Ruiz, C Saro, M A Gassull
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  ABSTRACT: Uncontrolled studies suggest that granulocyteaphaeresis might be useful in the management of active ulcerative colitis. To assess the efficacy of granulocyteaphaeresis treatment in active steroid-dependent inflammatory bowel disease. We conducted a multicentre, prospective, open, pilot study in patients with steroid-dependent inflammatory bowel disease. All patients were started on 60 mg/day of prednisone; after 1 week, a five-session programme of granulocyteaphaeresis (once per week) was started. The steroid dose was tapered weekly if there was clinical improvement. Remission was defined as an inactive clinical activity index together with complete withdrawal of steroids at week 6. The patients were followed up for at least 6 months or until disease relapse. Twenty-six patients (14 ulcerative colitis, 12 Crohn's disease) were included. More than a half had been previously treated with immunomodulators. Remission was achieved in 62 and 70% of ulcerative colitis and Crohn's disease, respectively. During a median follow-up of 12.6 months, six of eight ulcerative colitis patients maintained their clinical remission; however, only one Crohn's disease patient remained in remission after the first 6 months of follow-up. Granulocyteaphaeresis is a safe treatment option in inflammatory bowel disease. A five-session programme of granulocyteaphaeresis seems to be efficient in the treatment of steroid-dependent ulcerative colitis, but not in Crohn's disease.
  Alimentary Pharmacology & Therapeutics 01/2005; 20(11-12):1347-52. · 3.77 Impact Factor
• Article: [Incidence and prevalence of autoimmune hepatitis in the area of the Hospital de Sagunto (Spain)].

  J Primo, C Merino, J Fernández, J R Molés, P Llorca, J Hinojosa
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  ABSTRACT: Thirteen cases of autoimmune hepatitis (AIH) were diagnosed from 1990 to 2003 in the area of the Hospital de Sagunto (Valencia, Spain), which attends a population of 112,003 inhabitants aged more than 14 years (54,622 males and 57,381 females). The diagnostic criteria of the International Autoimmune Hepatitis Group were used and patients who, despite having a probable diagnosis of AIH, presented hepatitis C virus infection were excluded. The diagnosis was probable in one patient and definitive in 12. All patients, 11 females and two males aged 45.9 12.2 years (range: 28-66), were classified as AIH type 1. Among the population aged more than 14 years, the mean annual incidence of AIH was 0.83 cases/100,000 inhabitants (95% CI, 0.44-1.42) (range: 0-2.68), showing a significant trend to increase (b = 0.132; p = 0.019). The incidence was higher in women than in men (RR = 5.24; 95% CI, 1.16-23.62). The mean annual incidence was 1.37 (95% CI, 0.68-2.46) (range: 0-3,49) in women and was 0.26 (95% CI, 0.02-0.96) (range: 0-1.83) in men. By age, the maximum mean annual incidence was observed in the group aged 55-64 years (1.6 cases/100,000 inhabitants). The prevalence of AIH in September 2003 was 11.61 cases/100,000 inhabitants aged more than 14 years (95% CI, 6.78-19.86). The prevalence was 3.66 (95% CI, 1-13.35) in men and was 19.17 (95% CI, 10.70-34.33) in women.
  Gastroenterología y Hepatología 05/2004; 27(4):239-43. · 0.73 Impact Factor
• Article: [Plastic linitis as a manifestation of metastases from breast cancer].

  J R Molés, J Primo, J Hinojosa, J Fernández, A Lluch
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  ABSTRACT: We present the case of a woman of 48 years old, with a gastric metastases from breast lobular carcinoma that was operated eight years ago, being free of illness until today. The symptoms who presented her were totally inespecific and the diagnostic techniques of image realized were compatible with the diagnostic of plastic linitis. The histological findings of biopsy and hormonals receptors study confirmed the diagnostic of gastric metastases of primary breast carcinoma after a comparative study with the initial surgical piece. After starting hormonal and cistostatic treatment, the patient presented a partial improvement of her symptomatology with a survival that exceeds ten months. The gastric metastases of lobular carcinoma are not so infrequent as it was believed, and its diagnostic require a high index of suspicion, given the inespecifity of symptomatology that it used to present.
  Gastroenterología y Hepatología 12/2002; 25(9):549-51. · 0.73 Impact Factor
• Article: [Recommendations for the use of infliximab (Remicade) in Crohn's disease. GETECCU 2001].

  E Domènech, M Esteve-Comas, F Gomollón, J Hinojosa, A Obrador, J Panés, M A Gassull
  Gastroenterología y Hepatología 04/2002; 25(3):162-9. · 0.73 Impact Factor
• Article: Evolutive pattern in Crohn's disease: a simplified index using clinical parameters predicts obstructive behaviour.

  J Hinojosa, P Nos, J J Ramírez, M Hoyos, J R Molés, J Ponce, J Berenguer
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  ABSTRACT: Two clearly differentiated evolutive patterns of Crohn's disease, obstructive and fistulizing, exist, but the early clinical parameters which can predict the evolution are unknown. To evaluate whether clinical variables, present at the time of diagnosis, may help in predicting a subsequent evolutive behaviour. Ninety out of 140 evaluable patients were included. After a median of 50.2 months since diagnosis, 64 patients (71%) followed an obstructive pattern while 26 patients (28.9%) had a fistulizing form. Clinical variables were analysed as predictors of outcome. Logistic regression was carried out in order to obtain a mathematical model that would predict the evolution. The individual ability of the mathematical model to predict evolution was assessed using relative receiver operating characteristic (ROC) curves. The variables which were retained in the model were duration of disease before diagnosis (DD), onset of symptoms (OS), presence of anal disease (AD) and the presence of abdominal mass (AM). The equation z = -9.49 + 2.2643 (AD) - 0.0066 (DD) + 2.5282 (AM) + 1.3433 (OS) was obtained. The probability of evolution towards an obstructive form was P = 1/(1 + e(-Z)). This model can predict 96.88% of obstructive forms but only 53.85% of fistulizing forms. The mathematical point section (ROC curve) corresponds to a probability of 45.2%. Considering an obstructive pattern when the probabilities are above this point, the sensitivity is 98% and the specificity is 50%. The prediction of an obstructive pattern is feasible using simple clinical variables. The mathematical model obtained is useful for predicting this but not the fistulizing pattern.
  European Journal of Gastroenterology & Hepatology 04/2001; 13(3):245-9. · 1.76 Impact Factor
• Article: [Budesonide in inflammatory bowel disease: a meta-analysis].

  P Nos, J Hinojosa, F Gomollón, J Ponce
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  ABSTRACT: Budesonide is a synthetic glucocorticoid used in the Crohns's disease (CD) and ulcerative colitis (UC). The aim of the study was to evaluate its efficacy in inducing and maintaining remission of CD in oral administration and in inducing endoscopic and histologic remission in distal UC when was given as enema. Systematic review of controlled clinical trials was made and meta-analysis were performed using the Peto method. Eight studies provided data regarding CD (4 in induction of remission and 4 in maintenance therapy) and 4 regarding UC. CD-inducing remission: in total 560 patients were involved; 280 received 9 mg/d of budesonide and 280 received 40-46 mg/d of prednisolone. Clinical remission was similar in both groups [0.76 (0.54-1.06)] [0R (CI 95%)] and adverse events were more frequent in patients treated with prednisolone [0.42 (0.30-0.58)]. Plasma cortisol was evaluated in 292 patients (146 each group); values were significantly lower in prednisolone group [0.32 (0.20-0.50)]. CD-maintaining remission: in total 449 patients were enrolled; 174 and 90 received 3 mg/d or 6 mg/d of budesonide respectively and 185 received placebo. There were not significant differences between placebo and budesonide 3 mg/d [1.04 (0.56-1.92)]. Budesonide 6 mg/d was also similar to placebo group [0.91 (0.59-1.39)]. UC: 325 patients were included, 156 received budesonide and 169 were given conventional glucocorticoids. No significant differences were found between both groups in endoscopic remission rates [1.15 (0.71-1.88)]. Budesonide is as useful as prednisolone in treatment of active CD and it has a lower impact in serum cortisol levels. Nevertheless, at evaluated dose, it is not useful for maintenance therapy. In UC is as effective as conventional glucocorticoids.
  Medicina Clínica 02/2001; 116(2):47-53. · 1.38 Impact Factor
• Article: [Azathioprine and 5-ASA in the prevention of postoperative recurrence of Crohn's disease].

  P Nos, J Hinojosa, V Aguilera, J R Molés, M Pastor, J Ponce, J Berenguer
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  ABSTRACT: Recurrence of Crohn's disease (CD) lesions in the neo-ileum after apparently curative resection frequently occurs after surgery. The most appropriate prophylactic treatment has not been clearly defined. This study evaluated the efficacy of 5-ASA and azathioprine in decreasing postoperative recurrence and analysed the presence of variables associated with recurrence. Thirty-nine patients (mean age 32.8 years, range 18-61) with a history of ileal or ileocecal surgical resection were studied. They received 5-ASA (3 mg/day) or azathioprine (50 mg/day) immediately after the operation and for 2 years thereafter. Patients were followed clinically (Crohn's disease activity index) and serologically every 3 months and by imaging methods every 6 months. The latter included colonoscopy with ileoscopy and if not available, small bowel barium or ultrasonographic study. Laboratory tests included ESR, C-reactive protein, white blood cell and platelet count, fibrinogen and albumin. The end-point evaluated included clinical recurrence (CR), serological recurrence (SR: alteration of at least three of the above-mentioned variables) and morphologic recurrence (MR: endoscopic recurrence > 1 according to Rutgeerts score or radiological or ultrasonographic recurrence). Eighteen patients received azathioprine and 21 received 5-ASA. Thirty-four patients were evaluated. The cumulative proportion of patients with recurrence was 29% (CR), 35% (SR) and 50% (MR). Statistical analysis did not show significant differences between the two groups. Twenty-seven patients completed the 2-year study (11 in the azathioprine group and 16 in the 5-ASA group). Crude relapse rates were 37% (CR), 44% (SR) and 69% (MR) in the 5-ASA group and 36% (CR), 45% (SR) and 64% (MR) in the azathioprine group. No statistically significant differences were observed between groups. No variables associated with recurrence were detected. In conclusion, treatment does not prevent a high percentage of postsurgical recurrence. 5-ASA (3 g/day) and azathioprine (50 mg/day) showed similar efficacy in the prevention of recurrence.
  Gastroenterología y Hepatología 11/2000; 23(8):374-8. · 0.73 Impact Factor
• Article: Comparison of heparin and steroids in the treatment of moderate and severe ulcerative colitis.

  J Panés, M Esteve, E Cabré, J Hinojosa, M Andreu, M Sans, F Fernandez-Bañares, F Feu, M A Gassull, J M Piqué
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  ABSTRACT: Unfractionated heparin has been found to reduce symptoms and improve healing as adjuvant therapy in patients with ulcerative colitis. The current study evaluated the efficacy and safety of unfractionated heparin in the treatment of ulcerative colitis in comparison with methylprednisolone. A multicenter randomized trial with blinded endpoint evaluation was conducted in patients hospitalized for moderate or severe ulcerative colitis. Patients were randomized to receive heparin as a continuous infusion or methylprednisolone (0.75-1 mg x kg(-1) x day(-1)). Twenty-five patients entered the study: 13 received methylprednisolone and 12 received heparin. By day 10, 69% of patients in the methylprednisolone group, but none in the heparin group, achieved significant improvement or remission. C-reactive protein levels significantly decreased in the methylprednisolone group but not in the heparin group. Three patients in the heparin group were withdrawn before day 10 because of an adverse event: rectal bleeding needing transfusion (2 cases) or surgery (1 case). The proportion of patients with persistent rectal bleeding at day 10 was 31% in the methylprednisolone group and 90% in the heparin group (P<0.05). Unfractionated heparin as monotherapy is not effective in the treatment of moderate or severe ulcerative colitis and is associated with significant bleeding complications.
  Gastroenterology 10/2000; 119(4):903-8. · 11.68 Impact Factor