In these 3 placebo-controlled trials, efficacy of ustekinumab in the treatment of axSpA was not demonstrated. The safety profile was consistent with that of studies in other indications. This article is protected by copyright. All rights reserved.

ObjectiveTo evaluate the safety and efficacy of intravenous (IV) golimumab treatment in psoriatic arthritis (PsA).MethodsIn this phase III, randomized, double‐blind, placebo‐controlled trial, patients were randomly assigned to receive IV placebo (n = 239) or golimumab at 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 14. Controlled secondary end points included change from baseline in Health Assessment Questionnaire disability index (HAQ DI) score at week 14, proportions of patients with ACR50 and ACR70 responses and ≥75% improvement on the Psoriasis Area and Severity Index (a PASI75 response) at week 14, and change from baseline at week 24 in the total modified Sharp/van der Heijde score (SHS) with modifications for patients with PsA.ResultsAt week 14, an ACR20 response was achieved by 75.1% of patients in the golimumab group compared with 21.8% of patients in the placebo group (P < 0.001). Greater proportions of golimumab‐treated patients had an ACR50 response (43.6% versus 6.3%), an ACR70 response (24.5% versus 2.1%), and a PASI75 response (59.2% versus 13.6%) at week 14 (P < 0.001 for all). Patients in the golimumab group had greater mean changes at week 14 in HAQ DI score (–0.60 versus –0.12; P < 0.001). At week 24, the mean change in total PsA‐modified SHS was –0.4 in the golimumab group and 2.0 in the placebo group (P < 0.001). Through week 24, 40.6% of patients in the placebo group and 46.3% of patients in the golimumab group had ≥1 adverse event (AE); infections were the most common type.ConclusionPatients receiving IV golimumab at 2 mg/kg had significantly greater improvements in the signs and symptoms of PsA and less radiographic progression through week 24. AEs were consistent with those seen with other anti–tumor necrosis factor agents.

Objective.To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS).Methods.In a phase III, randomized, double-blind, placebo (PBO)-controlled trial, 208 patients were randomized (1:1) to intravenous (IV) infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, 12, and every 8 weeks, or PBO (n = 103) at weeks 0, 4, and 12, with crossover to GOL at Week 16. The primary endpoint was ≥ 20% improvement from baseline in the Assessment of Spondyloarthritis International Society Criteria (ASAS20) at Week 16. Secondary endpoints included ASAS40, ≥ 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), and change in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16. Safety was monitored through Week 28.Results.Significantly greater proportions of GOL-treated patients had ASAS20 response at Week 2 (37.1% vs 19.4%; p = 0.005) and at Week 16 (73.3% vs 26.2%; p < 0.001). At Week 16, 41.0% of those receiving GOL achieved BASDAI50 compared with 14.6% of those taking PBO (p < 0.001), and the GOL group had greater mean improvement in BASFI (−2.4 vs −0.5; p < 0.001). Through Week 16, 23.3% of patients in the PBO group and 32.4% of patients in the GOL group had ≥ 1 adverse event (AE); infections being the commonest type of AE. Through Week 28, two GOL-treated patients had a serious AE.Conclusion.GOL 2 mg/kg administered IV at weeks 0, 4, and every 8 weeks significantly reduced the signs and symptoms of AS in adults. AE were consistent with other antitumor necrosis factor therapies, with no new safety signals (Clinicaltrials.gov: NCT02186873).

OROS methylphenidate, in the flexible dosage range from 36 to 108 mg/d, was well tolerated for up to 1 year in adults with ADHD.

EDITORIAL SYNOPSIS Salt and water depletion has been noted in 10 patients with long-established ileostomies. Marked renal conservation of sodium and water was present in a number of apparently healthy ileostomy patients. The sodium and potassium concentrations of ileostomy material showed little variation when these patients were in good health but there was a decrease in the sodium concentration and an increase in the potassium concentration during episodes of salt depletion. Greater attention needs to be paid to the fluid and electrolyte requirements of ileostomy patients after they have left hospital.Increased fluid and electrolyte losses are the inevitable result of an ileostomy. They are most marked during the post-operative period and continue even when normal ileostomy function is established.Fowler, Cooke, Brooke, and Cox (1959) state that the body is then well able to conserve essential fluid and electrolytes; this view is supported by two large follow-up studies by Rogers, Bargen, and Black (1954) and by Brooke (1956) who do not mention the occurrence of fluid and electrolyte disturbances. However, these disturbances are not uncommon in our experience as 10 of 60 out-patients with ileostomies who were seen in the period January 1959 to June 1961 developed symptoms of sodium and water depletion. With a view to decreasing the frequency of the latter complication we have studied fluid and electrolyte losses both in apparently healthy and in salt-depleted patients. The clinical features of the 10 patients with salt and water depletion and the results of the study will be described. CLINICAL EXPERIENCETen patients who had had either a subtotal or total colectomy with ileostomy for ulcerative colitis from one month to two years previously developed sodium and water depletion. Five of the group were admitted to hospital. Each patient had been in good health until the onset of the present illness.Acute sodium and water depletion occurred in three patients as a result of an illness suggestive of gastro-enteritis. Each patient complained of diarrhoea and vomiting; other members of one patient's family had a similar illness. One patient fainted after his ileostomy bag rapidly filled; another developed postural hypotension and was anuric for two days before admission. A third patient had marked hypotension when seen by the referring doctor and was found to be dehydrated on arrival. Rapid intravenous fluid and electrolyte replacement was necessary in two patients to restore their usual state of health.Sodium depletion developed less dramatically in seven patients, two of whom became oliguric. Three patients complained of headache, anorexia, nausea, and muscle cramps during a hot spell. Salt and water intake was increased but several days passed before a sense of well-being returned. Another three patients had symptoms of sodium depletion during episodes of transient intestinal obstruction producing colicky abdominal pain and diarrhoea. Anorexia, malaise, and muscle cramps disappeared after crushed salt tablets were...