Efficacy, Safety and Steroid-sparing Effect of Topical Cyclosporine A 0.05% for Vernal Keratoconjunctivitis in Indian Children

Purpose: To evaluate the efficacy, safety, and steroid-sparing effect of topical cyclosporine A (Cs A) 0.05% in patients with moderate to severe steroid dependent vernal keratoconjunctivitis (VKC). Methods: A prospective, comparative, placebo controlled study was carried out on 68 VKC patients, with 34 patients treated with topical Cs A 0.05% and the remaining 34 with topical carboxymethyl cellulose 0.5% (placebo). Both groups also received topical loteprednol etabonate 0.5%. Symptom (itching, photophobia, tearing, and discharge) score, sign (tarsal and limbal papillae, corneal involvement, and conjunctival hyperemia) score, and drug score (steroid drop usage/day/eye) were recorded at baseline and each followup visit. The intraocular pressure (IOP) measurement and evaluation of any ocular side effects were carried out. Results: Significant reduction in symptom score and sign score was seen in both groups. Cs A group significantly showed more reduction in symptom (P < 0.0001 in all follow-up visits) and sign (P < 0.0001 in all follow-up visits) scores compared to the placebo group. At day 7, mean steroid usage reduced from 4 to 3.44 ± 0.5 and 3.79 ± 0.4 in Cs A and placebo groups, respectively (P < 0.0001). Steroid drops completely stopped in 21 patients at day 60 in the Cs A group compared to none in the placebo group. No significant rise in IOP or any side effects were noted in either group. Conclusion: Topical Cs A 0.05% is effective and safe in patients with moderate to severe VKC with good steroid-sparing effect.

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Impact of rituximab on anthropometric indices among childhood steroid-dependent nephrotic syndromes

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-318019 ◽

2020 ◽

pp. archdischild-2019-318019

Author(s):

Rajiv Sinha ◽

Sushmita Banerjee ◽

Anwesha Mukherjee ◽

Shakil Akhtar ◽

Subal Pradhan

Keyword(s):

Body Mass Index ◽

Short Stature ◽

Body Mass ◽

Retrospective Review ◽

Anthropometric Parameters ◽

Anthropometric Indices ◽

Steroid Dependent ◽

Sparing Effect ◽

Steroid Sparing

BackgroundThere is scarcity of data on impact of rituximab on anthropometrical parameters (weight, height and body mass index i.e. BMI SD score (SDS)) among children with steroid-dependent nephrotic syndromes (SDNS).MethodsMulticentre retrospective review.Results102 children with SDNS (male: 63%; n=64), median age 7 (IQR: 4.3–9.6) years, received a total of 217 rituximab infusions (total 110 cycles). At median follow-up of 2.1 (IQR: 1.3–2.8) years, 58 (57%) children were off steroids and a significant fall in steroid threshold for relapse was noted (median 0.6; IQR 0.4–0.9 to median 0.3; IQR 0.12 - 0.5 mg/kg/alternate day, p=0.005). Anthropometric parameters (BMI SDS: 0.92±1.8 to 0.25±1.47, p=0.003; weight SDS: 0.20±1.6 to −0.11±1.3, p=0.01; and height SDS: −0.93±1.88 to −0.45±1.54, p=0.04) as well as obesity (38% to 20%, p=0.003) and short stature (11% to 3%, p=0.02) improved. Results remained significant even when analysis was restricted to children ≤12 years (n=88), (BMI SDS: 0.97±1.98 to 0.25±1.5, p=0.001; weight SDS: 0.33±1.6 to 0.02±1.2, p=0.01; and height SDS: −0.67±1.84 to −0.186±1.42, p=0.001).ConclusionsUse of rituximab resulted in significant steroid sparing effect with an improvement in both growth and obesity parameters.

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P588 Steroid sparing effect of adalimumab in cortisone–depended ulcerative colitis patients

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.709 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S539-S539

Author(s):

M Sina ◽

E Pengili ◽

X Pemaj ◽

D Osmanaj ◽

I Bibolli ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Remission ◽

Tertiary Hospital ◽

Average Dose ◽

Biologic Treatment ◽

Steroid Dose ◽

Steroid Dependent ◽

Sparing Effect ◽

Steroid Sparing

Abstract Background Corticosteroids are indicated for induction of remission in moderate to severe ulcerative colitis (UC) patients. However, due to their adverse effects associated with long-term use, steroids are not indicated as a maintenance therapy. The aim of this study was to assess the steroid sparing effect of adalimumab (ADA) in steroid-dependent UC patients. Methods This is a prospective study carried out at a tertiary hospital center in Albania from 2016–2020, including consecutive moderate-to-severe UC patients. All patients received biologic therapy with subcutaneous ADA 160/80mg at weeks 0/2 followed by 40mg every 2 weeks. We evaluated the steroid-sparing effect of ADA measuring the number of steroid–free patients and the average steroid dose at baseline before initiating biologic treatment and at week 8, 24, 52, 104, 156. Clinical remission was defined as total Mayo score ≤ 2 points. Results We enrolled 26 UC patients, mean age 47.3 ± 16.1 (24–85) years, 55.6% were females. The average disease duration before starting ADA was 7.3 ± 7.0 years (range 1–33); 44.4% had pancolitis and 55.6% left side colitis. 8(29.6%) patients were on combination therapy with azathioprine. 17/26 (65.4%) patients were taking prednisone at the time of the first ADA injection with an average dose of 17.7mg. The number of steroid-free patients at week 8, 24, 52, 104 and 156 was 12/26 (46.2%), 16/26 (61.5%), 15/21 (71.4%), 11/14 (78.6%), 8/9 (88.9%) respectively. At the end of the follow-up (week 156), the proportion of steroid free patient was significantly higher than at baseline [88.9% (8/9) vs 34.6% (7/26), p=0.005]. The reduction of the average dose of prednisone (8.8 mg, 4 mg, 6.8mg, 3.8mg and 3,8mg at week 8, 24, 52, 104 and 156 respectively), was also statistically significant (p<0.01). Clinical remission rates were 7.7% (2/26) at week 8, 47.6% (10/21) at week 52, 42.9% (6/14) at week 104 and 44.4 % (4/9) at week 156. Conclusion In our cohort, ADA administration to moderate–to severe UC significantly reduced the steroid dose and the proportion of patients taking cortisone during 3 years follow-up.

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Efficacy of Topical Tacrolimus 0.05% Suspension in Steroid-Resistant and Steroid-Dependent Vernal Keratoconjunctivitis

10.53350/pjmhs211572150 ◽

2021 ◽

Vol 15 (7) ◽

pp. 2150-2155

Author(s):

Mitra Akbari

Keyword(s):

Side Effects ◽

Adverse Effects ◽

Corneal Opacity ◽

Vernal Keratoconjunctivitis ◽

Topical Steroids ◽

Steroid Resistant ◽

Topical Tacrolimus ◽

Steroid Dependent ◽

The Mean

Objective: The purpose of this study was to investigate the safety and effectiveness of topical tacrolimus 0.05% suspension in the management of prolonged steroid-dependent and -resistant vernal keratoconjunctivitis (VKC). Materials and methods: The present interventional prospective case series were conducted on the research units suffering from refractory VKC between 2017, April and 2020, December. Despite routine drug treatment, consisting of topical steroids (steroid-resistant group), all subjects exhibited active symptomatic illness or were dependent on topical steroids (steroid-dependent group). After discontinuation of all medications for at least 1 week, the patients received eye drop (topical tacrolimus 0.05%) minimally for six months. Objective and subjective signs and symptoms were examined for alterations after one week, and one and six months of treatment. Analyses were continued for probable systemic and ocular adverse effects. Results: The study included 28 eyes of 14 participants (including 4 females and 10 males), with the mean age of 22 ± 8 years (between 11 and 38 years), and the mean VKC duration of 12 ± 6 years (between 5 and 23 years), as well as follow up period of 10±2 months (between 6 and 12 months). The results showed an improvement (P<0.001) in the symptoms such as mucus discharge, foreign body sensation, photosensitivity, redness, burning and itching. The initial sign was conjunctival hyperemia, which improved one week after treatment. Other objective signs including, conjunctival and limbal papillary hypertrophy, corneal pannus and corneal punctate epithelial erosions improved at least one month after treatment. No changes were observed in corneal opacity during follow-up (p> 0.05). There were no systemic or ocular adverse effects. Conclusion: This is the first time that tacrolimus suspension drops 0.05%, are used in these cases. Topical tacrolimus 0.05% was shown to be an effectiveness and safe agent to treat the refractory VKC. This drug is recommended to be prescribed prior to the appearance of side effects such as corneal opacity, irreversible deficiency in limbal stem cell, and steroid side effects. Keywords: Vernal keratoconjunctivitis, Tacrolimus eye drop, Refractory

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POS0338 STEROID-SPARING EFFECT OF ANAKINRA IN GIANT-CELL ARTERITIS: A CASE SERIES WITH CLINICAL, BIOLOGICAL AND ICONOGRAPHIC LONG-TERM ASSESSMENTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1623 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 397.1-397

Author(s):

S. Deshayes ◽

K. Ly ◽

V. Rieu ◽

G. Maigné ◽

N. M. Silva ◽

...

Keyword(s):

Giant Cell Arteritis ◽

Giant Cell ◽

Interleukin 1 ◽

Oral Prednisone ◽

Large Vessel ◽

Daily Dose ◽

Sparing Effect ◽

Steroid Sparing

Background:The treatment of giant cell arteritis (GCA) relies on corticosteroids but is burdened by a high rate of relapses and adverse effects. Anti-interleukin-6 treatments show a clear benefit with a significant steroid-sparing effect, but late relapses occur after treatment discontinuation. In addition to interleukin-6, interleukin-1 also appears to play a significant role in GCA pathophysiology.Objectives:We report herein the efficacy of anakinra, an interleukin-1 receptor antagonist, in 6 GCA patients exhibiting corticosteroid dependence or resistance, specifically analyzing the outcome of aortitis in 4 of them, and including the long-term follow-up of 2 previously described patients (1).Methods:This retrospective study analyzed the cases of all GCA patients treated with anakinra from the French Study Group for Large Vessel Vasculitis.Patients had to satisfy the following two criteria to be enrolled in this retrospective study. First, their diagnosis of GCA should be based on the fulfillment of at least 3 criteria of the American College of Rheumatology (ACR) for GCA or on the satisfaction of 2 of these criteria along with the demonstration of LVI on imaging. Second, patients should have received anakinra because of corticosteroid dependence or resistance.Corticosteroid dependence was defined as ≥2 relapses or the combination of 2 of the following criteria: a daily dose of oral prednisone >20 mg/day (or 0.3 mg/kg) at 6 months; a daily dose of oral prednisone >10 mg/day (or 0.2 mg/kg) at 12 months; and/or a treatment maintained >24 months because of a relapsing disease course. Corticosteroid resistance was defined as persistent increased inflammatory parameters at month 3 despite a steroid dosage over 0.5 mg/kg.Results:After a median duration of anakinra therapy of 19 [18–32] months, all 6 patients exhibited complete clinical and biological remission. Among the 4 patients with large-vessel involvement, 2 had a disappearance of aortitis under anakinra, and 2 showed a decrease in vascular uptake. After a median follow-up of 56 [48–63] months, corticosteroids were discontinued in 4 patients, and corticosteroid dosage could be decreased to 5 mg/day in 2 patients. One patient relapsed 13 months after anakinra introduction in the context of increasing the daily anakinra injection interval to every 48 hours. Three patients experienced transient injection-site reactions, and 1 patient had pneumonia.Figure 1.Steroid dosages before and after the introduction of anakinra in 6 patients with giant-cell arteritis and corticosteroid dependence or resistance. The black arrow indicates the time of anakinra introduction.Conclusion:In this short series, anakinra appears to be an efficient and safe steroid-sparing agent in refractory GCA, with a possible beneficial effect on large-vessel involvement.References:[1]Ly K-H, Stirnemann J, Liozon E, Michel M, Fain O, Fauchais A-L. Interleukin-1 blockade in refractory giant cell arteritis. Joint Bone Spine 2014;81:76–8.Disclosure of Interests:Samuel Deshayes: None declared, Kim LY: None declared, Virginie Rieu: None declared, Gwénola Maigné: None declared, Nicolas Martin Silva: None declared, Alain Manrique: None declared, Jacques Monteil: None declared, Hubert de Boysson Speakers bureau: Roche-Chugai, Grant/research support from: Roche-Chugai, Achille Aouba Grant/research support from: SOBI

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COMPARATIVE STUDY OF THE EFFICACY OF TOPICAL LOTEPREDNOL ETABONATE AND FLUOROMETHOLONE IN THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS : A RANDOMISED CONTROLLED STUDY

10.36106/ijsr/5403062 ◽

2021 ◽

pp. 8-10

Author(s):

Nandita Chaturvedi ◽

Nidhi Nidhi ◽

Malobika Bhattacharya

Keyword(s):

Side Effects ◽

Signs And Symptoms ◽

Subjective Symptom ◽

Controlled Study ◽

Vernal Keratoconjunctivitis ◽

Topical Steroids ◽

Loteprednol Etabonate ◽

Randomised Controlled Study ◽

Before And After ◽

Randomised Controlled

Introduction:Vernal keratoconjunctivitis(VKC) is a chronic, recurrent, inammatory disease of ocular surface showing seasonal exacerbation, affecting young children. Topical steroids are the mainstay in the treatment of ocular allergy, but their use should be judicious since they carry serious side effects . Loteprednol and uorometholone carry better safety prole. Present study was conducted with the aim of comparing the efcacy of these two widely used steroids.Objectives:To compare total subjective symptom score (TSSS), total objective sign score (TOSS) and side effects of medications before and after treatment at each visit.Materials & Methods:A prospective randomised controlled study was performed on 92 patients of VKC over four weeks. Patients were allotted to either of the two arms of treatment (i.e. LP 0.5% or FML 0.1%). Subjective and objective assessments of the signs and symptoms of VKC were done using standard scoring methodologies at 7, 14, 21 and 28 days post treatment. The main outcome measure was measured in terms of TSSS and TOSS before and after treatment at each visit. Secondary outcomes included side effects. Statistical analysis of the data collected was carried out.Results: Loteprednol showed greater reduction in symptoms initially but by the end of study there was no statistically signicant difference in effect between the two drugs.Conclusions: Final improvement in clinical features and safety prole, at the end of 4 weeks was similar in eyes treated with either of the two drugs. Hence, both the drugs can be safely used in the treatment of VKC.

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The Effects of 6-Week Supplementation with Multicomponent Herbal Extract on Exercise Performance, Antioxidant Status and Telomere Length, and Self-Reported Side Effects in Healthy Men: A Randomized Controlled Pilot Trial

Current Topics in Nutraceutical Research ◽

10.37290/ctnr2641-452x.19:520-524 ◽

2020 ◽

Vol 19 (4) ◽

pp. 520-524

Author(s):

Valdemar Stajer ◽

Nikola Todorovic ◽

Darinka Korovljev ◽

Nebojsa Maksimovic ◽

Suzana Miljkovic ◽

...

Keyword(s):

Placebo Group ◽

Side Effects ◽

Antioxidant Capacity ◽

Telomere Length ◽

Exercise Performance ◽

Antioxidant Status ◽

Herbal Extract ◽

Healthy Men ◽

Randomized Controlled

The main aim of this study was to examine the effects of medium-term supplementation with an eight-herbs extract on running performance, biomarkers of antioxidant status and telomere length, and self-reported outcome measures of safety events in healthy men. Ten healthy young men (age 23.1±3.2 years, weight 73.7±9.9kg, and height 179.4±8.0cm) volunteered to participate in this randomized controlled trial. The participants were allocated in a double-blind cross-over design to receive either an eight-herbs extract or placebo during a 6-week intervention period. Two-way mixed analysis of variance (treatment vs. time interaction) revealed no significant differences for exercise performance outcomes and telomere length between groups (P>0.05). Compared with placebo, P-DNA provoked a significant rise in serum total antioxidant capacity (316.0±183.4µmol/mL at baseline; 792.7±68.1µmol/mL at follow-up in the eight-herbs extract group vs. 298.1±90.7µmol/mL at follow-up in the placebo group; P<0.001), and less reduction in serum superoxide dismutase levels at follow-up (150.4±5.1IU/mL at baseline; 145.5±3.0IU/mL at follow-up in the eight-herbs extract group vs. 139.3±3.3IU/mL at follow-up in the placebo group; P=0.01). No participant reported any side effects of either intervention. The eight-herbs extract can thus be recommended as a well tolerated dietary supplement that can enhance antioxidant capacity in healthy men. This trial was registered at ClinicalTrials.gov (NCT04263246).

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Treating Severe Pediatric Keratoconjunctivitis with Topical Cyclosporine A

Klinische Monatsblätter für Augenheilkunde ◽

10.1055/a-1556-1182 ◽

2021 ◽

Author(s):

Julia Biermann ◽

Friederike Bosche ◽

Nicole Eter ◽

Flemming Beisse

Keyword(s):

Cyclosporine A ◽

Treatment Plan ◽

Corneal Opacity ◽

Corneal Neovascularization ◽

Visual Development ◽

Vernal Keratoconjunctivitis ◽

Upper Eyelid ◽

Sparing Effect ◽

One Year

AbstractThe incidence of chronic keratoconjunctivitis, which potentially causes long-term loss of visual acuity due to corneal opacity, is considerably less common in children than in adults. It is therefore in danger of being overlooked. In children the appropriate treatment is therefore often introduced too late, or to an insufficient extent. In this article we would like to raise awareness about the diagnosis of chronic keratoconjunctivitis in children, and to present an effective treatment plan for severe stages of the disease. There are two forms of chronic keratoconjunctivitis that occur most frequently in children: hyperergic blepharokeratoconjunctivitis (hBKC) and vernal keratoconjunctivitis (VKC). With hBKC, the patient often has a history of recurring hordeolum and also presents with blepharitis; it is characterized by the marked presence of corneal neovascularization in the lower circumference of the cornea. VKC is typically characterized by changes under the upper eyelid, with marked changes to the superior limbus. If there is a risk of complications involving the cornea, or in the presence of such complications, a consistent long-term topical immunosuppressive and anti-inflammatory treatment is required. Both of these properties are combined in the active ingredient cyclosporine A. Other advantages of topical CSA treatment are its steroid-sparing effect and the long-term reduction of exacerbations. Parents need to be informed about the chronic nature of these two diseases and their tendency to recur; because of these characteristics, treatment, in most cases, should be envisaged for at least one year in order to effectively disrupt the complex immunologic processes. This safeguards the childʼs visual development and prevents amblyopia caused by scarring and astigmatism. We hope that the data presented will lower the barriers related to prescribing CSA for topical eye application in children.

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P605 Eight-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.733 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S505-S505

Author(s):

C Cassieri ◽

R Pica ◽

E V Avallone ◽

G Brandimarte ◽

M Zippi ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Side Effects ◽

Bowel Disease ◽

Efficacy And Safety ◽

Loss Of Response ◽

Steroid Dependent ◽

Azathioprine Treatment ◽

Inflammatory Bowel ◽

Maintenance Of Remission

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment. Methods Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Results Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up < 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%. Conclusion Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.

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