Psoriatic Arthritis

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: Cognitive impairment may be one of the neurological manifestations of psoriatic arthritis (PsA).

Major finding: Patients with PsA scored worse on the Montreal Cognitive Assessment (MoCA) vs. controls (P = .01). Additionally, the proportion of patients with cognitive impairment according to MoCA was significantly higher among cases vs. controls (91.9% vs. 58.3%, P = .002).

Study details: The data come from a cross-sectional case-control study involving 37 patients with PsA and 36 healthy controls.

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Garcia LOKL et al. Acta Neurol Belg. 2021 Mar 13. doi: 10.1007/s13760-021-01644-y.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year; and these improvements were associated with improvements in disease activity and patient functional capability outcomes.

Major finding: At week 8, patients receiving IV golimumab vs. placebo had greater improvements in EuroQol-5 dimension-5 level index (0.14 vs. 0.04) and visual analog scale (VAS; 17.16 vs. 3.69), daily productivity VAS (−2.91 vs. −0.71), and Work Limitations Questionnaire productivity loss score (−2.92 vs. −0.78). At week 52, improvements were similar in the golimumab and placebo-crossover groups. HRQoL and productivity correlated with disease activity and functional capability, with continued association from week 8 through week 52.

Study details: In this phase 3 GO-VIBRANT trial, 480 patients with PsA were randomly assigned to receive IV golimumab 2 mg/kg (n=241) at weeks 0, 4, and then every 8 weeks (q8w) through week 52 or placebo (n=239) at weeks 0, 4, and then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52.

Disclosures: This study was supported by Janssen Research & Development, LLC, Spring House, PA. Some study investigators are employees of Janssen Global Services, LLC and own stock in Johnson & Johnson, of which Janssen Global Services, LLC is a wholly owned subsidiary. Some study authors reported receiving support from and consulting for Janssen.

Source: Ogdie A et al. Clin Rheumatol. 2021 Mar 2. doi: 10.1007/s10067-021-05639-1.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: The presence of depression/anxiety symptoms reduces the probability of achieving sustained minimal disease activity (MDA) in patients with psoriatic arthritis (PsA), regardless of the method used to define depression/anxiety.

Major finding: When depression/anxiety was defined as a score of 38 or lower on the Mental Component Summary of the Short Form-36 questionnaire (definition 1), the odds ratio (OR) for reaching sustained MDA was 0.30 (P less than .0001). The OR values were 0.34 (P less than .0001) and 0.47 (P less than .0001) for a score of 56 or lower on the Mental Health sub-scale (definition 2) and for rheumatologist’s report of a diagnosis or treatment for depression/anxiety (definition 3), respectively.

Study details: The data come from a study of 743 patients with PsA.

Disclosures: No study sponsor was identified. Several of the authors are affiliated with the Psoriatic Disease Program of the Krembil Research Institute of University Health Network in Toronto, which is supported by the Krembil Foundation. Dr. A Wong was supported by a Krembil Psoriatic Arthritis Fellowship and Dr. V Chandran was supported by a Pfizer Chair Rheumatology Research Award from the Department of Medicine, University of Toronto.

Source: Wong A et al. Arthritis Care Res (Hoboken). 2021 Mar 4. doi: 10.1002/acr.24593.

Key clinical point: Alcohol consumption, older age, suffering from fatty liver when less than 45 years old, and elevated high-sensitivity C-reactive protein (hs-CRP) level appear to increase the risk of transition from subclinical to clinical psoriatic arthritis (PsA).

Major finding: Older age (greater than 45 years; odds ratio [OR], 10.15; P = 0.00), alcohol consumption (OR, 3.43; P = .03), and elevated hs-CRP (OR, 1.05; P = 0.03) were associated with an increased risk of progression from subclinical PsA to clinical PsA. For patients aged less than 45 years old, the association between fatty liver and clinical PsA was statistically significant.

Study details: The data come from a retrospective case-control study of 25 patients with clinically confirmed PsA (cases) and 137 controls without confirmed PsA.

Disclosures: This study was funded by the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University, Chengdu, Sichuan, China and West China Precision Medicine Industrial Technology Institutes. The authors declared no conflicts of interest.

Source: Wang Y et al. Rheumatol Ther. 2021 Mar 5. doi: 10.1007/s40744-021-00295-y.

Key clinical point: Alcohol consumption, older age, suffering from fatty liver when less than 45 years old, and elevated high-sensitivity C-reactive protein (hs-CRP) level appear to increase the risk of transition from subclinical to clinical psoriatic arthritis (PsA).

Major finding: Older age (greater than 45 years; odds ratio [OR], 10.15; P = 0.00), alcohol consumption (OR, 3.43; P = .03), and elevated hs-CRP (OR, 1.05; P = 0.03) were associated with an increased risk of progression from subclinical PsA to clinical PsA. For patients aged less than 45 years old, the association between fatty liver and clinical PsA was statistically significant.

Study details: The data come from a retrospective case-control study of 25 patients with clinically confirmed PsA (cases) and 137 controls without confirmed PsA.

Disclosures: This study was funded by the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University, Chengdu, Sichuan, China and West China Precision Medicine Industrial Technology Institutes. The authors declared no conflicts of interest.

Source: Wang Y et al. Rheumatol Ther. 2021 Mar 5. doi: 10.1007/s40744-021-00295-y.

Key clinical point: Alcohol consumption, older age, suffering from fatty liver when less than 45 years old, and elevated high-sensitivity C-reactive protein (hs-CRP) level appear to increase the risk of transition from subclinical to clinical psoriatic arthritis (PsA).

Major finding: Older age (greater than 45 years; odds ratio [OR], 10.15; P = 0.00), alcohol consumption (OR, 3.43; P = .03), and elevated hs-CRP (OR, 1.05; P = 0.03) were associated with an increased risk of progression from subclinical PsA to clinical PsA. For patients aged less than 45 years old, the association between fatty liver and clinical PsA was statistically significant.

Study details: The data come from a retrospective case-control study of 25 patients with clinically confirmed PsA (cases) and 137 controls without confirmed PsA.

Disclosures: This study was funded by the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University, Chengdu, Sichuan, China and West China Precision Medicine Industrial Technology Institutes. The authors declared no conflicts of interest.

Source: Wang Y et al. Rheumatol Ther. 2021 Mar 5. doi: 10.1007/s40744-021-00295-y.

Key clinical point: Continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimal disease activity (MDA) in biologic-naive patients with psoriatic arthritis (PsA). In case of treatment interruption, re-treatment with IXE following relapse may restore disease control.

Major finding: Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks) vs. continued IXE treatment (median was not estimable because less than 50% of patients had relapsed by the end of study period; P less than .0001). The cumulative relapse rate from week 24 to week 104 was higher for the withdrawal vs. continued treatment group (85% vs. 38%; P less than .0001). Median time to re-achieving MDA on retreatment was 4.1 weeks; 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.

Study details: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks. Between weeks 36 and 64, 158 patients who achieved sustained MDA (greater than 3 months) were randomized (1:1) to continue on 80 mg IXE every 2 weeks or placebo until week 104.

Disclosures: This study was funded by Eli Lilly and Company. Some study investigators reported owning stock in, being an employee of, receiving support from, and/or consulting for Eli Lilly and Company.

Source: Coates LC et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41716.

Key clinical point: Continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimal disease activity (MDA) in biologic-naive patients with psoriatic arthritis (PsA). In case of treatment interruption, re-treatment with IXE following relapse may restore disease control.

Major finding: Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks) vs. continued IXE treatment (median was not estimable because less than 50% of patients had relapsed by the end of study period; P less than .0001). The cumulative relapse rate from week 24 to week 104 was higher for the withdrawal vs. continued treatment group (85% vs. 38%; P less than .0001). Median time to re-achieving MDA on retreatment was 4.1 weeks; 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.

Study details: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks. Between weeks 36 and 64, 158 patients who achieved sustained MDA (greater than 3 months) were randomized (1:1) to continue on 80 mg IXE every 2 weeks or placebo until week 104.

Disclosures: This study was funded by Eli Lilly and Company. Some study investigators reported owning stock in, being an employee of, receiving support from, and/or consulting for Eli Lilly and Company.

Source: Coates LC et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41716.

Key clinical point: Continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimal disease activity (MDA) in biologic-naive patients with psoriatic arthritis (PsA). In case of treatment interruption, re-treatment with IXE following relapse may restore disease control.

Major finding: Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks) vs. continued IXE treatment (median was not estimable because less than 50% of patients had relapsed by the end of study period; P less than .0001). The cumulative relapse rate from week 24 to week 104 was higher for the withdrawal vs. continued treatment group (85% vs. 38%; P less than .0001). Median time to re-achieving MDA on retreatment was 4.1 weeks; 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.

Study details: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks. Between weeks 36 and 64, 158 patients who achieved sustained MDA (greater than 3 months) were randomized (1:1) to continue on 80 mg IXE every 2 weeks or placebo until week 104.

Disclosures: This study was funded by Eli Lilly and Company. Some study investigators reported owning stock in, being an employee of, receiving support from, and/or consulting for Eli Lilly and Company.

Source: Coates LC et al. Arthritis Rheumatol. 2021 Mar 7. doi: 10.1002/art.41716.

Key clinical point: Brodalumab demonstrated significant and rapid improvements in signs and symptoms of psoriatic arthritis (PsA) vs. placebo in 2 phase 3 trials.

Major finding: The percentage of patients achieving American College of Rheumatology (ACR)20 response at week 16 was significantly higher in the 140 mg and 210 mg brodalumab treatment groups than in the placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001). Results were similar at week 24. The proportion of brodalumab-treated patients achieving ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis was significantly higher than placebo-treated patients (P less than .01). Brodalumab was well tolerated.

Study details: In the AMVISION-1 and AMVISION-2 trials, a total of 962 adult patients with active PsA refractory to conventional treatment were randomly assigned (1:1:1) to either subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks.

Disclosures: The trials were funded by LEO Pharma. K Raymond is an employee of LEO Pharma. KF Hjuler was an employee of LEO Pharma at the time the study was conducted. PJ Mease, PS Helliwell, KF Hjuler and IB McInnes reported ties with various pharmaceutical companies.

Source: Mease PJ et al. Ann Rheum Dis. 2021 Feb. doi: 10.1136/annrheumdis-2019-216835.

Key clinical point: Brodalumab demonstrated significant and rapid improvements in signs and symptoms of psoriatic arthritis (PsA) vs. placebo in 2 phase 3 trials.

Major finding: The percentage of patients achieving American College of Rheumatology (ACR)20 response at week 16 was significantly higher in the 140 mg and 210 mg brodalumab treatment groups than in the placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001). Results were similar at week 24. The proportion of brodalumab-treated patients achieving ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis was significantly higher than placebo-treated patients (P less than .01). Brodalumab was well tolerated.

Study details: In the AMVISION-1 and AMVISION-2 trials, a total of 962 adult patients with active PsA refractory to conventional treatment were randomly assigned (1:1:1) to either subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks.

Disclosures: The trials were funded by LEO Pharma. K Raymond is an employee of LEO Pharma. KF Hjuler was an employee of LEO Pharma at the time the study was conducted. PJ Mease, PS Helliwell, KF Hjuler and IB McInnes reported ties with various pharmaceutical companies.

Source: Mease PJ et al. Ann Rheum Dis. 2021 Feb. doi: 10.1136/annrheumdis-2019-216835.

Key clinical point: Brodalumab demonstrated significant and rapid improvements in signs and symptoms of psoriatic arthritis (PsA) vs. placebo in 2 phase 3 trials.

Major finding: The percentage of patients achieving American College of Rheumatology (ACR)20 response at week 16 was significantly higher in the 140 mg and 210 mg brodalumab treatment groups than in the placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001). Results were similar at week 24. The proportion of brodalumab-treated patients achieving ACR50/70, Psoriasis Area and Severity Index 75/90/100 and resolution of dactylitis and enthesitis was significantly higher than placebo-treated patients (P less than .01). Brodalumab was well tolerated.

Study details: In the AMVISION-1 and AMVISION-2 trials, a total of 962 adult patients with active PsA refractory to conventional treatment were randomly assigned (1:1:1) to either subcutaneous brodalumab 140 mg or 210 mg or placebo at weeks 0, 1 and every 2 weeks up to 24 weeks.

Disclosures: The trials were funded by LEO Pharma. K Raymond is an employee of LEO Pharma. KF Hjuler was an employee of LEO Pharma at the time the study was conducted. PJ Mease, PS Helliwell, KF Hjuler and IB McInnes reported ties with various pharmaceutical companies.

Source: Mease PJ et al. Ann Rheum Dis. 2021 Feb. doi: 10.1136/annrheumdis-2019-216835.

Key clinical point: Pain intensity has limited predictive value for preterm or excess mortality, whereas recent glucocorticoid use and comorbidities were associated with an increased risk of early mortality in patients with psoriatic arthritis.

Major finding: Higher mean pain intensity was associated with an increased risk of mortality (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10). However, this association attenuated after adjusting for additional confounders. Recent glucocorticoid use (OR, 5.60; 95% CI, 3.71-8.45), concurrent chronic obstructive pulmonary disease (OR, 1.72; 95% CI, 1.06-2.80), diabetes mellitus (OR, 1.86; 95% CI, 1.19-2.90), cancer (OR, 7.17; 95% CI, 4.70-10.93), and cardiovascular disease (OR, 3.04; 95% CI, 2.06-4.49) were all associated with early mortality.

Study details: This nested case-control study included 276 patients with psoriatic arthritis who died (cases) and 1,187 matched controls using data from the nationwide DANBIO register and Danish healthcare registers.

Disclosures: This study was supported by the Danish Psoriasis Foundation Grant, the Danish Rheumatism Foundation Grant, and a grant from Aalborg University and Aalborg University hospital. The authors declared no conflicts of interest.

Source: Vela J et al. Rheumatology (Oxford). 2021 Mar 1. doi: 10.1093/rheumatology/keab192.

Key clinical point: Pain intensity has limited predictive value for preterm or excess mortality, whereas recent glucocorticoid use and comorbidities were associated with an increased risk of early mortality in patients with psoriatic arthritis.

Major finding: Higher mean pain intensity was associated with an increased risk of mortality (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10). However, this association attenuated after adjusting for additional confounders. Recent glucocorticoid use (OR, 5.60; 95% CI, 3.71-8.45), concurrent chronic obstructive pulmonary disease (OR, 1.72; 95% CI, 1.06-2.80), diabetes mellitus (OR, 1.86; 95% CI, 1.19-2.90), cancer (OR, 7.17; 95% CI, 4.70-10.93), and cardiovascular disease (OR, 3.04; 95% CI, 2.06-4.49) were all associated with early mortality.

Study details: This nested case-control study included 276 patients with psoriatic arthritis who died (cases) and 1,187 matched controls using data from the nationwide DANBIO register and Danish healthcare registers.

Disclosures: This study was supported by the Danish Psoriasis Foundation Grant, the Danish Rheumatism Foundation Grant, and a grant from Aalborg University and Aalborg University hospital. The authors declared no conflicts of interest.

Source: Vela J et al. Rheumatology (Oxford). 2021 Mar 1. doi: 10.1093/rheumatology/keab192.

Key clinical point: Pain intensity has limited predictive value for preterm or excess mortality, whereas recent glucocorticoid use and comorbidities were associated with an increased risk of early mortality in patients with psoriatic arthritis.

Major finding: Higher mean pain intensity was associated with an increased risk of mortality (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02-1.10). However, this association attenuated after adjusting for additional confounders. Recent glucocorticoid use (OR, 5.60; 95% CI, 3.71-8.45), concurrent chronic obstructive pulmonary disease (OR, 1.72; 95% CI, 1.06-2.80), diabetes mellitus (OR, 1.86; 95% CI, 1.19-2.90), cancer (OR, 7.17; 95% CI, 4.70-10.93), and cardiovascular disease (OR, 3.04; 95% CI, 2.06-4.49) were all associated with early mortality.

Study details: This nested case-control study included 276 patients with psoriatic arthritis who died (cases) and 1,187 matched controls using data from the nationwide DANBIO register and Danish healthcare registers.

Disclosures: This study was supported by the Danish Psoriasis Foundation Grant, the Danish Rheumatism Foundation Grant, and a grant from Aalborg University and Aalborg University hospital. The authors declared no conflicts of interest.

Source: Vela J et al. Rheumatology (Oxford). 2021 Mar 1. doi: 10.1093/rheumatology/keab192.

Apremilast (Otezla) monotherapy may be an effective option in oligoarticular psoriatic arthritis, Alexis R. Ogdie, MD, reported at the 2021 Rheumatology Winter Clinical Symposium.

Her analysis of apremilast data from the CORRONA Registry was among several recent highlights in psoriatic arthritis (PsA) cited by speakers at the meeting. Other significant developments included a large pan-Scandinavian study that reassuringly found no increased risk of solid cancers in tumor necrosis factor (TNF) inhibitor–treated patients with PsA, and evidence to suggest a sex difference in the efficacy of both secukinumab (Cosentyx) and adalimumab (Humira), with men responding better than women to two biologics with differing mechanisms of action.
 

A role for apremilast in oligoarticular disease?

Dr. Ogdie presented an analysis of 150 patients in the U.S. observational CORRONA Registry who initiated monotherapy for oligoarticular PsA and were followed for 6 months. Thirty-four started on apremilast, 15 on methotrexate, and 101 on a biologic. Even though the apremilast group had higher baseline disease activity than did those who started on methotrexate, at 6 months a swollen joint count of 1 or 0 was present in 41% of the apremilast-treated patients, compared with none on methotrexate and 15% on a biologic agent.

A tender joint count of 0-1 was documented at 6 months in 24% of patients on apremilast, 13% with methotrexate, and 21% on a biologic agent. Apremilast’s numeric superiority in outcomes compared to methotrexate in this exploratory study wasn’t subjected to statistical analysis because of the small sample size. However, the ongoing phase 4, double-blind, placebo-controlled, multicenter FOREMOST trial in 330 patients with early oligoarticular PsA should provide more definitive efficacy data, noted Dr. Ogdie, a rheumatologist and epidemiologist at the University of Pennsylvania, Philadelphia.

RWCS program director Arthur Kavanaugh, MD, said, “The most recent EULAR [European Alliance of Associations for Rheumatology] PsA guidelines totally discount apremilast, and I think mostly on the basis of cost, but then they also say that in groups of people it’s not as effective as methotrexate.”

“This study shows to me that, even though it’s a registry, with all the caveats about getting data from registries, apremilast certainly can be an effective drug,” said Dr. Kavanaugh, a rheumatologist and professor of medicine at the University of California, San Diego.

Another valuable piece of information from the CORRONA analysis is that it zeros in on patients with oligoarticular PsA.

“Almost all of our PsA studies are focused on people with polyarticular disease. What about those who have lesser involvement? That, of course, is important in the clinic,” he noted.

Dr. Ogdie concurred.

“If we study only polyarticular disease and we make all of our assumptions based on polyarticular disease, we might be leaving out at least half of the patients with PsA. And those patients may not need a bigger gun. Apremilast and methotrexate are kind of in the same group for that mild oligoarticular disease, and they probably work just fine,” she said.

A final point: “We really don’t have good outcome measures to study oligoarticular disease well. The ACR20 is not good because a 20% improvement in three joints is not readily measurable. That’s why trialists enroll patients with high joint count numbers,” according to the rheumatologist.

No increased risk of solid cancers in PsA patients treated with TNF inhibitors

A new analysis of clinical rheumatology registries in five Nordic countries finally puts to rest any concerns that treatment of PsA with TNF inhibitors is associated with increased risk of solid cancers. The same group previously reported no link between TNF inhibitors and lymphoma in PsA.

The solid cancers study included 9,655 PsA patients who started a first TNF inhibitor during 2001-2017, 14,809 others not treated with biologics, and 31,350 matched general population controls. Linkage to Swedish, Norwegian, Danish, Icelandic, and Finnish national cancer registries showed that the adjusted risk for solid cancer in TNF inhibitor–treated, compared with biologic-naive PsA patients, was 1.0. Similarly, the pooled standardized incidence ratio of solid cancer in TNF inhibitor–treated PsA patients compared to the general population was 1.0. There was no signal of a differential risk for incident cancer for any of the eight malignancies studied: lung, colorectal, breast, prostate, uterine, brain, liver, and pancreatic cancer.

“I like this study a lot because it’s specific to PsA rather than extrapolating from rheumatoid arthritis data, where we have a bunch more information for a much longer period of time, but it’s a different population,” Dr. Kavanaugh said.

Dr. Ogdie said, “I talk to my patients about this particular study or the same group’s earlier lymphoma study all the time.”

“I have to say, these are important data for the dermatology world because there are dermatologists who are still not convinced that TNF inhibitors don’t have an increased risk of malignancy. This kind of information is going to be helpful,” observed Eric M. Ruderman, MD, professor of medicine (rheumatology) at Northwestern University, Chicago.
 

Greater efficacy for biologics in males than females with PsA?

A secondary analysis of the phase 3b EXCEED trial raised the intriguing possibility that both secukinumab, an interleukin-17A inhibitor, and adalimumab, a TNF inhibitor, have greater efficacy in men than in women with PsA. In this randomized trial of 853 biologic-naive patients with PsA, the ACR20 response rate to secukinumab at week 52 was 61% in females versus 74% in males, with ACR50 rates of 43% in females and 55.3% in males. The ACR20 rate with adalimumab was 51.5% in females and 70.2% in males. Similarly, the corresponding ACR50s were 32.6% and 55.3%, respectively. Minimal disease activity was achieved in 36.2% of women and 51% of men on secukinumab, and in 24.2% of women and 49.8% of men on adalimumab.

“These are randomized patients, so you really shouldn’t see these big differences in minimal disease activity,” Dr. Ogdie noted. “The question is why do men seem to respond better to therapy than women? I don’t think it’s the fibromyalgia-ness. There’s probably some biologic rationale for this that we just don’t understand yet. Maybe hormonal interactions.”

This gender difference in response is an important issue because it can potentially distort outcomes in head-to-head drug trials, Dr. Ruderman added.

“That gender difference is not likely to be huge if you’re looking at a placebo-controlled trial because the difference between the active drug and placebo is going to outweigh it. But when you have two active drugs, if there’s an imbalance in terms of how many men or women there are on each of the two drugs, you may end up with an efficacy difference that’s not real but is based on gender and not response to the drug,” he explained.

Roy M. Fleischmann, MD, a rheumatologist and clinical trialist at the University of Texas, Dallas, rose from the audience to pronounce the EXCEED male-versus-female analysis “very interesting.”

“We should go back and look at other trials and see if that occurred, and if it did, then we have to think about that going forward,” he proposed.

Dr. Ogdie, Dr. Kavanaugh, and Dr. Ruderman reported having financial relationships with numerous pharmaceutical companies.

[email protected]

Apremilast (Otezla) monotherapy may be an effective option in oligoarticular psoriatic arthritis, Alexis R. Ogdie, MD, reported at the 2021 Rheumatology Winter Clinical Symposium.

Her analysis of apremilast data from the CORRONA Registry was among several recent highlights in psoriatic arthritis (PsA) cited by speakers at the meeting. Other significant developments included a large pan-Scandinavian study that reassuringly found no increased risk of solid cancers in tumor necrosis factor (TNF) inhibitor–treated patients with PsA, and evidence to suggest a sex difference in the efficacy of both secukinumab (Cosentyx) and adalimumab (Humira), with men responding better than women to two biologics with differing mechanisms of action.
 

A role for apremilast in oligoarticular disease?

Dr. Ogdie presented an analysis of 150 patients in the U.S. observational CORRONA Registry who initiated monotherapy for oligoarticular PsA and were followed for 6 months. Thirty-four started on apremilast, 15 on methotrexate, and 101 on a biologic. Even though the apremilast group had higher baseline disease activity than did those who started on methotrexate, at 6 months a swollen joint count of 1 or 0 was present in 41% of the apremilast-treated patients, compared with none on methotrexate and 15% on a biologic agent.

A tender joint count of 0-1 was documented at 6 months in 24% of patients on apremilast, 13% with methotrexate, and 21% on a biologic agent. Apremilast’s numeric superiority in outcomes compared to methotrexate in this exploratory study wasn’t subjected to statistical analysis because of the small sample size. However, the ongoing phase 4, double-blind, placebo-controlled, multicenter FOREMOST trial in 330 patients with early oligoarticular PsA should provide more definitive efficacy data, noted Dr. Ogdie, a rheumatologist and epidemiologist at the University of Pennsylvania, Philadelphia.

RWCS program director Arthur Kavanaugh, MD, said, “The most recent EULAR [European Alliance of Associations for Rheumatology] PsA guidelines totally discount apremilast, and I think mostly on the basis of cost, but then they also say that in groups of people it’s not as effective as methotrexate.”

“This study shows to me that, even though it’s a registry, with all the caveats about getting data from registries, apremilast certainly can be an effective drug,” said Dr. Kavanaugh, a rheumatologist and professor of medicine at the University of California, San Diego.

Another valuable piece of information from the CORRONA analysis is that it zeros in on patients with oligoarticular PsA.

“Almost all of our PsA studies are focused on people with polyarticular disease. What about those who have lesser involvement? That, of course, is important in the clinic,” he noted.

Dr. Ogdie concurred.

“If we study only polyarticular disease and we make all of our assumptions based on polyarticular disease, we might be leaving out at least half of the patients with PsA. And those patients may not need a bigger gun. Apremilast and methotrexate are kind of in the same group for that mild oligoarticular disease, and they probably work just fine,” she said.

A final point: “We really don’t have good outcome measures to study oligoarticular disease well. The ACR20 is not good because a 20% improvement in three joints is not readily measurable. That’s why trialists enroll patients with high joint count numbers,” according to the rheumatologist.

No increased risk of solid cancers in PsA patients treated with TNF inhibitors

A new analysis of clinical rheumatology registries in five Nordic countries finally puts to rest any concerns that treatment of PsA with TNF inhibitors is associated with increased risk of solid cancers. The same group previously reported no link between TNF inhibitors and lymphoma in PsA.

The solid cancers study included 9,655 PsA patients who started a first TNF inhibitor during 2001-2017, 14,809 others not treated with biologics, and 31,350 matched general population controls. Linkage to Swedish, Norwegian, Danish, Icelandic, and Finnish national cancer registries showed that the adjusted risk for solid cancer in TNF inhibitor–treated, compared with biologic-naive PsA patients, was 1.0. Similarly, the pooled standardized incidence ratio of solid cancer in TNF inhibitor–treated PsA patients compared to the general population was 1.0. There was no signal of a differential risk for incident cancer for any of the eight malignancies studied: lung, colorectal, breast, prostate, uterine, brain, liver, and pancreatic cancer.

“I like this study a lot because it’s specific to PsA rather than extrapolating from rheumatoid arthritis data, where we have a bunch more information for a much longer period of time, but it’s a different population,” Dr. Kavanaugh said.

Dr. Ogdie said, “I talk to my patients about this particular study or the same group’s earlier lymphoma study all the time.”

“I have to say, these are important data for the dermatology world because there are dermatologists who are still not convinced that TNF inhibitors don’t have an increased risk of malignancy. This kind of information is going to be helpful,” observed Eric M. Ruderman, MD, professor of medicine (rheumatology) at Northwestern University, Chicago.
 

Greater efficacy for biologics in males than females with PsA?

A secondary analysis of the phase 3b EXCEED trial raised the intriguing possibility that both secukinumab, an interleukin-17A inhibitor, and adalimumab, a TNF inhibitor, have greater efficacy in men than in women with PsA. In this randomized trial of 853 biologic-naive patients with PsA, the ACR20 response rate to secukinumab at week 52 was 61% in females versus 74% in males, with ACR50 rates of 43% in females and 55.3% in males. The ACR20 rate with adalimumab was 51.5% in females and 70.2% in males. Similarly, the corresponding ACR50s were 32.6% and 55.3%, respectively. Minimal disease activity was achieved in 36.2% of women and 51% of men on secukinumab, and in 24.2% of women and 49.8% of men on adalimumab.

“These are randomized patients, so you really shouldn’t see these big differences in minimal disease activity,” Dr. Ogdie noted. “The question is why do men seem to respond better to therapy than women? I don’t think it’s the fibromyalgia-ness. There’s probably some biologic rationale for this that we just don’t understand yet. Maybe hormonal interactions.”

This gender difference in response is an important issue because it can potentially distort outcomes in head-to-head drug trials, Dr. Ruderman added.

“That gender difference is not likely to be huge if you’re looking at a placebo-controlled trial because the difference between the active drug and placebo is going to outweigh it. But when you have two active drugs, if there’s an imbalance in terms of how many men or women there are on each of the two drugs, you may end up with an efficacy difference that’s not real but is based on gender and not response to the drug,” he explained.

Roy M. Fleischmann, MD, a rheumatologist and clinical trialist at the University of Texas, Dallas, rose from the audience to pronounce the EXCEED male-versus-female analysis “very interesting.”

“We should go back and look at other trials and see if that occurred, and if it did, then we have to think about that going forward,” he proposed.

Dr. Ogdie, Dr. Kavanaugh, and Dr. Ruderman reported having financial relationships with numerous pharmaceutical companies.

[email protected]

Apremilast (Otezla) monotherapy may be an effective option in oligoarticular psoriatic arthritis, Alexis R. Ogdie, MD, reported at the 2021 Rheumatology Winter Clinical Symposium.

Her analysis of apremilast data from the CORRONA Registry was among several recent highlights in psoriatic arthritis (PsA) cited by speakers at the meeting. Other significant developments included a large pan-Scandinavian study that reassuringly found no increased risk of solid cancers in tumor necrosis factor (TNF) inhibitor–treated patients with PsA, and evidence to suggest a sex difference in the efficacy of both secukinumab (Cosentyx) and adalimumab (Humira), with men responding better than women to two biologics with differing mechanisms of action.
 

A role for apremilast in oligoarticular disease?

Dr. Ogdie presented an analysis of 150 patients in the U.S. observational CORRONA Registry who initiated monotherapy for oligoarticular PsA and were followed for 6 months. Thirty-four started on apremilast, 15 on methotrexate, and 101 on a biologic. Even though the apremilast group had higher baseline disease activity than did those who started on methotrexate, at 6 months a swollen joint count of 1 or 0 was present in 41% of the apremilast-treated patients, compared with none on methotrexate and 15% on a biologic agent.

A tender joint count of 0-1 was documented at 6 months in 24% of patients on apremilast, 13% with methotrexate, and 21% on a biologic agent. Apremilast’s numeric superiority in outcomes compared to methotrexate in this exploratory study wasn’t subjected to statistical analysis because of the small sample size. However, the ongoing phase 4, double-blind, placebo-controlled, multicenter FOREMOST trial in 330 patients with early oligoarticular PsA should provide more definitive efficacy data, noted Dr. Ogdie, a rheumatologist and epidemiologist at the University of Pennsylvania, Philadelphia.

RWCS program director Arthur Kavanaugh, MD, said, “The most recent EULAR [European Alliance of Associations for Rheumatology] PsA guidelines totally discount apremilast, and I think mostly on the basis of cost, but then they also say that in groups of people it’s not as effective as methotrexate.”

“This study shows to me that, even though it’s a registry, with all the caveats about getting data from registries, apremilast certainly can be an effective drug,” said Dr. Kavanaugh, a rheumatologist and professor of medicine at the University of California, San Diego.

Another valuable piece of information from the CORRONA analysis is that it zeros in on patients with oligoarticular PsA.

“Almost all of our PsA studies are focused on people with polyarticular disease. What about those who have lesser involvement? That, of course, is important in the clinic,” he noted.

Dr. Ogdie concurred.

“If we study only polyarticular disease and we make all of our assumptions based on polyarticular disease, we might be leaving out at least half of the patients with PsA. And those patients may not need a bigger gun. Apremilast and methotrexate are kind of in the same group for that mild oligoarticular disease, and they probably work just fine,” she said.

A final point: “We really don’t have good outcome measures to study oligoarticular disease well. The ACR20 is not good because a 20% improvement in three joints is not readily measurable. That’s why trialists enroll patients with high joint count numbers,” according to the rheumatologist.

No increased risk of solid cancers in PsA patients treated with TNF inhibitors

A new analysis of clinical rheumatology registries in five Nordic countries finally puts to rest any concerns that treatment of PsA with TNF inhibitors is associated with increased risk of solid cancers. The same group previously reported no link between TNF inhibitors and lymphoma in PsA.

The solid cancers study included 9,655 PsA patients who started a first TNF inhibitor during 2001-2017, 14,809 others not treated with biologics, and 31,350 matched general population controls. Linkage to Swedish, Norwegian, Danish, Icelandic, and Finnish national cancer registries showed that the adjusted risk for solid cancer in TNF inhibitor–treated, compared with biologic-naive PsA patients, was 1.0. Similarly, the pooled standardized incidence ratio of solid cancer in TNF inhibitor–treated PsA patients compared to the general population was 1.0. There was no signal of a differential risk for incident cancer for any of the eight malignancies studied: lung, colorectal, breast, prostate, uterine, brain, liver, and pancreatic cancer.

“I like this study a lot because it’s specific to PsA rather than extrapolating from rheumatoid arthritis data, where we have a bunch more information for a much longer period of time, but it’s a different population,” Dr. Kavanaugh said.

Dr. Ogdie said, “I talk to my patients about this particular study or the same group’s earlier lymphoma study all the time.”

“I have to say, these are important data for the dermatology world because there are dermatologists who are still not convinced that TNF inhibitors don’t have an increased risk of malignancy. This kind of information is going to be helpful,” observed Eric M. Ruderman, MD, professor of medicine (rheumatology) at Northwestern University, Chicago.
 

Greater efficacy for biologics in males than females with PsA?

A secondary analysis of the phase 3b EXCEED trial raised the intriguing possibility that both secukinumab, an interleukin-17A inhibitor, and adalimumab, a TNF inhibitor, have greater efficacy in men than in women with PsA. In this randomized trial of 853 biologic-naive patients with PsA, the ACR20 response rate to secukinumab at week 52 was 61% in females versus 74% in males, with ACR50 rates of 43% in females and 55.3% in males. The ACR20 rate with adalimumab was 51.5% in females and 70.2% in males. Similarly, the corresponding ACR50s were 32.6% and 55.3%, respectively. Minimal disease activity was achieved in 36.2% of women and 51% of men on secukinumab, and in 24.2% of women and 49.8% of men on adalimumab.

“These are randomized patients, so you really shouldn’t see these big differences in minimal disease activity,” Dr. Ogdie noted. “The question is why do men seem to respond better to therapy than women? I don’t think it’s the fibromyalgia-ness. There’s probably some biologic rationale for this that we just don’t understand yet. Maybe hormonal interactions.”

This gender difference in response is an important issue because it can potentially distort outcomes in head-to-head drug trials, Dr. Ruderman added.

“That gender difference is not likely to be huge if you’re looking at a placebo-controlled trial because the difference between the active drug and placebo is going to outweigh it. But when you have two active drugs, if there’s an imbalance in terms of how many men or women there are on each of the two drugs, you may end up with an efficacy difference that’s not real but is based on gender and not response to the drug,” he explained.

Roy M. Fleischmann, MD, a rheumatologist and clinical trialist at the University of Texas, Dallas, rose from the audience to pronounce the EXCEED male-versus-female analysis “very interesting.”

“We should go back and look at other trials and see if that occurred, and if it did, then we have to think about that going forward,” he proposed.

Dr. Ogdie, Dr. Kavanaugh, and Dr. Ruderman reported having financial relationships with numerous pharmaceutical companies.

[email protected]

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.

Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.

The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.

Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.

The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.

Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.

The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

The Food and Drug Administration has warned two manufacturers about illegal marketing of drugs containing cannabidiol (CBD) for over-the-counter use without an approved new drug application, for using substandard manufacturing processes, and for failure to comply with current good manufacturing practices. These warnings add to 51 previous warning letters issued by the FDA since 2015 to other manufacturers of products containing CBD who were violating the Federal Food, Drug, and Cosmetic Act.

In a news release, the agency explained that its two most recent letters, sent to Honest Globe Inc. on March 15 and BioLyte Laboratories LLC on March 18, were issued because CBD has “known pharmacologic effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA.” They also describe the companies’ failures to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” FDA Principal Deputy Commissioner Amy P. Abernethy, MD, PhD, said in the release. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient [Epidiolex]. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”

The specific products from Santa Ana, Calif.–based Honest Globe that the FDA called unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act included Elixicure Original Pain Relief and Elixicure Lavender Pain Relief, both of which were described as containing CBD. Products from Grand Rapids, Mich.–based BioLyte Laboratories LLC that the FDA similarly cited for violations included Silver Gel, Silver Gel with Aloe, Silver Liquid Supplement, Therapeutic Pain Gel, Pain Relief Cream, and Magnesium Oil Spray.

The agency has asked the two companies to respond to its letters within 15 working days, “stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

[email protected]

The Food and Drug Administration has warned two manufacturers about illegal marketing of drugs containing cannabidiol (CBD) for over-the-counter use without an approved new drug application, for using substandard manufacturing processes, and for failure to comply with current good manufacturing practices. These warnings add to 51 previous warning letters issued by the FDA since 2015 to other manufacturers of products containing CBD who were violating the Federal Food, Drug, and Cosmetic Act.

In a news release, the agency explained that its two most recent letters, sent to Honest Globe Inc. on March 15 and BioLyte Laboratories LLC on March 18, were issued because CBD has “known pharmacologic effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA.” They also describe the companies’ failures to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” FDA Principal Deputy Commissioner Amy P. Abernethy, MD, PhD, said in the release. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient [Epidiolex]. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”

The specific products from Santa Ana, Calif.–based Honest Globe that the FDA called unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act included Elixicure Original Pain Relief and Elixicure Lavender Pain Relief, both of which were described as containing CBD. Products from Grand Rapids, Mich.–based BioLyte Laboratories LLC that the FDA similarly cited for violations included Silver Gel, Silver Gel with Aloe, Silver Liquid Supplement, Therapeutic Pain Gel, Pain Relief Cream, and Magnesium Oil Spray.

The agency has asked the two companies to respond to its letters within 15 working days, “stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

[email protected]

The Food and Drug Administration has warned two manufacturers about illegal marketing of drugs containing cannabidiol (CBD) for over-the-counter use without an approved new drug application, for using substandard manufacturing processes, and for failure to comply with current good manufacturing practices. These warnings add to 51 previous warning letters issued by the FDA since 2015 to other manufacturers of products containing CBD who were violating the Federal Food, Drug, and Cosmetic Act.

In a news release, the agency explained that its two most recent letters, sent to Honest Globe Inc. on March 15 and BioLyte Laboratories LLC on March 18, were issued because CBD has “known pharmacologic effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA.” They also describe the companies’ failures to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” FDA Principal Deputy Commissioner Amy P. Abernethy, MD, PhD, said in the release. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient [Epidiolex]. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”

The specific products from Santa Ana, Calif.–based Honest Globe that the FDA called unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act included Elixicure Original Pain Relief and Elixicure Lavender Pain Relief, both of which were described as containing CBD. Products from Grand Rapids, Mich.–based BioLyte Laboratories LLC that the FDA similarly cited for violations included Silver Gel, Silver Gel with Aloe, Silver Liquid Supplement, Therapeutic Pain Gel, Pain Relief Cream, and Magnesium Oil Spray.

The agency has asked the two companies to respond to its letters within 15 working days, “stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

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