Chronic migraine treatment: from OnabotulinumtoxinA onwards

BackgroundOnabotulinumtoxinA (OnabotA) is effective in Chronic Migraine (CM) during first year of treatment and longer. In real clinical setting, CM patients with acute Medication Overuse (MO) or concurrently receiving oral preventatives are treated with OnabotA. We aim to assess evolution of CM patients beyond first year on OnabotA.MethodsData were retrospectively collected in three headache units. We analyzed cases who had received at least five sessions of OnabotA according to PREEMPT protocol. We continued OnabotA therapy when a reduction of number of headache days of at least 30% was achieved.ResultsWe included 115 patients (98 females, 17 males) who completed 7.6 ± 2.3 (5–13) OnabotA procedures. Previously they had not responded to topiramate and, at least, one other preventative. Age at inclusion was 45.3 ± 12 (14–74) years, and latency between CM onset and OnabotA therapy was 43.1 ± 38.2 (6–166) months. At first OnabotA session 92 patients (80%) fulfilled MO criteria and 107 (93%) received a concurrent oral preventative. In 42 cases (36.5%) OnabotA dose was increased over 155 units. After first year in 57 out of 92 patients (61.9%) MO was discontinued. Among those receiving preventatives, in 52 out of 107 they were retired (48.6%). In 22 cases (19.1%) OnabotA administration was delayed to the fourth or fifth month and in 12 (10.4%) it was temporally stopped. Finally, in 18 patients (15.7%) OnabotA was discontinued due to lack of efficacy beyond first year of treatment.ConclusionOur results suggest that discontinuation of acute medication overuse and oral preventive therapies are achievable objectives in long-term using of OnabotA in CM patients.

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“…Efficacy of OnabotA in our series was also similar as it was described in studies in a real-life setting [8–15]. …”

Section: Discussionsupporting

confidence: 86%

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

et al. 2016

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“…However, liver toxicity with their daily administration was found. Thus further developments of some CGRP-RAs including telcagepant MK-0974 and MK-3207 were terminated [18–20, 55], two CGRP-RAs, B144370A and BMS-927711, showed a good clinical efficacy in the phase II studies but their development status is not clear and it is not known whether these drugs showed liver toxicity [52, 54], and ubrogepant MK-1602, has been tested in two phase II trials, but the results have not been reported yet [55]. CGRP-mAbs are macromolecules made of proteins that directly target CGRP or its receptor.…”

Section: Discussionmentioning

confidence: 99%

The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis

et al. 2017

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BackgroundMigraine has been recognized as one of the leading causes of disability in the 2013 Global Burden of Disease Study and seriously affects the quality of patients’ life, current treatment options are not ideal. Monoclonal antibodies to calcitonin gene-related peptide and its receptor (CGRP-mAbs) appear more promising for migraine because of considerably better effect and safety profiles. The objective of this study is to systematically assess the clinical efficacy and safety of CGRP-mAbs for migraine therapy.MethodsA systematic literature search in PubMed, Cochrane Library and Baidu Scholar was performed to identify randomized controlled trials (RCTs), which compared the effect and safety of CGRP-mAbs with placebo on migraine. Regarding the efficacy, the reduction of monthly migraine days from baseline to weeks 1–4, 5–8, and 9–12; responder rates were extracted as the outcome measures of the effects of CGRP-mAbs. Regarding the safety, total adverse events, the main adverse events, and other adverse events were evaluated.ResultsWe found significant reduction of monthly migraine days in CGRP-mAbs vs. placebo (weeks 1–4: SMD −0.49, 95% CI −0.61 to −0.36; weeks 5–8: SMD −0.43, 95% CI −0.56 to −0.30; weeks 9–12: SMD −0.37, 95% CI −0.49 to −0.24). 50% and 75% responder rates (OR 2.59, 95% CI 1.99 to 3.37; and OR 2.91, 95% CI 2.06 to 4.10) were significantly increased compared with placebo. There was no significant difference in total adverse events (OR 1.17, 95% CI 0.91 to 1.51), and the main adverse events including upper respiratory tract infection (OR 1.44, 95% CI 0.82 to 2.55), nasopharyngitis (OR 0.59, 95% CI 0.30 to 1.16), nausea (OR 0.61, 95% CI 0.29 to 1.32), injection-site pain (OR 1.73, 95% CI 0.95 to 3.16) and back pain (OR 0.97, 95% CI 0.49 to 1.90) were not obviously changed compared with placebo control, but the results showed significant increase of dizziness in CGRP-mAbs vs. placebo (OR 3.22, 95% CI 1.09 to 9.45).ConclusionsThis meta-analysis suggests that CGRP-mAbs are effective in anti-migraine therapy with few adverse reactions, but more and larger sample-size RCTs are required to verify the current findings.

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“…WHO ranks migraine as the sixth highest cause of disability worldwide when considered alone, and the third highest when MOH is included [5]. According to U.S. figures, the total annual median cost for medical services and analgesics for the relief of migraine, low back pain, and fibromyalgia is roughly $5,000 and more than $25,000 for treating HIV-related pain and multiple sclerosis [6].…”

Section: Introductionmentioning

confidence: 99%

Botulinum neurotoxin type A for the treatment of pain: not just in migraine and trigeminal neuralgia

et al. 2017

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BackgroundDespite their huge epidemiological impact, primary headaches, trigeminal neuralgia and other chronic pain conditions still receive suboptimal medical approach, even in developed countries. The limited efficacy of current pain-killers and prophylactic treatments stands among the main reasons for this phenomenon. Botulinum neurotoxin (BoNT) represents a well-established and licensed treatment for chronic migraine, but also an emerging treatment for other types of primary headache, trigeminal neuralgia, neuropathic pain, and an increasing number of pain conditions.MethodsWe searched and critically reviewed evidence for the efficacy of BoNT for the treatment of chronic pain.ResultsMeta-analyses and randomized controlled trials (RCTs) suggest that BoNT potentially represents a multi-purpose drug for the treatment of pain in several disorders due to a favorable safety profile and a long-lasting relief after a single injection.ConclusionsBoNT is an emerging treatment in different pain conditions. Future RCTs should explore the use of BoNT injection therapy combined with systemic drugs and/or physical therapies as new pain treatment strategies.

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Chronic migraine treatment: from OnabotulinumtoxinA onwards

Cited by 22 publications

References 112 publications

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

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

The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis

Botulinum neurotoxin type A for the treatment of pain: not just in migraine and trigeminal neuralgia

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