Although PsA affects men and women equally, the impact of the disease is often worse in women. In a large study from the Netherlands, in which 855 patients were carefully evaluated and follow up, Mulder MLM et al show that both subjective and objective measures of disease activity is more severe in women than men. The PsA Disease Activity Score, a validated composite measure of PsA disease activity, was also higher in women than men. The impact of disease on quality of life and function was significantly more in women and they were less often meeting treatment target. Further research into the impact of sex and gender in PsA is warranted and sex/gender-specific measures for managing PsA is required.

Janus kinase inhibitors (JAKi) are important new molecules increasingly being used in the management of inflammatory diseases. Tofacitinib is already available for the treatment of PsA. McInnes IB et al published results on the efficacy of upadacitinib, a more selective JAK1i already approved for treatment of RA, in treating PsA. In this phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs, the proportion of patients achieving at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) than with placebo (36.2%; P less than .001). Upadacitinib 15mg was found to have comparable efficacy as adalimumab (ACR20 65.0%), a well-established anti-TNF agent. However, adverse events were more frequent with upadacitinib.

Adverse events when on treatment with JAKi have recently come into sharp focus. Reassuringly, results from the OPAL Balance study, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA on treatment with tofacitinib confirmed the long-term safety and efficacy of tofacitinib in patients with PsA. Nash P et al reported 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent with previous reports. However, given the reports of higher adverse events with tofacitinib compared to anti-TNF drugs in high-risk rheumatoid arthritis patients, more data is required to fully understand the risk profile of JAKi in patients with immune-mediated inflammatory diseases, including PsA.

With several drugs currently available to treat PsA and the paucity of head-to-head trials between them, choosing the most efficacious drug for treating patients with PsA has become challenging. To address this issue a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA was conducted. In a study sponsored by Janssen, Mease PJ et al report that guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to anti IL-17A and subcutaneous anti-TNF agents for achieving ACR20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents. The results indicate that guselkumab is as effective as other established agents in treating PsA, but formal head-to-head clinical trials will provide better evidence of relative efficacy and safety.

Although PsA affects men and women equally, the impact of the disease is often worse in women. In a large study from the Netherlands, in which 855 patients were carefully evaluated and follow up, Mulder MLM et al show that both subjective and objective measures of disease activity is more severe in women than men. The PsA Disease Activity Score, a validated composite measure of PsA disease activity, was also higher in women than men. The impact of disease on quality of life and function was significantly more in women and they were less often meeting treatment target. Further research into the impact of sex and gender in PsA is warranted and sex/gender-specific measures for managing PsA is required.

Janus kinase inhibitors (JAKi) are important new molecules increasingly being used in the management of inflammatory diseases. Tofacitinib is already available for the treatment of PsA. McInnes IB et al published results on the efficacy of upadacitinib, a more selective JAK1i already approved for treatment of RA, in treating PsA. In this phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs, the proportion of patients achieving at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) than with placebo (36.2%; P less than .001). Upadacitinib 15mg was found to have comparable efficacy as adalimumab (ACR20 65.0%), a well-established anti-TNF agent. However, adverse events were more frequent with upadacitinib.

Adverse events when on treatment with JAKi have recently come into sharp focus. Reassuringly, results from the OPAL Balance study, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA on treatment with tofacitinib confirmed the long-term safety and efficacy of tofacitinib in patients with PsA. Nash P et al reported 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent with previous reports. However, given the reports of higher adverse events with tofacitinib compared to anti-TNF drugs in high-risk rheumatoid arthritis patients, more data is required to fully understand the risk profile of JAKi in patients with immune-mediated inflammatory diseases, including PsA.

With several drugs currently available to treat PsA and the paucity of head-to-head trials between them, choosing the most efficacious drug for treating patients with PsA has become challenging. To address this issue a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA was conducted. In a study sponsored by Janssen, Mease PJ et al report that guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to anti IL-17A and subcutaneous anti-TNF agents for achieving ACR20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents. The results indicate that guselkumab is as effective as other established agents in treating PsA, but formal head-to-head clinical trials will provide better evidence of relative efficacy and safety.

Although PsA affects men and women equally, the impact of the disease is often worse in women. In a large study from the Netherlands, in which 855 patients were carefully evaluated and follow up, Mulder MLM et al show that both subjective and objective measures of disease activity is more severe in women than men. The PsA Disease Activity Score, a validated composite measure of PsA disease activity, was also higher in women than men. The impact of disease on quality of life and function was significantly more in women and they were less often meeting treatment target. Further research into the impact of sex and gender in PsA is warranted and sex/gender-specific measures for managing PsA is required.

Janus kinase inhibitors (JAKi) are important new molecules increasingly being used in the management of inflammatory diseases. Tofacitinib is already available for the treatment of PsA. McInnes IB et al published results on the efficacy of upadacitinib, a more selective JAK1i already approved for treatment of RA, in treating PsA. In this phase 3 trial involving 1,704 patients with PsA who had an inadequate response to at least 1 nonbiologic disease-modifying antirheumatic drugs, the proportion of patients achieving at least 20% improvement in American College of Rheumatology (ACR20) response was significantly higher with upadacitinib 15 mg (70.6%) and 30 mg (78.5%) than with placebo (36.2%; P less than .001). Upadacitinib 15mg was found to have comparable efficacy as adalimumab (ACR20 65.0%), a well-established anti-TNF agent. However, adverse events were more frequent with upadacitinib.

Adverse events when on treatment with JAKi have recently come into sharp focus. Reassuringly, results from the OPAL Balance study, a 36-month, long-term extension phase 3 study involving 686 adult patients with active PsA on treatment with tofacitinib confirmed the long-term safety and efficacy of tofacitinib in patients with PsA. Nash P et al reported 1 instance of mortality occurred in tofacitinib group during the risk period (incidence, 0.1 patients with events [95% confidence interval, 0.0-0.3] per 100 person-years). The incidences of adverse events for herpes zoster, serious infections, opportunistic infections, adjudicated malignancies, and major adverse cardiovascular events were consistent with previous reports. However, given the reports of higher adverse events with tofacitinib compared to anti-TNF drugs in high-risk rheumatoid arthritis patients, more data is required to fully understand the risk profile of JAKi in patients with immune-mediated inflammatory diseases, including PsA.

With several drugs currently available to treat PsA and the paucity of head-to-head trials between them, choosing the most efficacious drug for treating patients with PsA has become challenging. To address this issue a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA was conducted. In a study sponsored by Janssen, Mease PJ et al report that guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to anti IL-17A and subcutaneous anti-TNF agents for achieving ACR20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents. The results indicate that guselkumab is as effective as other established agents in treating PsA, but formal head-to-head clinical trials will provide better evidence of relative efficacy and safety.

Key clinical point: In this real-world analysis of patients with psoriatic arthritis (PsA), interleukin-12/23 inhibitor (IL-12/23i) demonstrated longer persistence and higher adherence than tumor necrosis factor inhibitors (TNFi) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Major finding: At 1 year, persistence was significantly longer among patients who initiated IL-12/23i vs. TNFi (269 vs. 215 days) or tsDMARD (269 vs. 213 days; both P less than .001). Adherence was significantly higher among patients who initiated IL-12/23i vs. TNFi (0.64 vs. 0.56; P = .004) or tsDMARDs (0.64 vs. 0.58; P = .027).

Study details: In this retrospective observational analysis, 7,205 patients with PsA who newly initiated a targeted immune modulator were matched (1:1) in IL-12/23i vs. TNFi (n=238), IL-12/23i vs. tsDMARD (n=238), and IL-12/23i vs. IL-17i (n=189) patient pairs.

Disclosures: This study was funded by Janssen Scientific Affairs, LLC. LA Walsh declared receiving grants and/or serving as a consultant for various pharmaceutical companies. Q Cai, I Lin, CD Pericone, and SD Chakravarty declared being current employees of Janssen Scientific Affairs, LLC and stockholders in Johnson & Johnson.

Source: Walsh JA et al. Adv Ther. 2021 Mar 23. doi: 10.1007/s12325-021-01687-w.

Key clinical point: In this real-world analysis of patients with psoriatic arthritis (PsA), interleukin-12/23 inhibitor (IL-12/23i) demonstrated longer persistence and higher adherence than tumor necrosis factor inhibitors (TNFi) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Major finding: At 1 year, persistence was significantly longer among patients who initiated IL-12/23i vs. TNFi (269 vs. 215 days) or tsDMARD (269 vs. 213 days; both P less than .001). Adherence was significantly higher among patients who initiated IL-12/23i vs. TNFi (0.64 vs. 0.56; P = .004) or tsDMARDs (0.64 vs. 0.58; P = .027).

Study details: In this retrospective observational analysis, 7,205 patients with PsA who newly initiated a targeted immune modulator were matched (1:1) in IL-12/23i vs. TNFi (n=238), IL-12/23i vs. tsDMARD (n=238), and IL-12/23i vs. IL-17i (n=189) patient pairs.

Disclosures: This study was funded by Janssen Scientific Affairs, LLC. LA Walsh declared receiving grants and/or serving as a consultant for various pharmaceutical companies. Q Cai, I Lin, CD Pericone, and SD Chakravarty declared being current employees of Janssen Scientific Affairs, LLC and stockholders in Johnson & Johnson.

Source: Walsh JA et al. Adv Ther. 2021 Mar 23. doi: 10.1007/s12325-021-01687-w.

Key clinical point: In this real-world analysis of patients with psoriatic arthritis (PsA), interleukin-12/23 inhibitor (IL-12/23i) demonstrated longer persistence and higher adherence than tumor necrosis factor inhibitors (TNFi) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

Major finding: At 1 year, persistence was significantly longer among patients who initiated IL-12/23i vs. TNFi (269 vs. 215 days) or tsDMARD (269 vs. 213 days; both P less than .001). Adherence was significantly higher among patients who initiated IL-12/23i vs. TNFi (0.64 vs. 0.56; P = .004) or tsDMARDs (0.64 vs. 0.58; P = .027).

Study details: In this retrospective observational analysis, 7,205 patients with PsA who newly initiated a targeted immune modulator were matched (1:1) in IL-12/23i vs. TNFi (n=238), IL-12/23i vs. tsDMARD (n=238), and IL-12/23i vs. IL-17i (n=189) patient pairs.

Disclosures: This study was funded by Janssen Scientific Affairs, LLC. LA Walsh declared receiving grants and/or serving as a consultant for various pharmaceutical companies. Q Cai, I Lin, CD Pericone, and SD Chakravarty declared being current employees of Janssen Scientific Affairs, LLC and stockholders in Johnson & Johnson.

Source: Walsh JA et al. Adv Ther. 2021 Mar 23. doi: 10.1007/s12325-021-01687-w.

Key clinical point: Fatigue is a prevalent phenomenon among patients with psoriatic arthritis (PsA) and strongly correlated with quality of life (QoL), disease activity, and levels of serum interleukin-17 (IL-17).

Major finding: Level of PsA disease activity was significantly correlated with measures of fatigue, functional capacity, and QoL (P less than .001). Moreover, QoL (P = .001), disease activity (P = .019), and serum IL-17 (P = .029) were significant independent predictive factors for fatigue.

Study details: The findings come from an analysis of 80 adults with PsA from the outpatient clinics of Physical Medicine, Rheumatology, & Rehabilitation Department, Tanta University Hospitals randomly selected during the period from December 2019 to August 2020.

Disclosures: This study did not receive any funding. All the authors declared no conflicts of interest.

Source: Gado SE et al. Expert Rev Clin Immunol. 2021 Apr 2. doi: 10.1080/1744666X.2021.1905522.

Key clinical point: Fatigue is a prevalent phenomenon among patients with psoriatic arthritis (PsA) and strongly correlated with quality of life (QoL), disease activity, and levels of serum interleukin-17 (IL-17).

Major finding: Level of PsA disease activity was significantly correlated with measures of fatigue, functional capacity, and QoL (P less than .001). Moreover, QoL (P = .001), disease activity (P = .019), and serum IL-17 (P = .029) were significant independent predictive factors for fatigue.

Study details: The findings come from an analysis of 80 adults with PsA from the outpatient clinics of Physical Medicine, Rheumatology, & Rehabilitation Department, Tanta University Hospitals randomly selected during the period from December 2019 to August 2020.

Disclosures: This study did not receive any funding. All the authors declared no conflicts of interest.

Source: Gado SE et al. Expert Rev Clin Immunol. 2021 Apr 2. doi: 10.1080/1744666X.2021.1905522.

Key clinical point: Fatigue is a prevalent phenomenon among patients with psoriatic arthritis (PsA) and strongly correlated with quality of life (QoL), disease activity, and levels of serum interleukin-17 (IL-17).

Major finding: Level of PsA disease activity was significantly correlated with measures of fatigue, functional capacity, and QoL (P less than .001). Moreover, QoL (P = .001), disease activity (P = .019), and serum IL-17 (P = .029) were significant independent predictive factors for fatigue.

Study details: The findings come from an analysis of 80 adults with PsA from the outpatient clinics of Physical Medicine, Rheumatology, & Rehabilitation Department, Tanta University Hospitals randomly selected during the period from December 2019 to August 2020.

Disclosures: This study did not receive any funding. All the authors declared no conflicts of interest.

Source: Gado SE et al. Expert Rev Clin Immunol. 2021 Apr 2. doi: 10.1080/1744666X.2021.1905522.

Key clinical point: Among biologic-naive individuals with psoriatic arthritis (PsA), interleukin-12/23 (IL-12/23) antagonists were less effective than tumor necrosis factor-alpha (TNF-α) inhibitors. PDE4 treatment was significantly less effective than TNF-α inhibitors among biologic-experienced individuals.

Major finding: Among biologic-naïve individuals, IL-12/23 was less effective than TNF-α (adjusted relative risk [aRR], 0.63; 95% confidence interval [CI], 0.45-0.89), whereas PDE4 treatment was less effective than TNF-α inhibitor among biologic-experienced individuals (aRR, 0.67; 95% CI, 0.46-0.96).

Study details: Findings are from a retrospective study of 2,730 commercially insured and Medicare Advantage beneficiaries with PsA.

Disclosures: The authors did not declare any specific funding for this research. GC Alexander declared being Chair of FDA’s peripheral and central nervous system advisory committee, serving as a paid advisor to IQVIA, and being a consultant and holding equity in Monument Analytics. JR Curtis declared receiving consultancies and funding from pharmaceutical companies.

Source: Zhang H et al. RMD Open. 2021 Apr 16. doi: 10.1136/rmdopen-2020-001399.

Key clinical point: Among biologic-naive individuals with psoriatic arthritis (PsA), interleukin-12/23 (IL-12/23) antagonists were less effective than tumor necrosis factor-alpha (TNF-α) inhibitors. PDE4 treatment was significantly less effective than TNF-α inhibitors among biologic-experienced individuals.

Major finding: Among biologic-naïve individuals, IL-12/23 was less effective than TNF-α (adjusted relative risk [aRR], 0.63; 95% confidence interval [CI], 0.45-0.89), whereas PDE4 treatment was less effective than TNF-α inhibitor among biologic-experienced individuals (aRR, 0.67; 95% CI, 0.46-0.96).

Study details: Findings are from a retrospective study of 2,730 commercially insured and Medicare Advantage beneficiaries with PsA.

Disclosures: The authors did not declare any specific funding for this research. GC Alexander declared being Chair of FDA’s peripheral and central nervous system advisory committee, serving as a paid advisor to IQVIA, and being a consultant and holding equity in Monument Analytics. JR Curtis declared receiving consultancies and funding from pharmaceutical companies.

Source: Zhang H et al. RMD Open. 2021 Apr 16. doi: 10.1136/rmdopen-2020-001399.

Key clinical point: Among biologic-naive individuals with psoriatic arthritis (PsA), interleukin-12/23 (IL-12/23) antagonists were less effective than tumor necrosis factor-alpha (TNF-α) inhibitors. PDE4 treatment was significantly less effective than TNF-α inhibitors among biologic-experienced individuals.

Major finding: Among biologic-naïve individuals, IL-12/23 was less effective than TNF-α (adjusted relative risk [aRR], 0.63; 95% confidence interval [CI], 0.45-0.89), whereas PDE4 treatment was less effective than TNF-α inhibitor among biologic-experienced individuals (aRR, 0.67; 95% CI, 0.46-0.96).

Study details: Findings are from a retrospective study of 2,730 commercially insured and Medicare Advantage beneficiaries with PsA.

Disclosures: The authors did not declare any specific funding for this research. GC Alexander declared being Chair of FDA’s peripheral and central nervous system advisory committee, serving as a paid advisor to IQVIA, and being a consultant and holding equity in Monument Analytics. JR Curtis declared receiving consultancies and funding from pharmaceutical companies.

Source: Zhang H et al. RMD Open. 2021 Apr 16. doi: 10.1136/rmdopen-2020-001399.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Clinical examination (CE) enthesitis indices should be interpreted with caution in patients with psoriatic arthritis (PsA) and concurrent fibromyalgia. Imaging including ultrasound should be preferred over CE to detect enthesitis in these patients.

Major finding: Patients with PsA with vs. without fibromyalgia had higher CE enthesitis scores (Leeds Enthesitis Index, 2.7 vs. 1.0; P less than .0001; Spondyloarthritis Research Consortium of Canada Enthesitis Index, 7.6 vs. 2.4; P less than .0001); however, ultrasound total scores (P = .87) were not different. No correlation was observed between ultrasound scores and CE enthesitis indices in patients having concurrent fibromyalgia.

Study details: Findings are from a prospective study of 106 outpatients with established PsA who underwent CE for enthesitis and ultrasonographic examination for inflammatory and structural lesions of enthesitis.

Disclosures: The authors received no financial support for research, authorship, and/or publication of the article. The authors declared no competing interests.

Source: SapsfordM et al. Ther Adv Musculoskelet Dis. 2021 Mar 29. doi: 10.1177/1759720X211003812.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Patients with psoriatic arthritis (PsA) are more likely to have additional medical conditions beyond skin and joints than those with psoriasis alone.

Major finding: During follow-up, 12% of patients had an indication for PsA. Rates of comorbidities like hypertension, hyperlipidemia, fatigue, diabetes, chronic pulmonary disease, obesity, cardiovascular disease, depression, and anxiety were at least 1.1-1.7 times higher in the psoriasis-PsA vs. psoriasis-only group.

Study details: This was a retrospective study of 19,333 patients with prevalent psoriasis with no prior evidence of PsA from the United States.

Disclosures: The study was funded by UCB Pharma. R Suruki and E Lee declared being employees and shareholders of UCB Pharma. M Skornicki, P Prince, and A Louder declared being employees of Aetion Inc.

Source: Skornicki M et al. Adv Ther. 2021 Apr 5. doi: 10.1007/s12325-021-01698-7.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: Under tight settings for monitoring and treatment, women vs. men with psoriatic arthritis (PsA) had more severe disease and were less likely to achieve low disease activity (LDA), particularly if overweight.

Major finding: Women vs. men had worse mean PsA Disease Activity Score (3.5 vs. 2.7; P less than .001) and were more likely to not reach LDA (odds ratio [OR], 1.62; P = .002). Being overweight was associated with not reaching LDA (OR, 2.41-3.43; P less than .05) in women but not in men.

Study details: Findings are from secondary analysis of routine practice data of 855 outpatients with PsA who were critically monitored and treated.

Disclosures: The study was supported by the regional junior researcher grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, the Netherlands. The authors declared no competing interests.

Source: Mulder MLM et al. Rheumatology (Oxford). 2021 Apr 8. doi: 10.1093/rheumatology/keab338.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Key clinical point: In patients with psoriatic arthritis (PsA), efficacy of the novel interleukin (IL)-23p19 inhibitor guselkumab for joint improvement was comparable to IL-17A and subcutaneous tumor necrosis factor (TNF) inhibitors while offering a better efficacy for skin manifestations.

Major finding: Guselkumab 100 mg every 8 weeks and every 4 weeks were comparable to IL-17A and subcutaneous TNF inhibitors for American College of Rheumatology 20 response. Guselkumab showed better Psoriasis Area Severity Index 90 and 75 responses than most of the other agents.

Study details: Data come from a network meta-analysis of 26 phase 3, randomized controlled trials that evaluated 13 targeted therapies among adults with active PsA.

Disclosures: This work was supported by Janssen Research and Development. The authors including the lead author reported receiving grants, consulting fees, speaker fees, and/or honoraria from various sources. S Peterson, A Schubert, SD Chakravarty, CS Karyekar, and S Nair reported being employees of Janssen Pharmaceuticals and shareholder of Johnson & Johnson.

Source: Mease PJ et al. Rheumatology (Oxford). 2021 Mar 24. doi: 10.1093/rheumatology/keab119.

Plasma levels of von Willebrand factor may be a useful biomarker of traumatic brain injury (TBI) and its severity, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.

“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
 

A specific marker of acute injury?

Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.

The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.

Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.

The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.

There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.

“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.

In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.

They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.

Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.

Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.

“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.

The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.

“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.

Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
 

Point-of-care test?

Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.

Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.

The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.

The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.

One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.

But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.

“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.

One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”

The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Plasma levels of von Willebrand factor may be a useful biomarker of traumatic brain injury (TBI) and its severity, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.

“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
 

A specific marker of acute injury?

Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.

The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.

Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.

The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.

There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.

“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.

In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.

They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.

Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.

Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.

“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.

The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.

“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.

Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
 

Point-of-care test?

Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.

Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.

The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.

The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.

One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.

But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.

“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.

One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”

The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Plasma levels of von Willebrand factor may be a useful biomarker of traumatic brain injury (TBI) and its severity, new research suggests. “Reliable detection of this biomarker at very early time points may allow for prompt TBI detection and therefore intervention,” said study investigator Rachel Elizabeth Thomas, MD, PhD, a neurology resident at the University of Pennsylvania, Philadelphia, while presenting study findings at the American Academy of Neurology’s 2021 annual meeting.

“The level reflects the degree of severity and provides some degree of prognostic information,” she added.
 

A specific marker of acute injury?

Von Willebrand factor is a glycoprotein released in the endothelium in response to local trauma. It plays a part in hemostasis and inflammation and is an indicator of traumatic microvascular injury. Research has shown that it is a biomarker of cerebrovascular pathology. In addition, increased expression of the factor is associated with vascular and neurodegenerative dementia.

The researchers examined whether von Willebrand factor is a biomarker of mild, repetitive TBI. They measured plasma levels of von Willebrand factor in 17 professional boxers before and after boxing bouts.

Eligible participants were between the ages of 18 and 35 years. They had a score of greater than or equal to 1 on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ-3), had competed in at least three 3-minute bouts, and had withstood 25 or more blows to the head.

The investigators compared the plasma levels of von Willebrand factor of the boxers with those of 42 patients who presented to the University of Pennsylvania Trauma Center with TBI and with those of 23 uninjured control persons.

There was no significant difference in plasma levels of von Willebrand factor between boxers before the bout (13.15 µg/mL) and the control persons (6.16 µg/mL). Among the boxers, levels of von Willebrand factor increased by a factor of 1.8 within 30 minutes after bouts, compared with the levels among the control persons. The mean post-bout von Willebrand factor level was 25.09 µg/mL.

“Von Willebrand factor may be more specific for acute injuries, given that it does not seem to stay chronically elevated,” said Dr. Thomas.

In addition, the researchers found a significant positive correlation (r = 0.51; P = .03) between the fold change in plasma von Willebrand factor levels and the number of blows to the head that the athletes sustained.

They also found a significant positive correlation between fold change in von Willebrand factor and RPQ-3 score (r = 0.69; P = .002). These objective and subjective data suggest that levels of von Willebrand factor reflect injury severity, said Dr. Thomas.

Among patients hospitalized with TBI, levels of von Willebrand factor were significantly higher than among control persons (73.2 µg/mL vs. 40.8 µg/mL; P < .0009). The investigators found a linear correlation between plasma von Willebrand factor level and RPQ-3 score (r = 0.24) that was not statistically significant.

Levels of von Willebrand factor among patients hospitalized with TBI were higher on average and demonstrated a greater degree of variability than the levels among boxers immediately after a bout.

“This is not unexpected, given that this group represents a more heterogeneous population with varied forms of acute blunt injury, as compared to the boxers, who have undergone relatively repetitive, milder trauma,” Dr. Thomas said.

The traditional biomarkers of neurotrauma reflect neuronal and glial injury, whereas von Willebrand factor is an indicator of vascular trauma.

“Although on its own, von Willebrand factor is not specific to intracranial vascular injury, paired together with markers such as neurofilament light, GFAP [glial fibrillary acidic protein], and tau, it could be utilized to identify TBI-associated microvascular injury and thus delineate between specific TBI endophenotypes,” said Dr. Thomas. It could distinguish, for example, predominantly neuronal injury from predominantly vascular injury.

Because von Willebrand factor plays a role in the neurovascular unit and is a marker of microvascular injury, the investigators intend to pair measurements of plasma von Willebrand factor with advanced imaging techniques to evaluate cerebral blood flow or cerebrovascular reactivity. Such a study could help determine whether von Willebrand factor levels correlate with the degree of vascular injury and cerebrovascular dysregulation.
 

Point-of-care test?

Commenting on the findings, Kristine O’Phelan, MD, professor of clinical neurology and director of neurocritical care in the department of neurology at the University of Miami, said von Willebrand factor’s likely utility would be as a marker of injury in patients with mild TBI or sports-related concussion.

Imaging and clinical exams do not always reveal these injuries, Dr. O’Phelan added. “Having a biomarker that you can easily test in the blood would be extremely helpful,” she said.

The most exciting part of this study is that it indicates the potential to develop a point-of-care test for use on the athletic field or the battlefield for early detection of mild TBI, she added.

The fact that the test for von Willebrand factor has already been developed is an advantage, said Dr. O’Phelan. The normal and abnormal values of the test are clearly understood. “I do think that they will still need to calibrate it for head injury, because that’s not usually what the test is used for,” said Dr. O’Phelan.

One of the study’s strengths is that the investigators compared patients with TBI with control persons who had exercised, she added, because such a comparison helps clarify the biomarker’s relationship to the injury. Another strength is the application of the test to injuries of various types and of different degrees of severity.

But the biomarker will need to be tested in a larger population, said Dr. O’Phelan. In addition, there is a need to identify the right patient population for this test, as well as the best time frame for its application and potential factors that could confound the test results.

“I do worry a little bit about using early biomarkers for prognosis, particularly in severe TBI, because there’s so many variables that go into outcome,” said Dr. O’Phelan. This test likely would be administered in the first hours after injury, but many factors might affect patients’ outcomes, she added.

One influential factor is age. “If you have a von Willebrand factor of whatever number, that might have different importance in a 30-year-old than in an 80-year-old,” said Dr. O’Phelan. “We need to understand how to interpret those findings better.”

The study was supported by the National Institute for Neurological Disorders and Stroke, the U.S. Department of Defense, and the Pennsylvania Department of Health. Dr. Thomas and Dr. O’Phelan have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent.

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).

The affected lots include 15-mg, 30-mg, 60-mg, 90-mg and 120-mg formulations of NP Thyroid tablets, packed in 100-count and 7-count bottles.

The list of the specific recalled lots is published on the Food and Drug Administration website.

Acella reports that, so far, 43 reports of serious adverse events that could be related to the recall have been received.

Symptoms suggesting patients may have received a subpotent batch include the common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, Acella reports.

“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the company cautions in the recall statement.

Acella adds that toxic cardiac manifestations of hyperthyroidism, including cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease.

While Acella is notifying affected parties to discontinue distribution of the recalled products, it advises that patients who are currently taking NP Thyroid from the lots being recalled “should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.”

In November 2020, a recall of NP Thyroid was issued after FDA testing found subpotent levels, as low as 87% of the labeled amount, of LT4 in some lots.

And earlier, in May 2020, the company recalled 13 lots of the tablets due to excessive potency, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.

NP Thyroid is a type of desiccated animal thyroid product that was long the standard of care for hypothyroidism prior to the advent of the synthetic hypothyroidism drug, Synthroid (levothyroxine sodium), now the most commonly used hypothyroidism treatment.

On its website, Acella refers to NP Thyroid as a “natural choice for thyroid therapy,” as desiccated thyroid is commonly referred to.

However, one of the most common concerns about desiccated thyroid is a tendency to have unreliable concentrations of active ingredients, as discussed in American Thyroid Association recommendations.

The “amounts of both T4 and T3 can vary in every batch of desiccated thyroid, making it harder to keep blood levels right,” the ATA states.

“Finally, even desiccated thyroid pills have chemicals (binders) in them to hold the pill together, so they are not completely ‘natural.’ ”

Consumers with questions about the recall are advised to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET.
 

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent.

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).

The affected lots include 15-mg, 30-mg, 60-mg, 90-mg and 120-mg formulations of NP Thyroid tablets, packed in 100-count and 7-count bottles.

The list of the specific recalled lots is published on the Food and Drug Administration website.

Acella reports that, so far, 43 reports of serious adverse events that could be related to the recall have been received.

Symptoms suggesting patients may have received a subpotent batch include the common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, Acella reports.

“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the company cautions in the recall statement.

Acella adds that toxic cardiac manifestations of hyperthyroidism, including cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease.

While Acella is notifying affected parties to discontinue distribution of the recalled products, it advises that patients who are currently taking NP Thyroid from the lots being recalled “should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.”

In November 2020, a recall of NP Thyroid was issued after FDA testing found subpotent levels, as low as 87% of the labeled amount, of LT4 in some lots.

And earlier, in May 2020, the company recalled 13 lots of the tablets due to excessive potency, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.

NP Thyroid is a type of desiccated animal thyroid product that was long the standard of care for hypothyroidism prior to the advent of the synthetic hypothyroidism drug, Synthroid (levothyroxine sodium), now the most commonly used hypothyroidism treatment.

On its website, Acella refers to NP Thyroid as a “natural choice for thyroid therapy,” as desiccated thyroid is commonly referred to.

However, one of the most common concerns about desiccated thyroid is a tendency to have unreliable concentrations of active ingredients, as discussed in American Thyroid Association recommendations.

The “amounts of both T4 and T3 can vary in every batch of desiccated thyroid, making it harder to keep blood levels right,” the ATA states.

“Finally, even desiccated thyroid pills have chemicals (binders) in them to hold the pill together, so they are not completely ‘natural.’ ”

Consumers with questions about the recall are advised to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET.
 

In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent.

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).

The affected lots include 15-mg, 30-mg, 60-mg, 90-mg and 120-mg formulations of NP Thyroid tablets, packed in 100-count and 7-count bottles.

The list of the specific recalled lots is published on the Food and Drug Administration website.

Acella reports that, so far, 43 reports of serious adverse events that could be related to the recall have been received.

Symptoms suggesting patients may have received a subpotent batch include the common signs of hypothyroidism, such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, Acella reports.

“There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development,” the company cautions in the recall statement.

Acella adds that toxic cardiac manifestations of hyperthyroidism, including cardiac pain, palpitations or cardiac arrhythmia may occur in elderly patients and patients with underlying cardiac disease.

While Acella is notifying affected parties to discontinue distribution of the recalled products, it advises that patients who are currently taking NP Thyroid from the lots being recalled “should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.”

In November 2020, a recall of NP Thyroid was issued after FDA testing found subpotent levels, as low as 87% of the labeled amount, of LT4 in some lots.

And earlier, in May 2020, the company recalled 13 lots of the tablets due to excessive potency, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.

NP Thyroid is a type of desiccated animal thyroid product that was long the standard of care for hypothyroidism prior to the advent of the synthetic hypothyroidism drug, Synthroid (levothyroxine sodium), now the most commonly used hypothyroidism treatment.

On its website, Acella refers to NP Thyroid as a “natural choice for thyroid therapy,” as desiccated thyroid is commonly referred to.

However, one of the most common concerns about desiccated thyroid is a tendency to have unreliable concentrations of active ingredients, as discussed in American Thyroid Association recommendations.

The “amounts of both T4 and T3 can vary in every batch of desiccated thyroid, making it harder to keep blood levels right,” the ATA states.

“Finally, even desiccated thyroid pills have chemicals (binders) in them to hold the pill together, so they are not completely ‘natural.’ ”

Consumers with questions about the recall are advised to email Acella Pharmaceuticals at [email protected] or call 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET.