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Sarcopenia and poor balance increase risk for vertebral spinal osteoporotic fracture in women with RA
Key clinical point: Sarcopenia and poor balance were associated with a higher risk for vertebral spinal osteoporotic fracture (VOPF), disease activity, and joint structure damage in women with rheumatoid arthritis (RA).
Major finding: Women with vs without RA had a significantly higher incidence of sarcopenia (60.0% vs 11.1%; P < .0001), poor balance (44.1% vs 7.9%; P < .0001), and VOPF (21% vs 3.2%; P < .0001). Among women with RA, those with vs without VOPF had a significantly higher incidence of sarcopenia (75.6% vs 55.8%; P < .0001) and poor balance (68.3% vs 37.7%; P < .0001) and those with vs without sarcopenia and poor balance had a higher disease activity, more serious joint damage, and worse joint function (all P < .05).
Study details: This study included 195 women with RA and 126 age- and sex-matched healthy individuals.
Disclosures: This study did not declare any source of funding. The authors declared no competing interests.
Source: Zhang M et al. Effect of sarcopenia and poor balance on vertebral spinal osteoporotic fracture in female rheumatoid arthritis. Sci Rep. 2022;12:9477 (Jun 8). Doi: 10.1038/s41598-022-13339-2
Key clinical point: Sarcopenia and poor balance were associated with a higher risk for vertebral spinal osteoporotic fracture (VOPF), disease activity, and joint structure damage in women with rheumatoid arthritis (RA).
Major finding: Women with vs without RA had a significantly higher incidence of sarcopenia (60.0% vs 11.1%; P < .0001), poor balance (44.1% vs 7.9%; P < .0001), and VOPF (21% vs 3.2%; P < .0001). Among women with RA, those with vs without VOPF had a significantly higher incidence of sarcopenia (75.6% vs 55.8%; P < .0001) and poor balance (68.3% vs 37.7%; P < .0001) and those with vs without sarcopenia and poor balance had a higher disease activity, more serious joint damage, and worse joint function (all P < .05).
Study details: This study included 195 women with RA and 126 age- and sex-matched healthy individuals.
Disclosures: This study did not declare any source of funding. The authors declared no competing interests.
Source: Zhang M et al. Effect of sarcopenia and poor balance on vertebral spinal osteoporotic fracture in female rheumatoid arthritis. Sci Rep. 2022;12:9477 (Jun 8). Doi: 10.1038/s41598-022-13339-2
Key clinical point: Sarcopenia and poor balance were associated with a higher risk for vertebral spinal osteoporotic fracture (VOPF), disease activity, and joint structure damage in women with rheumatoid arthritis (RA).
Major finding: Women with vs without RA had a significantly higher incidence of sarcopenia (60.0% vs 11.1%; P < .0001), poor balance (44.1% vs 7.9%; P < .0001), and VOPF (21% vs 3.2%; P < .0001). Among women with RA, those with vs without VOPF had a significantly higher incidence of sarcopenia (75.6% vs 55.8%; P < .0001) and poor balance (68.3% vs 37.7%; P < .0001) and those with vs without sarcopenia and poor balance had a higher disease activity, more serious joint damage, and worse joint function (all P < .05).
Study details: This study included 195 women with RA and 126 age- and sex-matched healthy individuals.
Disclosures: This study did not declare any source of funding. The authors declared no competing interests.
Source: Zhang M et al. Effect of sarcopenia and poor balance on vertebral spinal osteoporotic fracture in female rheumatoid arthritis. Sci Rep. 2022;12:9477 (Jun 8). Doi: 10.1038/s41598-022-13339-2
RA: Rapid improvements in patient-reported outcomes with upadacitinib vs abatacept
Key clinical point: Upadacitinib vs abatacept treatment resulted in rapid and greater improvements in patient-reported physical function, pain, and overall health in patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to biologic disease modifying antirheumatic drugs (bDMARDs-IR).
Major finding: At 12 weeks, a higher proportion of patients receiving upadacitinib vs abatacept reported clinically meaningful improvements in the Health Assessment Questionnaire Disability Index (HAQ-DI; 74% vs 64%; P < .05), with significant improvements in patient-assessed disease activity (least-squares mean change [LSMC] −33.9 vs −28.4), pain (LSMC −35.3 vs −30.0), HAQ-DI (LSMC −0.65 vs −0.48), and EQ-5D-5L index (LSMC 0.26 vs 0.21; all P < .05) scores.
Study details: Findings are from a post hoc analysis of the SELECT-CHOICE phase 3 trial including 612 patients with moderate-to-severe RA and bDMARDs-IR patients who were randomly assigned to receive upadacitinib or abatacept with concomitant conventional synthetic disease modifying antirheumatic drugs.
Disclosures: This study was funded by AbbVie Inc. Six authors declared being current or former employees or stockholders of AbbVie or a company receiving consulting fees from AbbVie. The other authors reported ties with AbbVie and various sources.
Source: Bergman M et al. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. Arthritis Res Ther. 2022;24:15 (Jun 24). Doi: 10.1186/s13075-022-02813-x
Key clinical point: Upadacitinib vs abatacept treatment resulted in rapid and greater improvements in patient-reported physical function, pain, and overall health in patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to biologic disease modifying antirheumatic drugs (bDMARDs-IR).
Major finding: At 12 weeks, a higher proportion of patients receiving upadacitinib vs abatacept reported clinically meaningful improvements in the Health Assessment Questionnaire Disability Index (HAQ-DI; 74% vs 64%; P < .05), with significant improvements in patient-assessed disease activity (least-squares mean change [LSMC] −33.9 vs −28.4), pain (LSMC −35.3 vs −30.0), HAQ-DI (LSMC −0.65 vs −0.48), and EQ-5D-5L index (LSMC 0.26 vs 0.21; all P < .05) scores.
Study details: Findings are from a post hoc analysis of the SELECT-CHOICE phase 3 trial including 612 patients with moderate-to-severe RA and bDMARDs-IR patients who were randomly assigned to receive upadacitinib or abatacept with concomitant conventional synthetic disease modifying antirheumatic drugs.
Disclosures: This study was funded by AbbVie Inc. Six authors declared being current or former employees or stockholders of AbbVie or a company receiving consulting fees from AbbVie. The other authors reported ties with AbbVie and various sources.
Source: Bergman M et al. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. Arthritis Res Ther. 2022;24:15 (Jun 24). Doi: 10.1186/s13075-022-02813-x
Key clinical point: Upadacitinib vs abatacept treatment resulted in rapid and greater improvements in patient-reported physical function, pain, and overall health in patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to biologic disease modifying antirheumatic drugs (bDMARDs-IR).
Major finding: At 12 weeks, a higher proportion of patients receiving upadacitinib vs abatacept reported clinically meaningful improvements in the Health Assessment Questionnaire Disability Index (HAQ-DI; 74% vs 64%; P < .05), with significant improvements in patient-assessed disease activity (least-squares mean change [LSMC] −33.9 vs −28.4), pain (LSMC −35.3 vs −30.0), HAQ-DI (LSMC −0.65 vs −0.48), and EQ-5D-5L index (LSMC 0.26 vs 0.21; all P < .05) scores.
Study details: Findings are from a post hoc analysis of the SELECT-CHOICE phase 3 trial including 612 patients with moderate-to-severe RA and bDMARDs-IR patients who were randomly assigned to receive upadacitinib or abatacept with concomitant conventional synthetic disease modifying antirheumatic drugs.
Disclosures: This study was funded by AbbVie Inc. Six authors declared being current or former employees or stockholders of AbbVie or a company receiving consulting fees from AbbVie. The other authors reported ties with AbbVie and various sources.
Source: Bergman M et al. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. Arthritis Res Ther. 2022;24:15 (Jun 24). Doi: 10.1186/s13075-022-02813-x
RA: Ozoralizumab shows promise in patients with inadequate response to methotrexate
Key clinical point: Ozoralizumab at a dose of 30 or 80 mg significantly improved clinical outcomes compared to placebo and was well tolerated with no new safety signals in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate therapy.
Major finding: A significantly higher proportion of patients receiving 30/80 mg ozoralizumab vs placebo achieved ≥ 20% improvement in American College of Rheumatology criteria (79.6%/75.3% vs 37.3%; P < .001) at 16 weeks and had structural damage nonprogression (73.0%/73.4% vs 56.0%; P < .01) at 24 weeks. No new adverse events were reported.
Study details: The data come from the phase 2/3 OHZORA trial including 381 patients with active RA and an inadequate response to methotrexate who were randomly assigned to receive ozoralizumab (30 or 80 mg) or placebo in combination with methotrexate for 24 weeks.
Disclosures: This trial was sponsored by Taisho Pharmaceutical Co., Ltd. Three authors reported being employees of Taisho Pharmaceutical. Several authors reported receiving grants, consulting fees, or speaking fees from various sources.
Source: Takeuchi T et al. Phase II/III results of the anti-TNF multivalent NANOBODY® compound ‘ozoralizumab’ in patient with rheumatoid arthritis (OHZORA trial). Arthritis Rheumatol. 2022 Jun 21. doi: 10.1002/art.42273.
Key clinical point: Ozoralizumab at a dose of 30 or 80 mg significantly improved clinical outcomes compared to placebo and was well tolerated with no new safety signals in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate therapy.
Major finding: A significantly higher proportion of patients receiving 30/80 mg ozoralizumab vs placebo achieved ≥ 20% improvement in American College of Rheumatology criteria (79.6%/75.3% vs 37.3%; P < .001) at 16 weeks and had structural damage nonprogression (73.0%/73.4% vs 56.0%; P < .01) at 24 weeks. No new adverse events were reported.
Study details: The data come from the phase 2/3 OHZORA trial including 381 patients with active RA and an inadequate response to methotrexate who were randomly assigned to receive ozoralizumab (30 or 80 mg) or placebo in combination with methotrexate for 24 weeks.
Disclosures: This trial was sponsored by Taisho Pharmaceutical Co., Ltd. Three authors reported being employees of Taisho Pharmaceutical. Several authors reported receiving grants, consulting fees, or speaking fees from various sources.
Source: Takeuchi T et al. Phase II/III results of the anti-TNF multivalent NANOBODY® compound ‘ozoralizumab’ in patient with rheumatoid arthritis (OHZORA trial). Arthritis Rheumatol. 2022 Jun 21. doi: 10.1002/art.42273.
Key clinical point: Ozoralizumab at a dose of 30 or 80 mg significantly improved clinical outcomes compared to placebo and was well tolerated with no new safety signals in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate therapy.
Major finding: A significantly higher proportion of patients receiving 30/80 mg ozoralizumab vs placebo achieved ≥ 20% improvement in American College of Rheumatology criteria (79.6%/75.3% vs 37.3%; P < .001) at 16 weeks and had structural damage nonprogression (73.0%/73.4% vs 56.0%; P < .01) at 24 weeks. No new adverse events were reported.
Study details: The data come from the phase 2/3 OHZORA trial including 381 patients with active RA and an inadequate response to methotrexate who were randomly assigned to receive ozoralizumab (30 or 80 mg) or placebo in combination with methotrexate for 24 weeks.
Disclosures: This trial was sponsored by Taisho Pharmaceutical Co., Ltd. Three authors reported being employees of Taisho Pharmaceutical. Several authors reported receiving grants, consulting fees, or speaking fees from various sources.
Source: Takeuchi T et al. Phase II/III results of the anti-TNF multivalent NANOBODY® compound ‘ozoralizumab’ in patient with rheumatoid arthritis (OHZORA trial). Arthritis Rheumatol. 2022 Jun 21. doi: 10.1002/art.42273.
Real-world efficacy and safety of second-line therapies for RA
Key clinical point: The drug discontinuation and 1-year response rates of Janus kinase inhibitors (JAKi), interleukin-6 inhibitors (IL-6i), and abatacept as second-line therapies for rheumatoid arthritis (RA) appeared to be similar to those of tumor necrosis factor-inhibitors (TNFi). However, JAKi and IL-6i were more often discontinued for adverse events and less for ineffectiveness.
Major finding: Compared with TNFi, the 1-year response rate and treatment retention were not significantly different for abatacept, IL-6i, and JAKi, but IL6-i (adjusted hazard ratio [aHR] 0.76; 95% CI 0.67-0.85) and JAKi (aHR 0.75; 95% CI 0.67-0.83) were less frequently discontinued because of inefficacy and often because of adverse events.
Study details: This study evaluated data of 31,846 treatment courses (TNFi: n = 17,522; abatacept: n = 2775; IL-6i: n = 3863; and JAKi: n = 7686) from 19 registers.
Disclosures: The registers were supported by Fundacion Española de Reumatología, the Spanish Medicines and Health Products Agency, and other sources. Several authors reported receiving personal or speaking fees, grants, or honoraria, or serving on speaker’s bureaus for various sources.
Source: Lauper K et al. Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration. Ann Rheum Dis. 2022 (Jun 15. Doi: 10.1136/annrheumdis-2022-222586
Key clinical point: The drug discontinuation and 1-year response rates of Janus kinase inhibitors (JAKi), interleukin-6 inhibitors (IL-6i), and abatacept as second-line therapies for rheumatoid arthritis (RA) appeared to be similar to those of tumor necrosis factor-inhibitors (TNFi). However, JAKi and IL-6i were more often discontinued for adverse events and less for ineffectiveness.
Major finding: Compared with TNFi, the 1-year response rate and treatment retention were not significantly different for abatacept, IL-6i, and JAKi, but IL6-i (adjusted hazard ratio [aHR] 0.76; 95% CI 0.67-0.85) and JAKi (aHR 0.75; 95% CI 0.67-0.83) were less frequently discontinued because of inefficacy and often because of adverse events.
Study details: This study evaluated data of 31,846 treatment courses (TNFi: n = 17,522; abatacept: n = 2775; IL-6i: n = 3863; and JAKi: n = 7686) from 19 registers.
Disclosures: The registers were supported by Fundacion Española de Reumatología, the Spanish Medicines and Health Products Agency, and other sources. Several authors reported receiving personal or speaking fees, grants, or honoraria, or serving on speaker’s bureaus for various sources.
Source: Lauper K et al. Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration. Ann Rheum Dis. 2022 (Jun 15. Doi: 10.1136/annrheumdis-2022-222586
Key clinical point: The drug discontinuation and 1-year response rates of Janus kinase inhibitors (JAKi), interleukin-6 inhibitors (IL-6i), and abatacept as second-line therapies for rheumatoid arthritis (RA) appeared to be similar to those of tumor necrosis factor-inhibitors (TNFi). However, JAKi and IL-6i were more often discontinued for adverse events and less for ineffectiveness.
Major finding: Compared with TNFi, the 1-year response rate and treatment retention were not significantly different for abatacept, IL-6i, and JAKi, but IL6-i (adjusted hazard ratio [aHR] 0.76; 95% CI 0.67-0.85) and JAKi (aHR 0.75; 95% CI 0.67-0.83) were less frequently discontinued because of inefficacy and often because of adverse events.
Study details: This study evaluated data of 31,846 treatment courses (TNFi: n = 17,522; abatacept: n = 2775; IL-6i: n = 3863; and JAKi: n = 7686) from 19 registers.
Disclosures: The registers were supported by Fundacion Española de Reumatología, the Spanish Medicines and Health Products Agency, and other sources. Several authors reported receiving personal or speaking fees, grants, or honoraria, or serving on speaker’s bureaus for various sources.
Source: Lauper K et al. Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration. Ann Rheum Dis. 2022 (Jun 15. Doi: 10.1136/annrheumdis-2022-222586
Higher prevalence of CPPD and chondrocalcinosis in seronegative than seropositive RA
Key clinical point: Calcium pyrophosphate deposition disease (CPPD) and chondrocalcinosis are more prevalent in seronegative vs seropositive rheumatoid arthritis (RA), and the symmetry of arthritis and the acuteness of attack best differentiate CPDD and RA.
Major finding: CPPD (84.9% vs 15.1%) and chondrocalcinosis (32.3% vs 16.6%; P < .001) were more prevalent in seronegative vs seropositive RA, with acute attacks being more frequent in CPDD (67.9%) than seronegative (28.2%) or seropositive (25.9%; P < .001) RA and symmetric arthritis being more prevalent in RA than CPDD (P = .007).
Study details: This was a retrospective cross-sectional study including 503 patients, of which 262 had RA (142 seropositive, 120 seronegative), 181 had CPPD, 30 had gout, and 30 had polymyalgia rheumatica.
Disclosures: This study did not declare any specific source of funding. No competing interests were declared.
Source: Krekeler M et al. High prevalence of chondrocalcinosis and frequent comorbidity with calcium pyrophosphate deposition disease in patients with seronegative rheumatoid arthritis. RMD Open. 2022;8:e002383 (Jun 14). Doi: 10.1136/rmdopen-2022-002383
Key clinical point: Calcium pyrophosphate deposition disease (CPPD) and chondrocalcinosis are more prevalent in seronegative vs seropositive rheumatoid arthritis (RA), and the symmetry of arthritis and the acuteness of attack best differentiate CPDD and RA.
Major finding: CPPD (84.9% vs 15.1%) and chondrocalcinosis (32.3% vs 16.6%; P < .001) were more prevalent in seronegative vs seropositive RA, with acute attacks being more frequent in CPDD (67.9%) than seronegative (28.2%) or seropositive (25.9%; P < .001) RA and symmetric arthritis being more prevalent in RA than CPDD (P = .007).
Study details: This was a retrospective cross-sectional study including 503 patients, of which 262 had RA (142 seropositive, 120 seronegative), 181 had CPPD, 30 had gout, and 30 had polymyalgia rheumatica.
Disclosures: This study did not declare any specific source of funding. No competing interests were declared.
Source: Krekeler M et al. High prevalence of chondrocalcinosis and frequent comorbidity with calcium pyrophosphate deposition disease in patients with seronegative rheumatoid arthritis. RMD Open. 2022;8:e002383 (Jun 14). Doi: 10.1136/rmdopen-2022-002383
Key clinical point: Calcium pyrophosphate deposition disease (CPPD) and chondrocalcinosis are more prevalent in seronegative vs seropositive rheumatoid arthritis (RA), and the symmetry of arthritis and the acuteness of attack best differentiate CPDD and RA.
Major finding: CPPD (84.9% vs 15.1%) and chondrocalcinosis (32.3% vs 16.6%; P < .001) were more prevalent in seronegative vs seropositive RA, with acute attacks being more frequent in CPDD (67.9%) than seronegative (28.2%) or seropositive (25.9%; P < .001) RA and symmetric arthritis being more prevalent in RA than CPDD (P = .007).
Study details: This was a retrospective cross-sectional study including 503 patients, of which 262 had RA (142 seropositive, 120 seronegative), 181 had CPPD, 30 had gout, and 30 had polymyalgia rheumatica.
Disclosures: This study did not declare any specific source of funding. No competing interests were declared.
Source: Krekeler M et al. High prevalence of chondrocalcinosis and frequent comorbidity with calcium pyrophosphate deposition disease in patients with seronegative rheumatoid arthritis. RMD Open. 2022;8:e002383 (Jun 14). Doi: 10.1136/rmdopen-2022-002383
Menopausal status and use of sex hormones influence remission in female patients with RA
Key clinical point: Female reproductive status influences the likelihood of achieving rheumatoid arthritis (RA) remission, with odds being higher in the premenopausal vs perimenopausal status and with the use of exogenous sex hormones.
Major finding: Female patients in perimenopause vs premenopause were less likely to achieve remission (adjusted hazard ratio [aHR] 0.78; 95% CI 0.61-0.99). The use of exogenous sex hormones was significantly associated with a higher likelihood of achieving remission (aHR 1.20; P = .038).
Study details: This study pooled individual patient data from 5 phase 3 trials and evaluated 4455 female patients with moderate-to-severe active RA and varying menopausal status and exogenous sex hormone use who were randomly assigned to receive tocilizumab or conventional synthetic disease-modifying antirheumatic drugs.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Daraghmeh DN et al. Female reproductive status and exogenous sex hormone use in rheumatoid arthritis patients treated with tocilizumab and csDMARDs. Rheumatology (Oxford). 2022 (Jun 22). Doi: 10.1093/rheumatology/keac357
Key clinical point: Female reproductive status influences the likelihood of achieving rheumatoid arthritis (RA) remission, with odds being higher in the premenopausal vs perimenopausal status and with the use of exogenous sex hormones.
Major finding: Female patients in perimenopause vs premenopause were less likely to achieve remission (adjusted hazard ratio [aHR] 0.78; 95% CI 0.61-0.99). The use of exogenous sex hormones was significantly associated with a higher likelihood of achieving remission (aHR 1.20; P = .038).
Study details: This study pooled individual patient data from 5 phase 3 trials and evaluated 4455 female patients with moderate-to-severe active RA and varying menopausal status and exogenous sex hormone use who were randomly assigned to receive tocilizumab or conventional synthetic disease-modifying antirheumatic drugs.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Daraghmeh DN et al. Female reproductive status and exogenous sex hormone use in rheumatoid arthritis patients treated with tocilizumab and csDMARDs. Rheumatology (Oxford). 2022 (Jun 22). Doi: 10.1093/rheumatology/keac357
Key clinical point: Female reproductive status influences the likelihood of achieving rheumatoid arthritis (RA) remission, with odds being higher in the premenopausal vs perimenopausal status and with the use of exogenous sex hormones.
Major finding: Female patients in perimenopause vs premenopause were less likely to achieve remission (adjusted hazard ratio [aHR] 0.78; 95% CI 0.61-0.99). The use of exogenous sex hormones was significantly associated with a higher likelihood of achieving remission (aHR 1.20; P = .038).
Study details: This study pooled individual patient data from 5 phase 3 trials and evaluated 4455 female patients with moderate-to-severe active RA and varying menopausal status and exogenous sex hormone use who were randomly assigned to receive tocilizumab or conventional synthetic disease-modifying antirheumatic drugs.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Daraghmeh DN et al. Female reproductive status and exogenous sex hormone use in rheumatoid arthritis patients treated with tocilizumab and csDMARDs. Rheumatology (Oxford). 2022 (Jun 22). Doi: 10.1093/rheumatology/keac357
Efficacy and safety of external concurrent occipital and trigeminal neurostimulation in migraine treatment
Key clinical point: External concurrent occipital and trigeminal neurostimulation (eCOT-NS) was well tolerated, safe, and an effective treatment that provided fast and durable relief and freedom from pain in patients with migraine with or without aura.
Major finding: A significantly higher proportion of patients in the active vs sham eCOT-NS arm reported pain relief after 2 hours of treatment initiation (60% vs 37%; P = .018), freedom from pain at 2 hours after treatment initiation without any rescue medication (46% vs 12%; P < .001), and improvement in their most bothersome symptom (81% vs 60%; P = .047). No serious adverse events were reported.
Study details: Findings are from the RIME study, a randomized, double-blind, sham-controlled study including 187 adults with migraine with or without aura who were randomly assigned to receive active (n = 94) or sham (n = 93) eCOT-NS.
Disclosures: This study was supported by Neurolief Ltd. Several authors reported receiving research grants or honoraria or serving as consultants or advisory board members for various sources, including Neurolief Ltd.
Source: Tepper SJ et al. Migraine treatment with external concurrent occipital and trigeminal neurostimulation—A randomized controlled trial. Headache. 2022 (Jun 24). Doi: 10.1111/head.14350
Key clinical point: External concurrent occipital and trigeminal neurostimulation (eCOT-NS) was well tolerated, safe, and an effective treatment that provided fast and durable relief and freedom from pain in patients with migraine with or without aura.
Major finding: A significantly higher proportion of patients in the active vs sham eCOT-NS arm reported pain relief after 2 hours of treatment initiation (60% vs 37%; P = .018), freedom from pain at 2 hours after treatment initiation without any rescue medication (46% vs 12%; P < .001), and improvement in their most bothersome symptom (81% vs 60%; P = .047). No serious adverse events were reported.
Study details: Findings are from the RIME study, a randomized, double-blind, sham-controlled study including 187 adults with migraine with or without aura who were randomly assigned to receive active (n = 94) or sham (n = 93) eCOT-NS.
Disclosures: This study was supported by Neurolief Ltd. Several authors reported receiving research grants or honoraria or serving as consultants or advisory board members for various sources, including Neurolief Ltd.
Source: Tepper SJ et al. Migraine treatment with external concurrent occipital and trigeminal neurostimulation—A randomized controlled trial. Headache. 2022 (Jun 24). Doi: 10.1111/head.14350
Key clinical point: External concurrent occipital and trigeminal neurostimulation (eCOT-NS) was well tolerated, safe, and an effective treatment that provided fast and durable relief and freedom from pain in patients with migraine with or without aura.
Major finding: A significantly higher proportion of patients in the active vs sham eCOT-NS arm reported pain relief after 2 hours of treatment initiation (60% vs 37%; P = .018), freedom from pain at 2 hours after treatment initiation without any rescue medication (46% vs 12%; P < .001), and improvement in their most bothersome symptom (81% vs 60%; P = .047). No serious adverse events were reported.
Study details: Findings are from the RIME study, a randomized, double-blind, sham-controlled study including 187 adults with migraine with or without aura who were randomly assigned to receive active (n = 94) or sham (n = 93) eCOT-NS.
Disclosures: This study was supported by Neurolief Ltd. Several authors reported receiving research grants or honoraria or serving as consultants or advisory board members for various sources, including Neurolief Ltd.
Source: Tepper SJ et al. Migraine treatment with external concurrent occipital and trigeminal neurostimulation—A randomized controlled trial. Headache. 2022 (Jun 24). Doi: 10.1111/head.14350
Vitamin D3 supplementation to topiramate therapy shows promise for pediatric migraine
Key clinical point: Vitamin D3 (5000 IU daily) supplementation as an adjuvant therapy to topiramate was well tolerated and safe, and an effective strategy for pediatric migraine prophylaxis.
Major finding: After 16 weeks of treatment, the monthly headache frequency (6.23 vs 9.79 attacks/month; P = .01) and disability from headache score (17.56 vs 25.18; P = .04) were significantly lower in the vitamin D3 supplementation vs placebo group, with >50% decrease in the monthly headache attack frequency being reported by a significantly higher proportion of patients receiving vitamin D3 supplementation vs placebo (75.0% vs 53.5%; P = .01) and no serious adverse events being reported.
Study details: The findings are from a double-blind, prospective case-control study including 60 children and adolescents (aged 5-14 years) with migraine who were randomly assigned to receive topiramate with vitamin D3 supplementation or placebo.
Disclosures: This study did not receive any financial support. The authors declared no competing interests.
Source: Elmala MK et al. The impact of vitamin D3 supplementation to topiramate therapy on pediatric migraine prophylaxis. J Child Neurol. 2022 (Jun 22). Doi: 10.1177/08830738221092882
Key clinical point: Vitamin D3 (5000 IU daily) supplementation as an adjuvant therapy to topiramate was well tolerated and safe, and an effective strategy for pediatric migraine prophylaxis.
Major finding: After 16 weeks of treatment, the monthly headache frequency (6.23 vs 9.79 attacks/month; P = .01) and disability from headache score (17.56 vs 25.18; P = .04) were significantly lower in the vitamin D3 supplementation vs placebo group, with >50% decrease in the monthly headache attack frequency being reported by a significantly higher proportion of patients receiving vitamin D3 supplementation vs placebo (75.0% vs 53.5%; P = .01) and no serious adverse events being reported.
Study details: The findings are from a double-blind, prospective case-control study including 60 children and adolescents (aged 5-14 years) with migraine who were randomly assigned to receive topiramate with vitamin D3 supplementation or placebo.
Disclosures: This study did not receive any financial support. The authors declared no competing interests.
Source: Elmala MK et al. The impact of vitamin D3 supplementation to topiramate therapy on pediatric migraine prophylaxis. J Child Neurol. 2022 (Jun 22). Doi: 10.1177/08830738221092882
Key clinical point: Vitamin D3 (5000 IU daily) supplementation as an adjuvant therapy to topiramate was well tolerated and safe, and an effective strategy for pediatric migraine prophylaxis.
Major finding: After 16 weeks of treatment, the monthly headache frequency (6.23 vs 9.79 attacks/month; P = .01) and disability from headache score (17.56 vs 25.18; P = .04) were significantly lower in the vitamin D3 supplementation vs placebo group, with >50% decrease in the monthly headache attack frequency being reported by a significantly higher proportion of patients receiving vitamin D3 supplementation vs placebo (75.0% vs 53.5%; P = .01) and no serious adverse events being reported.
Study details: The findings are from a double-blind, prospective case-control study including 60 children and adolescents (aged 5-14 years) with migraine who were randomly assigned to receive topiramate with vitamin D3 supplementation or placebo.
Disclosures: This study did not receive any financial support. The authors declared no competing interests.
Source: Elmala MK et al. The impact of vitamin D3 supplementation to topiramate therapy on pediatric migraine prophylaxis. J Child Neurol. 2022 (Jun 22). Doi: 10.1177/08830738221092882
Acute migraine: Favorable safety profile of oral CGRP receptor antagonists vs triptans
Key clinical point: Oral calcitonin gene-related peptide (CGRP) receptor antagonists appeared to be safer and better tolerated than triptans for the treatment of acute migraine and could be a viable option for patients who experience overall triptan-associated adverse events (AE).
Major finding: Oral CGRP receptor antagonists were safer than triptans in terms of any AE (risk ratio [RR] 0.78; P = .03) and treatment-related AE (RR 0.68; P < .00001), with the incidence of dizziness (RR 0.69; P = .01), dry mouth (RR 0.72; P = .02), fatigue (RR 0.52; P = .001), paresthesia (RR 0.34; P < .0001), and somnolence (RR 0.65; P = .004) being lower with oral CGRP receptor antagonists vs triptans.
Study details: The data come from a meta-analysis of 15 trials including 13,270 patients who received oral CGRP receptor antagonists (n = 8240), placebo (n = 4253), or triptans (n = 777) for the treatment of acute migraine.
Disclosures: This study was funded by a National Research Foundation of Korea grant funded by the Korea government. The authors declared no competing interests.
Source: Lee S et al. Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: A systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 (Jun 22). Doi: 10.1007/s00228-022-03347-6
Key clinical point: Oral calcitonin gene-related peptide (CGRP) receptor antagonists appeared to be safer and better tolerated than triptans for the treatment of acute migraine and could be a viable option for patients who experience overall triptan-associated adverse events (AE).
Major finding: Oral CGRP receptor antagonists were safer than triptans in terms of any AE (risk ratio [RR] 0.78; P = .03) and treatment-related AE (RR 0.68; P < .00001), with the incidence of dizziness (RR 0.69; P = .01), dry mouth (RR 0.72; P = .02), fatigue (RR 0.52; P = .001), paresthesia (RR 0.34; P < .0001), and somnolence (RR 0.65; P = .004) being lower with oral CGRP receptor antagonists vs triptans.
Study details: The data come from a meta-analysis of 15 trials including 13,270 patients who received oral CGRP receptor antagonists (n = 8240), placebo (n = 4253), or triptans (n = 777) for the treatment of acute migraine.
Disclosures: This study was funded by a National Research Foundation of Korea grant funded by the Korea government. The authors declared no competing interests.
Source: Lee S et al. Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: A systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 (Jun 22). Doi: 10.1007/s00228-022-03347-6
Key clinical point: Oral calcitonin gene-related peptide (CGRP) receptor antagonists appeared to be safer and better tolerated than triptans for the treatment of acute migraine and could be a viable option for patients who experience overall triptan-associated adverse events (AE).
Major finding: Oral CGRP receptor antagonists were safer than triptans in terms of any AE (risk ratio [RR] 0.78; P = .03) and treatment-related AE (RR 0.68; P < .00001), with the incidence of dizziness (RR 0.69; P = .01), dry mouth (RR 0.72; P = .02), fatigue (RR 0.52; P = .001), paresthesia (RR 0.34; P < .0001), and somnolence (RR 0.65; P = .004) being lower with oral CGRP receptor antagonists vs triptans.
Study details: The data come from a meta-analysis of 15 trials including 13,270 patients who received oral CGRP receptor antagonists (n = 8240), placebo (n = 4253), or triptans (n = 777) for the treatment of acute migraine.
Disclosures: This study was funded by a National Research Foundation of Korea grant funded by the Korea government. The authors declared no competing interests.
Source: Lee S et al. Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: A systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 (Jun 22). Doi: 10.1007/s00228-022-03347-6
Levetiracetam shows some potential as prophylactic treatment of episodic migraine
Key clinical point: Levetiracetam reduced attack frequency, headache days, and days with acute drug intake as the prophylactic treatment for episodic migraine along with an overall tolerable safety profile.
Major finding: During the last 4 weeks of treatment, levetiracetam significantly reduced the number of migraine attacks (P < .001), days with migraine (P = .001), and use of acute drugs for migraine attack (P < .001), with 46.0% of patients showing at least 50% reduction in migraine attack frequency and the mean number of migraine attacks decreasing from 5.2 ± 2.1 to 3.4 ± 2.7.
Study details: The data come from a prospective, open-label study including 50 patients with episodic migraine who received 1000 mg levetiracetam (starting dose 500 mg) twice a day for 12 weeks.
Disclosures: This study was supported by UCB Chemie GmbH Germany. Some authors declared serving as consultants for various sources.
Source: Evers S et al. Levetiracetam in the prophylactic treatment of episodic migraine: A prospective open label study. Cephalalgia. 2022 (May 27). Doi: 10.1177/03331024221103815
Key clinical point: Levetiracetam reduced attack frequency, headache days, and days with acute drug intake as the prophylactic treatment for episodic migraine along with an overall tolerable safety profile.
Major finding: During the last 4 weeks of treatment, levetiracetam significantly reduced the number of migraine attacks (P < .001), days with migraine (P = .001), and use of acute drugs for migraine attack (P < .001), with 46.0% of patients showing at least 50% reduction in migraine attack frequency and the mean number of migraine attacks decreasing from 5.2 ± 2.1 to 3.4 ± 2.7.
Study details: The data come from a prospective, open-label study including 50 patients with episodic migraine who received 1000 mg levetiracetam (starting dose 500 mg) twice a day for 12 weeks.
Disclosures: This study was supported by UCB Chemie GmbH Germany. Some authors declared serving as consultants for various sources.
Source: Evers S et al. Levetiracetam in the prophylactic treatment of episodic migraine: A prospective open label study. Cephalalgia. 2022 (May 27). Doi: 10.1177/03331024221103815
Key clinical point: Levetiracetam reduced attack frequency, headache days, and days with acute drug intake as the prophylactic treatment for episodic migraine along with an overall tolerable safety profile.
Major finding: During the last 4 weeks of treatment, levetiracetam significantly reduced the number of migraine attacks (P < .001), days with migraine (P = .001), and use of acute drugs for migraine attack (P < .001), with 46.0% of patients showing at least 50% reduction in migraine attack frequency and the mean number of migraine attacks decreasing from 5.2 ± 2.1 to 3.4 ± 2.7.
Study details: The data come from a prospective, open-label study including 50 patients with episodic migraine who received 1000 mg levetiracetam (starting dose 500 mg) twice a day for 12 weeks.
Disclosures: This study was supported by UCB Chemie GmbH Germany. Some authors declared serving as consultants for various sources.
Source: Evers S et al. Levetiracetam in the prophylactic treatment of episodic migraine: A prospective open label study. Cephalalgia. 2022 (May 27). Doi: 10.1177/03331024221103815