Effective Treatment For Ulcerative Colitis Research Articles

P424 Economic evaluation of vedolizumab SC for the treatment of moderate-to-severe ulcerative colitis in Canada

Abstract Background Vedolizumab intravenous (IV), a gut selective humanised monoclonal antibody, is indicated for the management of moderately to severely active Ulcerative Colitis (UC) and has been shown in the only head-to-head clinical trial within UC to be superior to adalimumab (NCT02497469). Furthermore, the novel vedolizumab subcutaneous (SC) has recently been proven to be an effective treatment of UC (NCT02611830). The objective of this study is to estimate the comparative cost-effectiveness of vedolizumab IV with updated efficacy data, and vedolizumab SC for the first time. Both vedolizumab IV and SC have been compared with other publicly reimbursed biologics for the treatment of patients with moderate-to-severe UC from a Canadian public healthcare payer perspective. Methods A hybrid decision tree/Markov model was developed to simulate the clinical course of UC, translating the disease course into costs and quality-adjusted life-years (QALYs). Comparative efficacy of vedolizumab SC, vedolizumab IV, adalimumab, infliximab IV, and golimumab were sourced from a network meta-analysis. Drug and disease management costs (2019 $CAD) were sourced from Ontario public payer schedules of benefits. Utilities were sourced from the literature. Clinical and economic outcomes were projected over a lifetime and discounted at 1.5% annually. Results Within a mixed bio-naïve/experienced population, vedolizumab SC resulted in slightly more QALYs than vedolizumab IV and dominated adalimumab (Table 1); vedolizumab SC yielded an incremental cost-effectiveness ratio (ICER) of $CAD 6,727 per QALY and $CAD 52,673 per QALY relative to golimumab and to infliximab (for which the price of a biosimilar was used), respectively. Further scenario analysis within bio-naïve populations supported the robustness of the base-case results, demonstrating that vedolizumab SC or vedolizumab IV were either dominant or cost-effective across all scenarios. Conclusion Our analysis suggests that vedolizumab SC and vedolizumab IV are a cost-effective therapeutic alternative relative to other biologics for moderate-to-severe UC in Canada. Future research will expand the analysis across all biologic comparators as they are used in the real world.

DOP58 Tofacitinib for ulcerative colitis: Results of the ICC Registry, a nationwide prospective observational cohort study

Abstract Background Tofacitinib is a janus kinase 1 and 3 inhibitor approved for the treatment of ulcerative colitis (UC). Real-world evidence is needed to evaluate the effectiveness, usage and safety in daily practice. Methods UC patients in whom tofacitinib was started in 15 hospitals (8 academic, 7 non-academic) participated in the ICC Registry: a Dutch prospective, observational registry. Visits were planned at baseline, Week 12, and 24. Patients with both clinical (Short Clinical Colitis Activity Index (SCCAI) >2) and objective disease activity (endoscopy (Mayo >0), C-reactive protein (CRP) >5 mg/l or faecal calprotectin (FCP) >250 µg/g) were included. In this study, corticosteroid-free clinical remission (SCCAI ≤2), biochemical remission (FCP ≤250 µg/g), combined corticosteroid-free clinical and biochemical remission, predictors of remission, safety outcomes, dose optimisation, and effect on lipids were determined at Week 24. Only patients from centres with routine endoscopic follow-up (regardless of symptoms) were analysed to determine endoscopic remission (Mayo = 0) at Week 12. All analyses were done on an intention-to-treat basis. Results In total, 111 UC patients (95% anti-TNF, 60% vedolizumab, 4% ustekinumab exposed) were followed for a median of 24 weeks (IQR 12–26). All patients had both active clinical and objective disease (SCCAI 8 (IQR 5–11), FCP 1800µg/g (IQR 633–2682)). Corticosteroid-free clinical, biochemical, and combined corticosteroid-free clinical and biochemical remission rate at week 24 was 29%, 25%, and 19%, respectively. Endoscopic remission was achieved in 21% of patients (n = 33) at Week 12. Prior vedolizumab exposure was associated with a lower remission rate at week 24 (OR 0.33, 95% CI 0.11–0.94) in multivariable analysis. In total, 36 patients (88 per 100 patient-years) experienced tofacitinib-related adverse events (most common: cutaneous lesions and headache) of which 6 patients (18 per 100 patient-years) discontinued treatment. No thromboembolic events were reported. We observed 4 cases of herpes zoster re-activation but no severe infections (requiring hospitalisation). During follow-up 14 hospitalisations and 5 (4.5%) colectomies were performed. Cholesterol, HDL, and LDL increased between baseline and week 12 (18% (95% CI 9–26, n = 35), 18% (95% CI 8–28, n = 35) and 27% (95% CI 14–39, n = 35), respectively). At week 24, 33% of patients used 10 mg twice daily. Conclusion Tofacitinib is an effective treatment for UC after anti-TNF and/or vedolizumab failure. We did observe a relatively high rate of adverse events in this refractory UC cohort.

Formulation and evaluation of Prednisolone retention enema as dispersible tablet and vehicle for the treatment of ulcerative colitis

Ulcerative colitis is a chronic idiopathic inflammatory bowel disease that causes chronic inflammation and damage in the gastrointestinal (GI) tract that typically presents in the second or third decade of life with bloody diarrhoea and abdominal cramps. The objective of the present work was to formulate and evaluate of Prednisolone retention enema as a dispersible tablet and it is suspended in suitable vehicle for the treatment of ulcerative colitis. In the present work, an attempt has been made to formulate and evaluate Prednisolone retention enema as a dispersible tablet by using three different methods (direct compression (F1 to F3, wet granulation (F4 and F5) and slugging method (F6)). Prepared dispersible tablets were administered with the help of vehicle for the effective treatment of ulcerative colitis. Dispersible tablets were evaluated for various parameters. In vitro drug release and microbiological evaluation studies were performed to the best formulation in rectal suspension. Then the best formulation was subjected to carry out for stability studies at three different temperatures. Among the six formulations, F6 formulation showed better results. FT-IR study showed that there was no interaction between a drug and excipients. In vitro drug release and microbiological evaluation studies were performed for F6 formulation in rectal suspension. About 99.06 % of the drug was released at 60 min. and also it was found to be microbiologically stable. Results from the stability studies showed that F6 formulation alone and with rectal suspension was stable for a period of 90 days. It was concluded that F6 formulation in rectal suspension possesses a promising future for the treatment of ulcerative colitis.

Application and efficacy of solution focused brief therapy in patients with ulcerative colitis

Objective To investigate the application value of solution focused brief therapy in the caring of patients with ulcerative colitis (UC). Methods A total of 180 active UC patients were assigned into control group (90 cases) and observation group (90 cases) using random number table. The two groups were given continuous nursing. For the observation group, the patients received the intervention of solution-focused brief therapy. SF-36 Health Survey (SF-36), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and treatment efficacy rate before and after the interventions were compared between the two groups. Univariate analysis was used to determine the related factors of effective treatment of UC. Results Before the intervention, there was no significant difference in the eight scales of SF-36 between the two groups (P>0.05). After the intervention, the eight scales of SF-36, ie, physical functioning, role limitations due to physical health problems, bodily pain, vitality, general health, social functioning, role limitations due to emotional health problems, and mental health were (70.0±20.9), (72.2±16.3), (71.9±21.7), (68.7±18.2), (70.4±19.3), (69.5±20.4), (68.9±19.3), (72.6±19.7) points in the observation group, and (62.2±18.7), (66.3±18.8), (65.7±15.2), (62.6±17.4), (62.9±14.9), (63.5±14.6),(61.9±15.2), (64.1±14.5) points in the control group, and there was significant difference between the two groups (t=2.220-3.291, P 0.05). After the intervention, SASand SDS was (37.3±10.8), (36.8±10.6) points in the observation group and (41.0±11.6), (41.3±12.7) points in the control group, and there was significant difference between the two groups (t=2.215, 2.581, P<0.05). The efficacy rate was 88.9% (80/90) in the observation group, and 73.3%(66/90) in the control group, and there was significant difference between the two groups (χ2=7.420, P=0.024). Solution focused brief therapy was the related factor of effective treatment in UC patients (χ2=7.107, P=0.008). Conclusions Solution focused brief therapy could improve the quality of life, reduce anxiety and depression, and increase the treatment efficacy in patients with UC, which was an effective intervention method with clinical application value. Key words: Ulcerative colitis; Solution focused brief therapy; Anxiety; Depression

FORMULATION AND EVALUATION OF COLON TARGETED MATRIX TABLETS OF IBUPROFEN

Ulcerative colitis is a chronic condition of inflammation and ulcers in colon and rectum, the present study aim was to developed Ibuprofen colon targeted matrix tablet for the effective treatment of Ulcerative colitis. Formulation of Ibuprofen matrix tablets was prepare by using different polymers such as Eudragit S 100 and Ethyl cellulose (as carriers) in different ratios. Ibuprofen tablet were prepared by direct compression method. Based on FT-IR study drug and excipient compatibility was checked and confirmed the nil interactions. The prepared tablets were coated with an enteric polymer and were evaluated for the physicochemical parameters such as hardness, thickness, content uniformity, drug content and in vitro-drug release studies. Among the six formulation F6 showed better drug release 98.51% of Ibuprofen. The stability study was also conducted, the results showed there is no significant changes of drug content and other parameter, which make a clearance of Ibuprofen matrix tablet formulation.

Andrographolide affects Th1/Th2/Th17 responses of peripheral blood mononuclear cells from ulcerative colitis patients.

Ulcerative colitis (UC) is a chronic, idiopathic, inflammatory bowel disease of the colon. T cell responses have been associated with the pathology of UC. Andrographispaniculata (AP) extract has been previously reported as an effective treatment of UC. The present study aimed to explore the effects of andrographolide, the primary active component of AP, on the T cell responses of patients with UC. Peripheral blood mononuclear cells (PBMCs) were isolated from patients with UC and treated with various concentrations of andrographolide (0, 10, 20 and 30µg/ml). Andrographolide decreased interferon γ, interleukin (IL)‑23 and IL‑17A, however it increased IL‑4 in a dose‑dependent manner, as indicated by ELISA assay. Andrographolide treatment resulted in a decreased percentage of T helper (Th)1 and Th17 cells and an increased proportion of Th2 cells, as demonstrated by flow cytometry analysis. T‑bet (a Th1‑specific transcription factor) and RAR‑related orphan receptor γt (key transcription factor of Th17 cells) expression was decreased, but GATA‑3 (Th2 lineage‑specific transcription factor) expression was increased following andrographolide treatment as indicated by western blot analysis. These results demonstrated the inhibitory effects on Th1/Th17 responses and the promoting effects on Th2 responses of andrographolide. Experiments on IL‑23‑treated PBMCs from healthy donors revealed similar effects of andrographolide on Th1/Th2/Th17 responses. In summary, these results suggest that andrographolide may be an effective candidate for the treatment of IL‑23‑mediated diseases.

Assessing the Optimal Position for Vedolizumab in the Treatment of Ulcerative Colitis: A Simulation Model.

Vedolizumab, an α4β7 integrin monoclonal antibody inhibiting gut lymphocyte trafficking, is an effective treatment for ulcerative colitis (UC). We evaluated the optimal position of vedolizumab in the UC treatment paradigm. Using Markov modeling, we assessed multiple algorithms for the treatment of UC. The base case was a 35-year-old male with steroid-dependent moderately to severely active UC without previous immunomodulator or biologic use. The model included 4 different algorithms over 1 year, with vedolizumab use prior to: initiating azathioprine (Algorithm 1), combination therapy with infliximab and azathioprine (Algorithm 2), combination therapy with an alternative anti-tumor necrosis factor (anti-TNF) and azathioprine (Algorithm 3), and colectomy (Algorithm 4). Transition probabilities and quality-adjusted life-year (QALY) estimates were derived from the published literature. Primary analyses included simulating 100 trials of 100,000 individuals, assessing clinical outcomes, and QALYs. Sensitivity analyses employed longer time horizons and ranges for all variables. Algorithm 1 (vedolizumab use prior to all other therapies) was the preferred strategy, resulting in 8981 additional individuals in remission, 18 fewer cases of lymphoma, and 1087 fewer serious infections per 100,000 patients compared with last-line use (A4). Algorithm 1 also resulted in 0.0197 to 0.0205 more QALYs compared with other algorithms. This benefit increased with longer time horizons. Algorithm 1 was preferred in all sensitivity analyses. The model suggests that treatment algorithms positioning vedolizumab prior to other therapies should be considered for individuals with moderately to severely active steroid-dependent UC. Further prospective research is needed to confirm these simulated results.

An Observational Chart Review on the Efficacy of Subcutaneous Methotrexate in Mild to Moderate Ulcerative Colitis and the Description of Occurrence of Adenomatous Polyps in Afflicted Patients

Ulcerative Colitis (UC) is a type of Inflammatory Bowel Disease (IBD) that affects the large intestine and produces mainly symptoms of abdominal pain and bloody stools. Chart reviews of patients from July 2011 to July 2012 with mild to moderate UC enrolled in a community-based NIH trial on the efficacy of 8 weeks of 12.5 mg once daily subcutaneous methotrexate demonstrated no significant improvement of abdominal pain and bloody stools. In their patient diaries and IBD Questionnaire, all 9 patients reported a sense of heaviness or abdominal fullness, bloating or cramps. The patients experienced decreased energy levels and depressed feelings with anxiety and decreased sleep at night. Overall, the majority of them reported a decreased quality of life despite the 8 week trial of MTX. We also noted in the chart review the incidental finding of histopathologically-confirmed distal adenomatous polyps in all 9 patients for which we postulate the following: 1) that distal adenomatous polyps may be a risk factor in UC, 2) that surgical removal or polypectomy for these polyps, if diagnosed earlier especially in those younger than 40 years of age, may delay progression or prevent development of UC, 3) the presence of polyps in all 9 patients could have prevented the desired therapeutic response from methotrexate, and 4) that the presence of the polyps may indicate that low dose methotrexate is not an effective treatment for UC. The presence of intestinal polyps realigns the structural integrity and dynamics of the movement of the intestinal walls and valves, causing affected patients to frequently report feelings of discomfort and lethargy. It is important to understand that further diagnosis and therapies for UC and IBD are accompanied with ethical questions, such as treating affected patients with cytotoxic medications and performing colonoscopies under the standard age care of 50 years. Further research needs to address combination therapies and other risk factors such diets and preservatives to determine the full extent of this potential ground-breaking science.

Immunoprotective Effect of Probiotic Dahi Containing Lactobacillus acidophilus and Bifidobacterium bifidum on Dextran Sodium Sulfate-Induced Ulcerative Colitis in Mice.

In the present study, probiotic Dahi (LaBb Dahi) containing Lactobacillus acidophilus LaVK2 and Bifidobacterium bifidum BbVK3 was selected as a probiotic therapy to investigate its protective effect on dextran sodium sulfate (DSS)-induced ulcerative colitis model in mice that mimics the picture in human. LaBb Dahi was prepared by co-culturing Dahi bacteria (Lactococcus lactis ssp. cremoris NCDC-86 and Lactococcus lactis ssp. lactis biovar diacetylactis NCDC-60) along with selected strain of L. acidophilus LaVK2 and B. bifidum BbVK3 in buffalo milk (3% fat). Four groups of swiss albino male mice (12 each) were fed buffalo milk (3% fat), buffalo milk (3% fat) plus DSS, Dahi plus DSS, and LaBb Dahi plus DSS, respectively, for 17days with basal diet. The myeloperoxidase (MPO) activity, levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and interferon (IFN-γ) were assessed as inflammatory markers, and the histopathological picture of the colon of mice was studied. DSS-induced colitis appeared to induce significant increase in MPO activity, levels of TNF-α, IL-6 and IFN-γ. Feeding with LaBb Dahi offered significant reduction in MPO activity, levels of TNF-α, IL-6 and IFN-γ when compared to either buffalo milk group or group III (Dahi). The present study suggests that LaBb probiotic Dahi can be used to combat DSS-induced biochemical and histological changes and to achieve more effective treatment for ulcerative colitis.

Moxibustion for ulcerative colitis: a systematic review and meta-analysis

BackgroundComplementary and alternative medicine (CAM) is increasingly used for treatment of inflammatory bowel disease (IBD). Acupuncture-type treatments are among the most popular options. Several studies have reported that moxibustion is effective in ulcerative colitis (UC). The objective of this review was to assess the clinical evidence for or against moxibustion as a treatment for UC.MethodsWe searched the literature using 18 databases from their inception to February 10, 2010, without language restrictions. We included randomized clinical trials (RCTs), in which human patients with UC were treated with moxibustion. Studies were included if they were placebo-controlled or controlled against a drug therapy or no treatment group. The methodological quality of all RCTs was assessed using the Cochrane risk of bias.ResultsIn total, five RCTs were included. All were of low methodological quality. They compared the effects of moxibustion with conventional drug therapy. Three tested moxibustion against sulfasalazine and two against sulfasalazine plus other drugs. A meta-analysis of five RCTs showed favorable effects of moxibustion on the response rate compared to conventional drug therapy (n = 407; risk ratio = 1.24, 95% CI = 1.11 to 1.38; P < 0.0001; heterogeneity: I2 = 16%).ConclusionsCurrent evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.

Mesalamine Restores Angiogenic Balance in Experimental Ulcerative Colitis by Reducing Expression of Endostatin and Angiostatin: Novel Molecular Mechanism for Therapeutic Action of Mesalamine

Mesalamine (5-aminosalicylate acid, 5-ASA) is an effective treatment for ulcerative colitis (UC). The mechanisms of its actions are not fully understood. Because angiogenesis is critical for healing UC, we examined whether 5-ASA alters the angiogenic balance between angiogenic factors [e.g., vascular endothelial growth factor (VEGF)] and antiangiogenic factors (e.g., endostatin and angiostatin) in the colon in experimental UC. Rats were treated with saline or 5-ASA (100 mg/kg) twice daily and euthanized 3 or 7 days after iodoacetamide-induced UC. Clinical signs (e.g., lethargy, diarrhea) and UC lesions were measured. Expression of VEGF, endostatin, angiostatin, tissue necrosis factor alpha (TNF-alpha), and matrix metalloproteinases (MMPs) 2 and 9 was determined by Western blots, enzyme-linked immunosorbent assay, and zymography in the distal colon. 5-ASA treatment reduced lethargy and diarrhea and significantly decreased colonic lesions (by approximately 50%) compared with saline treatment in UC (both, P < 0.05). 5-ASA did not reverse the increased levels of VEGF, but it significantly reduced expression of endostatin and angiostatin in UC compared with vehicle treatment (both, P < 0.05). Furthermore, 5-ASA treatment significantly diminished increased activity of TNF-alpha and MMP9 in UC. This is the first demonstration that 5-ASA treatment reverses an imbalance between the angiogenic factor VEGF and antiangiogenic factors endostatin and angiostatin in experimental UC. The effect of 5-ASA in UC may be caused by the down-regulation of expression of endostatin and angiostatin by modulation of MMP2 and MMP9 via inhibition of TNFalpha. The inhibition of antiangiogenic factors may represent a novel molecular mechanism of the therapeutic action of 5-ASA.

Mucosal gene signatures to predict response to infliximab in patients with ulcerative colitis

Background and aims:Infliximab is an effective treatment for ulcerative colitis with over 60% of patients responding to treatment and up to 30% reaching remission. The mechanism of resistance to anti-tumour...

5-ASA in ulcerative colitis: Improving treatment compliance

5-Aminosalicylic acid (5-ASA) compounds are a highly effective treatment for ulcerative colitis (UC). While UC patient compliance in clinical studies is over 90%, only 40% of patients in every day life take their prescribed therapy. Adherence to medication has been emphasized recently by a Cochrane meta-analysis that has suggested that future trials of 5-ASA in UC should look at patient compliance rather than drug efficacy. Better compliance can be obtained by reducing the number of tablets and times of administration. Given that the 5-ASA formulations have different delivery systems that split the active moiety in various regions of the intestine, it is particularly important that an adequate dose of the drug arrives at the inflamed part of the colon. 5-ASA Multi matrix (MMx) is a novel, high strength (1.2 g), oral formulation designed for once-daily dosing. It releases the active moiety throughout the colon. Different studies with this compound have shown that it is as effective as 5-ASA enema in the treatment of mild-to-moderate, left-sided UC, and is comparable to a pH-dependent, delayed release 5-ASA (Asacol), even if given once daily. Recently, the effectiveness in the acute phase of UC has been confirmed also in maintenance. In conclusion, at present, 5-ASA MMx seems theoretically the best agent for maintaining patient compliance, and consequently, treatment effectiveness.

Granulocyte–monocyte apheresis for the treatment of ulcerative colitis—is this the end of the road?

The pathogenesis of ulcerative colitis involves activated granulocytes, monocytes and macrophages. Apheresis has been suggested as a safe and effective treatment for ulcerative colitis. This Practice Point commentary discusses the findings and limitations of a multicenter, randomized, sham-controlled trial by Sands and colleagues, who investigated the efficacy of leukocyte apheresis in patients with moderate-to-severe ulcerative colitis. The results of this trial show no significant difference in outcomes between sham-treated and apheresis-treated patients. Rates of clinical remission, clinical response, endoscopic remission and response, and changes in Mayo score and Quality of Life score were similar between sham-treated and apheresis-treated patients. These findings contradict the results of previous studies, and serve to emphasize the importance of performing rigorous and appropriately designed clinical trials with established end points to determine the efficacy of therapy in IBD. The same standard of rigorous evaluation must be applied to new devices as is applied to pharmaceutical products.

PPARγ agonists as a new class of effective treatment for ulcerative colitis

PPARγ agonists as a new class of effective treatment for ulcerative colitis

An experimental study on ulcerative colitis as a potential target for probiotic therapy by Lactobacillus acidophilus with or without “olsalazine”

Traditional medical treatments for ulcerative colitis (UC) are still compromised by its adverse effects and not potent enough to keep in remission for long-term periods. So, new therapies that are targeted at specific disease mechanisms have the potential to provide more effective and safe treatments for ulcerative colitis. Probiotics is recently introduced as a therapy for ulcerative colitis. In the present study, Lactobacillus acidophilus was selected as a probiotic therapy to investigate its effects in oxazolone-induced colitis model in rats that mimics the picture in human. The rats were grouped (8 rats each) as normal control group (Group I), Group II served as untreated oxazolone-induced colitis, Group III oxazolone-induced colitis treated with probiotic L. acidophilus (1 × 10 7 colony-forming units (CFU)/mL/day oral for 14 days), Group IV oxazolone-induced colitis treated with olsalazine (60 mg/kg/day oral for 14 days), Group V oxazolone-induced colitis treated with probiotic L. acidophilus and olsalazine in the same doses and duration. Disease activity index (DAI) was recorded, serum levels of C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and intrleukin-6 (IL-6) was assessed as inflammatory markers and the histopathological picture of the colon of each rat was studied. Disease activity index (DAI) showed significant positive correlation with the elevated serum levels of CRP ( r = 0.741, p < 0.05), TNF-α ( r = 0.802, p < 0.05) and IL-6 ( r = 0.801, p < 0.05). Treatment with either L. acidophilus (group III) or olsalazine (group IV) resulted in significant reduction in serum levels of CRP, TNF-α and IL-6, as well as disease activity index (DAI). Treatment with combination of L. acidophilus and olsalazine (group V) offered more significant reduction in serum levels of CRP, TNF-α, IL-6 and disease activity index (DAI) when compared to either group II (untreated group), group III (treated with L. acidophilus) or group IV (treated with olsalazine). So, it was concluded that L. acidophilus probiotic could be recommended as adjuvant therapy in combination with olsalazine to achieve more effective treatment for ulcerative colitis. For application in human, this needs to be verified in further clinical studies.

Tacrolimus for Active Ulcerative Colitis? Yes! (Even Though Cochrane Says “No”)

Tacrolimus for Active Ulcerative Colitis? Yes! (Even Though Cochrane Says “No”)

The efficacy of azathioprine for the treatment of inflammatory bowel disease: a 30 year review.

There are limited data on factors predicting response to azathioprine and uncertainty regarding the optimal duration of treatment. The notes of patients attending the Oxford IBD clinic from 1968 to 1999 were reviewed. Remission was defined as no need for oral steroids for at least three months and relapse was defined as active disease requiring steroids. A total of 622 of 2205 patients were treated with azathioprine (272 Crohn's disease, 346 ulcerative colitis, and four indeterminate colitis). Mean duration of the initial course of treatment was 634 days. The overall remission rates were 45% for Crohn's disease and 58% for ulcerative colitis. For the 424 patients who received more than six months of treatment, remission rates were 64% and 87%, respectively. Factors favouring remission were ulcerative colitis (p=0.0001), lower white blood cell (WBC) or neutrophil count (p=0.0001), higher mean cell volume (p=0.0001), and older age (p=0.05). For Crohn's disease, colonic disease favoured remission (p=0.03). Factors that were not significant were age, sex, lymphocyte count, and dose (mg/kg). The proportion of patients remaining in remission at one, three, and five years was 0.95, 0.69, and 0.55, respectively. The chance of remaining in remission was higher if WBC was less than 5 x 10(9) (p=0.03) and in male patients (p=0.01; Crohn's disease only). There was no difference in relapse rates between Crohn's disease and ulcerative colitis. After stopping azathioprine, the proportion of patients remaining in remission at one, three, and five years was 0.63, 0.44, and 0.35 (222 patients). Duration of azathioprine treatment did not affect the relapse rate after stopping treatment (p=0.68). Azathioprine is effective treatment for ulcerative colitis and Crohn's disease. The efficacy of azathioprine is reasonably well sustained over five years.

Glucocorticoid unresponsiveness in severe ulcerative colitis

See article on page 382 Although relatively little is known about the cellular and molecular immunopathology of ulcerative colitis, most would agree that it is an inflammatory disease. There is...