ObjectiveTo evaluate patient perspectives regarding utilization of intravenous (IV) therapy for inflammatory arthritis (IA).MethodsThis was a single-center, noninterventional, patient questionnaire-based study of adult IA patients currently receiving IV biologics. At a single visit, patients completed the questionnaire comprising 30 questions centered on their experience receiving an intravenously administered therapy to treat their IA. The questionnaire included questions on patient demographics, disease characteristics, and previous biologic treatment for IA (subcutaneous [SC] and IV). Patients rated their level of agreement with statements regarding satisfaction with current IV biologic therapy and potential advantages and disadvantages of IV biologic therapy using a 5-point Likert scale (1= strongly disagree, 5= strongly agree).ResultsOne hundred patients were enrolled and completed the survey; 66% were female and the mean age was 58 years. Before IV treatment, 97% of patients received information regarding therapy options. Ninety patients ranked their satisfaction with current IV therapy as 4 or 5. The proportion of patients with an “extremely favorable” perception of IV therapy increased from 33% to 71% following initiation of their current medication. Thirty-one patients had previously received SC therapies to treat their IA.ConclusionThese results demonstrated an overall favorable perception of IV therapy among this patient population. Patients previously treated with SC therapy also had a positive shift in the perception of IV therapy after initiating IV therapy. Patients’ perception and preference for treatment options should be highly considered by the treating physician during or as part of a shared decision-making process.
BackgroundActhar Gel is an adrenocorticotropic (ACTH) analogue (1). ACTH gel has been approved by the FDA for the treatment of RA since 1952. Nevertheless, there is limited data on the clinical and structural benefits of using Acthar Gel in the treatment of RA. ACTH consists of 39 amino acids, the first 13 of which may be cleaved to form alpha-melanocyte-stimulating hormone (alpha-MSH). Emerging evidence related to the melanocortin system suggests that ACTH may have mechanisms of action in addition to steroidogenesis.(2) ACTH by virtue of inhibitory influences on cytokine action and inflammatory cell migration has been reported to be effective in multiple inflammatory disorders in humans and adrenalectomized rats (3). This may have significant relevance in the management of inflammatory disorders such as RA.ObjectivesTo study the effects of Acthar Gel on clinical and structural endpoints in early RA patientsMethods10 patients with early RA, with a minimum of 6 tender and swollen joints, a CDAI score of >6.0 and with the presence of at least 1 of osteitis, synovitis, or erosions on MRI (Esaote 0.3T) were enrolled in this 24 week, open-label study using 15 mg MTX weekly in all patients and Acthar Gel 80 units weekly or biweeklyResultsWe report interim results on 10 patients of which 5 patients were dosed weekly with 80 units Acthar Gel and 5 patients were dosed biweekly with 80 units Acthar Gel. Eight of the 10 patients showed a clinical response as measured by improvement in CDAI score as compared to Baseline. Clinical remission was achieved in 2 patients, low disease activity in 3 patients, moderate disease activity in 3 patients, 1 patient remained at high disease activity and 1 patient terminated early due to lack of efficacy (table 1). When comparing the two treatment groups (weekly or biweekly dosing), all of the 5 patients who were dosed biweekly not only demonstrated a clinical response including 2 remissions, but they also showed a structural response of regression of synovitis and either regression or nominal change in osteitis as demonstrated by MRI (table 1). Of the 5 patients who were dosed weekly there was 1 ET for lack of efficacy and 1 treatment failure. There were no significant changes in erosions on MRI and X-ray in both groups possibly due to the short duration of the study. No significant adverse events notedConclusionsThe results of the interim analysis of 10 patients in this pilot study suggest a clinical and structural benefit using Acthar Gel in combination with MTX in early RA. The steroidogenic effect of Acthar Gel as well as the non-steroidogenic effect through the melanocortin system suggests that further evaluation of the use of Acthar Gel in the many different scenarios of the treatment of RA should be explored. The implications, if proven, could result in more effective treatment of early RA and reduction in the need for step-up biologic therapy. To the best of our knowledge this is the first report of the potential clinical and structural benefit of the use of Acthar Gel in the manag...
Long-COVID is a syndrome characterized by debilitating symptoms that persist over 3 months after infection with the SARS-CoV-2 virus. It affects 15 to 33% of COVID-19 recovered patients and has no dedicated treatment. First, we found that β-caryophyllene and pregnenolone have a significant synergistic effect in the resolution of LPS-induced sepsis and inflammation in mice. Then we combined these two compounds with seven others and designed a unique dietary supplement formulation to alleviate long COVID inflammatory and neurological disorders. We performed a one-arm open-labeled study at a single site with 51 eligible patients from 18 states. Each participant recorded the severity level of 12 symptoms (including fatigue, weakness, cardiac and neurological symptoms, shortness of breath, gastrointestinal disorders, ageusia or anosmia, anxiety, joint pain, rash, cough, and insomnia) at baseline, 2- and 4-week time points. On average, all the symptoms were significantly milder after 2 weeks, with further improvement after 4 weeks. Importantly, each symptom was significantly attenuated in 72 to 84% of the participants. There were no significant adverse effects. Our data indicate that the use of this nutraceutical product is a safe and significantly efficient option to reduce multiple symptoms of long COVID.
BackgroundTofacitinib has been shown to reduce the clinical signs and symptoms of some RA patients at an approved dose of 5 mg bid. Studies report that 10 mg bid is an effective dose. This is the first community practice trial to measure the clinical and structural benefits of stepping up the initial dose of 5 mg bid in non-responders to 10 mg bid in order to achieve a clinical response using a treat to target approach.ObjectivesThis study evaluates the optimal dose of tofacitinib (5 mg bid VS 10 mg bid) needed to reach treatment target in a cohort of patients with active RA while comparing the corresponding structural findings measured by low field MRI.Methods20 RA patients who were unresponsive to either methotrexate (10–25 mg weekly) or MTX plus up to 2 prior biologics with synovitis, osteitis or erosions on Baseline MRI (Esaote 0.3T) were treated with 5 mg bid tofacitinib with a treat to target goal of Low Disease Activity (LDA) or remission depending on the Clinical Activity Index (CDAI) score at Baseline. If the target was not met and sustained for 3 months, the dose of tofacitinib was increased to 10 mg bid in an attempt to reach target. MRIs of the hand/wrist were blindly read by a musculoskeletal radiologist using a rheumatoid arthritis MRI scoring system (RAMRIS). A CDAI score of >10 was needed at study entry.ResultsOf the 20 enrolled patients, 6 remained at 5 mg bid and 14 were dose escalated to 10 mg bid most at the 12 week period. Of the 5 mg bid group, 3 completed the trial at target and 3 early termed (ET) for lack of efficacy, relocation and AE. Structurally, there was no change in erosions in all 3 patients; 2 showed regression of synovitis and 1 showed no change; 2 showed regression in osteitis and 1 no change. Of the 14 patients escalated to 10 mg bid, 11 completed the trial with 7 remissions, 2 at LDA, and 1 at MDA. 3 patients ET due to lack of efficacy. In the 10 mg bid group, 9 patients showed no change in erosions, 1 regression and 1 progression. 5 patients showed no change in synovitis and 6 showed regression, and 7 showed no change in osteitis, 3 showed regression and 1 showed progression. The CRP values correlated with the improvement of the clinical and structural results, in particular, the levels improved after the dose was increased to 10 mg bid.ConclusionsOur results suggest that a significant number of patients treated with the standard dose of 5 mg bid may potentially have improved outcomes including LDA or remission when treated at a higher dose (10 mg bid). As is evidenced by the results in this study, 11 of the 14 patients had significant improved response after treatment with the step up dose. It would appear that this improved result occurs by 3 months of therapy. Furthermore, the structural findings correlate in large part to the clinical findings showing stabilization or improvement in the majority of patients. A larger study is needed to validate these clinical and structural responses as well as to evaluate the safety outcomes using 10 mg bid for intervals of more than 12 ...
Background Certolizumab pegol (CZP) significantly improved signs and symptoms of RA in a diverse group of patients, including 37.6% who previously used a TNF inhibitor.1 Objectives To evaluate short-term non-contrast low-field MRI for predicting long-term efficacy of CZP in patients with moderate to severe active RA who failed at least one non-biologic or biologic DMARD. Methods In this 2-center open-label study, 20 adult RA pts with DAS > 4.4, on stable dose of MTX, received CZP 400 mg at week (wk) 0, 2 and 4, followed by 200 mg every two wks for 52 wks. All patients had unilateral hand and wrist non-contrast MRI using 0.2 T extremity unit at baseline, 6wk, 16wk and 52wk. The images were scored according to the RAMRIS system and 9-point cartilage loss (CL) scale by a radiologist blinded to visit order. Results Baseline patients’ characteristics were as follows: Mean (SD) age 52.2 (16.9) years old, 70% female, Mean (SD) disease duration 7.3 (5.6) years, 50 % of pts were RF+, 60% anti-CCP+. Mean (SD) MTX dose was 17.25 (3.0) mg/week, Prednisone 2.5 (5.0) mg, 85% of pts were previously on a biologic. Tender/Swollen Joint Count (out of 68/66) was 34/16. Mean (SD) HAQ 4.38 (1.68), DAS28 6.60 (1.06), DAS28CRP 5.74 (0.66). 16/20 pts completed 52 wks. No serious adverse events were reported in this patient population. DAS28 and RAPID scores were significantly reduced at wks: 6, 12, 16, 24, 40, 48 and 52 compared with baseline (Wilcoxon; p<0.001). ACR20/50/70 response rates at 16 & 52 wks (with non-completers considered as non-responders) were 60/30/15 & 45/30/20 %, respectively. At wk 12, 80% and at wk 52, 69% of pts achieved moderate or good EULAR response. Only two pts achieved low disease activity (DAS<3.2) at wk 52. 80% of patients had a DAS28 improvement of ≥ 1.2 by week 12. Of these, 25% did not achieve EULAR response at wk 52. None of the remaining 20% of pts with DAS28 improvement < 1.2 by wk 12, had a EULAR response at wk 52. 52-wk EULAR responders had significantly higher improvement in the OST scores at 16 wks, as compared to non-responders (p= 0.043). Changes in SYN, ERO or CL scores did not differ substantially between the two groups (Figure 1). All pts who improved their OST scores by wk 16, were clinical responders at wks 12 and 52. 12-wk clinical responders had 73% probability of EULAR response at wk 52, but if they also had 16-wk OST improvement, the probability was 100% (PPV=1.0). Conversely, if OST worsened, the probability of achieving EULAR response at 52 wks was only 33% (NPV = 0.66). Image/graph Conclusions In this preliminary study of an active RA population who failed at least one DMARD and included 85% of pts who previously used a biologic, improvement of osteitis on MRI predicted long-term clinical response to CZP. This finding may be particularly significant in determining therapeutic choices in patients with RA who have previously used a biologic. Our observations were based on a small patient population and suggest a trend without statistical relevance. Larger studies should be done...
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