scholarly journals Sustained Response To Onabotulinumtoxin A In Patients With Chronic Migraine: Real-Life Data

2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Simona Guerzoni ◽  
Carlo Baraldi ◽  
Luana Evangelista ◽  
Ilaria Frattale ◽  
...  
Keyword(s):  
Clinical Response ◽  
Chronic Migraine ◽  
Treatment Cycle ◽  
Real Life ◽  
Sustained Response ◽  
Response To Treatment ◽  
Main Body ◽  
The Third ◽  
Onabotulinumtoxin A

Abstract Background Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM. Main body In this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥50% reduction in headache days during any three-month treatment cycle compared with the three months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response. The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22-38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P=0.030) and a lower number of headache days (median 25 vs 30; P=0.013) at baseline compared with non-responders. Conclusions About two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.

scholarly journals Sustained Response To Onabotulinumtoxin A In Patients With Chronic Migraine: Real-Life Data

2020 ◽  
Author(s):  
Raffaele Ornello ◽  
Simona Guerzoni ◽  
Carlo Baraldi ◽  
Luana Evangelista ◽  
Ilaria Frattale ◽  
...  
Keyword(s):  
Clinical Response ◽  
Chronic Migraine ◽  
Treatment Cycle ◽  
Real Life ◽  
Sustained Response ◽  
Response To Treatment ◽  
Main Body ◽  
The Third ◽  
Onabotulinumtoxin A

Abstract Background. Treatment with onabotulinumtoxin A (BT-A) is safe and effective for chronic migraine (CM). Several studies assessed possible predictors of response to treatment with BT-A, but there is little knowledge on the frequency and predictors of sustained response. The aim of this study was to evaluate sustained response to BT-A in patients with CM.Main body. In this prospective open-label study, 115 patients with CM and treated with BT-A were consecutively enrolled in two Italian headache centers and followed up for 15 months. Anytime responders were defined as those patients who achieved a ≥50% reduction in headache days during any three-month treatment cycle compared with the three months prior to initiation of BT-A treatment. Sustained responders were defined as those who achieved a ≥50% reduction in headache days within the third treatment cycle and maintained response until the end of follow-up. Non-responders were defined as those patients who never achieved a ≥50% reduction in headache days during the follow-up. Headache characteristics prior to BT-A treatment were assessed in order to evaluate their ability in predicting treatment response.The 115 enrolled patients (84.3% female; median age 50 years) had a median migraine duration of 30 years (interquartile range 22-38). At the end of follow-up, 66 patients (57.4%) were classified as anytime responders. Among the 51 patients who achieved a clinical response within the third month of treatment, 33 (64.7%) were sustained responders. Patients with sustained response had a lower CM duration (median 31 vs 65 months; P=0.030) and a lower number of headache days (median 25 vs 30; P=0.013) at baseline compared with non-responders.Conclusions. About two thirds of patients who gain ≥50% response to BT-A within the third cycle of treatment maintain this positive response over time. More recent onset of CM and more headache-free days at baseline are associated with sustained response. We suggest not to delay preventive treatment of CM with BT-A, in order to increase the likelihood to achieve sustained clinical response.

Wearing Off Response to OnabotulinumtoxinA in Chronic Migraine: Analysis in a Series of 193 Patients

Pain Medicine ◽  
2019 ◽  
Vol 20 (9) ◽  
pp. 1815-1821 ◽  
Author(s):  
Sonia Quintas ◽  
David García-Azorín ◽  
Patricia Heredia ◽  
Blanca Talavera ◽  
Ana Beatriz Gago-Veiga ◽  
...  
Keyword(s):  
Clinical Response ◽  
Chronic Migraine ◽  
Treatment Cycle ◽  
Real Life ◽  
Cumulative Effect ◽  
Full Length ◽  
Clinical Predictors ◽  
Duration Of Response ◽  
Wearing Off

Abstract Objective Long-term real-life studies have supported a cumulative effect of OnabotulinumtoxinA (OnabotA) for the prophylactic treatment of chronic migraine (CM) during consecutive cycles, and individual adaptations have been described to improve clinical response. Methods This was a cohort longitudinal retrospective study of consecutive adult patients from the Headache Unit of the Hospital Clínico Universitario de Valladolid and the Hospital Universitario de La Princesa (Madrid) on OnabotA treatment for chronic migraine from May 2012 to December 2017. All patients were followed for 24 weeks. Full-length response to OnabotA was defined as ≥50% reduction in headache days for at least 12 weeks, and wearing off response was defined as a clinical response but with duration shorter than 10 weeks. We have analyzed the incidence and clinical predictors of this wearing off response. Results A total of 193 patients were included, of whom 91 (47.1%) were considered full-length responders and 45 (23.3%) wearing off responders. No statistically significant clinical predictors (including demographic variables and baseline headache characteristics) of full-length response or wearing off response were detected in our study. An increase in dose during the second treatment cycle was attempted in 68.9% of the wearing off patients, achieving a longer duration of response of up to 12 weeks in 74.2%. Conclusions Wearing off response to OnabotA during the first treatment cycle is not uncommon in patients with CM. Increasing the dose in subsequent cycles could improve clinical response, but further multicenter long-term studies are needed to establish predictors and solutions to this problem.

scholarly journals Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Raffaele Ornello ◽  
Simona Guerzoni ◽  
Carlo Baraldi ◽  
Luana Evangelista ◽  
Ilaria Frattale ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real Life ◽  
Sustained Response ◽  
Life Data ◽  
Onabotulinumtoxin A ◽  
Real Life Data

Onabotulinumtoxin‐A in Chronic Migraine: Should Timing and Definition of Non‐Responder Status Be Revised? Suggestions From a Real‐Life Italian Multicenter Experience

2019 ◽  
Vol 59 (8) ◽  
pp. 1300-1309 ◽  
Author(s):  
Fabrizio Vernieri ◽  
Matteo Paolucci ◽  
Claudia Altamura ◽  
Patrizio Pasqualetti ◽  
Vincenzo Mastrangelo ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real Life ◽  
Onabotulinumtoxin A ◽  
Definition Of

scholarly journals P663 Efficacy of tofacitinib in patients with ulcerative colitis after previous ineffective biological therapies

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S545-S546
Author(s):  
M Rutka ◽  
K Farkas ◽  
D Pigniczki ◽  
K Szántó ◽  
B Anita ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Induction Therapy ◽  
Dose Escalation ◽  
Real Life ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Mayo Score ◽  
Number Of Patients

Abstract Background Tofacitinib (TFC) is an oral, small-molecule Janus kinase inhibitor, which was recently approved for moderate to severe ulcerative colitis (UC). The aim of the current real-life study was to determine efficacy of TFC induction therapy regarding the clinical response and remission in patients with active UC. We evaluated short-term efficacy data in a Hungarian cohort with prior exposure to other biological agents such as anti-TNF drugs and vedolizumab. Methods In this single-centre retrospective study, patients with TFC introduction were included. Since January 2019, a total of 16 patients received an oral TFC induction therapy in a dose of 10 mg twice daily for 8 weeks. Endoscopic activity was evaluated by endoscopic Mayo (eMayo) score before the introduction of TFC and in case of an inadequate therapeutic response to the 5-mg-therapy to confirm therapeutic decision-making. Based on the evaluation of clinical symptoms and laboratory parameters, we either kept the dosage or reduced the dose to 5 mg according to local regulations. We also collected data from the 16. and 24. weeks of the therapy. Primary endpoints were a clinical response (as a reduction in partial Mayo Score [pMayo] by minimum 3 points) or remission (as a Mayo score of the maximum of 2 points and without blood in stool) at week 8. Results Sixteen patients had received the induction therapy (mean age: 36 years, 7 males and 9 females) in our centre. After 8 weeks, 12 (75%) patients responded to the TFC induction therapy and 6 (37.5%) of them were in remission. Four patients were primary non-responders (25%). Corticosteroid therapy (18 ± 7 mg) was required during the induction in 4 responder cases, which could be stepped down by week 8. As a continuous maintenance therapy, 4 patients have already reached the 16th week and 8 have completed the 24th week. By the end of the follow-up, 12 patients responded and 10 was in remission. During the observation period, 3 patients had to remain on 10 mg TFC dose, 6 patients required dose escalation from 5 mg to 10 mg and 5 mg was sufficient in case of only 3 patients after the introduction. Endoscopic activity showed a moderate decrease from 2.5 ± 0.5 eMayo score to 2 ± 1 (n = 7) until week 16. In respect the responder patients, CRP levels decreased from the mean of 7.23 to 5.02. No serious side-effects were observed during the follow-up. Conclusion After the 8-week TFC induction therapy, the response rate was high and only every fourth patients were non-responder. A low number of patients had adequate reactions to the 5 mg-therapy after the introduction, but TFC is effective with dose-escalation in respect of clinical response and remission in patients with UC, who have had an inadequate response to previous biological therapy.

scholarly journals P668 Real-life comparison of different anti-TNF biologic therapies for ulcerative colitis treatment: A retrospective cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S548-S549
Author(s):  
B Barberio ◽  
F Zingone ◽  
R D’Incà ◽  
C Marinelli ◽  
M C Maccarone ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Drug Exposure ◽  
Real Life ◽  
Intention To Treat ◽  
Tnf Α ◽  
Ulcerative Colitis Treatment ◽  
Similar Good

Abstract Background Currently, ulcerative colitis (UC) can be treated with different anti-Tumor Necrosis Factor (TNF) drugs, which selection is mainly based on physician’s perspective. Indeed, head-to-head comparison studies evaluating the effectiveness and tolerability of anti-TNF drugs are lacking. The aim of this study was to compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate to severe UC. Methods Retrospectively, 122 UC patients treated with Infliximab (IFX) Originator and Biosimilar, Adalimumab (ADA) and Golimumab (GOL) were included. We performed an intention to treat analysis to evaluate the clinical response, clinical remission, steroid-free clinical remission and endoscopy response according to the different time-points of the follow-up (ie. after induction, at 30 and 52 weeks). Baseline and post-induction predictor factors of these outcomes were evaluated using multivariate logistic regressions models. Data were analyzed using STATA11 software. Results Overall clinical response was 79.5% after induction, 79.5% at 30 weeks, 75.4% at 52 weeks, while the overall steroid-free clinical remission was 42.6%, 45.1%, 55.7%, respectively. After induction, a higher rate of treatment failure was observed in GOL group. Moreover, at the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL (38.7% and 54.8% with p = 0.006 and p = 0.003, respectively). At week 52, endoscopic response was achieved by 46.5% of the population (IFX Originator: 46.7%; IFX Biosimilar: 40%; ADA: 51.6%; GOL: 22.6%; p = 0.003). Conclusion Among the different anti-TNF treatment, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile. Current possibility of optimising also GOL will clarify whether these discrepancies are due to reduced drug exposure to GOL.

scholarly journals Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

2021 ◽  
Author(s):  
Antonio Tursi ◽  
Giammarco Mocci ◽  
Walter Elisei ◽  
Leonardo Allegretta ◽  
Raffaele Colucci ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Clinical Remission ◽  
Real Life ◽  
Mucosal Healing ◽  
Term Treatment ◽  
Short Term Treatment ◽  
Mayo Score

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

scholarly journals Real-life data in 115 chronic migraine patients treated with Onabotulinumtoxin A during more than one year

2016 ◽  
Vol 17 (1) ◽  
Author(s):  
I. Aicua-Rapun ◽  
E. Martínez-Velasco ◽  
A. Rojo ◽  
A. Hernando ◽  
M. Ruiz ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Real Life ◽  
Life Data ◽  
Onabotulinumtoxin A ◽  
Real Life Data ◽  
One Year

Concentrations of doxycycline and penicillin G in sera and cerebrospinal fluid of patients treated for neuroborreliosis.

1996 ◽  
Vol 40 (5) ◽  
pp. 1104-1107 ◽  
Author(s):  
M Karlsson ◽  
S Hammers ◽  
I Nilsson-Ehle ◽  
A S Malmborg ◽  
B Wretlind
Keyword(s):  
Cerebrospinal Fluid ◽  
Borrelia Burgdorferi ◽  
Treatment Failure ◽  
Clinical Response ◽  
Drug Administration ◽  
Drug Concentration ◽  
Response To Treatment ◽  
Penicillin G ◽  
Good Clinical Response

Concentrations of doxycycline and penicillin G in serum and cerebrospinal fluid (CSF) were analyzed in 46 patients during treatment for neuroborreliosis. Twenty patients were treated intravenously with penicillin G at 3 g every 6 h (q6h), and 26 patients were treated orally with doxycycline at 200 mg q24h. All samples were collected on day 13 of treatment. The median concentrations of penicillin G in serum were 0.5, 37, and 5.6 micrograms/ml before and 1 and 3 h after drug administration, and that in CSF was 0.5 (range, 0.3 to 1.6) microgram/ml after 2 to 3 h. The median concentrations of doxycycline in serum were 2.1, 6.1, and 4.7 micrograms/ml before and 2 and 6 h after drug administration, and that in CSF was 0.6 (range, 0.4 to 2.5) microgram/ml after 4 h. All patients had concentrations of penicillin G or doxycycline in CSF above the lowest reported MICs of penicillin G (0.003 microgram/ml) and doxycycline (0.12 microgram/ml) for Borrelia burgdorferi. However, no patients had a drug concentration in CSF above the highest reported MIC of penicillin G (8 micrograms/ml), and only one had a drug concentration in CSF above the highest reported MIC of doxycycline (2 micrograms/ml), despite good clinical response to treatment. No treatment failure or relapse was observed during a 1-year follow-up, although one patient treated with penicillin G and one treated with doxycycline were retreated because of residual pain. The chosen dosages of penicillin G and doxycycline seem to give sufficient concentrations in serum and CSF for the treatment of neuroborreliosis.

scholarly journals Long term outcome for onabotulinumtoxinA (Botox) therapy in chronic migraine: A 2-year prospective follow-up audit of patients attending the Hull (UK) migraine clinic

2021 ◽  
Vol 4 ◽  
pp. 251581632098544
Author(s):  
Fayyaz Ahmed ◽  
Alina Buture ◽  
Taukir Tanvir ◽  
Modar Khalil
Keyword(s):  
Chronic Migraine ◽  
Real World ◽  
Episodic Migraine ◽  
Sustained Response ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Large Patient ◽  
Number Of Patients

Objective: The objective of this prospective audit was to determine the long term outcome of patients diagnosed with chronic migraine who were treated with onabotulinumtoxinA for the prevention of chronic migraine. Background: While long term and real-world studies have confirmed the safety and efficacy of onabotulinumtoxinA in CM, there remains limited information from large patient numbers on the number of cycles and duration of onabotulinumtoxinA needed to successfully convert chronic migraine to episodic migraine, development of resistance to treatment and sustainability of response after stopping treatment. Methods: A total of 655 adult patients diagnosed with chronic migraine who received onabotulinumtoxinA at the Hull Migraine Clinic were followed up prospectively for a minimum of 2 years. OnabotulinumtoxinA was delivered as per the PREEMPT study protocol and patients were asked to keep a headache diary for at least 30 days prior to and continuously after receiving onabotulinumtoxinA. The primary outcome assessed in this prospective real-world audit was either the number of patients who achieved a ≥50% reduction in headache days or migraine days or an increment in crystal clear days twice that of baseline in a 30-day period. Patients were also assessed for analgesic medication overuse. Results: Treatment data were available for 655 patients who commenced treatment between July 2010 and October 2016 and followed for at least 2 years (24–70 months), with the last follow-up taking place in September 2018. Of the 655 patients, 380 patients responded to treatment after two cycles and went on to receive the third cycle. Of these, 152 patients were still on active treatment at 2 years. A further 61 patients had relapsed and were on treatment at 2 years. Of the 228 patients who stopped treatment, 112 were successfully converted to episodic migraine and showed a sustained response, 28 reverted to chronic migraine after the initial response despite continuing treatment (developed resistance), 14 were lost to follow up and 61 patients after achieving remission relapsed after a mean of 9 months (range 4–24 months) and recommenced treatment with onabotulinumtoxinA. Conclusion: After a minimum of 2 years, 29.4% of patients with chronic migraine who initially responded to treatment were successfully converted to episodic migraine and maintained a sustained response. Forty percent of the initial cohort of responders continued therapy with onabotulinumtoxinA to manage their chronic migraine.

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