scholarly journals Natalizumab treatment shows low cumulative probabilities of confirmed disability worsening to EDSS milestones in the long-term setting

2018 ◽  
Vol 24 ◽  
pp. 11-19 ◽  
Author(s):  
Maria Trojano ◽  
Helmut Butzkueven ◽  
Ludwig Kappos ◽  
Heinz Wiendl ◽  
Tim Spelman ◽  
...  
Keyword(s):  
Natalizumab Treatment ◽  
Cumulative Probabilities

scholarly journals P665 Which second-line biologic after anti-TNF failure during Crohn’s disease: Ustekinumab or vedolizumab, a multicentre retrospective study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S547-S547 ◽  
Author(s):  
C Rayer ◽  
X Roblin ◽  
D Laharie ◽  
B Caron ◽  
M Flamant ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Side Effects ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Risk Model ◽  
Second Line ◽  
Faecal Calprotectin ◽  
Drug Survival ◽  
Cumulative Probabilities

Abstract Background Anti-TNF antibodies treatments are the only first-line reimbursed biologics for Crohn’s disease (CD) in several countries. Recently, Vedolizumab (VDZ) and Ustekinumab (UST) were added to the therapeutic armamentarium for CD refractory to a first anti-TNF antibody. However, studies comparing these two compounds remain unavailable. Our aim was to compare their efficacy in second-line treatment in CD after failure of one TNF antagonist. Methods All patients with CD refractory (primary or secondary non-responders) to first anti-TNF treatment and receiving UST or VDZ as a second biologic were included retrospectively in 10 French tertiary centres. The remission and clinical response were assessed at week 14. On the long-term, the cumulative probabilities of being in remission were estimated using the Kaplan–Meier method and the associated factors using a Cox proportional risk model. The drug survival to assess efficacy as well as side effects was assessed by actuarial analysis. Results 88 patients were included, 50 (57%) females (mean age: 41 ± 15 years), 61 (69%) being treated with UST and 27 (31%) with VDZ. The first anti-TNF was discontinued for primary or secondary non-response in 66 (75%) patients and for side effects in 22 (25%) patients, without any difference between the anti-TNF antibody previously used. Among the 55 patients with endoscopic data at baseline, 55 (98%) had ulceration, a CRP above 5mg/l for 33/71 (46%) patients and a faecal calprotectin > 250 µg/g for the 12 patients tested. At week 14, no difference was observed for clinical response and clinical remission according to the type of treatment: the rate of clinical response and remission were 74% (UST)/58% (VDZ) (p = 0.20) and 33% (UST)/26% (VDZ) (p = 0.56), respectively. The only factor associated with short-term remission was the lack of optimisation prior to anti-TNF discontinuation (p = 0.038) regardless of the type of second-line therapy (UST, p = 0.02; VDZ, p = 0.03). After a mean follow-up of 67 weeks, the cumulative probabilities of being in remission at 6 and 12 months were 16% and 34% for UST and 25% and 44% for VDZ, respectively (p = 0.24 for UST vs. VDZ). The drug survival was higher in the UST group as compared with the VDZ group (HR (UST vs. VDZ) = 2.36 [1.02–5.5], p = 0.04). Conclusion Our preliminary results suggest that VDZ and UST have similar efficacy in the short- and long-term response when used as a second-line biologic therapy in CD refractory to a first anti-TNF antibody. These results will be complemented for the congress by the inclusion of additional patients recruited into this registry.

scholarly journals Salvage surgery for continent ileostomies (CI) after a first successful revision: more long-term blame on the reservoir than the nipple valve

2021 ◽  
Author(s):  
Karl-Wilhelm Ecker ◽  
Mathias Tönsmann ◽  
Nils Karl Josef Ecker ◽  
Gabriela Möslein
Keyword(s):  
Revisional Surgery ◽  
Underlying Disease ◽  
Cumulative Probability ◽  
Nipple Valve ◽  
Retrospective Data Analysis ◽  
Kaplan Meier ◽  
Linear Rise ◽  
Cumulative Probabilities

Abstract Purpose The aim of the study was to investigate the underlying cause of long-term complications in patients requiring at least one revision surgery of a continent ileostomy (CI) and to analyze functional outcome. Methods Only patients with CI at least one revision were included in the retrospective data analysis. Four different classes of complications (Cl A–D) were defined: Cl A = Nipple valve (NV), Cl B = pouch, Cl C = outlet (stoma), and Cl D = afferent loop (AL). Associations between underlying disease and origin of complications were analyzed. Cumulative probabilities were calculated using Kaplan–Meier analysis. Results A total of 77 patients were identified with a follow-up of 30 years, requiring 133 surgeries for 148 complications (c.). Cl A 49 c. (33.1%), Cl B 50 c. (33.8%), Cl C 39 c. (26.4%), and Cl D 10 c. (6.8%). Cl A and C complications were not correlated to underlying disease, whereas Cl B and D complications were only found in ulcerative colitis (UC) and Crohn’s disease (CD). The cumulative probability of a second revision showed a linear rise, reaching 62.5% after 20 years. Cl A and B complications both reached 42.1%. Eleven (14.3%) patients (10 Cl B) had pouch failure in a follow-up period of 11.5 ± 8.7 years (1–31 years), whereas 66 (85.7%) had successful revisional surgery. Overall CI survival was 78.8% at 44 years. Conclusion CI survival is limited by inflammatory complications of the pouch based on the underlying disease and not by mechanical limitations of the NV. Trial registration numbers None.

REDUCED MS RELAPSE RATES WITH NATALIZUMAB: TOP UK COHORT

2015 ◽  
Vol 86 (11) ◽  
pp. e4.5-e4
Author(s):  
Richard Nicholas ◽  
Roger Berry
Keyword(s):  
Steroid Treatment ◽  
Long Term Outcomes ◽  
Open Label ◽  
Prior Therapy ◽  
Relapsing Remitting ◽  
Natalizumab Treatment ◽  
Previously Treated ◽  
The Uk ◽  
Relapsing Remitting Multiple Sclerosis

IntroductionThe Tysabri® Observational Program (TOP) is a 10-year, ongoing, global, open-label study of long-term outcomes in natalizumab-treated patients with relapsing-remitting multiple sclerosis.MethodsBaseline characteristics were summarised. On-treatment annualised relapse rate (ARR) was compared with baseline.ResultsAs of 1 May 2014, the UK cohort included 134 patients. Median disease duration was 5.3 years and 84 patients (62.7%) had prior treatment with ≥1 other therapy. ARR decreased from 2.21 at baseline to 0.29 (86.9% reduction; p<0.0001); on-treatment ARR was low with ≥6 months of treatment (0.29; 87.2% reduction; p<0.0001; n=120) and remained low after ≥3.5 years (0.33; 85.7% reduction; p<0.0001; n=20). In patients previously treated with interferon or glatiramer acetate, ARR decreased by 83.5%–87.7% (p≤0.0009). Relapses resulting in hospitalisation or steroid treatment decreased by 93.3% (p<0.0001) and 86.5% (p<0.0001), respectively.ConclusionsUK TOP patients exhibited ≥83.5% reduction in ARR with ≥6 months of natalizumab treatment regardless of prior therapy, a reduction maintained over ≥3.5 years with no waning of effect. Relapses resulting in hospitalisation or steroid treatment were significantly reduced post natalizumab therapy initiation.Sponsored by Biogen Idec Ltd. Disclosures: RN: grant and conference travel support from Biogen Idec Ltd. RB: employee of Biogen Idec Ltd.

scholarly journals Serum contactin-1 as a biomarker of long-term disease progression in natalizumab-treated multiple sclerosis

2021 ◽  
pp. 135245852110100
Author(s):  
Zoë YGJ van Lierop ◽  
Luuk Wieske ◽  
Marleen JA Koel-Simmelink ◽  
Madhurima Chatterjee ◽  
Iris Dekker ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Odds Ratio ◽  
Prognostic Biomarker ◽  
Disability Progression ◽  
Lower Baseline ◽  
Relapsing Remitting ◽  
Natalizumab Treatment

Background: Natalizumab treatment provides a model for non-inflammation-induced disease progression in multiple sclerosis (MS). Objective: To study serum contactin-1 (sCNTN1) as a novel biomarker for disease progression in natalizumab-treated relapsing-remitting MS (RRMS) patients. Methods: Eighty-nine natalizumab-treated RRMS patients with minimum follow-up of 3 years were included. sCNTN1 was analyzed at baseline (before natalizumab initiation), 3, 12, 24 months (M) and last follow-up (median 5.2 years) and compared to 222 healthy controls (HC) and 15 primary progressive MS patients (PPMS). Results were compared between patients with progressive, stable, or improved disability according to EDSS-plus criteria. Results: Median sCNTN1 levels (ng/mL,) in RRMS (baseline: 10.7, 3M: 9.7, 12M: 10.4, 24M: 10.8; last follow-up: 9.7) were significantly lower compared to HC (12.5; p ⩽ 0.001). It was observed that 48% of patients showed progression during follow-up, 11% improved, and 40% remained stable. sCNTN1 levels were significantly lower in progressors both at baseline and at 12M compared to non-progressors. A 1 ng/mL decrease in baseline sCNTN1 was consistent with an odds ratio of 1.23 (95% confidence interval 1.04–1.45) ( p = 0.017) for progression during follow-up. Conclusion: Lower baseline sCNTN1 concentrations were associated with long-term disability progression during natalizumab treatment, making it a possible blood-based prognostic biomarker for RRMS.

scholarly journals Stereotactic radiosurgery for pediatric brain arteriovenous malformations: long-term outcomes

2020 ◽  
Vol 25 (5) ◽  
pp. 497-505
Author(s):  
Ching-Jen Chen ◽  
Cheng-Chia Lee ◽  
Hideyuki Kano ◽  
Kathryn N. Kearns ◽  
Dale Ding ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Arteriovenous Malformations ◽  
Pediatric Patients ◽  
Cyst Formation ◽  
Tumor Formation ◽  
Long Term Outcomes ◽  
Risk Of Death ◽  
Brain Arteriovenous Malformations ◽  
Cumulative Probabilities

OBJECTIVEContrary to the better described obliteration- and hemorrhage-related data after stereotactic radiosurgery (SRS) of brain arteriovenous malformations (AVMs) in pediatric patients, estimates of the rarer complications, including cyst and tumor formation, are limited in the literature. The aim of the present study was to assess the long-term outcomes and risks of SRS for AVMs in pediatric patients (age < 18 years).METHODSThe authors retrospectively analyzed the International Radiosurgery Research Foundation pediatric AVM database for the years 1987 to 2018. AVM obliteration, post-SRS hemorrhage, cyst formation, and tumor formation were assessed. Cumulative probabilities, adjusted for the competing risk of death, were calculated.RESULTSThe study cohort comprised 539 pediatric AVM patients (mean follow-up 85.8 months). AVM obliteration was observed in 64.3% of patients, with cumulative probabilities of 63.6% (95% CI 58.8%–68.0%), 77.1% (95% CI 72.1%–81.3%), and 88.1% (95% CI 82.5%–92.0%) over 5, 10, and 15 years, respectively. Post-SRS hemorrhage was observed in 8.4% of patients, with cumulative probabilities of 4.9% (95% CI 3.1%–7.2%), 9.7% (95% CI 6.4%–13.7%), and 14.5% (95% CI 9.5%–20.5%) over 5, 10, and 15 years, respectively. Cyst formation was observed in 2.1% of patients, with cumulative probabilities of 5.5% (95% CI 2.3%–10.7%) and 6.9% (95% CI 3.1%–12.9%) over 10 and 15 years, respectively. Meningiomas were observed in 2 patients (0.4%) at 10 and 12 years after SRS, with a cumulative probability of 3.1% (95% CI 0.6%–9.7%) over 15 years.CONCLUSIONSAVM obliteration can be expected after SRS in the majority of the pediatric population, with a relatively low risk of hemorrhage during the latency period. Cyst and benign tumor formation after SRS can be observed in 7% and 3% of patients over 15 years, respectively. Longitudinal surveillance for delayed neoplasia is prudent despite its low incidence.

scholarly journals Long-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis

2017 ◽  
Vol Volume 11 ◽  
pp. 1035-1048 ◽  
Author(s):  
John Foley ◽  
Kavita Nair ◽  
Timothy Vollmer ◽  
Judith Stephenson ◽  
Timothy Niecko ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Natalizumab Treatment

scholarly journals Effectiveness of Selective Laser Trabeculoplasty Applied to 360° vs. 180° of the Angle

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Abraham Nirappel ◽  
Emma Klug ◽  
Rebecca Ye ◽  
Nathan Hall ◽  
Marika Chachanidze ◽  
...  
Keyword(s):  
Proportional Hazard ◽  
Selective Laser Trabeculoplasty ◽  
Proportional Hazard Model ◽  
Laser Trabeculoplasty ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Significant Difference ◽  
The Mean ◽  
Cumulative Probabilities

Purpose. To compare the effectiveness and safety of 360° and 180° of Selective Laser Trabeculoplasty (SLT) for the treatment of elevated intraocular pressure (IOP). Methods. Retrospective cohort study. The main outcome measure was the Kaplan–Meier analysis comparing the cumulative probabilities of survival between the 360° and 180° SLT groups in terms of IOP reduction. Success was defined as ≥20% IOP reduction from baseline with an IOP between 5–18 mmHg and ≤1 glaucoma medication added postoperatively. Additional outcome measures included changes in average IOP, number of glaucoma medications, and the incidence of postoperative IOP spikes. Measurements were obtained at 6 weeks, 1 year, and 2 years postoperatively. Results. Two hundred and fifty-eight eyes of 258 patients were included in the 360° group, and 196 eyes of 196 patients were included in the 180° group. The mean IOP reductions at 2 years were 2.21 ± 2.02 mmHg and 2.43 ± 1.81 mmHg ( p = 0.33 ) in the 180° and 360° groups, respectively. There were no significant differences in the incidence of postoperative IOP spikes between the two groups. There was a significant difference in the survival curves of the two groups ( p = 0.035 ). The Cox proportional-hazard model indicated that 360° of SLT application was a significant predictor of long-term success ( p = 0.030 ). Conclusions. 360° of SLT application seems to provide for greater long-term IOP control than 180° of application without putting patients at an elevated risk for postoperative IOP spikes.

Pregnancy and natalizumab: results of an observational study in 35 accidental pregnancies during natalizumab treatment

2011 ◽  
Vol 17 (8) ◽  
pp. 958-963 ◽  
Author(s):  
Kerstin Hellwig ◽  
Aiden Haghikia ◽  
Ralf Gold
Keyword(s):  
Post Partum ◽  
Termination Of Pregnancy ◽  
Control Group ◽  
Healthy Children ◽  
Relapsing Remitting ◽  
Planned Pregnancy ◽  
Natalizumab Treatment ◽  
Elective Termination ◽  
Relapsing Remitting Multiple Sclerosis

Background: Natalizumab, a therapeutic monoclonal antibody approved for the treatment of relapsing–remitting multiple sclerosis (RRMS), is recommended to be withdrawn 3 months prior to a planned pregnancy. Our aim was to analyse the safety and impact of natalizumab exposure on course of disease and pregnancy outcome. Objectives: Prospective follow-up of women with MS who became accidentally pregnant during natalizumab treatment in comparison with pregnancies of women with MS not exposed to disease-modifying treatments (DMT). Method: 35 women with MS who became accidentally pregnant while treated with natalizumab, and 23 women with MS who became pregnant devoid of any DMT as a control group, were chosen. Results: All pregnancies except one were followed in a prospective fashion. Of the women exposed to natalizumab during pregnancy, 29 women gave birth to 28 healthy children; one child was born with hexadactyly. Five pregnancies ended in an early miscarriage and one woman decided to undergo an elective termination of pregnancy. MS activity did not rebound during pregnancy or post partum after natalizumab was withdrawn, and no significant differences were observed when compared with the non-DMT-exposed control group. Conclusion: Our data may support the notion that an elective termination of pregnancy due to natalizumab exposure may not be necessary, but rather requires careful monitoring. Women should still be advised to stop natalizumab in the course of planned pregnancy until more data on long-term outcomes are available.

scholarly journals Stereotactic Radiosurgery for Pediatric Brain Arteriovenous Malformations: Long-Term Outcomes

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Ching-Jen Chen ◽  
Cheng-Chia Lee ◽  
Kathryn N Kearns ◽  
Dale Ding ◽  
Douglas Kondziolka ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Arteriovenous Malformations ◽  
Cyst Formation ◽  
Tumor Formation ◽  
Cumulative Probability ◽  
Long Term Outcomes ◽  
Risk Of Death ◽  
Brain Arteriovenous Malformations ◽  
Cumulative Probabilities

Abstract INTRODUCTION Contrary to the better described obliteration and hemorrhage data after stereotactic radiosurgery (SRS) treatment of brain arteriovenous malformations (AVMs) in pediatric patients, estimates of the rarer complications including cyst and tumor formation are limited in the literature. The aim of the study was to assess the long-term outcomes and risks of SRS for AVMs in pediatric (age < 18 yr) patients. METHODS We retrospectively analyzed the International Radiosurgery Research Foundation pediatric AVM database from 1987 to 2018. AVM obliteration, post-SRS hemorrhage, cyst formation, and tumor formation were assessed. Cumulative probabilities, adjusted for competing risk of death, were calculated. RESULTS The study cohort comprised 539 pediatric AVM patients (mean follow-up: 85.8 mo). AVM obliteration was observed in 64.3% of patients, with cumulative probabilities of 63.6% (95% CI: 58.8%-68.0%), 77.1% (95% CI: 72.1%-81.3%), and 88.1% (95% CI: 82.5%-92.0%) over 5, 10, and 15 yr, respectively. Post-SRS hemorrhage was observed in 8.4% of patients, with cumulative probabilities of 4.9% (95% CI: 3.1%-7.2%), 9.7% (95% CI: 6.4%-13.7%), and 14.5% (95% CI: 9.5%-20.5%) over 5, 10, and 15 yr, respectively. Cyst formation was observed in 2.1% of patients, with cumulative probabilities of 5.5% (95% CI: 2.3%-10.7%) and 6.9% (95% CI: 3.1%-12.9%) over 10 and 15 yr, respectively. Meningioma was observed in 2 patients (0.4%) at 10 and 12 yr after SRS, with cumulative probability of 3.1% (95% CI: 0.6%-9.7%) over 15 yr. CONCLUSION AVM obliteration can be expected after SRS in the majority of the pediatric population, with a relatively low risk of hemorrhage during the latency period. Cyst and benign tumor formation after SRS can be observed in 7% and 3% of patients over 15 yr, respectively. Longitudinal surveillance for delayed neoplasia is prudent despite its low incidence.

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