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ObjectiveMany types of treatment are available for patients with rheumatoid arthritis (RA), however, some patients fail to achieve remission. This report aims to determine the safety and efficacy of using repository corticotropin injection (RCI) as an adjunctive therapy in patients with RA refractory to at least three therapeutics with different mechanisms of action.MethodIn this open-label, interventional, single-group study, patients received 80 U RCI twice weekly via subcutaneous injection over 12 weeks. Changes in the Ritchie–Camp Articular Index and health assessment questionnaire scores were monitored for changes from baseline measures.ResultsEight patients were enrolled and consisted of seven females and one male with an average age of 64.6 years and disease duration of 20.9 years. Use of RCI resulted in significant improvement in swollen and tender joint counts. The disease activity score 28 and the physician and patient visual analog scale scores were significantly reduced at treatment week 12. The reduction in health assessment questionnaire scores did not reach statistical significance after RCI treatment. Once RCI therapy was discontinued, all improvements in disease activity score 28, physician and patient visual analog scale, and tender and swollen joint counts achieved during treatment were lost by the week 16 follow-up visit.ConclusionWhile larger clinical trials are necessary to further confirm the efficacy of RCI in patients with refractory RA, the response of patients with refractory RA in this study suggests that RCI can be an effective add-on therapy for patients who have exhausted several classes of treatments. Furthermore, this study suggests that RCI has an alternative mode of action, compared to other available antirheumatic drugs.

BackgroundAlthough there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and thus fail to achieve remission. Acthar Gel may have a potential role in enabling refractory RA patients to reach their treatment goals.ObjectivesTo assess the efficacy and safety of subcutaneous injections of Acthar Gel as adjunctive therapy in patients with active RA.MethodsThis is an ongoing, 17-week, prospective, single-center, open-label study with planned enrollment of 10 patients (≥18 years) with RA, as confirmed by a full count of 68 joints, who are currently not responding sufficiently to a biological agent and have previously inadequately responded to ≥2 biologic agents with different modes of action. Patients are administered 80 U Acthar Gel subcutaneously every 72 hours for 12 weeks, with assessments conducted at screening (Week -1), baseline (Week 0), and Weeks 2, 6, 12, 14, and 16. Primary outcome measures are tender joint count and swollen joint count (ACR Core Data Set 66/68-joint count) and 20-item Health Assessment Questionnaire (HAQ). Secondary outcome measures are acute erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels, Patient Global Visual Analogue Scale (VAS), and Physician Global VAS. Disease Activity Score for RA (DAS28) is also being calculated.ResultsSix patients (aged 54-80; 9-39 years since diagnosis of RA) have completed the trial so far. At end of treatment (Week 12), all had reductions from baseline in tender and swollen joint counts; 3 showed improvement in HAQ and 3 showed no change. Improvements in DAS28 (6 of 6 patients), ESR (4/6), CRP (4/6), and Patient (5/6) and Physician (6/6) Global VAS were also seen at end of treatment, with improvements in all measures generally receding 4 weeks post-treatment (Week 16). One patient experienced a mild skin reaction at the injection site, and 1 had hypoglycemic episodes. A third patient was hospitalized for hip pain unrelated to Acthar Gel. All resolved and no patients withdrew from treatment due to adverse events.ConclusionsIt is extremely difficult to provide effective treatment for patients with active RA who have not responded adequately to biological agents with 3 different mechanisms of action. This interim report of an ongoing trial indicates that 80 U Acthar Gel administered subcutaneously every 72 hours for 12 weeks may provide a treatment option for such patients.AcknowledgementsThis study is supported by an investigator-initiated research grant from Autoimmune and Rare Diseases Business (formerly Questcor) Mallinckrodt Pharmaceuticals.Disclosure of InterestT. Gillis Grant/research support from: received study drug and study funding from Autoimmune and Rare Diseases Business (formerly Questcor) Mallinckrodt Pharmaceuticals, M. Crane Grant/research support from: received study drug and study funding from Autoimmune and Rare Diseases Business (formerly Questcor) Mallinckrodt Pharmaceuticals, C. Hinkle Grant/research support from: received study dru...

Background: The number of people surviving critical illness is rising rapidly around the globe. Survivorship comes at a cost, with approximately half of patients with acute respiratory failure (ARF) experiencing clinically significant symptoms of anxiety, and 32–40% of survivors having substantial anxiety symptoms in the months or years after hospitalization. Methods: This feasibility study reports on 11 consecutive ARF patients receiving up to six sessions of a psychological intervention for self-management of anxiety. Results: All 11 patients accepted and received the psychological intervention. Four patients did not fully complete all 6 sessions due to death (n = 1, 2 sessions completed), and early hospital discharge (n = 3, patients completed 2, 3 and 5 sessions). The median (IQR) score (range: 0–100; minimal clinically important difference: 13) for the Visual Analog Scale-Anxiety (VAS-A) pre-intervention was 70 (57, 75) points. During the intervention, all 11 patients had a decrease in VAS-A, with a median (IQR) decrease of 44 (19, 48) points. Conclusions: This self-management intervention appears acceptable and feasible to implement among ARF patients during and after an ICU stay.

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