Scholarlink

Background <p>Real-world evidence on atogepant remains limited. GIANT2 explores the 24-week real-life effectiveness of atogepant in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) under routine clinical conditions.</p> Methods <p>GIANT2 is a 24-week, prospective, multicenter, real-world, study including consecutive patients with HFEM or CM with ≥3 preventive treatment failures, treated with atogepant 60 mg once daily. Co-primary endpoints: proportions achieving ≥50% and ≥75% reductions in monthly migraine days for HFEM or monthly headache days for CM at weeks 21–24 versus baseline. Secondary endpoints: changes in migraine/headache days, analgesic intake, pain intensity, disability, patient global impression of change, 100% response rates, tolerability and safety. Response rates at weeks 21–24 were also evaluated in patients with prioranti-CGRP mAb failure. Exploratory analyses: proportion of <Emphasis Type="Underline">&gt;</Emphasis>50% responders achieving <Emphasis Type="Underline">&gt;</Emphasis>30% reduction in NRS scores and response rates in subgroups combining psychiatric comorbidities, CM, and medication overuse headache (MOH).</p> Results <p>Of 233 patients enrolled, 156 completed <Emphasis Type="Underline">&gt;</Emphasis>24 weeks of treatment, with 37.2% having failed prior anti-CGRP mAbs. At weeks 21–24, 76.9% achieved a ≥ 50% response and 45.5% a ≥ 75% response, with ≥50% response more frequent in HFEM than CM (<i>p</i> = 0.005). A 100% response occurred in 5.1% of patients. All secondary endpoints improved significantly (<i>p</i> &lt; 0.001) with greater benefits at week 24 than week 12. No difference in effectiveness was observed between mAb-naïve patients and those with prior mAb failures, who achieved ≥50% and ≥75% response rates of 70.7% and 39.7%. A combined ≥50% frequency reduction and ≥30% pain reduction was achieved by 54.5% of patients. Among patients with psychiatric comorbidities, 63.0% were ≥50% responders, while among CM patients rates were 62.1% in those with MOH and 40.0% in those with both psychiatric comorbidities and MOH (≥75% responder rates 42.4%, 37.0%, and 28.0%). Adverse events occurred in 11.2% of patients and led to discontinuation in 1.3%.</p> Conclusions <p>GIANT2 shows that atogepant effectiveness increases from week 12 to 24 with a high proportion of responders and super-responders regardless of prior anti-CGRP mAb failure and reduces pain intensity in residual headaches in most patients. It is also effective in migraine subgroups combining psychiatric comorbidities, CM and MOH.</p> Trial registration <p>NCT06136442.</p> Graphical Abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Responders and super-responders to atogepant after 24 weeks of treatment in migraine: real-world evidence from the GIANT-2 study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月31日

查看全文
  • Piero Barbanti,
  • Gabriella Egeo,
  • Alberto Doretti,
  • Francesca Pistoia,
  • Steno Rinalduzzi,
  • Silvia Strumia,
  • Cinzia Aurilia,
  • Paola Scatena,
  • Massimo Autunno,
  • Antonio Salerno,
  • Alberto Galli,
  • Riccardo Altavilla,
  • Stefano Messina,
  • Carla Zanferrari,
  • Pietrantonio Bruno,
  • Cecilia Camarda,
  • Florindo D’Onofrio,
  • Veronica Iovene,
  • Angelo Ranieri,
  • Francesco Bono,
  • Jesuély Spieckert de Souza,
  • Antonio Carnevale,
  • Laura Di Clemente,
  • Maurizio Zucco,
  • Monica Laura Bandettini Di Poggio,
  • Luisa Vinciguerra,
  • Laura Borrello,
  • Giulia Fiorentini,
  • Rosario Vecchio,
  • Valeria Drago,
  • Paola Torelli,
  • Maria Albanese,
  • Carlo Tomino,
  • Stefano Bonassi,
  • Annamaria Porreca,
  • Marco Aguggia,
  • Gennaro Alfieri,
  • Diletta Alivernini,
  • Raffaella Ardau,
  • Maria Letizia Bartolozzi,
  • Maria Carmela Bloise,
  • Simone Braca,
  • Antonio Bruno,
  • Stefano Caproni,
  • Ilaria Cetta,
  • Alessandra Cherchi,
  • Bruno Colombo,
  • Eleonora Colombo,
  • Alfonso Coppola,
  • Domenico Cosenza,
  • Francesca Cortese,
  • Matteo De Bartolo,
  • Roberto De Simone,
  • Arianna Deidda,
  • Alessandra Del Bene,
  • Giulia Gallo,
  • Vittoria Carla D’Agostino Alfonsina Di Summa,
  • Valentina Favoni,
  • Ludovica Ferraù,
  • Isabella Ferdinanda Pestalozza,
  • Cinzia Finocchi,
  • Annalisa Gai,
  • Rosario Grugno,
  • Martina Guarinoni,
  • Elisabetta Iannaccone,
  • Giovanni Idone,
  • Vincenzo Laterza,
  • Riccardo Lo Presti,
  • Luca Lombardi,
  • Irene Madonia,
  • Andrea Mancioli,
  • Sara Matignaro,
  • Silvia Nizzoli,
  • Matteo Paolucci,
  • Maristella Piccininni,
  • Pietro Querzani,
  • Fabio Frediani,
  • Simone Quintana,
  • Micaela Robotti,
  • Pamela Rosettani,
  • Marco Russo,
  • Sergio Salvemini,
  • Giuliano Sette,
  • Alessandra Spalloni,
  • Gabriele Sixt,
  • Michela Sforza,
  • Alessandro Cocuzza,
  • Giorgio Spano,
  • Maria Erminia Stochino,
  • Denise Tedeschi,
  • Rossana Terlizzi,
  • Valentina Teresi,
  • Daniela Ungaro,
  • Fabio Valguarnera,
  • Gianluca Vita,
  • Laura Zanandrea,
  • Liliana Baiamonte,
  • Giulia Bozzo

摘要

Background

Real-world evidence on atogepant remains limited. GIANT2 explores the 24-week real-life effectiveness of atogepant in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) under routine clinical conditions.

Methods

GIANT2 is a 24-week, prospective, multicenter, real-world, study including consecutive patients with HFEM or CM with ≥3 preventive treatment failures, treated with atogepant 60 mg once daily. Co-primary endpoints: proportions achieving ≥50% and ≥75% reductions in monthly migraine days for HFEM or monthly headache days for CM at weeks 21–24 versus baseline. Secondary endpoints: changes in migraine/headache days, analgesic intake, pain intensity, disability, patient global impression of change, 100% response rates, tolerability and safety. Response rates at weeks 21–24 were also evaluated in patients with prioranti-CGRP mAb failure. Exploratory analyses: proportion of >50% responders achieving >30% reduction in NRS scores and response rates in subgroups combining psychiatric comorbidities, CM, and medication overuse headache (MOH).

Results

Of 233 patients enrolled, 156 completed >24 weeks of treatment, with 37.2% having failed prior anti-CGRP mAbs. At weeks 21–24, 76.9% achieved a ≥ 50% response and 45.5% a ≥ 75% response, with ≥50% response more frequent in HFEM than CM (p = 0.005). A 100% response occurred in 5.1% of patients. All secondary endpoints improved significantly (p < 0.001) with greater benefits at week 24 than week 12. No difference in effectiveness was observed between mAb-naïve patients and those with prior mAb failures, who achieved ≥50% and ≥75% response rates of 70.7% and 39.7%. A combined ≥50% frequency reduction and ≥30% pain reduction was achieved by 54.5% of patients. Among patients with psychiatric comorbidities, 63.0% were ≥50% responders, while among CM patients rates were 62.1% in those with MOH and 40.0% in those with both psychiatric comorbidities and MOH (≥75% responder rates 42.4%, 37.0%, and 28.0%). Adverse events occurred in 11.2% of patients and led to discontinuation in 1.3%.

Conclusions

GIANT2 shows that atogepant effectiveness increases from week 12 to 24 with a high proportion of responders and super-responders regardless of prior anti-CGRP mAb failure and reduces pain intensity in residual headaches in most patients. It is also effective in migraine subgroups combining psychiatric comorbidities, CM and MOH.

Trial registration

NCT06136442.

Graphical Abstract