Intravenous Infusions Of Infliximab Research Articles

Home vs Hospital Infusion of Biologic Agents for Patients With Inflammatory Bowel Diseases

Inflammatory bowel disease (IBD) therapy often requires biologic medications delivered by intravenous infusion.1-4 Historically, intravenous infusions of infliximab and vedolizumab in patients with IBD were delivered under direct supervision of clinicians in infusion centers at hospitals or clinics. Recently, intravenous infusions have transitioned into patient homes. Professional societies have differed on their recommendations for biologic home infusions (HI),5,6 yet limited data exist on the safety and efficacy of HI programs.7,8 Therefore, the primary aim of this study was to compare adverse outcomes (AOs), as defined as a composite of stopping therapy, IBD-related emergency-room (ER) visit, or IBD-related hospitalization, in patients with IBD receiving biologics as HI or at a hospital-based infusion center.

Restricted immune activation and internalisation of anti-idiotype complexes between drug and antidrug antibodies

ObjectivesTherapeutic antibodies can provoke an antidrug antibody (ADA) response, which can form soluble immune complexes with the drug in potentially high amounts. Nevertheless, ADA-associated adverse events are usually rare, although...

Long-Term Efficacy of Infliximab for Treatment of Severe Behcet’s Uveitis

Introduction: Behcet’s uveitis is a serious sight-threatening condition that may lead to blindness if not appropriately managed. The aim of the present study is to evaluate long-term effectiveness of infliximab in resistant Behcet’s uveitis. Methods: Medical records of 32 patients (56 eyes) were retrospectively analysed. Primary outcomes included ocular inflammatory activity, frequency of uveitis attacks and steroidsparing effect. Results: Mean follow-up was 33,2 months while mean age of patients at disease onset was 33,3 years. Ocular inflammation was bilateral in 75% of cases and consisted in panuveitis in 46,4 % of affected eyes. All patients received intravenous infusions of infliximab (5mg/kg) at weeks 0, 2, 4, 6 and every 6-8 weeks thereafter. Clinical remission was observed in 26 out 32 patients (81,2%). Mean number of uveitis attacks decreased from 2,56 to 0,65 during infliximab therapy (p<0.001) while systemic corticosteroids were tapered in 17 patients and suspended in 10 (31,2%). Conclusions: Our study suggested that infliximab is long-term effective in resistant Behcet uveitis, improving visual prognosis and stabilising clinical course of disease in a large cohort of patients with various pattern of BD including neuro-behcet forms.

TNF-alpha blockade may improve autonomic dysfunction in ankylosing spondylitis

The incidence of autonomic neuropathy in ankylosing spondylitis (AS) is well recognized. However, there are no studies demonstrating the therapeutic efficacy of TNF-alpha blockade in autonomic dysfunction of AS. We report here a case of a 36-year-old male of AS with high disease activity and autonomic symptoms, investigated for autonomic neuropathy. Non-invasive tests based on peripheral and cardiovascular autonomic neuropathy function were used for accurate assessment of autonomic neuropathy. The patient was treated with intravenous infusion of infliximab 5 mg/kg at weeks 0, 2, and 6. The 6 weeks therapy improved the disease activity, biomarkers of inflammation, and autonomic function. To the best of our knowledge, this is the first reported case of improvement in autonomic function associated with AS.

Combination Therapy With Infliximab and Azathioprine Is Superior to Monotherapy With Either Agent in Ulcerative Colitis

The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for ulcerative colitis (UC) have not been evaluated previously. This randomized, double-blind trial evaluated the efficacy and safety of 16 weeks of treatment with infliximab monotherapy, azathioprine monotherapy, or the 2 drugs combined in tumor necrosis factor-a antagonist-naive adults with moderate to severe UC. Patients were assigned randomly to receive intravenous infusions of infliximab 5 mg/kg at weeks 0, 2, 6, and 14 plus daily oral placebo capsules; oral azathioprine 2.5 mg/kg daily plus placebo infusions on the infliximab schedule; or combination therapy with the 2 drugs. Corticosteroid-free clinical remission (primary end point, week 16) was evaluated at weeks 8 and 16. The study was terminated before the enrollment target was reached. A total of 239 patients were included in efficacy analyses. Baseline characteristics were similar between treatment groups. Corticosteroid-free remission at week 16 was achieved by 39.7% (31 of 78) of patients receiving infliximab/azathioprine,compared with 22.1% (17 of 77) receiving infliximab alone(P =.017) and 23.7% (18 of 76) receiving azathioprine alone(P =.032). Mucosal healing at week 16 occurred in 62.8% (49 of 78) of patients receiving infliximab/azathioprine, compared with 54.6% (42 of 77) receiving infliximab (P = .295) and 36.8% (28 of 76) receiving azathioprine (P =.001). Serious infections occurred in 2 patients (1 patient receiving infliximab,and 1 patient receiving azathioprine). Anti–tumor necrosis factor-a–naive patients with moderate to severe UC treated with infliximab plus azathioprine were more likely to achieve corticosteroid-free remission at 16 weeks than those receiving either monotherapy. Combination therapy led to significantly better mucosal healing than azathioprine monotherapy. ClinicalTrials.gov number, NCT00537316.

Complications infectieuses liées au traitement par anti-TNFα : à propos de deux cas de leishmaniose

We report the cases of two patients treated with anti-TNF-alpha for uveitis. The first patient developed visceral leishmaniasis and the second cutaneous leishmaniasis. an 8-year-old girl was treated with corticosteroids and intravenous infliximab for juvenile idiopathic arthritis with bilateral anterior uveitis. After 12 months of treatment, she presented with fever, hepatosplenomegaly and thrombocytopenia. Visceral leishmaniasis was diagnosed, and she was treated successfully with parenteral liposomal Amphotericin-B (Ambisome(®)). Upon resolution, we re-instituted her treatment with infliximab. Second case: a 48-year-old man consulted us for severe panuveitis of the left eye with a serous retinal detachment. He was diagnosed with seronegative ankylosing spondylitis. His uveitis and arthritis were treated successfully with infliximab for 20 months, after which two cutaneous lesions appeared. The diagnosis of cutaneous leishmaniasis without visceral involvement was based on the presence of Leishmania in the skin scraping of a lesion. Intravenous infusions of infliximab were discontinued, and local treatment consisting of intralesional injections of meglumine antimonate salts (Glucantime(®)) was initiated, leading to rapid improvement. Anti-TNFα drugs are used frequently now. They appear promising in terms of efficacy, but one must carefully monitor patients for possible side effects, including infection.

Epidural Administration of Spinal Nerves With the Tumor Necrosis Factor-Alpha Inhibitor, Etanercept, Compared With Dexamethasone for Treatment of Sciatica in Patients With Lumbar Spinal Stenosis

Prospective randomized trial. To examine the effect of the tumor necrosis factor alpha (TNF-α) inhibitor, etanercept, on radicular pain by its epidural administration onto spinal nerves in patients with lumbar spinal stenosis. TNF-α is thought to play a crucial role in the radicular pain caused by lumbar disc herniation and spinal stenosis. Intravenous infusion of infliximab for sciatica has been examined in 2 studies; however, the results were equivocal. Eighty patients with low back and radicular leg pain were investigated. We diagnosed the patients by physical examination, and X-ray and magnetic resonance imaging. In 40 patients, we epidurally administered 2.0 mL of lidocaine and 10 mg of etanercept onto the affected spinal nerve, and 2.0 mL of lidocaine and 3.3 mg of dexamethasone was used in 40 patients. Low back pain, leg pain, and leg numbness were evaluated using a visual analogue scale (VAS) and Oswestry Disability Index (ODI) score before and for 1 month after epidural administration. Low back pain, leg pain, and leg numbness in the 2 groups were not significantly different before epidural administration. Epidural administration of etanercept was more effective than dexamethasone for leg pain (3 days, and 1, 2, and 4 weeks: P < 0.05), low back pain (3 days, and 1 and 2 weeks: P < 0.05), and leg numbness (3 days, and 1 and 2 weeks: P < 0.05). No adverse event was observed in either group. Our results indicate that epidural administration of a TNF-α inhibitor onto the spinal nerve produced pain relief, but no adverse event. TNF-α inhibitors may be useful tools for the treatment of radicular pain caused by spinal stenosis.

The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: Results of a prospective, multicenter, open-label study

In patients with psoriasis and inadequate response (IR) to tumor necrosis factor-α antagonist treatment, the incremental benefit of switching to another tumor necrosis factor-α antagonist is unknown. We sought to evaluate the clinical response to an etanercept-to-infliximab switch in patients with psoriasis and IR to etanercept. Adults with moderate-to-severe plaque psoriasis and IR to etanercept (≥ 4 months) were eligible for this open-label study (called PSUNRISE). Patients had a Physician Global Assessment (PGA) score of at least 2 (mild) on a 5-point scale with etanercept, with or without concomitant oral systemic methotrexate or cyclosporine at baseline and during the study. Patients received intravenous infusions of infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22. PGA was used to evaluate efficacy at week 10 (primary end point) and week 26 (durability). Safety was evaluated through the end of the study. Of 215 patients, only 10 received concomitant immunomodulators. At week 10, 65.4% of patients (138 of 211; 95% confidence interval 58.6%-71.8%) achieved a PGA score of clear (0) or minimal (1) (primary end point). This response was durable through week 26, at which time 61.3% (122 of 199; 95% confidence interval 54.2%-68.1%) achieved a PGA score of clear (0) or minimal (1). There were no unexpected side effects or safety concerns. This was an open-label, 26-week study; an incremental change of 1 PGA point, even mild to minimal, was considered clinically significant, as most psoriasis practitioners seek to achieve minimal psoriasis or clear skin. After switching to infliximab, a substantial proportion of patients with psoriasis and IR to etanercept experienced rapid and durable improvement.

Results of Seton Drainage and Infliximab Infusion for Complex Anal Crohn's Disease

To investigate the efficacy of infliximab for complicated perianal Crohn's disease with special reference to maintenance therapy. Between June 2002 and April 2009, 20 patients (15 men and 5 women, aged 31.4±2.9 years old (mean ± standard error)) with complicated fistulizing anal Crohn's disease underwent seton placement. For the induction therapy, intravenous infusion of infliximab was given 3 times after surgical treatment. Thereafter, infliximab was given every 8 weeks as maintenance therapy. Patients were followed-up for 31.8±4.2 months after the first infliximab infusion. The number of the infliximab treatments given was 13.6±2.5. After induction therapy, complete response (CR) was observed in 8 patients (40%), partial response (PR) in 9 and progress disease (PD) in 3. With (n=17) or without (n=3) maintenance therapy following the induction therapy, CR was observed in 15 of 20 patients (75%). Of the 17 patients who received maintenance therapy, CR was of observed in 13 patients, of whom 7 patients showed PR or PD before maintenance therapy. Seton drainage and infliximab therapy is effective in the patients with fistulizing perianal Crohn's disease. Maintenance infliximab therapy might be effective in patients with perianal Crohn's disease.

CUTANEOUS MELANOMA METASTATIC TO THE VITREOUS CAVITY

Purpose A clinical case of a postoperative sympathetic ophthalmia is presented and its response to the monoclonal antibody infliximab. Patients A 61-year-old woman. Results The treatment with prednisone, cyclosporine, azathioprine, and mycophenolate mofetil did not completely control the loss of visual acuity caused by the disease. Monthly intravenous infusions of infliximab (5 mg/kg) significantly improved the condition of the patient, allowing the cyclosporine and azathioprine to be withdrawn and the prednisone to be reduced to 10 mg/d. Conclusion The use of the immunosuppressive drug infliximab in combination with prednisone improved the prognosis of a patient suffering from sympathetic ophthalmia. The reported effectiveness of infliximab in the treatment of T lymphocyte-mediated diseases suggests that it could be used earlier in cases of sympathetic ophthalmia when treatment with corticosteroids must be shortened.

Endothelial dysfunction in ankylosing spondylitis improves after tumor necrosis factor-α blockade

Chronic inflammation in ankylosing spondylitis (AS) is associated with vascular endothelial dysfunction. Infliximab improves inflammatory disease activity in AS patients, but its effect on endothelial dysfunction has still not been tested in these patients. Twelve anti-TNF naive AS patients (mean age, 32.6 +/- 3.94 years; disease duration, 5.6 +/- 0.8 years) with high disease activity [Bath ankylosing spondylitis disease activity index (BASDAI score > 4)] despite treatment with stable doses of conventional disease modifying anti-rheumatic drugs (DMARDs) were investigated. Inflammatory disease activity [BASDAI and Bath ankylosing spondylitis functional index (BASFI) scores, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels], serum nitrite concentration, and endothelium-dependent and endothelium-independent vasodilation of the brachial artery were measured at baseline and 12 weeks of therapy after single intravenous infusion of infliximab (5 mg/kg). Previous DMARD(s) regimen remained unchanged throughout the study period. After treatment with infliximab, flow-mediated vasodilation improved from 9.81 +/- 1.70% to 26.93 +/- 2.34% (p < 0.001), whereas there was no significant change in endothelium-independent vasodilation with nitroglycerin and baseline diameter (13.65 +/- 2.10% versus 14.59 +/- 1.93%, p = 0.08, and 4.45 +/- 0.15 versus 4.46 +/- 0.15 mm, p = 0.3, respectively). Nitrite concentration reduced from 6.50 +/- 0.21 to 2.57 +/- 0.18 micromol/l (p < 0.001), ESR from 40.90 +/- 6.00 to 11.50 +/- 1.38 mm in the first hour (p < 0.001), and CRP level from 29.08 +/- 4.11 to 2.69 +/- 0.43 mg/dl (p < 0.001). BASDAI and BASFI scores were significantly reduced from 5.40 +/- 1.14 to 1.40 +/- 0.70 (p < 0.05) and 5.05 +/- 1.76 to 0.20 +/- 0.63 (p < 0.05), respectively. The study suggests that in ankylosing spondylitis, endothelial dysfunction is a part of the disease process and infliximab improves both endothelial dysfunction and inflammatory disease activity.

Seven-year follow-up of infliximab therapy in rheumatoid arthritis patients with severe long-standing refractory disease: attrition rate and evolution of disease activity

IntroductionThis study is based on the results from a Belgian expanded access program in which patients with active refractory and erosive rheumatoid arthritis (RA) were treated with intravenous infusions of infliximab in combination with methotrexate. The objectives of this study were to evaluate the continuation rate of infliximab and its clinical effect over a 7-year period and to document the reasons for discontinuation.MethodsBetween 2000 and 2001, 511 patients with severe and refractory RA were enrolled and treated with infliximab. After 7 years, apart from routine clinical follow-up, treating rheumatologists were asked to complete a questionnaire designed specifically for the present study to evaluate the current therapy with infliximab, the level of disease activity (Disease Activity Score in 28 joints [DAS28]) and the reasons for infliximab discontinuation.ResultsAfter 7 years, 160 of 511 patients (31%) were still on infliximab treatment. The major reasons for infliximab discontinuation included lack of efficacy (104 patients), adverse events (107 patients) and elective change of therapy (70 patients). The majority of cases of treatment discontinuation for safety reasons occurred during the first 2 years. In contrast, discontinuation due to ineffectiveness showed a more constant rate over the 7-year period. Mean DAS for patients still on treatment with infliximab decreased from 5.7 (standard error [SE] 0.1) at baseline to 3.0 (SE 0.1) at year 4 and remained that low until year 7 (3.0 [SE 0.1]). Low disease activity (defined as DAS28 <3.2) was present in 60.9% of patients, and 45.5% achieved remission (DAS28 <2.6). DAS28 at the time of treatment discontinuation due to ineffectiveness decreased over the 7-year period from 5.6 (SE 0.3) in 2001 to 4.8 (SE 0.3) in 2008.ConclusionsThis observational study revealed that patients who continue to receive infliximab experience sustained clinical benefit. The majority of safety issues occurred during the first 2 years of infliximab therapy. We observed that the DAS at the time of therapy discontinuation showed a trend to decrease over time.

Treatment of Refractory Ulcerative Necrobiosis Lipoidica Diabeticorum With Infliximab

Necrobiosis lipoidica diabeticorum (NLD) is a rare, granulomatous inflammatory skin disease of unknown origin, sometimes associated with diabetes mellitus. Skin lesions usually develop on the lower extremities and can progress toward ulceration and scarring. Many treatments have been proposed, but few have demonstrated consistent efficacy, and no standard regimens have emerged to date. An 84-year-old woman with type 1 diabetes mellitus presented with a 3-year history of chronic right-lower-extremity erythematous papules and plaques that had developed into confluent ulcers with prominent granulation tissue and an orange-yellow hue. The results of a biopsy of the lesion was consistent with a diagnosis of NLD. The wound did not respond to 4 months of intensive local wound care. After the first intravenous infusion of infliximab (5 mg/kg), there was rapid reduction in wound size, pain, and drainage. There was complete wound healing with excellent cosmesis at 6 weeks (total of 3 infusions). Infliximab should be considered in the treatment of refractory, ulcerative NLD. Its anti-tumor necrosis factor activity may underlie its efficacy in targeting this granulomatous process, and further investigation should be undertaken to confirm these results.

Retrospective analysis of children with uveitis treated with infliximab

Tumor necrosis factor-alpha (TNF-alpha) antagonists have been successfully used in refractory cases of pediatric uveitis.(1-7) We report our experience with the monoclonal anti-TNF-alpha antibody infliximab in the treatment of uveitis in 20 children. Twenty children with noninfectious uveitis were treated with infliximab as an initial line of immunomodulatory therapy (4 children) or for uncontrolled intraocular inflammation despite aggressive immunosuppressive therapy (16 children). Intraocular inflammation was controlled in the short term in all children; resistance developed in 4 children after long-term therapy.

Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab

Infliximab, an anti-tumor necrosis factor alpha (anti-TNFalpha) antibody, is effective in the treatment of several immunoinflammatory diseases. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial. This study was undertaken to investigate whether serologic monitoring of infliximab bioavailability and immunogenicity in individual patients would be useful in optimizing treatment regimens to improve efficacy and tolerability. To avoid the use of solid-phase assays, two radioimmunoassays were developed: one for measurement of levels of anti-infliximab antibody, and a functional one for measurement of TNFalpha binding due to infliximab. Sera from 106 randomly selected rheumatoid arthritis patients were tested within 6 months of therapy initiation, and associations between findings of serum assays and disease activity, infusion reactions, and treatment failure occurring within 18 months were assessed. Trough serum infliximab levels after the first 2 intravenous infusions of infliximab at 3 mg/kg varied considerably between patients (range 0-22 microg/ml). At this stage, only 13% of the patients were anti-infliximab antibody positive. With subsequent infusions, the frequency of antibody positivity rose to 30% and 44% (at 3 months and 6 months, respectively), accompanied by diminished trough levels of infliximab. Indeed, low infliximab levels at 1.5 months predicted antibody development and later treatment failure. There were highly significant correlations between high levels of antibodies and later dose increases, side effects, and cessation of therapy. High baseline disease activity, judged by C-reactive protein level and Disease Activity Score, was associated with low levels of infliximab at the early stage of treatment and later development of anti-infliximab antibodies. Cotreatment with methotrexate resulted in slightly reduced antibody levels after 6 months; other disease-modifying antirheumatic drugs and prednisolone had no effect. Development of anti-infliximab antibodies, heralded by low preinfusion serum infliximab levels, is associated with increased risk of infusion reaction and treatment failure. Early monitoring may help optimize dosing regimens for individual patients, diminish side effects, and prevent prolonged use of inadequate infliximab therapy.

Infliximab Therapy in Patients with Chronic Sarcoidosis and Pulmonary Involvement

Evidence suggests that tumor necrosis factor (TNF)-alpha plays an important role in the pathophysiology of sarcoidosis. To assess the efficacy of infliximab in sarcoidosis. A phase 2, multicenter, randomized, double-blind, placebo-controlled study was conducted in 138 patients with chronic pulmonary sarcoidosis. Patients were randomized to receive intravenous infusions of infliximab (3 or 5 mg/kg) or placebo at Weeks 0, 2, 6, 12, 18, and 24 and were followed through Week 52. The primary endpoint was the change from baseline to Week 24 in percent of predicted FVC. Major secondary efficacy parameters included Saint George's Respiratory Questionnaire, 6-min walk distance, Borg's CR10 dyspnea score, and the proportion of Lupus Pernio Physician's Global Assessment responders for patients with facial skin involvement. Patients in the combined infliximab groups (3 and 5 mg/kg) had a mean increase of 2.5% from baseline to Week 24 in the percent of predicted FVC, compared with no change in placebo-treated patients (p = 0.038). No significant differences between the treatment groups were observed for any of the major secondary endpoints at Week 24. Results of post hoc exploratory analyses suggested that patients with more severe disease tended to benefit more from infliximab treatment. Infliximab therapy resulted in a statistically significant improvement in % predicted FVC at Week 24. The clinical importance of this finding is not clear. The results of this Phase 2 clinical study support further evaluation of anti-TNF-alpha therapy in severe, chronic, symptomatic sarcoidosis.

Four-year follow-up of infliximab therapy in rheumatoid arthritis patients with long-standing refractory disease: attrition and long-term evolution of disease activity

Although there is strong evidence supporting the short-term efficacy and safety of anti-tumour necrosis factor-α agents, few studies have examined the long-term effects. We evaluated 511 patients with long-standing refractory rheumatoid arthritis treated with intravenous infusions of infliximab 3 mg/kg at weeks 0, 2, 6, and 14 and every 8 weeks thereafter for 4 years. Among the initial 511 patients included in the study, 479 could be evaluated; of these, 295 (61.6%) were still receiving infliximab treatment at year 4 of follow-up. The most common reasons for treatment discontinuation were lack of efficacy (65 patients, 13.6%), safety (81 patients, 16.9%), and elective change (38 patients, 7.9%). Analysis of disease activity scores (DAS28 [disease activity score based on the 28-joint count]) over time showed that, after the initial rapid improvement during the first 6 to 22 weeks of therapy, a further decrease in disease activity of 0.2 units in the DAS28 score per year was observed. DAS28 scores, measured at week 14 or 22, were found to predict subsequent discontinuation due to lack of efficacy. In conclusion, long-term maintenance therapy with infliximab 3 mg/kg is effective in producing further reductions in disease activity. Disease activity measured by the DAS28 at week 14 or 22 of infliximab therapy was the best predictor of long-term attrition.

Interleukin‐1β influences the effect of infliximab on temporomandibular joint pain in rheumatoid arthritis

Objectives: The aim of this study was to investigate the influence of plasma and synovial fluid tumour necrosis factor alpha (TNFα), interleukin‐1beta (IL‐1β), IL‐6, soluble TNF receptor II (TNF‐sRII), IL‐1 receptor antagonist (IL‐1ra), soluble IL‐1 receptor II (IL‐1sRII) and IL‐10 on the effect of the TNFα antibody infliximab on temporomandibular joint (TMJ) pain in patients with active rheumatoid arthritis (RA).Methods: Fifteen patients with TMJ pain taking methotrexate were included in the study. The effect of intravenous infusions of infliximab was assessed after 14 or 22 weeks. TMJ resting and movement pain was assessed by a visual analogue scale (VAS) (0–100 mm) and samples of venous blood and TMJ synovial fluid were collected before and after treatment.Results: The effect of infliximab on TMJ pain was influenced by pretreatment plasma levels of IL‐1β, IL‐1ra, and IL‐10 as well as pretreatment levels of TMJ synovial fluid IL‐1sRII. High pretreatment levels of these cytokines and receptors as well as the presence of rheumatoid factor (RF) were associated with no or minor reduction in TMJ pain after treatment.Conclusions: Systemic treatment of RA with a combination of infliximab and methotrexate seems to be insufficient to alleviate TMJ pain in patients with RF or high pretreatment plasma levels of IL‐1β.

Infliximab no tratamento da artrite psoriásica grave

A artrite psoriásica tem sido reconhecida como doença imunomediada, em que há participação de células T produtoras de citocinas (fator de necrose tumoral-alfa). O infliximab é anticorpo monoclonal que se liga e inativa o fator de necrose tumoral-alfa. Relata-se um caso de artrite psoriásica grave, refratária a várias terapêuticas sistêmicas, tratado com infliximab 5mg/kg, em infusão venosa de três horas, nas semanas 0, 2, 6 e 14, associado com baixa dose de metotrexato, que apresentou excelente resposta terapêutica.

Local Injection of Infliximab for the Treatment of Perianal Crohn's Disease

Perianal disease is a serious complication of Crohn's disease and its surgical management is still controversial. It has been suggested that the local injection of infliximab has resulted in some potential benefit. This pilot study analyzed the feasibility and safety of such therapy in selected patients with severe perianal Crohn's disease. The study included 15 patients with complex perianal Crohn's disease in which sepsis was not controllable using surgical and medical therapy. Among them, four had previously undergone intravenous infusion of infliximab with no significant response, nine had contraindications for intravenous infusion, and two had associated stenosing ileitis and severe coloproctitis. The injection of 15 to 21 mg of infliximab, associated with surgical treatment, was performed at the internal and external orifices and along the fistula tract. Efficacy was measured by a complete morphologic evaluation using a personal score. No major adverse effects were reported. Ten of 15 patients healed after 3 to 12 infusions. Local injection of infliximab adjacent to the fistula tract of perianal Crohn's disease is safe and may help in fistula healing. A controlled, randomized trial is required to prove the value.