Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: Patients with plaque psoriasis were at risk of developing psoriatic arthritis (PsA) even if undergoing treatment with biologics; thus, screening for PsA at each follow-up visit should be strongly implemented.

Major finding: Overall, new-onset PsA developed in 8.5% of patients who were under treatment with any of the biologics including anti-tumor necrosis factor, anti-interleukin (IL)12/23, anti-IL17, and anti-IL23. No significant risk factors were identified for new-onset PsA.

Study details: Findings are from a 1-year prospective study including 118 patients with moderate-to-severe psoriasis without PsA who underwent treatment with biologics for at least 3 months.

Disclosures: This study did not receive any external funding. The authors declared no conflict of interests.

Source: Megna M et al. Biomedicines. 2021;9(10):1482 (Oct 15). Doi: 10.3390/biomedicines9101482.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: COVID-19 pandemic did not increase the occurrence of depressive symptoms among patients with psoriatic arthritis (PsA) compared with the period before the pandemic.

Major finding: Majority of patients did not have indications of depressive symptoms during (85.39%) and prior to (83.15%) the pandemic, with 14.61% and 16.85% of patients showing depressive symptoms during and prior to the pandemic, respectively. The prevalence of depressive symptoms was not significantly different before and during the pandemic (P = .803), irrespective of disease activity.

Study details: Findings are from a longitudinal study including 89 patients with PsA from a National Patient Register in Germany.

Disclosures: This study was funded by the German RheumaDatenRhePort Registry (RHADAR GbR). Most of the authors including the lead author declared being members, receiving honoraria, research support, or remuneration from various sources, including RHADAR Gbr.

Source: Engelbrecht M et al. Front Med. 2021(Nov 1). Doi: 10.3389/fmed.2021.748262.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: Ixekizumab was more effective than adalimumab in treating signs and symptoms of psoriatic arthritis (PsA), regardless of severity of concomitant psoriasis.

Major finding: At week 52, a significantly greater proportion of patients treated with ixekizumab vs. adalimumab achieved at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index simultaneously, irrespective of presence (38.8% vs. 17.6%; P = .026) or absence (39.3% vs. 28.1%; P = .014) of moderate-to-severe psoriasis at baseline.

Study details: Findings are from a post hoc analysis of the phase 3b/4 SPIRIT-H2H study including 566 patients who were biologic disease-modifying antirheumatic drugs-naive with active PsA and concomitant psoriasis. They were randomly assigned to either ixekizumab or adalimumab.

Disclosures: This study was funded by Eli Lilly and Company, Indianapolis, IN, USA. Some of the authors, including the lead author, reported ties with several sources including Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company.

Source: Kristensen LE et al. Rheumatol Ther. 2021(Oct 28). Doi: 10.1007/s40744-021-00388-8.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: The 2-year follow-up results of the phase 3 DISCOVER 2 study revealed the robust and sustained efficacy of 100 mg guselkumab every 4 weeks (Q4W) and 100 mg guselkumab every 8 weeks (Q8W) in improving signs and symptoms of psoriatic arthritis (PsA) in biologic-naive patients along with a consistent safety profile.

Major finding: At week 100, at least 20% improvement in American College of Rheumatology criteria was achieved by 76%, 74%, and 68% of patients who received guselkumab Q4W, guselkumab Q8W, and placebo, respectively, indicating a durable response. No new safety signals were identified.

Study details: Findings are from the phase 3 DISCOVER 2 study including 739 biologic-naive patients with active PsA, who were randomly assigned to 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo. A total of 652 patients completed treatment through week 100.

Disclosures: This study was funded by Janssen Research & Development, LLC, a Johnson & Johnson company. Six authors declared being employees and stockholders of Johnson & Johnson, and the others reported ties with several sources, including Janssen.

Source: McInnes IB et al. Arthritis Rheumatol. 2021(Nov 1). Doi: 10.1002/art.42010.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: Pregnant women with psoriatic arthritis (PsA), particularly those requiring antirheumatic treatment, are at increased risk for adverse pregnancy outcomes.

Major finding: Pregnancy in PsA vs. non-PsA women were associated with increased risk for preterm birth (adjusted odds ratio [aOR] 1.69; 95% CI 1.27-2.24), elective cesarean delivery (CD; aOR 1.77; 95% CI 1.43-2.20), and emergency CD (aOR 1.42; 95% CI 1.10-1.84) with the risk even more pronounced in pregnancies in women with PsA with exposure to antirheumatic treatment any time before or during pregnancy (preterm birth: aOR 1.98; 95% CI 1.27-2.86; elective CD: aOR 1.96; 95% CI 1.47-2.63; and emergency CD: aOR 1.67; 95% CI 1.18-2.36).

Study details: This was a cohort study including 921 pregnancies in patients with PsA matched with 9,210 pregnancies in non-PsA patients.

Disclosures: This study did not receive any funding. None of the authors declared any conflict of interests.

Source: Remaeus K et al. Arthritis Rheumatol. 2021 (Oct 20). Doi: 10.1002/art.41985.

Key clinical point: In patients with psoriatic arthritis (PsA), joint swelling was more closely related to and better predicted ultrasound-defined inflammation and active synovitis at 1 year than joint tenderness.

Major finding: Swollen joint count correlated better with greyscale and power Doppler (PD) joint scores (correlation coefficient [r] 0.37 and 0.47, respectively) than tender joint count (PD-joint score; r 0.33). Ultrasound verified active synovitis at 12-month follow-up was better predicted by swelling (odds ratio [OR] 6.33; 95% CI 3.70-10.83) vs. tenderness (OR 3.58; 95% CI 2.29-5.58) at baseline.

Study details: Findings are from a prospective study including 83 patients with PsA who underwent clinical and ultrasound examinations at 2 visits scheduled 12 months apart.

Disclosures: This work was funded by Pfizer. The authors declared no conflict of interests.

Source: Bosch P et al. Rheumatology. 2021;keab764 (Oct 21). Doi: 10.1093/rheumatology/keab764.

Key clinical point: In patients with psoriatic arthritis (PsA), joint swelling was more closely related to and better predicted ultrasound-defined inflammation and active synovitis at 1 year than joint tenderness.

Major finding: Swollen joint count correlated better with greyscale and power Doppler (PD) joint scores (correlation coefficient [r] 0.37 and 0.47, respectively) than tender joint count (PD-joint score; r 0.33). Ultrasound verified active synovitis at 12-month follow-up was better predicted by swelling (odds ratio [OR] 6.33; 95% CI 3.70-10.83) vs. tenderness (OR 3.58; 95% CI 2.29-5.58) at baseline.

Study details: Findings are from a prospective study including 83 patients with PsA who underwent clinical and ultrasound examinations at 2 visits scheduled 12 months apart.

Disclosures: This work was funded by Pfizer. The authors declared no conflict of interests.

Source: Bosch P et al. Rheumatology. 2021;keab764 (Oct 21). Doi: 10.1093/rheumatology/keab764.

Key clinical point: In patients with psoriatic arthritis (PsA), joint swelling was more closely related to and better predicted ultrasound-defined inflammation and active synovitis at 1 year than joint tenderness.

Major finding: Swollen joint count correlated better with greyscale and power Doppler (PD) joint scores (correlation coefficient [r] 0.37 and 0.47, respectively) than tender joint count (PD-joint score; r 0.33). Ultrasound verified active synovitis at 12-month follow-up was better predicted by swelling (odds ratio [OR] 6.33; 95% CI 3.70-10.83) vs. tenderness (OR 3.58; 95% CI 2.29-5.58) at baseline.

Study details: Findings are from a prospective study including 83 patients with PsA who underwent clinical and ultrasound examinations at 2 visits scheduled 12 months apart.

Disclosures: This work was funded by Pfizer. The authors declared no conflict of interests.

Source: Bosch P et al. Rheumatology. 2021;keab764 (Oct 21). Doi: 10.1093/rheumatology/keab764.

Key clinical point: The risk for serious infections (SI) was significantly lower in patients with psoriatic arthritis (PsA) vs. patients with rheumatoid arthritis (RA) who were receiving tumor necrosis factor inhibitors (TNFi).

Major finding: The crude incidence rate for SI was lower in patients with PsA (2.16; 95% CI 1.66-2.81) vs. those with RA (4.17; 95% CI 3.52-4.95). Patients with PsA vs. RA still had a lower risk of contracting SI even after adjusting for multiple factors (adjusted hazard ratio 0.65; P = .025).

Study details: Findings are from a prospective observational multicenter study including 1,352 and 1,007 patients with RA and PsA, respectively, from the Norwegian-Disease Modifying Anti-Rheumatic Drug Registry. A total of 3,169 TNFi treatment courses were included in the study.

Disclosures: This study was funded by South-Eastern Health Authority and received partial support from AbbVie, BMS, MSD, Pfizer, Roche, and UCB. The authors report receiving personal fees and grants from the above-mentioned sources and other pharmaceutical companies.

Source: Christensen IE et al. Ann Rheum Dis. 2021 (Oct 8). Doi: 10.1136/annrheumdis-2021-221007.

Key clinical point: The risk for serious infections (SI) was significantly lower in patients with psoriatic arthritis (PsA) vs. patients with rheumatoid arthritis (RA) who were receiving tumor necrosis factor inhibitors (TNFi).

Major finding: The crude incidence rate for SI was lower in patients with PsA (2.16; 95% CI 1.66-2.81) vs. those with RA (4.17; 95% CI 3.52-4.95). Patients with PsA vs. RA still had a lower risk of contracting SI even after adjusting for multiple factors (adjusted hazard ratio 0.65; P = .025).

Study details: Findings are from a prospective observational multicenter study including 1,352 and 1,007 patients with RA and PsA, respectively, from the Norwegian-Disease Modifying Anti-Rheumatic Drug Registry. A total of 3,169 TNFi treatment courses were included in the study.

Disclosures: This study was funded by South-Eastern Health Authority and received partial support from AbbVie, BMS, MSD, Pfizer, Roche, and UCB. The authors report receiving personal fees and grants from the above-mentioned sources and other pharmaceutical companies.

Source: Christensen IE et al. Ann Rheum Dis. 2021 (Oct 8). Doi: 10.1136/annrheumdis-2021-221007.

Key clinical point: The risk for serious infections (SI) was significantly lower in patients with psoriatic arthritis (PsA) vs. patients with rheumatoid arthritis (RA) who were receiving tumor necrosis factor inhibitors (TNFi).

Major finding: The crude incidence rate for SI was lower in patients with PsA (2.16; 95% CI 1.66-2.81) vs. those with RA (4.17; 95% CI 3.52-4.95). Patients with PsA vs. RA still had a lower risk of contracting SI even after adjusting for multiple factors (adjusted hazard ratio 0.65; P = .025).

Study details: Findings are from a prospective observational multicenter study including 1,352 and 1,007 patients with RA and PsA, respectively, from the Norwegian-Disease Modifying Anti-Rheumatic Drug Registry. A total of 3,169 TNFi treatment courses were included in the study.

Disclosures: This study was funded by South-Eastern Health Authority and received partial support from AbbVie, BMS, MSD, Pfizer, Roche, and UCB. The authors report receiving personal fees and grants from the above-mentioned sources and other pharmaceutical companies.

Source: Christensen IE et al. Ann Rheum Dis. 2021 (Oct 8). Doi: 10.1136/annrheumdis-2021-221007.

Key clinical point: Upadacitinib continued to demonstrate improvement in clinical manifestations of psoriatic arthritis (PsA) through week 56 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs) with no new adverse events.

Major finding: Consistent with week 24, a higher proportion of patients achieved at least 20% improvement in the American College of Rheumatology criteria with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Study details: Findings are from an analysis of 1,419 patients with active PsA and inadequate response to at least 1 non-bDMARD who completed 56 weeks of treatment in the phase 3 SELECT-PsA 1 study.

Disclosures: This study was sponsored by AbbVie. The authors reported receiving research grants, honoraria, and consulting fees from or serving as an advisory board member, being an employee, or being shareholders in various companies, including AbbVie.

Source: McInnes IB et al. RMD Open. 2021;7:e001838 (Oct 18). Doi:  10.1136/rmdopen-2021-001838.

Key clinical point: Upadacitinib continued to demonstrate improvement in clinical manifestations of psoriatic arthritis (PsA) through week 56 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs) with no new adverse events.

Major finding: Consistent with week 24, a higher proportion of patients achieved at least 20% improvement in the American College of Rheumatology criteria with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Study details: Findings are from an analysis of 1,419 patients with active PsA and inadequate response to at least 1 non-bDMARD who completed 56 weeks of treatment in the phase 3 SELECT-PsA 1 study.

Disclosures: This study was sponsored by AbbVie. The authors reported receiving research grants, honoraria, and consulting fees from or serving as an advisory board member, being an employee, or being shareholders in various companies, including AbbVie.

Source: McInnes IB et al. RMD Open. 2021;7:e001838 (Oct 18). Doi:  10.1136/rmdopen-2021-001838.

Key clinical point: Upadacitinib continued to demonstrate improvement in clinical manifestations of psoriatic arthritis (PsA) through week 56 in patients with inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs) with no new adverse events.

Major finding: Consistent with week 24, a higher proportion of patients achieved at least 20% improvement in the American College of Rheumatology criteria with upadacitinib (15 mg, 74.4%; 30 mg, 74.7%) vs. adalimumab (68.5%; P = .046) at week 56. No new safety signals were identified.

Study details: Findings are from an analysis of 1,419 patients with active PsA and inadequate response to at least 1 non-bDMARD who completed 56 weeks of treatment in the phase 3 SELECT-PsA 1 study.

Disclosures: This study was sponsored by AbbVie. The authors reported receiving research grants, honoraria, and consulting fees from or serving as an advisory board member, being an employee, or being shareholders in various companies, including AbbVie.

Source: McInnes IB et al. RMD Open. 2021;7:e001838 (Oct 18). Doi:  10.1136/rmdopen-2021-001838.

The newly detected Omicron COVID-19 variant may be highly infectious and less responsive to available vaccines than other variants, but it is too early to know how it compares to the Delta variant, top infectious disease official Anthony S. Fauci, MD, said Nov. 30.

Dr. Fauci, speaking at a White House COVID-19 briefing, said there’s a “very unusual constellation of changes” across the COVID-19 genome that indicates it is unlike any variant we have seen so far.

“This mutational profile is very different from other variants of interest and concern, and although some mutations are also found in Delta, this is not Delta,” Dr. Fauci said. “These mutations have been associated with increased transmissibility and immune evasion.”

Omicron is the fifth designated COVID-19 variant of concern.

Detected first in South Africa, Omicron has been found in 20 countries so far. There are no known cases yet in the United States, but it has been detected in Canada.

Omicron has more than 30 mutations to the spike protein, the part of the virus that binds to human cells, Dr. Fauci said.

Cross-protection from boosters

Though the mutations suggest there is increased transmission of this variant, he said it is too soon to know how this compares to the Delta variant. And although the vaccines may not be as effective against Omicron, Dr. Fauci said there will likely be some protection.

“Remember, as with other variants, although partial immune escape may occur, vaccines, particularly boosters, give a level of antibodies that even with variants like Delta give you a degree of cross-protection, particularly against severe disease,” he said.

“When we say that although these mutations suggest a diminution of protection and a degree of immune evasion, we still, from experience with Delta, can make a reasonable conclusion that you would not eliminate all protection against this particular variant,” Dr. Fauci said.

So far, there is no reason to believe Omicron will cause more severe illness than other variants of concern.

“Although some preliminary information from South Africa suggests no unusual symptoms associated with variant, we do not know, and it is too early to tell,” Dr. Fauci said.

He recommended that people continue to wear masks, wash hands, and avoid crowded indoor venues. Most importantly, he recommended that everyone get their vaccines and boosters.

“One thing has become clear over the last 20 months: We can’t predict the future, but we can be prepared for it,” CDC Director Rochelle P. Walensky, MD, said at the briefing. “We have far more tools to fight the variant today than we did at this time last year.”


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

The newly detected Omicron COVID-19 variant may be highly infectious and less responsive to available vaccines than other variants, but it is too early to know how it compares to the Delta variant, top infectious disease official Anthony S. Fauci, MD, said Nov. 30.

Dr. Fauci, speaking at a White House COVID-19 briefing, said there’s a “very unusual constellation of changes” across the COVID-19 genome that indicates it is unlike any variant we have seen so far.

“This mutational profile is very different from other variants of interest and concern, and although some mutations are also found in Delta, this is not Delta,” Dr. Fauci said. “These mutations have been associated with increased transmissibility and immune evasion.”

Omicron is the fifth designated COVID-19 variant of concern.

Detected first in South Africa, Omicron has been found in 20 countries so far. There are no known cases yet in the United States, but it has been detected in Canada.

Omicron has more than 30 mutations to the spike protein, the part of the virus that binds to human cells, Dr. Fauci said.

Cross-protection from boosters

Though the mutations suggest there is increased transmission of this variant, he said it is too soon to know how this compares to the Delta variant. And although the vaccines may not be as effective against Omicron, Dr. Fauci said there will likely be some protection.

“Remember, as with other variants, although partial immune escape may occur, vaccines, particularly boosters, give a level of antibodies that even with variants like Delta give you a degree of cross-protection, particularly against severe disease,” he said.

“When we say that although these mutations suggest a diminution of protection and a degree of immune evasion, we still, from experience with Delta, can make a reasonable conclusion that you would not eliminate all protection against this particular variant,” Dr. Fauci said.

So far, there is no reason to believe Omicron will cause more severe illness than other variants of concern.

“Although some preliminary information from South Africa suggests no unusual symptoms associated with variant, we do not know, and it is too early to tell,” Dr. Fauci said.

He recommended that people continue to wear masks, wash hands, and avoid crowded indoor venues. Most importantly, he recommended that everyone get their vaccines and boosters.

“One thing has become clear over the last 20 months: We can’t predict the future, but we can be prepared for it,” CDC Director Rochelle P. Walensky, MD, said at the briefing. “We have far more tools to fight the variant today than we did at this time last year.”


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

The newly detected Omicron COVID-19 variant may be highly infectious and less responsive to available vaccines than other variants, but it is too early to know how it compares to the Delta variant, top infectious disease official Anthony S. Fauci, MD, said Nov. 30.

Dr. Fauci, speaking at a White House COVID-19 briefing, said there’s a “very unusual constellation of changes” across the COVID-19 genome that indicates it is unlike any variant we have seen so far.

“This mutational profile is very different from other variants of interest and concern, and although some mutations are also found in Delta, this is not Delta,” Dr. Fauci said. “These mutations have been associated with increased transmissibility and immune evasion.”

Omicron is the fifth designated COVID-19 variant of concern.

Detected first in South Africa, Omicron has been found in 20 countries so far. There are no known cases yet in the United States, but it has been detected in Canada.

Omicron has more than 30 mutations to the spike protein, the part of the virus that binds to human cells, Dr. Fauci said.

Cross-protection from boosters

Though the mutations suggest there is increased transmission of this variant, he said it is too soon to know how this compares to the Delta variant. And although the vaccines may not be as effective against Omicron, Dr. Fauci said there will likely be some protection.

“Remember, as with other variants, although partial immune escape may occur, vaccines, particularly boosters, give a level of antibodies that even with variants like Delta give you a degree of cross-protection, particularly against severe disease,” he said.

“When we say that although these mutations suggest a diminution of protection and a degree of immune evasion, we still, from experience with Delta, can make a reasonable conclusion that you would not eliminate all protection against this particular variant,” Dr. Fauci said.

So far, there is no reason to believe Omicron will cause more severe illness than other variants of concern.

“Although some preliminary information from South Africa suggests no unusual symptoms associated with variant, we do not know, and it is too early to tell,” Dr. Fauci said.

He recommended that people continue to wear masks, wash hands, and avoid crowded indoor venues. Most importantly, he recommended that everyone get their vaccines and boosters.

“One thing has become clear over the last 20 months: We can’t predict the future, but we can be prepared for it,” CDC Director Rochelle P. Walensky, MD, said at the briefing. “We have far more tools to fight the variant today than we did at this time last year.”


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

An antiviral pill from Merck may help some high-risk patients survive a COVID-19 infection or help them stay out of the hospital, even though the risks of taking the drug aren’t yet fully known, according to a panel of experts that advises the Food and Drug Administration on its regulatory decisions for these types of drugs.

The FDA’s Antimicrobial Drugs Advisory Committee narrowly voted to authorize the drug molnupiravir, voting 13 to 10 to support emergency use, which requires a medication to meet a lower standard of evidence than does full approval.

The FDA is not bound by the committee’s vote but typically follows its advice.

If authorized by the agency, molnupiravir would be the first antiviral agent available as a pill to treat COVID-19. Other therapies to treat the infection are available — monoclonal antibodies and the drug remdesivir — but they are given by infusion.

The United Kingdom has already authorized the use of Merck’s drug.

“This was clearly a difficult decision,” said committee member Michael Green, MD, a pediatric infectious disease expert at the University of Pittsburg School of Medicine.

Green said he voted yes, and that the drug’s ability to prevent deaths in the study weighed heavily on his decision. He said given uncertainties around the drug both the company and FDA should keep a close eye on patients taking the drug going forward.

“Should an alternative oral agent become available that had a better safety profile and equal or better efficacy profile, the agency might reconsider its authorization,” he said.

Others didn’t agree that the drug should be allowed onto the market.

“I voted no,” said Jennifer Le, PharmD, a professor of clinical pharmacy at the University of California. Dr. Le said the modest benefit of the medication didn’t outweigh all the potential safety issues. “I think I just need more efficacy and safety data,” she said.

Initial results from the first half of people enrolled in the clinical trial found the pill cut the risk of hospitalization or death by 50% in patients at higher risk of severe outcomes from COVID-19.

But later results, released just days before the meeting, showed that the drug’s effectiveness had dropped to about 30%.

In the updated analysis, 48 patients out of the 709 who were taking the drug were hospitalized or died within 29 days compared to 68 out of 699 who randomly got the placebo. There was one death in the group that got molnupiravir compared to nine in the placebo group. Nearly all those deaths occurred during the first phase of the study.

On Nov. 30 Merck explained that the drug’s efficacy appeared to fall, in part, because the placebo group had experienced fewer hospitalizations and deaths than expected during the second half of the study, making the drug look less beneficial by comparison.

The company said it wasn’t sure why patients in the placebo group had fared so much better in later trial enrollments.

“The efficacy of this product is not overwhelmingly good,” said committee member David Hardy, MD, an infectious disease expert at Charles Drew University School of Medicine in Los Angeles. “And I think that makes all of us a little uncomfortable about whether this is an advanced therapeutic because it’s an oral medication rather than an intravenous medication,” he said during the panel’s deliberations.

“I think we have to be very careful about how we’re going to allow people to use this,” Dr. Hardy said.

Many who voted for authorization thought use of the drug should be restricted to unvaccinated people who were at high risk of severe COVID-19 outcomes, the same population enrolled in the clinical trial. People in the trial were considered at higher risk if they were over age 60, had cancer, chronic kidney disease, chronic obstructive pulmonary disease, were obese, or had heart disease or diabetes.

There are some significant limitations of the study that may affect how the drug is used. Vaccinated people couldn’t enroll in the study, so it’s not known if the medication would have any benefit for them. Nearly two-thirds of the U.S. population is fully vaccinated. The study found no additional benefit of the medication compared to the placebo in people who had detectable antibodies, presumably from a prior infection.

Animal studies found that the drug — which kills the virus by forcing it to make errors as it copies its genetic material inside cells — could disrupt bone formation. For that reason, the manufacturer and the FDA agreed that it should not be used in anyone younger than age 18.

Animal studies also indicated that the drug could cause birth defects. For that reason, the company said the drug shouldn’t be given to women who are pregnant or breastfeeding and said doctors should make sure women of childbearing age aren’t pregnant before taking the medication.

Some members of the panel felt that pregnant women and their doctors should be given the choice of whether or not to use the drug, given that pregnant women are at high risk for severe COVID-19 outcomes and infused therapies may not be available in all settings.

Other members of the committee said they were uncomfortable authorizing the drug given its potential to mutate the virus.

The drug, which forces the virus to mutate as it copies its RNA, eventually causes the virus to make so many errors in its genetic material that it can no longer make more of itself and the immune system clears it out of the body.

But it takes a few days to work — the drug is designed to be taken for 5 consecutive days -- and studies of the viral loads of patients taking the drug show that through the first 2 days, viral loads remain detectable as these mutations occur.

Studies by the FDA show some of those mutations in the spike protein are the same ones that have helped the virus become more transmissible and escape the protection of vaccines.

So the question is whether someone taking the medication could develop a dangerous mutation and then infect someone else, sparking the spread of a new variant.

Nicholas Kartsonis, MD, a vice president at Merck, said that the company was still analyzing data.

“Even if the probability is very low — 1 in 10,000 or 1 in 100,000 -- that this drug would induce an escape mutant for which the vaccines we have would not cover, that would be catastrophic for the whole world, actually,” said committee member James Hildreth, MD, an immunologist and president of Meharry Medical College, Nashville. “Do you have sufficient data on the likelihood of that happening?” he asked Dr. Kartsonis of Merck.

“So we don’t,” Dr. Kartsonis said.

He said, in theory, the risk of mutation with molnupiravir is the same as seen with the use of vaccines or monoclonal antibody therapies. Dr. Hildreth wasn’t satisfied with that answer.

“With all respect, the mechanism of your drug is to drive [genetic mutations], so it’s not the same as the vaccine. It’s not the same as monoclonal antibodies,” he said.

Dr. Hildreth later said he didn’t feel comfortable voting for authorization given the uncertainties around escape mutants. He voted no.

“It was an easy vote for me,” he said.

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

An antiviral pill from Merck may help some high-risk patients survive a COVID-19 infection or help them stay out of the hospital, even though the risks of taking the drug aren’t yet fully known, according to a panel of experts that advises the Food and Drug Administration on its regulatory decisions for these types of drugs.

The FDA’s Antimicrobial Drugs Advisory Committee narrowly voted to authorize the drug molnupiravir, voting 13 to 10 to support emergency use, which requires a medication to meet a lower standard of evidence than does full approval.

The FDA is not bound by the committee’s vote but typically follows its advice.

If authorized by the agency, molnupiravir would be the first antiviral agent available as a pill to treat COVID-19. Other therapies to treat the infection are available — monoclonal antibodies and the drug remdesivir — but they are given by infusion.

The United Kingdom has already authorized the use of Merck’s drug.

“This was clearly a difficult decision,” said committee member Michael Green, MD, a pediatric infectious disease expert at the University of Pittsburg School of Medicine.

Green said he voted yes, and that the drug’s ability to prevent deaths in the study weighed heavily on his decision. He said given uncertainties around the drug both the company and FDA should keep a close eye on patients taking the drug going forward.

“Should an alternative oral agent become available that had a better safety profile and equal or better efficacy profile, the agency might reconsider its authorization,” he said.

Others didn’t agree that the drug should be allowed onto the market.

“I voted no,” said Jennifer Le, PharmD, a professor of clinical pharmacy at the University of California. Dr. Le said the modest benefit of the medication didn’t outweigh all the potential safety issues. “I think I just need more efficacy and safety data,” she said.

Initial results from the first half of people enrolled in the clinical trial found the pill cut the risk of hospitalization or death by 50% in patients at higher risk of severe outcomes from COVID-19.

But later results, released just days before the meeting, showed that the drug’s effectiveness had dropped to about 30%.

In the updated analysis, 48 patients out of the 709 who were taking the drug were hospitalized or died within 29 days compared to 68 out of 699 who randomly got the placebo. There was one death in the group that got molnupiravir compared to nine in the placebo group. Nearly all those deaths occurred during the first phase of the study.

On Nov. 30 Merck explained that the drug’s efficacy appeared to fall, in part, because the placebo group had experienced fewer hospitalizations and deaths than expected during the second half of the study, making the drug look less beneficial by comparison.

The company said it wasn’t sure why patients in the placebo group had fared so much better in later trial enrollments.

“The efficacy of this product is not overwhelmingly good,” said committee member David Hardy, MD, an infectious disease expert at Charles Drew University School of Medicine in Los Angeles. “And I think that makes all of us a little uncomfortable about whether this is an advanced therapeutic because it’s an oral medication rather than an intravenous medication,” he said during the panel’s deliberations.

“I think we have to be very careful about how we’re going to allow people to use this,” Dr. Hardy said.

Many who voted for authorization thought use of the drug should be restricted to unvaccinated people who were at high risk of severe COVID-19 outcomes, the same population enrolled in the clinical trial. People in the trial were considered at higher risk if they were over age 60, had cancer, chronic kidney disease, chronic obstructive pulmonary disease, were obese, or had heart disease or diabetes.

There are some significant limitations of the study that may affect how the drug is used. Vaccinated people couldn’t enroll in the study, so it’s not known if the medication would have any benefit for them. Nearly two-thirds of the U.S. population is fully vaccinated. The study found no additional benefit of the medication compared to the placebo in people who had detectable antibodies, presumably from a prior infection.

Animal studies found that the drug — which kills the virus by forcing it to make errors as it copies its genetic material inside cells — could disrupt bone formation. For that reason, the manufacturer and the FDA agreed that it should not be used in anyone younger than age 18.

Animal studies also indicated that the drug could cause birth defects. For that reason, the company said the drug shouldn’t be given to women who are pregnant or breastfeeding and said doctors should make sure women of childbearing age aren’t pregnant before taking the medication.

Some members of the panel felt that pregnant women and their doctors should be given the choice of whether or not to use the drug, given that pregnant women are at high risk for severe COVID-19 outcomes and infused therapies may not be available in all settings.

Other members of the committee said they were uncomfortable authorizing the drug given its potential to mutate the virus.

The drug, which forces the virus to mutate as it copies its RNA, eventually causes the virus to make so many errors in its genetic material that it can no longer make more of itself and the immune system clears it out of the body.

But it takes a few days to work — the drug is designed to be taken for 5 consecutive days -- and studies of the viral loads of patients taking the drug show that through the first 2 days, viral loads remain detectable as these mutations occur.

Studies by the FDA show some of those mutations in the spike protein are the same ones that have helped the virus become more transmissible and escape the protection of vaccines.

So the question is whether someone taking the medication could develop a dangerous mutation and then infect someone else, sparking the spread of a new variant.

Nicholas Kartsonis, MD, a vice president at Merck, said that the company was still analyzing data.

“Even if the probability is very low — 1 in 10,000 or 1 in 100,000 -- that this drug would induce an escape mutant for which the vaccines we have would not cover, that would be catastrophic for the whole world, actually,” said committee member James Hildreth, MD, an immunologist and president of Meharry Medical College, Nashville. “Do you have sufficient data on the likelihood of that happening?” he asked Dr. Kartsonis of Merck.

“So we don’t,” Dr. Kartsonis said.

He said, in theory, the risk of mutation with molnupiravir is the same as seen with the use of vaccines or monoclonal antibody therapies. Dr. Hildreth wasn’t satisfied with that answer.

“With all respect, the mechanism of your drug is to drive [genetic mutations], so it’s not the same as the vaccine. It’s not the same as monoclonal antibodies,” he said.

Dr. Hildreth later said he didn’t feel comfortable voting for authorization given the uncertainties around escape mutants. He voted no.

“It was an easy vote for me,” he said.

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

An antiviral pill from Merck may help some high-risk patients survive a COVID-19 infection or help them stay out of the hospital, even though the risks of taking the drug aren’t yet fully known, according to a panel of experts that advises the Food and Drug Administration on its regulatory decisions for these types of drugs.

The FDA’s Antimicrobial Drugs Advisory Committee narrowly voted to authorize the drug molnupiravir, voting 13 to 10 to support emergency use, which requires a medication to meet a lower standard of evidence than does full approval.

The FDA is not bound by the committee’s vote but typically follows its advice.

If authorized by the agency, molnupiravir would be the first antiviral agent available as a pill to treat COVID-19. Other therapies to treat the infection are available — monoclonal antibodies and the drug remdesivir — but they are given by infusion.

The United Kingdom has already authorized the use of Merck’s drug.

“This was clearly a difficult decision,” said committee member Michael Green, MD, a pediatric infectious disease expert at the University of Pittsburg School of Medicine.

Green said he voted yes, and that the drug’s ability to prevent deaths in the study weighed heavily on his decision. He said given uncertainties around the drug both the company and FDA should keep a close eye on patients taking the drug going forward.

“Should an alternative oral agent become available that had a better safety profile and equal or better efficacy profile, the agency might reconsider its authorization,” he said.

Others didn’t agree that the drug should be allowed onto the market.

“I voted no,” said Jennifer Le, PharmD, a professor of clinical pharmacy at the University of California. Dr. Le said the modest benefit of the medication didn’t outweigh all the potential safety issues. “I think I just need more efficacy and safety data,” she said.

Initial results from the first half of people enrolled in the clinical trial found the pill cut the risk of hospitalization or death by 50% in patients at higher risk of severe outcomes from COVID-19.

But later results, released just days before the meeting, showed that the drug’s effectiveness had dropped to about 30%.

In the updated analysis, 48 patients out of the 709 who were taking the drug were hospitalized or died within 29 days compared to 68 out of 699 who randomly got the placebo. There was one death in the group that got molnupiravir compared to nine in the placebo group. Nearly all those deaths occurred during the first phase of the study.

On Nov. 30 Merck explained that the drug’s efficacy appeared to fall, in part, because the placebo group had experienced fewer hospitalizations and deaths than expected during the second half of the study, making the drug look less beneficial by comparison.

The company said it wasn’t sure why patients in the placebo group had fared so much better in later trial enrollments.

“The efficacy of this product is not overwhelmingly good,” said committee member David Hardy, MD, an infectious disease expert at Charles Drew University School of Medicine in Los Angeles. “And I think that makes all of us a little uncomfortable about whether this is an advanced therapeutic because it’s an oral medication rather than an intravenous medication,” he said during the panel’s deliberations.

“I think we have to be very careful about how we’re going to allow people to use this,” Dr. Hardy said.

Many who voted for authorization thought use of the drug should be restricted to unvaccinated people who were at high risk of severe COVID-19 outcomes, the same population enrolled in the clinical trial. People in the trial were considered at higher risk if they were over age 60, had cancer, chronic kidney disease, chronic obstructive pulmonary disease, were obese, or had heart disease or diabetes.

There are some significant limitations of the study that may affect how the drug is used. Vaccinated people couldn’t enroll in the study, so it’s not known if the medication would have any benefit for them. Nearly two-thirds of the U.S. population is fully vaccinated. The study found no additional benefit of the medication compared to the placebo in people who had detectable antibodies, presumably from a prior infection.

Animal studies found that the drug — which kills the virus by forcing it to make errors as it copies its genetic material inside cells — could disrupt bone formation. For that reason, the manufacturer and the FDA agreed that it should not be used in anyone younger than age 18.

Animal studies also indicated that the drug could cause birth defects. For that reason, the company said the drug shouldn’t be given to women who are pregnant or breastfeeding and said doctors should make sure women of childbearing age aren’t pregnant before taking the medication.

Some members of the panel felt that pregnant women and their doctors should be given the choice of whether or not to use the drug, given that pregnant women are at high risk for severe COVID-19 outcomes and infused therapies may not be available in all settings.

Other members of the committee said they were uncomfortable authorizing the drug given its potential to mutate the virus.

The drug, which forces the virus to mutate as it copies its RNA, eventually causes the virus to make so many errors in its genetic material that it can no longer make more of itself and the immune system clears it out of the body.

But it takes a few days to work — the drug is designed to be taken for 5 consecutive days -- and studies of the viral loads of patients taking the drug show that through the first 2 days, viral loads remain detectable as these mutations occur.

Studies by the FDA show some of those mutations in the spike protein are the same ones that have helped the virus become more transmissible and escape the protection of vaccines.

So the question is whether someone taking the medication could develop a dangerous mutation and then infect someone else, sparking the spread of a new variant.

Nicholas Kartsonis, MD, a vice president at Merck, said that the company was still analyzing data.

“Even if the probability is very low — 1 in 10,000 or 1 in 100,000 -- that this drug would induce an escape mutant for which the vaccines we have would not cover, that would be catastrophic for the whole world, actually,” said committee member James Hildreth, MD, an immunologist and president of Meharry Medical College, Nashville. “Do you have sufficient data on the likelihood of that happening?” he asked Dr. Kartsonis of Merck.

“So we don’t,” Dr. Kartsonis said.

He said, in theory, the risk of mutation with molnupiravir is the same as seen with the use of vaccines or monoclonal antibody therapies. Dr. Hildreth wasn’t satisfied with that answer.

“With all respect, the mechanism of your drug is to drive [genetic mutations], so it’s not the same as the vaccine. It’s not the same as monoclonal antibodies,” he said.

Dr. Hildreth later said he didn’t feel comfortable voting for authorization given the uncertainties around escape mutants. He voted no.

“It was an easy vote for me,” he said.

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