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Fostamatinib for warm antibody autoimmune hemolytic anemia: Phase 3, randomized, double-blind, placebo-controlled, global study (FORWARD)
Kuter, D. J., Piatek, C., Röth, A., Siddiqui, A., Numerof, R. P., Dummer, W.
American journal of hematology. 2023
Abstract
Warm antibody autoimmune hemolytic anemia (wAIHA) is characterized by hemolysis and symptomatic anemia with no approved treatment options. Fostamatinib is an oral spleen tyrosine kinase inhibitor approved in the US and Europe for treatment of adults with chronic immune thrombocytopenia. In this phase 3 study, patients with an insufficient response to ≥1 prior wAIHA treatment were randomized to fostamatinib or placebo. The primary endpoint was the proportion of patients to achieve a durable hemoglobin (Hgb) response (Hgb ≥10 g/dL and increase from baseline of ≥2 g/dL on 3 consecutive visits) during the 24-week treatment period. Ninety patients were randomized, 45 to each arm. Of the fostamatinib-treated patients, 35.6% achieved a durable Hgb response versus 26.7% on placebo (p = .398). A post hoc analysis revealed a large placebo response in Eastern European patients. Significantly more patients on fostamatinib from North America, Australia and Western Europe exhibited a durable Hgb response compared to placebo (36% vs. 10.7%, p = .030). After censoring for Hgb values impacted by steroid rescue received during screening and excluding 2 placebo patients found to likely not have wAIHA, a reanalysis demonstrated a difference in durable Hgb response between fostamatinib and placebo (15/45 [33.3%] vs. 6/43 [14.0%], p = .0395). At least 1 AE was reported in 42 (93.3%) and 40 (88.9%) patients receiving fostamatinib and placebo, respectively. The most common AEs in the fostamatinib group were diarrhea (26.7%), hypertension (24.4%), and fatigue (15.6%). In this study, fostamatinib demonstrated a clinically meaningful benefit for patients in Western regions, and no new safety signals were identified.
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2.
Efficacy of intralesional injections of platelet-rich plasma in patients with oral lichen planus: A pilot randomized clinical trial
Hijazi A, Ahmed W, Gaafar S
Clinical and experimental dental research. 2022
Abstract
OBJECTIVE To evaluate the clinical efficacy of intralesional platelet-rich plasma (PRP) injections compared to intralesional triamcinolone acetonide (TA) injections in the treatment of erosive oral lichen planus (EOLP). MATERIAL AND METHODS Twenty patients with EOLP were assigned randomly to either PRP or TA group. Patients received weekly intralesional injections for 4 weeks, and then followed up for 3 months on regular visits every 2 weeks. Pain scores using numerical pain score and clinical score were recorded by a blinded assessor each visit for all patients and remission score at the end of the trial was recorded. RESULTS Both groups showed significant improvement in the clinical parameters (pain and clinical score) "p = .001." Regarding remission of the lesions, 80% of patients in the PRP group showed complete remission compared to 70% in the TA group. However, there is no statistical significance when comparing the two groups in pain score, clinical score, or remission. CONCLUSIONS PRP injections could be considered as an effective alternative single treatment modality for EOLP. The protocol for this study registered in Clinicaltrials.gov registry under the identifier number: NCT03293368.
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3.
The efficacy of injectable platelet-rich fibrin in the treatment of symptomatic oral lichen planus
Al-Hallak N, Hamadah O, Mouhamad M, Kujan O
Oral diseases. 2022
Abstract
OBJECTIVES The use of autologous platelet concentrates has shown growing evidence as a promising therapy. We conducted a split-mouth study to evaluate the effectiveness of injectable platelet-rich fibrin (PRF) compared to triamcinolone acetonide (TA) in the treatment of oral lichen planus (OLP). MATERIALS AND METHODS This split-mouth randomized trial included twelve patients with symptomatic, bilateral OLP lesions. The participants were randomly allocated to receive a 1-mL intralesional PRF injection on one side of the buccal mucosa and a 0.5-mL TA injection on the counterpart side. The application was performed once a week for 4 weeks. The outcomes were measured using a visual analog scale score, REU score, and lesion areas. RESULTS Both injectable TA and PRF were effective in the management of oral lichen planus. After four weeks of treatment, there was an average reduction in the VAS score (68.5% i-PRF, 91% TA) and an average reduction in the REU score (74% i-PRF, 91% TA). There were no statistically significant differences between the two treatment methods (P > 0.05). CONCLUSIONS Intralesional injection with TA showed more effectiveness than i-PRF in the management of OPL lesions. Although, i-PRF cannot be considered a first-line treatment option, it showed promising alternative therapy choice with no side effects.
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4.
Evaluating the Efficacy of Intra-articular Injections of Platelet Rich Plasma (PRP) in Rheumatoid Arthritis Patients and its Impact on Inflammatory Cytokines, Disease Activity and Quality of Life
Saif, D. S., Hegazy, N. N., Zahran, E. S.
Current Rheumatology Reviews. 2021;17(2):232-241
Abstract
BACKGROUND Among rheumatoid arthritis patients (RA), general disease activity is well regulated by disease-modifying anti-rheumatic medications (DMARDS), but sometimes local inflammation still persists among a few joints. Adjuvant modern molecular interventions as Platelet Rich Plasma (PRP) with a suggested down regulating effect on inflammatory mediators has a proven effect in the management of RA. We aim to evaluate the therapeutic effect of intra-articular PRP versus steroid in RA patients and their impact on inflammatory cytokines IL1B, TNF α, local joint inflammation, disease activity and quality of life (QL). METHODS Open-labeled parallel randomized control clinical trial was carried out on 60 RA patients randomly divided into 2 groups, Group 1: included 30 patients received 3 intra-articular injections of PRP at a monthly interval, Group 2: included 30 patients received single intra-articular injection of steroid. They were subjected to clinical, laboratory, serum IL1B and TNF α assessment at baseline and at 3, and 6 months post injection. RESULTS Patients of both groups showed improvements in their scores of evaluating tools at 3months post injection and this improvement was persistent in the PRP group up to 6 months post injection while it was continued only for 3 months in the steroid group. CONCLUSION PRP is a safe, effective and useful therapy in treating RA patients who had an insufficient response and persistent pain and inflammation in just one or two joints through its down regulating effect on inflammatory cytokines IL1B, TNF α with subsequent improvement of local joint inflammation, disease activity and QL.
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5.
Efficacy of injectable platelet-rich fibrin in the erosive oral lichen planus: a split-mouth, randomized, controlled clinical trial
Saglam, E., Ozsagir, Z. B., Unver, T., Alinca, S. B., Toprak, A., Tunali, M.
Journal of Applied Oral Science : Revista Fob. 2021;29:e20210180
Abstract
OBJECTIVE Our study compared the effects of injectable platelet-rich fibrin (i-PRF) with those of corticosteroids in the treatment of erosive oral lichen planus (EOLP). METHODOLOGY This split-mouth study included 24 individuals diagnosed histopathologically with bilateral EOLP. One bilateral lesion was injected with i-PRF, whereas the other was injected with methylprednisolone acetate in four sessions at 15-day intervals. Visual analog scale (VAS) for pain and satisfaction, oral health impact profile scale-14, and the lesion size were used. RESULTS The intragroup comparisons showed a significant decrease in VAS-pain and lesion size in both the i-PRF group (from 81.88±17.74 to 13.33±18.34, and from 4.79±0.41 to 1.88±1.08, respectively) and the corticosteroid group (from 80.21±17.35 to 23.33±26.81, and from 4.71±0.46 to 2.21±1.35, respectively) in the 6th month compared to baseline (p<0.001). Moreover, VAS-satisfaction increased significantly in both the i-PRF group (from 26.67±17.8 to 85.63±16.24) and the corticosteroid group (from 28.33±17.05 to 74.38±24.11) in the 6th month compared to baseline (p<0.001). However, no significant difference in any value occurred in the intergroup comparisons. CONCLUSION In patients with EOLP, both methods decreased pain and lesion size similarly, and both increased satisfaction. Therefore, the use of i-PRF may be considered an option in cases refractory to topical corticosteroid therapy. Biochemical and histopathological studies are required to reveal the mechanism of i-PRF action in EOLP treatment.
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Efficacy of platelet-rich fibrin compared with triamcinolone acetonide as injective therapy in the treatment of symptomatic oral lichen planus: a pilot study
Bennardo F, Liborio F, Barone S, Antonelli A, Buffone C, Fortunato L, Giudice A
Clinical oral investigations. 2021
Abstract
OBJECTIVES Oral lichen planus (OLP) is a chronic immune-mediated disease that affects the oral cavity. Topical steroids are considered the treatment of choice for painful lesions of OLP. The aim of this split-mouth study was to compare the efficacy of platelet-rich fibrin (PRF) and triamcinolone acetonide (TA) injective therapies in patients with symptomatic OLP. MATERIALS AND METHODS Participants with symptomatic OLP were recruited in the Academic Hospital of Magna Graecia University of Catanzaro, Italy. Once a week for a month, patients randomly received a 0.5-mL TA injection in one buccal mucosa and 1-mL PRF injection in the opposite side. The measured outcomes were reduction of the lesions area and symptomatology modifications using visual analogue scale (VAS) score RESULTS Four weeks after the last injections, an average reduction of 59.8% in the lesion extension and an average reduction of 47.6% in the VAS score for PRF-treated sites were observed; the same variation for TA-treated sites was respectively of 59.2% and 40%. There were no statistically significant differences between the two groups. CONCLUSIONS PRF was effective in reducing OLP lesions extension and symptomatology, and it seems to be as effective as TA. Additional data should be collected with a larger sample size, at a longer follow-up and on the PRF lowest effective dose. CLINICAL RELEVANCE Current treatment options for OLP are limited. The study proved benefits of PRF injections in management of painful lesions of OLP comparable with TA.
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7.
Concomitant Immunosuppressive Therapy Use in Eculizumab-Treated Adults With Generalized Myasthenia Gravis During the REGAIN Open-Label Extension Study
Nowak RJ, Muppidi S, Beydoun SR, O'Brien FL, Yountz M, Howard JF Jr
Frontiers in neurology. 2020;11:556104
Abstract
Introduction: Chronic, broad-spectrum immunosuppressive therapy (IST) can be associated with side effects in many people with generalized myasthenia gravis (gMG), and treatment guidelines recommend that the IST dose be tapered once patients achieve a stable treatment response. We therefore examined IST use in eculizumab-treated patients with refractory gMG. Methods: The REGAIN open-label extension (OLE) enrolled 117 adults with refractory anti-acetylcholine receptor antibody-positive gMG who had completed the 6-month, randomized, double-blind, placebo-controlled REGAIN study of eculizumab. Eligible patients had received ≥2 ISTs for ≥1 year or ≥1 IST with intravenous immunoglobulin or plasma exchange ≥4 times in 1 year, without symptom control. During REGAIN, changes in concomitant MG therapies were not permitted; during the OLE, they were permitted at the investigators' discretion. Participants received eculizumab 1,200 mg every 2 weeks for up to 4 years; concomitant prednisone and related corticosteroids (PRED), azathioprine (AZA), and mycophenolate mofetil (MMF) use was recorded. Changes in MG Activities of Daily Living and Quantitative MG total scores, MG exacerbations, and adverse events were also recorded. Results: At last OLE assessment, 88.0% (103/117) of participants were using ≥1 IST vs. 98.3% (115/117) at OLE baseline. During the OLE, 76.9% (90/117) of patients experienced a total of 719 IST changes. Almost half of participants [48.7% (57/117)] stopped or decreased ≥1 IST owing to MG symptom improvement, representing 38.9% (280/719) of all changes. In patients who decreased and/or stopped ≥1 IST, mean daily doses of PRED, AZA, and MMF decreased between OLE baseline and last assessment by 60.8% [standard deviation (SD), 28.07; P < 0.0001], 89.1% (SD, 25.77; P < 0.0001), and 56.0% (SD, 32.99; P < 0.0001), respectively. Improved clinical outcomes were observed with eculizumab regardless of IST changes during the OLE, and eculizumab's safety profile was similar in patients who used PRED, AZA, and MMF. Conclusions: Use of ISTs by patients with previously refractory gMG decreased during eculizumab treatment in the REGAIN OLE. Clinical improvements with eculizumab were maintained by patients in all groups, including those who decreased and/or stopped concomitant ISTs. Trial registration: www.clinicaltrials.gov: NCT01997229, NCT02301624.
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8.
Comparative evaluation of effectiveness of autologous platelet rich plasma and intralesional corticosteroids in the management of erosive oral Lichen planus- a clinical study
Sethi Ahuja U, Puri N, More CB, Gupta R, Gupta D
Journal of oral biology and craniofacial research. 2020;10(4):714-718
Abstract
PURPOSE Oral Lichen planus is a potentially malignant autoimmune disorder, characterized by burning and pain in the affected mucosa which reduces the quality and comfort of patient's life. Various treatment modalities have been documented for OLP but due its malignant potential the alternative therapeutic approaches with least or no side effects are being in demand. One of such, yet unexplored treatment is Platelet rich plasma (PRP). This study aims to evaluate the effectiveness of intralesional PRP as compared to the Intralesional corticosteroids in the management of erosive OLP. MATERIALS AND METHODS The study sample consisted of 20 clinically and histopathologically confirmed patients of Erosive OLP among which 10 patients were given intralesional corticosteroids and 10 patients were administered intralesional PRP. All the patients were given weekly injections for 2 months and were followed up till 4 months for assessing the parameters such as pain/burning, erythema and size of the lesions. RESULTS The patients in both the groups showed a statistically significant reduction in all the assessed parameters of erosive lichen planus from baseline till 4 months of treatment and follow up. However, on comparison of the pain reduction, size of lesion and erythema scores between the two groups, the difference was found to be statistically insignificant. CONCLUSION The intralesional PRP was found to be of comparative effectiveness with respect to intralesional triamcinolone acetonide in the management of erosive OLP and with an added advantage of having less recurrence and no adverse effects.
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Mucous membrane grafting (fibrin glue vs. suture) for lid margin pathologies in Stevens-Johnson syndrome: randomized comparative study
Pushker N, Gorimanipalli B, Sharma N, Kashyap S, Bajaj MS
Eye (London, England). 2020
Abstract
OBJECTIVE To compare fibrin glue (with three cardinal sutures) (FG) and polygalactin suture (PS) for mucous membrane grafting (MMG) in terms of graft apposition and recurrence of lid margin keratinization (LMK) and metaplastic lashes (ML) in patients with Stevens-Johnson syndrome (SJS). DESIGN Prospective randomized comparative interventional study. METHODS Twenty patients diagnosed with SJS and lid margin abnormalities including LMK with or without ML were randomized to undergo either fibrin glue (FG)-assisted MMG (n = 10) or continuous 8-0 polygalactin suture (PS)-assisted MMG (n = 10). They were evaluated preoperatively and during follow-up at 1 week and 1, 2, 3, and 6 months. The parameters assessed were best-corrected visual acuity (BCVA), tear break-up time (TBUT), Schirmer-1 test, corneal and conjunctival complications, graft apposition and width (GW), LMK, ML, impression cytology, and operative time. The primary outcome measures are incidence of graft displacement and recurrence of LMK and ML. RESULTS None of the eyelids in FG group (0/40) and 1 eyelid in PS group (1/40) had graft displacement. Recurrence of LMK occurred in 7.5% of eyelids (3/40) in both the study groups. Recurrence of ML occurred in 2.5% (1/40) in FG group and 5% (2/40) in PS group. The mean operative time for MMG in FG group was 39.5 ± 2.40 min and in PS group was 56 ± 1.63 min (p = 0.001). CONCLUSIONS As graft apposition with suture involves significantly longer intraoperative time, if cost is not a limiting factor then fibrin glue is a viable option for the MMG for lid margin pathologies.
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10.
Reduced insulin need in patients with type 2 diabetes mellitus (T2DM) with iron deficiency anemia treated with sucrosomial iron vs intravenous sodium ferrigluconate. Multicentric prospective study
Giordano G, Parente A, Gigli R, Magri M, Berardi G, Carabellese B, D’Amico F, Luciano L, Fratangelo R, Niro G, et al
Haematologica. 2016;101((s1)):848.. pb2134.