scholarly journals P412 Maintenance therapy of vedolizumab (VDZ) after induction of remission by tacrolimus (TAC) in patients with refractory ulcerative colitis (UC)

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S377-S378
Author(s):  
A Ito ◽  
M Shun ◽  
O Teppei ◽  
T Katsutoshi

Abstract Background The number of patients with ulcerative colitis (UC) is increasing. As the number of patients increases, patient backgrounds become diverse, and treatment choices that match the background are required. Most UCs are mild, but about 30% are more than moderate. UCs with moderate or higher illness have resistance/dependence to steroids and are difficult to introduce remission. In recent years, many new drugs have appeared for remission induction therapy. However, in UC treatment, maintenance therapy that suppresses relapse after induction of remission is important. Maintaining long-term remission prevents deterioration in the quality of life and reduces the incidence of UC-related colorectal cancer. To that end, it is important to consider remission maintenance therapy. In patients with intractable UC who have been in remission with tacrolimus (TAC) and used vedolizumab (VDZ) as maintenance therapy, patient background, relapse rate (observation period 181.5 ± 25.9 days), (3) safety of TAC and VDZ combination The sex was examined. Methods Seven patients who received remission with TAC and maintained remission with VDZ between November 2018 and June 2019 were included. (1) Patient background at the time of introduction of TAC and VDZ, TAC administration period (day) until the start of VDZ, (2) Relapse rate, (3) AZA use history, side effects, and adverse events caused by the combined use of VED. Results (1) Patient background was age at TAC introduction (age) 44.4 ± 19.7, sex (male / female) 3/4, disease duration (year) 12 ± 11.5, CAI 14.4 ± 2.9, Hb 11 ± 0.8, CRP 5.5 ± 3.6, Endoscopic score (Mayo 3 ± 0, UCEIS 7 ± 1.1), CAI at the time of VDZ introduction 6 ± 3.3, Hb 11.3 ± 2.0, CRP 0.4 ± 0.5, TAC administration period until VDZ start 140 ± It was 155. (2) Six patients had a history of AZA use. 4 out of 6 cases with AZA history side effect due to AZA was observed. The side effects of AZA were leukopenia in 2 cases, headache in 2 cases, and liver injury in 1 case. (There were duplicate cases) (3) No adverse events were observed due to the combined use of TAC and VDZ. Conclusion TAC has clinical remission or symptom improvement for refractory UCVDZ had been administered since then. In cases where administration of AZA was difficult, VDZ was selected as maintenance therapy. There were no serious side effects from the combined use of TAC and VDZ. TAC is a drug that has a rapid effect. However, long-term administration of TAC is at risk for kidney damage. Therefore, we considered that maintenance therapy with VDZ after TAC is effective.

2010 ◽  
Vol 16a (2) ◽  
pp. 62-68
Author(s):  
Tina Bhutani ◽  
Kristine Busse

This clinical review outlines a practical approach to the use of acitretin in the treatment of psoriasis. Acitretin is approved by the Food and Drug Administration for the treatment of adult patients with chronic moderate to severe plaque psoriasis. It is an oral retinoid and is the only systemic agent that is not clinically immunosuppressive; it works primarily by enhancing differentiation and maturation of cells. Side effects associated with this medication are usually mild and manageable; serious adverse events are rare. Therefore, it can be used for long-term maintenance therapy or in combination with other topical or systemic agents and phototherapy.


2021 ◽  
Vol 12 ◽  
pp. 204062232110287
Author(s):  
Yuriko Nishikawa ◽  
Nobuhiro Sato ◽  
Shintaro Tsukinaga ◽  
Kan Uchiyama ◽  
Shigeo Koido ◽  
...  

Aims: An antibiotic combination of amoxicillin, tetracycline and metronidazole (ATM) is effective for ulcerative colitis (UC), but this regimen is discontinued in some cases due to adverse events. This study aimed to assess a revised combination, namely, amoxicillin, fosfomycin and metronidazole (AFM), in UC patients with the goal of reducing side effects while maintaining therapeutic efficacy. Methods: A prospective open-label trial was undertaken in 104 adult UC patients. A combination of oral amoxicillin (1500 mg), fosfomycin (3000 mg) and metronidazole (750 mg) was administered to patients daily for 2–4 weeks in addition to their conventional medication. Clinical assessment was performed using the Lichtiger index before treatment and at 0, 3, 6, 9 and 12 months and 2 and 3 years. Endoscopic evaluation was performed using the Mayo score before treatment and at 3 and 12 months. Results: The compliance rate was 99.2%. Response and remission rates were 80.8% and 63.5% at completion, 73.1% and 64.4% at 3 months, and 39.4% for both at 12 months, respectively. Of the 41 patients who were in remission at 12 months, 63.4% maintained that status until the 2-year follow-up. Similarly, 69.2% of those in remission at 2 years remained relapse free at the 3-year follow-up. Side effects were observed in 44.2% of the participants. Fever occurred in one patient (1.0%), which was lower than the rate observed with ATM therapy. Conclusion: These results indicate that AFM therapy induces remission and is appropriate for long-term maintenance of UC while producing fewer and milder adverse events than ATM therapy. Clinical trials: This study was registered in the University Hospital Medical Information Network (No. R000046546).


1990 ◽  
Vol 4 (7) ◽  
pp. 476-480 ◽  
Author(s):  
PB Miner ◽  
WL Biddle

Maintenance of remission is an important consideration in the medical care of patients with ulcerative colitis. The relapse rate is high when medications are discontinued. Many types of medications have been investigated for potential efficacy of maintaining remission. This paper reviews the literature on maintenance therapy for both distal and universal ulcerative colitis. Sulphasalazine is the drug of choice since il is effective and relatively low m cost. 5-aminosalicylic acid (5-ASA) derivatives, both oral and rectal forms, are also effective. Other medications such as metronidazole, cromolyn sodium and prednisone have nor been shown to be effective maintenance therapy. Strategies for maintenance are outlined and include possible regimens with 5-ASA enemas. While 1 g of 5-ASA is effective, the long term relapse rate is similar co that seen with sulphasalazine. Patients capered co 1 g 5-ASA enemas have a good chance of maintaining remission if the colitis does not flare within the first few months, because most colites will flare up early on. Other possible regimens include intermittent enemas, eg, every other night or every third night. Patients in remission can be safely maintained in remission with sulphasalazine or one of its 5-ASA derivatives.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Peter Rutherford ◽  
Dieter Götte

Abstract Background and Aims ANCA associated vasculitis (AAV) is a relapsing remitting long term condition and patients are at risk of organ damage from both active AAV and its therapy in particular high dose and/or prolonged glucocorticoids (GC). The remission maintenance phase of AAV is critical for good long term outcomes including renal preservation as well as preventing AAV relapse. This retrospective study aimed to examine the definition of maintenance, therapy and clinical outcomes in patients managed in routine practice. Method 1478 AAV patients (France, Germany, Italy, Spain and UK) managed by 493 physicians (61% Nephrologists) who completed induction therapy for organ or life threatening AAV and initiated maintenance therapy between 2014-16 were studied. Data were collected retrospectively at the time maintenance was determined to begin by the physician and then at 6, 12, 18 and 36 months. Results 49% had granulomatosis with polyangiitis,; mean age 54.2 years with 56% male. 49% had incident AAV and 51% were studied from the time of a relapse requiring remission induction therapy. 70% received cyclophosphamide and GC and 30% received rituximab and GC as induction treatment with 28% receiving plasma exchange. Physicians defined time of the start of maintenance from induction treatment start with mean of 5.7 months on the basis of fixed time point 40%, starting new drug for maintenance 26%, reaching full remission 26% and no specific criteria 8%. At this time of maintenance start 43% were in full remission vs 50% in partial and 7% refractory. Various maintenance regimes were used, 21% received rituximab (88% 6 monthly and 8% 12 monthly, 4% other) at varying planned doses 34% 1g, 40% 500 mg and 23% 375 mg/m2, 4% other regime. Remission rates varied with patients experiencing disease relapse and many patients experienced adverse events (AE) and infections with prolonged GC use being common. Renal function was relatively unchanged and some patients had worsening eGFR, protein excretion or blood pressure. At the most recent clinical review patients had been followed for a mean of 50.7 months – 6% had died, 38% had relapsed at least once, and 11% required renal replacement therapy. 54% had no vasculitis activity, 26% were ANCA positive without active disease and 19% were still experiencing active disease. 32% were still receiving GCs - 22% of them receiving > 5mg/ day. Conclusion Maintenance therapy is variably defined but typically at 6 months from start of remission induction therapy. Achieving full remission and preventing relapse are still clinical problems and many patients require ongoing GC therapy to maintain remission. Infectious complications and adverse events are common and renal disease remains an ongoing clinical problem.


Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1289
Author(s):  
Volodymyr Gavrysyuk ◽  
Ievgenia Merenkova ◽  
Yaroslav Dziublyk ◽  
Nataliia Morska ◽  
Nataliia Pendalchuk ◽  
...  

Background: There is insufficient information in the literature on the comparative efficacy and tolerability of methotrexate (MTX) and methylprednisolone (MP) in patients with pulmonary sarcoidosis in assessing primary outcomes and the relapse rate. Purpose: The aim of our study was to evaluate primary and long-term outcomes of using MTX and MP in patients with pulmonary sarcoidosis. Methods: A total of 143 patients with newly diagnosed pulmonary sarcoidosis, verified by high-resolution computed tomography (CT) data, were examined. Corticosteroid (CS) therapy was used in 97 patients using MP at a dose of 0.4 mg/kg body weight for 4 weeks, followed by a dose reduction to 0.1 mg/kg by the end of the sixth month. The total duration of CS therapy was 12 months on average. Forty-six patients were treated with MTX at a dose of 10 mg/week (28) and 15 mg/week (18) per os for 6 to 12 months. The study of the relapse rate was conducted within 12 months after the CT data normalization in 60 patients after CS therapy and in 24 after MTX treatment. Results: MP treatment was successfully completed in 68 (70.1%), and MTX in 29 (60.4%) patients. In five MP patients (5.2%) and in five (10.9%) MTX, treatment was discontinued due to serious side effects. In seven (7.2%) MP patients and ten (21.7%) MTX patients, treatment required additional therapy due to the lack of efficacy. Progression with MP treatment (17–17.5%) was more common than with MTX (2–4.3%; Chi square = 4.703, p = 0.031). Relapses after MP therapy were observed in 26 (43.3%) patients, and after MTX therapy in 2 (8.3%; Chi square = 9.450, p = 0.003). Conclusion: In patients with pulmonary sarcoidosis, MTX monotherapy does not differ significantly from MP monotherapy in terms of the level of efficacy and the rate of serious side effects. Increasing the MTX dose from 10 to 15 mg/week accelerates the rate of regression of sarcoidosis, improves treatment efficacy, and does not affect the rate of serious side effects. When using MTX, there is a significant decrease in the incidence of treatment resistance and the relapse rate.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Scheggi ◽  
I Olivotto ◽  
N Ceschia ◽  
I Merilli ◽  
V Andrei ◽  
...  

Abstract Background Despite optimal medical and surgical treatment, mortality in infective endocarditis (IE) remains high. Aim of this study was to identify predictors of long term mortality for any cause, adverse event rate, relapse rate and valvular dysfunction at follow-up, in a high-volume surgical center. Methods We retrospectively analyzed 358 consecutive patients (127 women) admitted to our department with definite diagnosis of IE not device-related. IE occurred on native valves in 224 patients (63%); the infection involved the aortic valve in 192 (54%), mitral valve in 139 (39%) and tricuspid valve in 26 (7%). Overall 285 (80%) patients underwent surgery and 73 (20%) were treated conservatively, 38 due to absence of surgical indication and 35 due to refusal or prohibitive surgical risk. Long-term follow-up was obtained by structured telephone interviews. Primary endpoints were all-cause mortality, freedom from recurrent endocarditis, postoperative incidence of major adverse events (hospitalization for any cause, pace-maker implantation, new onset of atrial fibrillation, sternal dehiscence), worsening of left ventricular ejection fraction (LVEF) and valvular dysfunction. Results Mean age was 65 years (SD 15.2). Mean vegetation length was 8.9 mm (SD 7.6). Endocarditis was left-sided in 332 (93%). Average follow-up was 6 months. At univariable analysis, mortality was associated with female gender (p=0.031), age (p<0.001), higher EuroSCORE 2 (p<0.001), chronic renal failure (p<0.001), diabetes (p=0.002), brain embolism on presentation (p=0.05), double valve infection (p=0.008), low ejection fraction (p<0.001), paravalvular extension (p=0.031), prosthetic infection (p=0.018), exclusion from surgery if indicated (p<0.001), high procalcitonin levels (p=0.035); factors associated with a significantly lower mortality were streptococcal infection (p=0.04; OR 0.34) and early surgery (p=0.009, OR 0.55). At multivariable analysis independent predictors of all-cause mortality were lower EF, EuroSCORE2, procalcitonin levels and diabetes. Non-fatal adverse events were associated with renal failure (p 0.035, OR 2.8). Relapse rate was associated with S aureus infection (p=0.005, OR 3.8), right-sided endocarditis (p<0.001, OR 6.7) and drug abuse (p<0.001, OR 9.4). Conclusions The present study shows that low EF, EuroSCORE2, procalcitonin levels and diabetes are independent predictors of death in patients with IE. Non-fatal adverse events are more frequent in patients with renal failure. Relapse rate is higher in drug abusers. These informations may help personalize follow-up strategies after acute admission for IE. Funding Acknowledgement Type of funding source: None


2021 ◽  
pp. 43-45
Author(s):  
Reena J. Wani ◽  
Sanjay Panchal ◽  
Kinjal Chauhan ◽  
Varun J. Wani ◽  
Priya H. Manihar ◽  
...  

Since the beginning of the COVID-19 Pandemic and Lockdown on March 2020 till date, measures like hand hygiene, social distancing and testing have worked only partially to contain the cases and deaths. Cooper and Nair Hospitals were amongst the nodal centres identied in January 2021 to launch the Nationwide Vaccination drive in Mumbai. Aim: To highlight the pattern of vaccination roll-out, procedures in various phases and discuss concerns, challenges and effect on our workforce and workplan. Methodology: We reviewed the patterns, uptake of vaccine, procedures and problems faced by our vaccination centres from January 15 till April 30 (4 months). We also looked into adverse events following immunization (AEFI) reported. th th Results: Over 68,000 vaccine doses have been administrated in Cooper alone by April end, and issues were analysed in detail with special reference to logistics & challenges. AEFI were very few. We found that initially anxiety about side effects, concerns about choice of vaccine and long-term effects were the major impediments to vaccination. Later on, the demand exceeded the supply. Conclusion: Although vaccination is not the nal answer, it is an important tool to improve our response to the pandemic. Reviewing, restructuring available resources is essential in pandemic situations. Proper planning, counselling and choice in the way forward in this crisis.


Author(s):  
Graham H R Smith ◽  
W Keith Henry ◽  
Daniel Podzamczer ◽  
Maria Del Mar Masiá ◽  
Christopher J Bettacchi ◽  
...  

Abstract Background In the LATTE-2 phase IIb study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with HIV-1. Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over ~5 years. Methods After 20 weeks of oral cabotegravir + abacavir/lamivudine, participants were randomized to cabotegravir + rilpivirine LA Q8W or Q4W or continue oral ART through the 96-week maintenance period. In the extension period through Week 256, participants continued their current LA regimen (randomized Q8W/Q4W groups) or switched from oral ART to Q8W or Q4W LA therapy (extension-switch groups). Endpoints assessed included proportion of participants with HIV-1 RNA <50 copies/mL (Snapshot algorithm) and adverse events (AEs). Results At Week 256, 186 (81%) of 230 participants in randomized Q8W/Q4W groups and 41 (93%) of 44 participants in extension-switch groups had HIV-1 RNA <50 copies/mL. No protocol-defined virologic failures occurred after Week 48. Injection-site reactions infrequently resulted in discontinuation (4 [2%] and 1 [2%] participants in randomized Q8W/Q4W and extension-switch groups, respectively). Three participants in randomized Q8W/Q4W groups experienced drug-related serious AEs, including 1 fatal serious AE (Q4W group); none occurred in extension-switch groups. Of 25 participants with AEs leading to withdrawal, 20 were in the randomized Q4W group; no AE leading to withdrawal occurred in >1 participant. Conclusions Cabotegravir + rilpivirine LA exhibited long-term efficacy and tolerability, demonstrating its durability as maintenance therapy for HIV-1 infection (ClinicalTrials.gov, NCT02120352).


Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Ziad Alkutobi ◽  
Deena Laila ◽  
Mohammad Tariq

Abstract Background Denosumab and zoledronate are increasingly prescribed for primary and secondary osteoporosis long-term management. Methods A retrospective audit was conducted at Basildon Hospital during 2012-2019 using the NICE guidelines standards to evaluate the long term safety and efficacy of denosumab and zoledronate. Number of patients was 84, diagnosed with osteoporosis or osteopenia, 34 of them received 10 or more denosumab injections and 50 patients planned to receive 5 zoledronate infusions (9 patients received 5 and 38 patients received 4). Results Forty percent of the patients were at their 8th decade followed by 28.57% and 21.42 % at their 9th and 7th decades respectively. More than 90% were Caucasian females. Primary prevention was in 39.28% and secondary prevention in 60.71%. The commonest sites of fracture were the wrist and vertebrae at 34.37% for each; followed by the neck of femur and humerous at 12.5% for each. Denosumab was the 1st, 2nd, 3rd or 4th line of treatment in 9.52%, 13.09%, 16.66% and 1.19% respectively; whereas zoledronate was the 1st, 2nd or 3rd line of treatment in 13.09%, 40.47% and 5.95% respectively. The commonest reason for choosing denosumab as the first line was chronic kidney disease, whereas the reason for choosing it as the 2nd or 3rd line was inefficacy of bisphosphonate in 69% or gastrointestinal side effects in 14%. Zoledronate was chosen in all cases because of intolerability to oral bisphosphonate or gastrointestinal side effects. Repeat DXA scan was performed after the 5th, 10th denosumab injections and the 3rd zoledronate infusions. After the 5th Denosumab, DXA scan showed improvement or stability in 100% and 85.29% at the spine and hip respectively whilst deterioration was seen in 14.7% at the hip. After the 10th denosumab, the rate of improvement or stability at the spine was reduced to 88.23% and decline was seen in 2.94%. At the hip area, 73.52% continued to show improvement or stability, whilst 17.66 % showed deterioration. After the 3rd zoledronate, 98% and 88% showed improvement or stability at the spine and hip respectively whilst deterioration seen in 2% and 12% at the spine and hip respectively. One patient on zoledronate experienced dental issues after the 4th injection and stopped treatment. There were no jaw osteonecrosis, no new fractures and no significant side effects with either denosumab or zoledronate. Ninety percent of patients who completed 10 denosumab injections were planned to continue for another 5 injections. Conclusion After the period of 3-5 years, denosumab and zoledronate were well tolerated and BMD was either stable or improved at both spinal and hip sites. There were few cases of deterioration mainly at the hip area with both zoledronate and denosumab. Future researches are needed to stratify guidelines on discontinuation of denosumab. Disclosures Z. Alkutobi None. D. Laila None. M. Tariq None. A. Nandagudi None.


Rheumatology ◽  
2019 ◽  
Vol 59 (4) ◽  
pp. 718-726 ◽  
Author(s):  
Dina Omar ◽  
Yu Chen ◽  
Ye Cong ◽  
Lingli Dong

Abstract Objective To assess the safety and efficacy of glucocorticoids (GCs), immunosuppressive agents (IM) and rituximab (RTX), alone or in combination, for the treatment of IgG4-RD. Methods Relevant articles published were searched in the databases with relevant key words. Network meta-analysis was conducted, with various outcomes including relapse rate, remission rate and adverse events. Data were calculated with odds ratio (ORs) and 95% CI. P-score was used to rank the treatments. Results A total of 15 studies involving 1169 patients were included. Network meta-analysis indicated that RTX maintenance therapy had the lowest relapse rate of all treatments (OR = 0.10, 95% CI [0.01, 1.63]), whereas GCs + IM was associated with a lower relapse rate compared with GCs alone (OR = 0.39, 95% CI [0.20, 0.80]). Further, patients treated with GCs + IM had a higher remission rate than those given GCs (OR= 3.36, 95% CI [1.44, 7.83]), IM (OR= 55.31, 95% CI [13.73, 222.73]) monotherapies or RTX induction therapy only (OR= 7.38, 95% CI [1.56, 34.94]). The rate of adverse events was comparable among the different treatment groups. Conclusion Treatment of IgG4-RD patients with GCs and IM was associated with higher remission rates and lower relapse rates, as well as comparable safety profiles compared with GC, IM and RTX induction therapy. RTX maintenance therapy had a larger reduction in the relapse rate compared with GC and IM. The current evidence should be carefully scrutinized as the included studies were observational in design. Larger randomized controlled trials are needed to confirm.


Sign in / Sign up

Export Citation Format

Share Document