THU0153 Open-label evaluation of the quality of life of patients treated with etanercept in common rheumatology usage (ecru)

Although fatigue is a common symptom in multiple sclerosis (MS), its pathomechanisms are incompletely understood. Glatiramer acetate (GA), an immunomodulatory agent approved for treatment of relapsing-remitting MS (RRMS), possesses unique mechanisms of action and has been shown to exhibit beneficial effects on MS fatigue. The objective of this study was to correlate clinical, neuropsychological, and immunological parameters in RRMS patients with fatigue before and during treatment with GA. In a prospective, open-label, multicenter trial, 30 patients with RRMS and fatigue were treated with GA for 12 months. Inclusion criterion was the presence of fatigue as one of the most frequent and disabling symptoms. Before and during treatment, fatigue was assessed using the Fatigue Severity Scale (FSS), the MS-FSS, and the Modified Fatigue Impact Scale (MFIS). In addition, fatigue and quality of life were assessed using the Visual Analog Scales (VAS). Laboratory assessments included screening of 188 parameters using real-time PCR microarrays followed by further analysis of several cytokines, chemokines, and neurotrophic factors. Fatigue self-assessments were completed in 25 patients. After 12 months of treatment with GA, 13 of these patients improved in all three scales (with the most prominent effects on the MFIS), whereas 5 patients had deteriorated. The remaining 7 patients exhibited inconsistent effects within the three scales. Fatigue and overall quality of life had improved, as assessed via VAS. Laboratory assessments revealed heterogeneous mRNA levels of cytokines, chemokines, and neurotrophic factors. In conclusion, we were not able to correlate clinical and molecular effects of GA in patients with RRMS and fatigue.

Download Full-text

Clinical Efficacy of 25% l-Ascorbic Acid (C'ensil) in the Treatment of Melasma

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2008.07092 ◽

2009 ◽

Vol 13 (2) ◽

pp. 74-81 ◽

Cited By ~ 22

Author(s):

Seon-Wook Hwang ◽

Doo-Jin Oh ◽

Deborah Lee ◽

Jung-Wook Kim ◽

Sung-Wook Park

Keyword(s):

Quality Of Life ◽

Ascorbic Acid ◽

Skin Pigmentation ◽

Severity Index ◽

Transepidermal Water Loss ◽

Open Label ◽

Effective Treatment Modality ◽

Quality Of Life Scale ◽

Life Scale

Background: l-Ascorbic acid is used to treat melasma; however, it is quickly oxidized in aqueous solutions. Thus, C'ensil, a formulation containing 25% l-ascorbic acid and a chemical penetration enhancer, was created to promote the penetration of l-ascorbic acid into the skin. Objective: To evaluate the efficacy of C'ensil in patients with melasma. Methods: Forty subjects with melasma were treated with C'ensil during an open-label trial over a period of 16 weeks. Each subject's skin pigmentation was assessed every 4 weeks using the Melasma Area and Severity Index (MASI) and mexameter score. In addition, transepidermal water loss, skin dryness and irritation, and quality of life (Melasma Quality of Life Scale [MelasQoL]) were evaluated. Results: After 16 weeks, a significant decrease was noted in the degree of pigmentation based on the patients' MASI and mexameter scores. MelasQoL scores also decreased, indicating an increase in the subjects' quality of life. Conclusion: Our data indicate that C'ensil is an effective treatment modality for melasma.

Download Full-text

S1056 Quality-of-Life Improvements in Patients with Crohn's Disease Treated for 3 Years with Adalimumab in An Open-Label Extension of CHARM

Gastroenterology ◽

10.1016/s0016-5085(09)60806-4 ◽

2009 ◽

Vol 136 (5) ◽

pp. A-179 ◽

Cited By ~ 1

Author(s):

Edward V. Loftus ◽

Jean-Frederic Colombel ◽

Paul Rutgeerts ◽

David T. Rubin ◽

Naijun Chen ◽

...

Keyword(s):

Quality Of Life ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Open Label ◽

Open Label Extension

Download Full-text

Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS)

European Journal of Cancer ◽

10.1016/j.ejca.2021.04.028 ◽

2021 ◽

Vol 152 ◽

pp. 116-128

Author(s):

Helen Gogas ◽

Reinhard Dummer ◽

Paolo A. Ascierto ◽

Ana Arance ◽

Mario Mandalà ◽

...

Keyword(s):

Quality Of Life ◽

Phase Iii ◽

Open Label ◽

Phase Iii Study ◽

Braf Mutant

Download Full-text

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽

10.1093/neuros/nyx363 ◽

2017 ◽

Vol 83 (1) ◽

pp. 146-153 ◽

Cited By ~ 2

Author(s):

Pierre-Yves Borius ◽

Stéphanie Ranque Garnier ◽

Karine Baumstarck ◽

Frédéric Castinetti ◽

Anne Donnet ◽

...

Keyword(s):

Quality Of Life ◽

Pain Relief ◽

Cancer Pain ◽

Controlled Trial ◽

Analgesic Efficacy ◽

Standards Of Care ◽

Control Group ◽

Efficacy And Safety ◽

Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

Download Full-text