Long term structural effects of combination therapy in patients with early rheumatoid arthritis: five year follow up of a prospective double blind controlled study

Abstract Oral mucositis (OM) is a severely debilitating side effect of chemoradiotherapy that often causes significant pain, diminished quality of life, and increased risk of infections. Palifermin decreases the incidence and duration of severe OM in HM pts receiving myelotoxic therapy and HSCT. Palifermin safety and efficacy have not been established in the non-HM setting. Since the rHuKGF receptor is not expressed by HM, palifermin is not expected to interfere with long-term disease outcomes in this pt population. Aim: We assessed palifermin’s effects on the long-term disease outcomes (survival, disease progression, secondary malignancies) in pts with HM. Methods: Long-term follow-up data were pooled from a 1998 phase 2, double-blind, placebo-controlled study (n=86) and a 2000 double-blind, placebo-controlled phase 3 study (n=212). The analysis included 152 pts treated with palifermin and 146 pts treated with placebo. Pts were assessed at 6-month intervals during the first year and annually thereafter until death or loss to follow-up. The Kaplan-Meier (K–M) method provided estimates of the safety endpoints. Data reported here are as of August 2004. Results: There were 298 pts (152 palifermin: 146 placebo) monitored for long-term follow-up. The median follow-up period was 23.3 months for palifermin and 23.5 months for placebo. The overall survival and progression-free survival curves (p=0.474 and p=0.253, respectively) are similar between the palifermin and placebo groups. Secondary malignancies occurred in only 6 of 152 (3%) palifermin and 5 of 146 (4%) placebo pts. All secondary malignancies were myelodysplastic syndromes: 9 patients with diagnoses of Non-Hodgkin’s lymphoma and 2 patients of Hodgkin’s Disease. The number of deaths was similar between the groups (30% palifermin; 27% placebo); most deaths occurred within 12 months of randomization and were attributable to the underlying HM disease. Conclusion: Use of palifermin for the prevention of severe OM has shown no negative impact on long-term disease outcomes, including survival, in the HSCT setting for patients with HM.

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334 LONG TERM SAFETY AND EFFICACY OF COMBINATION THERAPY WITH VARDENAFIL 10 MG AND TAMSULOSIN 0,4 MG FOR PERSISTENT IRRITATIVE LUTS: A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY

European Urology Supplements ◽

10.1016/s1569-9056(11)60330-8 ◽

2011 ◽

Vol 10 (2) ◽

pp. 123 ◽

Cited By ~ 1

Author(s):

M. Gacci ◽

G. Vittori ◽

G. Siena ◽

M.A. Rossetti ◽

N. Tosi ◽

...

Keyword(s):

Combination Therapy ◽

Controlled Study ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo

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AB0253 The Relation between Pain and Inflammation in Early Rheumatoid Arthritis – Long-Term Follow up in the Swedish Population-Based EIRA and SRQ Register

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2014-eular.2126 ◽

2014 ◽

Vol 73 (Suppl 2) ◽

pp. 887.2-888

Author(s):

M.E. Sandberg ◽

R. Altawil ◽

L. Alfredsson ◽

L. Klareskog ◽

S. Saevarsdottir ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Early Rheumatoid Arthritis ◽

Population Based ◽

Swedish Population ◽

Long Term Follow Up

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Intramuscular versus ultrasound-guided intratenosynovial glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis: a randomised, double-blind, controlled study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-209840 ◽

2016 ◽

Vol 76 (4) ◽

pp. 666-672 ◽

Cited By ~ 8

Author(s):

Mads Ammitzbøll-Danielsen ◽

Mikkel Østergaard ◽

Viktoria Fana ◽

Daniel Glinatsi ◽

Uffe Møller Døhn ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Isotonic Saline ◽

Group Versus ◽

Controlled Study ◽

Fisher Exact Test ◽

Double Blind ◽

Exact Test ◽

Patient Reported ◽

Registration Number

ObjectiveThe aim of this study was to compare the efficacy of intramuscular versus ultrasound (US)-guided intratenosynovial glucocorticoid injection in providing disease control after 2, 4 and 12 weeks in patients with rheumatoid arthritis(RA) with tenosynovitis.MethodsFifty patients with RA and tenosynovitis were randomised into two double-blind groups: (A) ‘intramuscular group’, receiving intramuscular injection of betamethasone and US-guided intratenosynovial isotonic saline injection and (B) ‘intratenosynovial group’ receiving saline intramuscularly and US-guided intratenosynovial betamethasone injection. All patients were in stable disease-modifying anti-rheumatic drug treatment prior to and during the study. Patients were excluded, and considered non-responders, if any treatments were altered during the follow-up period. ‘US tenosynovitis remission’, defined as US tenosynovitis grey-scale score ≤1 and colour Doppler score=0, was assessed at week 4 (primary outcome), and weeks 2 and 12, using non-responder imputation for missing data.ResultsUS tenosynovitis remission at week 4 was achieved in 25% (6/24) in the ‘intramuscular group’ versus 64% (16/25) in the ‘intratenosynovial group’, that is, a difference of −39 percentage point (pp) (CI −65pp to −13pp), Fisher exact test p=0.001. Corresponding values for the ‘intramuscular group’ versus the ‘intratenosynovial group’ at 2 and 12 weeks were 21% (5/24) versus 48% (13/25), that is, a difference of −27pp (CI −53pp to −2pp), p=0.072 and 8% (2/24) versus 44% (11/25), that is, difference of −36pp (−58pp to −13pp), p=0.003. Most US, clinical and patient-reported scores improved more in the ‘intratenosynovial group’ at all follow-up visits.ConclusionsIn this randomised double-blind clinical trial, patients with RA and tenosynovitis responded significantly better to US-guided intratenosynovial glucocorticoid injection than to intramuscular glucocorticoid injection, both at 4 and 12 weeks follow-up.Trial registration numberEudraCT nr: 2013-003486-34.

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Treatment of aggression with topiramate in male borderline patients, part II: 18-month follow-up

European Psychiatry ◽

10.1016/j.eurpsy.2007.09.004 ◽

2008 ◽

Vol 23 (2) ◽

pp. 115-117 ◽

Cited By ~ 25

Author(s):

Marius K. Nickel ◽

Thomas H. Loew

Keyword(s):

Weight Loss ◽

Anger Expression ◽

Controlled Study ◽

Term Therapy ◽

Significant Weight Loss ◽

Double Blind ◽

Long Term Treatment ◽

Borderline Patients

AbstractObjectiveWe previously tested topiramate, an anticonvulsant, in the treatment of aggression in men with borderline personality disorder (BPD) (Nickel M, Nickel C, Kaplan P, Lahmann C, Mühlbacher M, Tritt K, et al. Treatment of aggression with topiramate in male borderline patients: a double-blind, placebo-controlled study. Biol Psychiatry 2005;57:495–9), and found significant changes on most scales of the state–trait anger expression inventory (STAXI) and significant weight loss eight weeks later. The aim of this trial was to assess topiramate's efficacy in the long-term therapy for aggression in men with BPD.MethodsThis 18-month follow-up observation, in which the previous patients (topiramate group: n = 22; former placebo group: n = 22) were examined bianually, was carried out.ResultsAccording to the intent-to-treat principle, significant changes on all scales of the STAXI were observed in the subjects treated with topiramate. Additional significant weight loss was observed. All subjects tolerated topiramate relatively well.ConclusionsTopiramate appears to be an effective, relatively safe agent in the long-term treatment of patients with BPD. Mild, non-transient weight loss can be expected.

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