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Appraisal of adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis 5. The Chair welcomed invited experts: Mr Richard Bridgeman, Dr Karl Gaffney, Dr Andrew Keat, Mr Terry Orsler and Jane Skerrett, assessment group representatives: Professor Adrian Bagust, Rumona Dickson and Claire McLeod to the meeting and they introduced themselves to the Committee. The Chair asked all Committee members to declare any relevant conflicts of interest. 6.1. Professor David Barnett, Professor AE Ades, Dr Tom Aslan, Mrs Elizabeth Brain, Dr Karl Claxton, Mrs Fiona Duncan, Professor Chris Eccleston, Dr Paul Ewings, Professor John Geddes, Mr John Goulston, Dr Terry John, Professor Richard Lilford, Dr Simon Maxell, Dr Katherine Payne, Dr Ann Richardson, Mr Mike Spencer, Dr Debbie Stephenson, Mr David Thomson, Dr Luke Twelves, Dr Norman Vetter, Professor Mary Watkins, Dr Paul Watson all declared that they knew of no personal specific, personal non-specific, non-personal specific or non-personal non-specific interest for any of the technologies to be considered as part of the appraisal of adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis. FtsZ is the first non-regulatory element to appear at the septum site of bacteria, and the function of the septum has been shown to depend on correct FtsZ function.1 FtsZ is a cytosolic protein that polymerizes in a GTP-dependent manner and has been shown to be the bacterial tubulin homologue. 2 The sequence similarity between FtsZ and tubulin, however, is generally low 20% identity ; . FtsZ is a very promising target for new antimicrobial drugs because of its central role in bacterial cell division. Over the course of a 30 year programme to design synthetic inhibitors of tubulin polymerization, thousands of analogues have been prepared at the Southern Research Institute SRI ; and screened as polymerization inhibitors.3 These compounds were shown to compete with colchicine for its binding site.4 Our initial hypotheses were that this class of compounds, the 2-alkoxycarbonylaminopyridines, should inhibit M. tuberculosis FtsZ and that the low degree of sequence homology between FtsZ and tubulin was consistent with finding compounds specific for M. tuberculosis. Over 200 compounds from the SRI repository were submitted to the Tuberculosis Antimicrobial Acquisition and Coordinating Facility TAACF ; for screening, and several were found to have antimicrobial activity. We selected two of these, SRI-7614 and SRI-3072, for further study. Harlan Miller was present at the genesis of the Earl B. and Loraine H. Miller not related ; Children's Hospital - volunteering his time and business expertise. A leader in the Long Beach community, partner in a prominent insurance firm, Everett H. "Harlan" and wife Phyllis have always given back to the community, especially to its children. Both learned the value of service to others from their families. Harlan's grandfather was Chief of Staff at the old Seaside Hospital and according to Phyllis, "a good old family doctor." And that "family doctor" picked up a plot of farmland. This year, the Millers gave a portion of that plot to the Memorial Medical Center Foundation to establish The Everett H. Miller, Jr. and Phyllis L. Miller Endowment for the Child Life Program at Miller Children's Hospital. "Child Life is important to us, " says Harlan, "because it helps all the children in the hospital, regardless of their diagnosis." Child Life services are not reimbursable by insurance, so the program is dependent on philanthropic gifts and grants. The program's mission is to reduce anxiety and suffering of hospitalized children by helping them understand and cope with potentially traumatic aspects of illness and treatment. Child Life Specialists who have Bachelor's or Master's degrees in child development and undergo a rigorous internship and credentialing process ; , offer preparation for medical procedures, therapeutic play, and emotional support for children and their families. "Our primary goal is to normalize the hospital environment, " says Child Life Manager, Rita Bright. The program has five dedicated playrooms decorated with whimsical underwater motifs. "What children in the hospital need, " says Rita, "is to be able to forget that they're in the hospital." Playrooms allow hospitalized children to socialize with other children. What looks like play has serious meaning for a child. Play is the work of children, according to Rita. In therapeutic play with Child Life specialists, children rehearse what is yet to happen and reenact what has already occurred. This is their way of working through traumatic events. Rita and her team prepare children and adolescents for procedures, using tours of the actual facilities, photos, drawings and real and toy medical equipment.

Hospitalized patients with severe, active, steroid-refractory ulcerative colitis. Patients were randomly assigned to receive placebo or infliximab 5 mg kg, 10 mg kg or 20 mg kg. None of the placebo-treated patients n 3 ; responded, whereas five of eight infliximab-treated patients benefited at two weeks, with a decrease in modified Truelove and Witt's scores. Despite this report, infliximab should not be used in patients with ulcerative colitis outside the context of a clinical trial until formal, large randomized, controlled studies are completed. Uncontrolled data have shown that infliximab can be used successfully to treat Crohn's disease arising in an ileoanal pouch 22 ; . Successful treatment of pyoderma gangrenosum 23 ; , Behet's 24 ; , perineal cutaneous Crohn's disease 25 ; , and both the sponylarthropathy and peripheral arthritis associated with Crohn's disease 26 ; has been reported. DISCUSSION Infliximab has proved to be a significant advance in the therapeutic armamentarium for clinicians who treat patients with Crohn's disease. Well designed, randomized, controlled trials have demonstrated benefits in patients with moderate to severe or fistulizing Crohn's disease refractory to other therapies. Furthermore, it is the only therapeutic agent that has shown efficacy in patients with fistulizing Crohn's disease in a randomized, placebo controlled clinical trial. The rapid onset of action and associated mucosal healing are therapeutically attractive and set this agent apart from more traditional therapies such as 5-acetylsalicylic acid agents, glucocorticoids and immunomodulators. The agent should be used as adjuvant therapy in patients with moderate to severe Crohn's disease who fail to respond to or cannot tolerate other therapies, and as a first-line therapy in patients with complicated fistulizing Crohn's disease. The high drug acquisition costs associated with infliximab make patient selection an important issue. Clinicians should select patients according to the practice guidelines put forward by the Canadian Association of Gastroenterology. It is recognized that unique situations will arise that will predicate the use of infliximab outside the context of the proposed guidelines. For example, in a small group of patients, infliximab therapy may be considered as a bridge to long term immunosuppressive therapy if, in the clinical judgment of the treating physician, the patient's clinical status is likely to not improve or deteriorate while awaiting the delayed effects of immunosuppressive therapy. The selection process should include a careful history, physical and laboratory measurements to insure that the patient does not have any contraindication to therapy with infliximab. Particular attention should be paid to any evidence of active infection, history of tuberculosis or exposure to tuberculosis ; , history of malignancy, or symptoms and signs of intestinal obstruction. A careful evaluation for the presence of underlying abscess is important in patients with fistulizing Crohn's disease. Infliximab should be withCan J Gastroenterol Vol 15 No 6 June 2001 and infliximab.

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