Psoriatic Arthritis ICYMI

Key clinical point: Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) was associated with a significantly lower incidence of psoriatic arthritis (PsA) compared with narrow-band ultraviolet light B (nb-UVB) phototherapy in patients with moderate-to-severe chronic plaque psoriasis.

Major finding: The annual incidence rate for PsA was lower in patients prescribed bDMARDs vs phototherapy (1.20 vs 2.17 cases per 100 patients/year; P = .006). Treatment with bDMARD was associated with a lower risk for incident PsA (adjusted hazard ratio, 0.27; P = .004).

Study details: The data come from a retrospective, nonrandomized study involving 464 patients with moderate-to-severe plaque psoriasis who were prescribed either at least 5 years of bDMARDs (n=234) or at least 3 nb-UVB phototherapy courses (n=230).

Disclosures: This work was supported by the European Union’s Horizon 2020 Research and Innovation Program. P Gisondi, L Idolazzi, and G Girolomoni reported receiving consultancy and/or speaker fees from various sources.

Source: Gisondi P et al. Ann Rheum Dis. 2021 Jun 18. doi: 10.1136/annrheumdis-2021-219961.

Key clinical point: Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) was associated with a significantly lower incidence of psoriatic arthritis (PsA) compared with narrow-band ultraviolet light B (nb-UVB) phototherapy in patients with moderate-to-severe chronic plaque psoriasis.

Major finding: The annual incidence rate for PsA was lower in patients prescribed bDMARDs vs phototherapy (1.20 vs 2.17 cases per 100 patients/year; P = .006). Treatment with bDMARD was associated with a lower risk for incident PsA (adjusted hazard ratio, 0.27; P = .004).

Study details: The data come from a retrospective, nonrandomized study involving 464 patients with moderate-to-severe plaque psoriasis who were prescribed either at least 5 years of bDMARDs (n=234) or at least 3 nb-UVB phototherapy courses (n=230).

Disclosures: This work was supported by the European Union’s Horizon 2020 Research and Innovation Program. P Gisondi, L Idolazzi, and G Girolomoni reported receiving consultancy and/or speaker fees from various sources.

Source: Gisondi P et al. Ann Rheum Dis. 2021 Jun 18. doi: 10.1136/annrheumdis-2021-219961.

Key clinical point: Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) was associated with a significantly lower incidence of psoriatic arthritis (PsA) compared with narrow-band ultraviolet light B (nb-UVB) phototherapy in patients with moderate-to-severe chronic plaque psoriasis.

Major finding: The annual incidence rate for PsA was lower in patients prescribed bDMARDs vs phototherapy (1.20 vs 2.17 cases per 100 patients/year; P = .006). Treatment with bDMARD was associated with a lower risk for incident PsA (adjusted hazard ratio, 0.27; P = .004).

Study details: The data come from a retrospective, nonrandomized study involving 464 patients with moderate-to-severe plaque psoriasis who were prescribed either at least 5 years of bDMARDs (n=234) or at least 3 nb-UVB phototherapy courses (n=230).

Disclosures: This work was supported by the European Union’s Horizon 2020 Research and Innovation Program. P Gisondi, L Idolazzi, and G Girolomoni reported receiving consultancy and/or speaker fees from various sources.

Source: Gisondi P et al. Ann Rheum Dis. 2021 Jun 18. doi: 10.1136/annrheumdis-2021-219961.

Key clinical point: Among patients with psoriatic arthritis (PsA), those receiving tofacitinib experienced more rapid pain improvement compared with placebo.

Major finding: Median days to 30% or higher and 50% or higher initial pain improvement in patients receiving tofacitinib vs those switching from placebo to tofacitinib was 55.0 (95% confidence interval [CI], 29.0-57.0) vs 106.0 (95% CI, 64.0-115.0) and 85.0 (95% CI, 57.0-92.0) vs 169.0 (95% CI, 120.0-189.0), respectively.

Study details: This was a post hoc analysis of 2 phase 3 OPAL Broaden and OPAL Beyond trials involving 238 patients with active PsA randomly assigned to receive tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib), or adalimumab.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as consultant and/or receiving grant/research support and consultancy fees from various sources including Pfizer Inc. Three authors reported being employees and stockholders of Pfizer Inc.

Source: de Vlam K et al. RMD Open. 2021 Jul 5. doi: 10.1136/rmdopen-2021-001609.

Key clinical point: Among patients with psoriatic arthritis (PsA), those receiving tofacitinib experienced more rapid pain improvement compared with placebo.

Major finding: Median days to 30% or higher and 50% or higher initial pain improvement in patients receiving tofacitinib vs those switching from placebo to tofacitinib was 55.0 (95% confidence interval [CI], 29.0-57.0) vs 106.0 (95% CI, 64.0-115.0) and 85.0 (95% CI, 57.0-92.0) vs 169.0 (95% CI, 120.0-189.0), respectively.

Study details: This was a post hoc analysis of 2 phase 3 OPAL Broaden and OPAL Beyond trials involving 238 patients with active PsA randomly assigned to receive tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib), or adalimumab.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as consultant and/or receiving grant/research support and consultancy fees from various sources including Pfizer Inc. Three authors reported being employees and stockholders of Pfizer Inc.

Source: de Vlam K et al. RMD Open. 2021 Jul 5. doi: 10.1136/rmdopen-2021-001609.

Key clinical point: Among patients with psoriatic arthritis (PsA), those receiving tofacitinib experienced more rapid pain improvement compared with placebo.

Major finding: Median days to 30% or higher and 50% or higher initial pain improvement in patients receiving tofacitinib vs those switching from placebo to tofacitinib was 55.0 (95% confidence interval [CI], 29.0-57.0) vs 106.0 (95% CI, 64.0-115.0) and 85.0 (95% CI, 57.0-92.0) vs 169.0 (95% CI, 120.0-189.0), respectively.

Study details: This was a post hoc analysis of 2 phase 3 OPAL Broaden and OPAL Beyond trials involving 238 patients with active PsA randomly assigned to receive tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib), or adalimumab.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as consultant and/or receiving grant/research support and consultancy fees from various sources including Pfizer Inc. Three authors reported being employees and stockholders of Pfizer Inc.

Source: de Vlam K et al. RMD Open. 2021 Jul 5. doi: 10.1136/rmdopen-2021-001609.

Key clinical point: Secukinumab improved disease burden in patients with psoriatic arthritis (PsA), regardless of previous tumor necrosis factor inhibitor (TNFi) exposure.

Major finding: Higher proportion of TNFi-naive patients receiving secukinumab 300 and 150 mg vs placebo showed resolution in 66 swollen joint count (SJC66; 41.5% and 27.7% vs 16.8%, respectively) and 68 tender joint counts (24.4% and 13.4% vs 5.7%, respectively; all P less than .05). Among patients with inadequate response to TNFi (TNFi-IR), those who received secukinumab 150 mg vs placebo experienced significant SJC66 resolution (20.8% vs 12.3%; P less than .05).

Study details: Findings are from a pooled analysis of 4 phase 3 randomized controlled trials (FUTURE 2, FUTURE 3, FUTURE 4, and FUTURE 5) involving 2049 patients with PsA who were either TNFi naive (n=1436) or TNFi-IR (n=613). Patients received either secukinumab 300 mg (n=461), secukinumab 150 mg (n=907), or placebo (n=681).

Disclosures: This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The authors including the lead author reported receiving grant support, speaker fees, and/or consulting fees from various sources. O Chambenoit and X Meng reported being employees and stockholders of Novartis.

Source: Orbai AM et al. Rheumatol Ther. 2021 Jul 3. doi: 10.1007/s40744-021-00337-5.

Key clinical point: Secukinumab improved disease burden in patients with psoriatic arthritis (PsA), regardless of previous tumor necrosis factor inhibitor (TNFi) exposure.

Major finding: Higher proportion of TNFi-naive patients receiving secukinumab 300 and 150 mg vs placebo showed resolution in 66 swollen joint count (SJC66; 41.5% and 27.7% vs 16.8%, respectively) and 68 tender joint counts (24.4% and 13.4% vs 5.7%, respectively; all P less than .05). Among patients with inadequate response to TNFi (TNFi-IR), those who received secukinumab 150 mg vs placebo experienced significant SJC66 resolution (20.8% vs 12.3%; P less than .05).

Study details: Findings are from a pooled analysis of 4 phase 3 randomized controlled trials (FUTURE 2, FUTURE 3, FUTURE 4, and FUTURE 5) involving 2049 patients with PsA who were either TNFi naive (n=1436) or TNFi-IR (n=613). Patients received either secukinumab 300 mg (n=461), secukinumab 150 mg (n=907), or placebo (n=681).

Disclosures: This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The authors including the lead author reported receiving grant support, speaker fees, and/or consulting fees from various sources. O Chambenoit and X Meng reported being employees and stockholders of Novartis.

Source: Orbai AM et al. Rheumatol Ther. 2021 Jul 3. doi: 10.1007/s40744-021-00337-5.

Key clinical point: Secukinumab improved disease burden in patients with psoriatic arthritis (PsA), regardless of previous tumor necrosis factor inhibitor (TNFi) exposure.

Major finding: Higher proportion of TNFi-naive patients receiving secukinumab 300 and 150 mg vs placebo showed resolution in 66 swollen joint count (SJC66; 41.5% and 27.7% vs 16.8%, respectively) and 68 tender joint counts (24.4% and 13.4% vs 5.7%, respectively; all P less than .05). Among patients with inadequate response to TNFi (TNFi-IR), those who received secukinumab 150 mg vs placebo experienced significant SJC66 resolution (20.8% vs 12.3%; P less than .05).

Study details: Findings are from a pooled analysis of 4 phase 3 randomized controlled trials (FUTURE 2, FUTURE 3, FUTURE 4, and FUTURE 5) involving 2049 patients with PsA who were either TNFi naive (n=1436) or TNFi-IR (n=613). Patients received either secukinumab 300 mg (n=461), secukinumab 150 mg (n=907), or placebo (n=681).

Disclosures: This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The authors including the lead author reported receiving grant support, speaker fees, and/or consulting fees from various sources. O Chambenoit and X Meng reported being employees and stockholders of Novartis.

Source: Orbai AM et al. Rheumatol Ther. 2021 Jul 3. doi: 10.1007/s40744-021-00337-5.

Key clinical point: In a real-world cohort of patients with psoriatic arthritis (PsA), achievement of treatment targets was similar after 6 months of treatment with ustekinumab or tumor necrosis factor (TNF) inhibitors.

Major finding: After 6 months of treatment, the proportion of patients achieving clinical Disease Activity Index for PsA (odds ratio [OR], 0.73; 95% confidence interval [CI], 0.46-1.15), low disease activity (LDA; OR, 0.74; 95% CI, 0.53-1.04), minimal disease activity (OR, 0.87; 95% CI, 0.61-1.25), and very LDA (OR, 0.74; 95% CI, 0.42-1.30) was not significantly different in ustekinumab vs TNF inhibitor groups. Both the groups reported similar adverse and serious adverse events.

Study details: Findings are from an analysis of 868 patients with PsA from the observational PsABio study, who were treated with first-line to third-line ustekinumab or TNF inhibitors.

Disclosures: PsABio study was sponsored by Janssen. The authors including the lead author reported receiving grants/research support and/or personal fees from various sources including Janssen. W Noël, P Bergmans, and E Theander reported being full-time employees of Janssen.

Source: Smolen JS et al. Ann Rheum Dis. 2021 Jun 23. doi: 10.1136/annrheumdis-2021-220263.

Key clinical point: In a real-world cohort of patients with psoriatic arthritis (PsA), achievement of treatment targets was similar after 6 months of treatment with ustekinumab or tumor necrosis factor (TNF) inhibitors.

Major finding: After 6 months of treatment, the proportion of patients achieving clinical Disease Activity Index for PsA (odds ratio [OR], 0.73; 95% confidence interval [CI], 0.46-1.15), low disease activity (LDA; OR, 0.74; 95% CI, 0.53-1.04), minimal disease activity (OR, 0.87; 95% CI, 0.61-1.25), and very LDA (OR, 0.74; 95% CI, 0.42-1.30) was not significantly different in ustekinumab vs TNF inhibitor groups. Both the groups reported similar adverse and serious adverse events.

Study details: Findings are from an analysis of 868 patients with PsA from the observational PsABio study, who were treated with first-line to third-line ustekinumab or TNF inhibitors.

Disclosures: PsABio study was sponsored by Janssen. The authors including the lead author reported receiving grants/research support and/or personal fees from various sources including Janssen. W Noël, P Bergmans, and E Theander reported being full-time employees of Janssen.

Source: Smolen JS et al. Ann Rheum Dis. 2021 Jun 23. doi: 10.1136/annrheumdis-2021-220263.

Key clinical point: In a real-world cohort of patients with psoriatic arthritis (PsA), achievement of treatment targets was similar after 6 months of treatment with ustekinumab or tumor necrosis factor (TNF) inhibitors.

Major finding: After 6 months of treatment, the proportion of patients achieving clinical Disease Activity Index for PsA (odds ratio [OR], 0.73; 95% confidence interval [CI], 0.46-1.15), low disease activity (LDA; OR, 0.74; 95% CI, 0.53-1.04), minimal disease activity (OR, 0.87; 95% CI, 0.61-1.25), and very LDA (OR, 0.74; 95% CI, 0.42-1.30) was not significantly different in ustekinumab vs TNF inhibitor groups. Both the groups reported similar adverse and serious adverse events.

Study details: Findings are from an analysis of 868 patients with PsA from the observational PsABio study, who were treated with first-line to third-line ustekinumab or TNF inhibitors.

Disclosures: PsABio study was sponsored by Janssen. The authors including the lead author reported receiving grants/research support and/or personal fees from various sources including Janssen. W Noël, P Bergmans, and E Theander reported being full-time employees of Janssen.

Source: Smolen JS et al. Ann Rheum Dis. 2021 Jun 23. doi: 10.1136/annrheumdis-2021-220263.

Key clinical point: The composite ultrasonography scores showed a significantly greater value for assessment of disease activity than clinical scores in patients with psoriatic arthritis (PsA) with coexisting fibromyalgia syndrome (FMS).

Major finding: Patients with coexisting PsA and FMS vs those without FMS had higher scores for several disease activity indices, including Composite Psoriatic Disease Activity Index, Disease Activity for PsA, and PsA Disease Activity Score (P less than .001). However, both groups had similar total ultrasonographic scores regardless of FMS (P = .68). A significant association was observed between FMS and higher scores on clinical activity indices (P less than .001) but not with the ultrasonography score.

Study details: The data come from a prospective study of 156 patients with PsA who were categorized into those with (n=42) and without (n=114) FMS.

Disclosures: No specific funding or conflicts of interest were reported.

Source: Polachek A et al. Ann Rheum Dis. 2021 Jul 2. doi: 10.1136/annrheumdis-2021-220562.

Key clinical point: The composite ultrasonography scores showed a significantly greater value for assessment of disease activity than clinical scores in patients with psoriatic arthritis (PsA) with coexisting fibromyalgia syndrome (FMS).

Major finding: Patients with coexisting PsA and FMS vs those without FMS had higher scores for several disease activity indices, including Composite Psoriatic Disease Activity Index, Disease Activity for PsA, and PsA Disease Activity Score (P less than .001). However, both groups had similar total ultrasonographic scores regardless of FMS (P = .68). A significant association was observed between FMS and higher scores on clinical activity indices (P less than .001) but not with the ultrasonography score.

Study details: The data come from a prospective study of 156 patients with PsA who were categorized into those with (n=42) and without (n=114) FMS.

Disclosures: No specific funding or conflicts of interest were reported.

Source: Polachek A et al. Ann Rheum Dis. 2021 Jul 2. doi: 10.1136/annrheumdis-2021-220562.

Key clinical point: The composite ultrasonography scores showed a significantly greater value for assessment of disease activity than clinical scores in patients with psoriatic arthritis (PsA) with coexisting fibromyalgia syndrome (FMS).

Major finding: Patients with coexisting PsA and FMS vs those without FMS had higher scores for several disease activity indices, including Composite Psoriatic Disease Activity Index, Disease Activity for PsA, and PsA Disease Activity Score (P less than .001). However, both groups had similar total ultrasonographic scores regardless of FMS (P = .68). A significant association was observed between FMS and higher scores on clinical activity indices (P less than .001) but not with the ultrasonography score.

Study details: The data come from a prospective study of 156 patients with PsA who were categorized into those with (n=42) and without (n=114) FMS.

Disclosures: No specific funding or conflicts of interest were reported.

Source: Polachek A et al. Ann Rheum Dis. 2021 Jul 2. doi: 10.1136/annrheumdis-2021-220562.

Key clinical point: Findings from this real-life cohort of patients with early psoriatic arthritis (PsA) confirm the safety and efficacy of guselkumab on peripheral and axial manifestations.

Major finding: After 12 months of guselkumab treatment, the mean Patient Global Assessment (P less than .0001), Visual Analogue Scale of Pain (P less than .001), and Disease Activity Score of PsA (P less than .0001) decreased significantly. Inflammatory low back pain disappeared as early as 24 weeks in all patients with concomitant axial disease. Low disease activity and remission were achieved by 65% and 35% of patients, respectively. No adverse events were reported.

Study details: The data come from an observational study involving 24 patients with early PsA who initiated therapy with guselkumab for severe skin involvement.

Disclosures: No specific funding was received for this study. The authors declared no conflicts of interest.

 Source: Pantano I et al. Rheumatology (Oxford). 2021 Jun 21. doi: 10.1093/rheumatology/keab509.

Key clinical point: Findings from this real-life cohort of patients with early psoriatic arthritis (PsA) confirm the safety and efficacy of guselkumab on peripheral and axial manifestations.

Major finding: After 12 months of guselkumab treatment, the mean Patient Global Assessment (P less than .0001), Visual Analogue Scale of Pain (P less than .001), and Disease Activity Score of PsA (P less than .0001) decreased significantly. Inflammatory low back pain disappeared as early as 24 weeks in all patients with concomitant axial disease. Low disease activity and remission were achieved by 65% and 35% of patients, respectively. No adverse events were reported.

Study details: The data come from an observational study involving 24 patients with early PsA who initiated therapy with guselkumab for severe skin involvement.

Disclosures: No specific funding was received for this study. The authors declared no conflicts of interest.

 Source: Pantano I et al. Rheumatology (Oxford). 2021 Jun 21. doi: 10.1093/rheumatology/keab509.

Key clinical point: Findings from this real-life cohort of patients with early psoriatic arthritis (PsA) confirm the safety and efficacy of guselkumab on peripheral and axial manifestations.

Major finding: After 12 months of guselkumab treatment, the mean Patient Global Assessment (P less than .0001), Visual Analogue Scale of Pain (P less than .001), and Disease Activity Score of PsA (P less than .0001) decreased significantly. Inflammatory low back pain disappeared as early as 24 weeks in all patients with concomitant axial disease. Low disease activity and remission were achieved by 65% and 35% of patients, respectively. No adverse events were reported.

Study details: The data come from an observational study involving 24 patients with early PsA who initiated therapy with guselkumab for severe skin involvement.

Disclosures: No specific funding was received for this study. The authors declared no conflicts of interest.

 Source: Pantano I et al. Rheumatology (Oxford). 2021 Jun 21. doi: 10.1093/rheumatology/keab509.

Key clinical point: Patients with psoriatic arthritis (PsA) with vs without nail involvement had higher rates of carotid plaque (CP) and carotid intima-media thickness (cIMT). Additionally, nail involvement in PsA was independently associated with CP risk.

Major finding: Patients with vs without nail involvement showed a higher prevalence of CP (53.1% vs 25.0%; P = .021) and cIMT (0.85 vs 0.59 mm; P = .026). The nail involvement was an independent risk factor for the presence of CP (odds ratio, 6.64; P = .006).

Study details: Findings are from a cross-sectional, observational study involving 64 patients with PsA. Patients with nail involvement were matched by age, gender, and type 2 diabetes mellitus diagnosis to those without nail involvement.

Disclosures: No specific funding or conflicts of interest were declared.

Source: Colunga-Pedraza IJ et al. Ann Rheum Dis. 2021 Jun 24. doi: 10.1136/annrheumdis-2021-220782.

Key clinical point: Patients with psoriatic arthritis (PsA) with vs without nail involvement had higher rates of carotid plaque (CP) and carotid intima-media thickness (cIMT). Additionally, nail involvement in PsA was independently associated with CP risk.

Major finding: Patients with vs without nail involvement showed a higher prevalence of CP (53.1% vs 25.0%; P = .021) and cIMT (0.85 vs 0.59 mm; P = .026). The nail involvement was an independent risk factor for the presence of CP (odds ratio, 6.64; P = .006).

Study details: Findings are from a cross-sectional, observational study involving 64 patients with PsA. Patients with nail involvement were matched by age, gender, and type 2 diabetes mellitus diagnosis to those without nail involvement.

Disclosures: No specific funding or conflicts of interest were declared.

Source: Colunga-Pedraza IJ et al. Ann Rheum Dis. 2021 Jun 24. doi: 10.1136/annrheumdis-2021-220782.

Key clinical point: Patients with psoriatic arthritis (PsA) with vs without nail involvement had higher rates of carotid plaque (CP) and carotid intima-media thickness (cIMT). Additionally, nail involvement in PsA was independently associated with CP risk.

Major finding: Patients with vs without nail involvement showed a higher prevalence of CP (53.1% vs 25.0%; P = .021) and cIMT (0.85 vs 0.59 mm; P = .026). The nail involvement was an independent risk factor for the presence of CP (odds ratio, 6.64; P = .006).

Study details: Findings are from a cross-sectional, observational study involving 64 patients with PsA. Patients with nail involvement were matched by age, gender, and type 2 diabetes mellitus diagnosis to those without nail involvement.

Disclosures: No specific funding or conflicts of interest were declared.

Source: Colunga-Pedraza IJ et al. Ann Rheum Dis. 2021 Jun 24. doi: 10.1136/annrheumdis-2021-220782.

Key clinical point: Patients with active psoriatic arthritis (PsA) and imaging-confirmed sacroiliitis treated with guselkumab every 4 weeks (Q4) or every 8 weeks (Q8) had greater mean improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) score than placebo.

Major finding: At week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52.

Study details: This was a post hoc analysis of 2 DISCOVER studies including 312 patients with PsA with imaging-confirmed sacroiliitis who were randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91).

Disclosures: This study was funded by Janssen Research & Development LLC. The authors including the lead author reported grants and/or personal fees from various sources. Some of the authors declared being employees of Janssen Scientific Affairs LLC and Janssen Global Services LLC. Ten authors owned shares/stock options in Johnson & Johnson.

Source: Mease PJ et al. Lancet Rheumatol. 2021 Jun 29. doi: 10.1016/S2665-9913(21)00105-3.

Key clinical point: Patients with active psoriatic arthritis (PsA) and imaging-confirmed sacroiliitis treated with guselkumab every 4 weeks (Q4) or every 8 weeks (Q8) had greater mean improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) score than placebo.

Major finding: At week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52.

Study details: This was a post hoc analysis of 2 DISCOVER studies including 312 patients with PsA with imaging-confirmed sacroiliitis who were randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91).

Disclosures: This study was funded by Janssen Research & Development LLC. The authors including the lead author reported grants and/or personal fees from various sources. Some of the authors declared being employees of Janssen Scientific Affairs LLC and Janssen Global Services LLC. Ten authors owned shares/stock options in Johnson & Johnson.

Source: Mease PJ et al. Lancet Rheumatol. 2021 Jun 29. doi: 10.1016/S2665-9913(21)00105-3.

Key clinical point: Patients with active psoriatic arthritis (PsA) and imaging-confirmed sacroiliitis treated with guselkumab every 4 weeks (Q4) or every 8 weeks (Q8) had greater mean improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) score than placebo.

Major finding: At week 24, guselkumab Q4 and Q8 groups vs placebo showed higher least-squares mean changes in BASDAI (−2.7 and −2.7 vs −1.3; P less than .0001) and ASDAS (−1.4 and −1.4 vs −0.7; P less than .0001) scores, which were maintained until week 52.

Study details: This was a post hoc analysis of 2 DISCOVER studies including 312 patients with PsA with imaging-confirmed sacroiliitis who were randomly assigned to either placebo (n=118), guselkumab Q4 (n=103), or Q8 (n=91).

Disclosures: This study was funded by Janssen Research & Development LLC. The authors including the lead author reported grants and/or personal fees from various sources. Some of the authors declared being employees of Janssen Scientific Affairs LLC and Janssen Global Services LLC. Ten authors owned shares/stock options in Johnson & Johnson.

Source: Mease PJ et al. Lancet Rheumatol. 2021 Jun 29. doi: 10.1016/S2665-9913(21)00105-3.

With 49% of the U.S. population fully vaccinated against SARS-CoV-2, a new study highlights the degree of vaccine hesitancy among patients with rheumatic disease to get the vaccine.

Halfpoint Images/Moment/Getty Images

The international study, published in May 2021 in Rheumatology, suggests that, of 1,258 patients surveyed worldwide, approximately 40% of patients said they would decline the vaccine.

“Sometimes it’s helpful to talk through their concerns,” said Jeffrey Curtis, MD, MPH, a University of Alabama at Birmingham rheumatologist who leads the American College of Rheumatology COVID-19 vaccine task force. Dr. Curtis recently reviewed the current literature on COVID-19 vaccination in patients with rheumatic and musculoskeletal diseases (RMDs) at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

COVID-19 vaccinations for patients with autoimmune inflammatory rheumatic disease (AIIRD) is not straightforward. The immune response can be blunted by existing treatments and disease flares can occur.

Courtesy UAB Photo

The latest version of COVID-19 vaccination guidance for patients with RMDs from the ACR addresses vaccine use and implementation strategies. The guidance was issued as conditional or provisional because of the lack of evidence. Its principals are largely based on accepted practice for other vaccines. The guidance is routinely updated as new evidence becomes available. In his presentation at GRAPPA, Dr. Curtis reviewed the latest version of the guidance, which he emphasized is a guidance only and not meant to replace clinical judgment or shared decision-making with patients.

“This is a platform for you to start from as you are thinking about and discussing with your patient what might be best for him or her,” he said.
 

Concerns about impact of disease activity, treatments on effectiveness

Dr. Curtis highlighted some controversial aspects of COVID-19 vaccines, including heterogeneity of rheumatic diseases and treatment. Patients with AIIRD, including psoriatic arthritis, spondyloarthritis, RA, and lupus, are at higher risk for hospitalized COVID-19 and worse outcomes, and as such, they are prioritized for vaccination by the Centers for Disease Control and Prevention.

However, for AIIRD patients, the immune response to COVID-19 vaccination can be “blunted,” according to one study. This may be because of glucocorticoid use or high disease activity. Immunomodulatory therapies, such as methotrexate, rituximab, and abatacept, are known to diminish vaccine response in general. The evidence is less clear for tumor necrosis factor and Janus kinase inhibitors, but they are thought to have the same impact on vaccine effectiveness, Dr. Curtis said. But in these cases, if the effect of a COVID-19 vaccine drops from 90% to 70%, the benefits of vaccination still far outweighs the risk of contracting COVID-19.

“Although we don’t have strong data with clinical outcomes for autoimmune disease or inflammatory disease patients, I’ll run a hypothetical and say: ‘Look, if this vaccine starts 90%-95% effective, even if it’s only 70% effective in somebody with lupus or vasculitis or someone who is taking a higher dose of steroids, I’ll take 70% over nothing if you chose to be vaccinated,’ ” he said.

The benefit of vaccination also outweighs the potential risk of disease flare, he said. The risk is real, but to date, no studies have pointed to a significant risk of disease flare or worsening. However, there have been reported cases of myocardial infarction.

Autoimmune manifestations after vaccination vs. after infection

Researchers writing in the June 29, 2021, issue of JAMA Cardiology described case reports of acute myocarditis in 23 people who received the BNT162b2-mRNA (Pfizer-BioNTech) or mRNA-1273 (Moderna) messenger RNA (mRNA) COVID-19 vaccines. Plus, there been subsequent reports of myocarditis in other patients, wrote David K. Shay, MD, MPH, in an accompanying editorial. Dr. Shay is a member of the CDC COVID-19 Response Team.

“What do we know about this possible association between myocarditis and immunization with mRNA-based COVID-19 vaccines, and what remains unclear? Acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism,” he said.

The cases of myocarditis are concerning, Dr. Curtis said, but the risk is very low with relatively few cases reported among 161 million fully vaccinated people in the United States.

“Certainly, we’re not seeking to minimize that, but the risk of getting COVID and some of the downstream sequelae (autoimmune manifestations) almost certainly outweigh the risks for some of the autoimmune manifestations or worsening [condition],” he said.

A nationwide cohort study from Denmark of 58,052 patients with inflammatory rheumatic disease published in December 2020 in Rheumatology, found that patients with COVID-19 who had an inflammatory rheumatic disease were more likely to be admitted to the hospital, compared with COVID-19 patients without rheumatic disease. Patients with rheumatic disease had a higher risk of a severe COVID-19 outcome, but it was not a statistically significant difference, said Dr. Curtis, adding that the individual factors such as age and treatment currently received largely determines the risk. The strongest associations between hospitalization for COVID-19 and rheumatic disease were found among patients with RA, vasculitis, and connective tissue disease. Dr. Curtis noted that his own new study results show that risk of death from a COVID-19 infection is higher for patients who have RA or psoriatic arthritis.

There have been published case reports of patients who have developed new-onset lupus, vasculitis, Kawasaki disease, multiple sclerosis, autoimmune cytopenias, and other manifestations after a COVID-19 infection. “These authors suggest that perhaps there is a transient influence on the immune system that leads to a loss of self-tolerance to antigens,” Dr. Curtis said. “Some patients may have an underlying predisposition to autoimmunity in which infections just unmask as we sometimes see with other infections – chronic hepatitis for example.”
 

Antibody tests not recommended

In its COVID-19 guidance, the ACR, like the Food and Drug Administration, recommends health care providers not to routinely order antibody tests for IgM or IgG to assess immunity after a person has been vaccinated or to assess the need for vaccination in an unvaccinated person. More research is needed to determine if antibodies provide protection, and if so, for how long and how much. Plus, the antibody testing process is not clear cut, so ordering the wrong test is possible, Dr. Curtis said. The tests should clearly differentiate between spike proteins or nucleocapsid proteins.

“The bottom line is that you might be ordering the wrong lab test. Even if you’re ordering the right lab test, I would assert that you probably don’t know what to do with the result. I would then ask you, ‘Does it mean they are protected? Does it mean they are not protected? What are you going to do with the results?’ ” he asked.

Kevin Winthrop, MD, MPH, a specialist in infectious diseases at Oregon Health & Science University, Portland, said that, at this point, it’s too early to know what antibody tests mean. “I think it is tempting to test some people, especially patients on B-cell depletion therapy and those on mycophenolate mofetil (MMF). Outside of those two types of [disease-modifying antirheumatic drug] users, I wouldn’t be tempted to test. We don’t know how well protected they are, but we assume they are protected to some extent,” he said. “They’re probably partially protected and as such, they should take the same precautions they were taking a year ago: masking and avoidance. I think that’s just how it’s going to be for those folks for another year until we get this thing sorted out.”
 

Modifications to existing rheumatic disease therapies

In its COVID-19 vaccine guidance, the ACR issued recommendations for some common rheumatic disease therapeutics before and/or after the COVID-19 vaccine is administered. The modifications are limited to MMF, methotrexate, JAK inhibitors, subcutaneous abatacept, acetaminophen, and NSAIDs. The recommendations include: hold mycophenolate for 1 week after vaccination if disease is stable; for patients with well-controlled disease, hold methotrexate for 1 week after each of the two mRNA vaccine doses; for patients with well-controlled disease receiving the Johnson & Johnson vaccine, hold methotrexate for 2 weeks after receiving the vaccine; hold JAK inhibitors for 1 week after each dose; for abatacept subcutaneous, hold treatment for 1 week before and after the first dose; and in patients with stable disease, hold acetaminophen and NSAIDs for 24 hours before vaccination, because taking either before vaccination could blunt the vaccine response, Dr. Curtis said.

Holding medication, such as methotrexate, could risk having a flare-up of disease. One study showed the rate of disease flare-up because of withholding standard treatment may be up to 11%, compared with 5.1% in patients who did not hold treatment, he said.

“The point is, if you hold some of these therapies, whether methotrexate or tofacitinib, arthritis will get a little bit worse,” Dr. Curtis said.

A study published on the preprint server medRxiv found that immunosuppressive therapies blunted the response of SARS-CoV-2 vaccines in patients with chronic inflammatory diseases, most significantly with glucocorticoids and B-cell therapies.

“That’s what’s led to a lot of the guidance statements about holding treatments for a week or 2 for rituximab. If you’re giving it at 6-month intervals, you want to schedule the vaccine dose or series at about month 5, or a month before the next cycle,” he said.

Talking with patients about COVID-19 vaccination

In talking with patients about vaccine safety, Dr. Curtis recommends addressing a few common misperceptions. First, COVID-19 viruses were not created with a live-attenuated virus (which would be contraindicated for immunosuppressed patients). “You can put patients’ mind at ease that none of the vaccine candidates or platforms – even those that say viral vector – put patients at risk for contracting the infection. These are nonreplicating. So, it’s like you extracted the engine that would allow this virus to replicate,” he said.

Of three COVID-19 vaccinations available in the United States, is one better than the other? The ACR COVID-19 vaccine task force did not reach a consensus on safety profiles of the vaccines because, without head-to-head comparisons, it’s impossible to know, he said.

In talking with patients, review the protocol for continuing with prescribed treatment modalities before the patient receives a COVID-19 vaccine. Safety concerns and concerns about the possibility of having a disease flare-up should be addressed, he said.

With 49% of the U.S. population fully vaccinated against SARS-CoV-2, a new study highlights the degree of vaccine hesitancy among patients with rheumatic disease to get the vaccine.

Halfpoint Images/Moment/Getty Images

The international study, published in May 2021 in Rheumatology, suggests that, of 1,258 patients surveyed worldwide, approximately 40% of patients said they would decline the vaccine.

“Sometimes it’s helpful to talk through their concerns,” said Jeffrey Curtis, MD, MPH, a University of Alabama at Birmingham rheumatologist who leads the American College of Rheumatology COVID-19 vaccine task force. Dr. Curtis recently reviewed the current literature on COVID-19 vaccination in patients with rheumatic and musculoskeletal diseases (RMDs) at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

COVID-19 vaccinations for patients with autoimmune inflammatory rheumatic disease (AIIRD) is not straightforward. The immune response can be blunted by existing treatments and disease flares can occur.

Courtesy UAB Photo

The latest version of COVID-19 vaccination guidance for patients with RMDs from the ACR addresses vaccine use and implementation strategies. The guidance was issued as conditional or provisional because of the lack of evidence. Its principals are largely based on accepted practice for other vaccines. The guidance is routinely updated as new evidence becomes available. In his presentation at GRAPPA, Dr. Curtis reviewed the latest version of the guidance, which he emphasized is a guidance only and not meant to replace clinical judgment or shared decision-making with patients.

“This is a platform for you to start from as you are thinking about and discussing with your patient what might be best for him or her,” he said.
 

Concerns about impact of disease activity, treatments on effectiveness

Dr. Curtis highlighted some controversial aspects of COVID-19 vaccines, including heterogeneity of rheumatic diseases and treatment. Patients with AIIRD, including psoriatic arthritis, spondyloarthritis, RA, and lupus, are at higher risk for hospitalized COVID-19 and worse outcomes, and as such, they are prioritized for vaccination by the Centers for Disease Control and Prevention.

However, for AIIRD patients, the immune response to COVID-19 vaccination can be “blunted,” according to one study. This may be because of glucocorticoid use or high disease activity. Immunomodulatory therapies, such as methotrexate, rituximab, and abatacept, are known to diminish vaccine response in general. The evidence is less clear for tumor necrosis factor and Janus kinase inhibitors, but they are thought to have the same impact on vaccine effectiveness, Dr. Curtis said. But in these cases, if the effect of a COVID-19 vaccine drops from 90% to 70%, the benefits of vaccination still far outweighs the risk of contracting COVID-19.

“Although we don’t have strong data with clinical outcomes for autoimmune disease or inflammatory disease patients, I’ll run a hypothetical and say: ‘Look, if this vaccine starts 90%-95% effective, even if it’s only 70% effective in somebody with lupus or vasculitis or someone who is taking a higher dose of steroids, I’ll take 70% over nothing if you chose to be vaccinated,’ ” he said.

The benefit of vaccination also outweighs the potential risk of disease flare, he said. The risk is real, but to date, no studies have pointed to a significant risk of disease flare or worsening. However, there have been reported cases of myocardial infarction.

Autoimmune manifestations after vaccination vs. after infection

Researchers writing in the June 29, 2021, issue of JAMA Cardiology described case reports of acute myocarditis in 23 people who received the BNT162b2-mRNA (Pfizer-BioNTech) or mRNA-1273 (Moderna) messenger RNA (mRNA) COVID-19 vaccines. Plus, there been subsequent reports of myocarditis in other patients, wrote David K. Shay, MD, MPH, in an accompanying editorial. Dr. Shay is a member of the CDC COVID-19 Response Team.

“What do we know about this possible association between myocarditis and immunization with mRNA-based COVID-19 vaccines, and what remains unclear? Acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism,” he said.

The cases of myocarditis are concerning, Dr. Curtis said, but the risk is very low with relatively few cases reported among 161 million fully vaccinated people in the United States.

“Certainly, we’re not seeking to minimize that, but the risk of getting COVID and some of the downstream sequelae (autoimmune manifestations) almost certainly outweigh the risks for some of the autoimmune manifestations or worsening [condition],” he said.

A nationwide cohort study from Denmark of 58,052 patients with inflammatory rheumatic disease published in December 2020 in Rheumatology, found that patients with COVID-19 who had an inflammatory rheumatic disease were more likely to be admitted to the hospital, compared with COVID-19 patients without rheumatic disease. Patients with rheumatic disease had a higher risk of a severe COVID-19 outcome, but it was not a statistically significant difference, said Dr. Curtis, adding that the individual factors such as age and treatment currently received largely determines the risk. The strongest associations between hospitalization for COVID-19 and rheumatic disease were found among patients with RA, vasculitis, and connective tissue disease. Dr. Curtis noted that his own new study results show that risk of death from a COVID-19 infection is higher for patients who have RA or psoriatic arthritis.

There have been published case reports of patients who have developed new-onset lupus, vasculitis, Kawasaki disease, multiple sclerosis, autoimmune cytopenias, and other manifestations after a COVID-19 infection. “These authors suggest that perhaps there is a transient influence on the immune system that leads to a loss of self-tolerance to antigens,” Dr. Curtis said. “Some patients may have an underlying predisposition to autoimmunity in which infections just unmask as we sometimes see with other infections – chronic hepatitis for example.”
 

Antibody tests not recommended

In its COVID-19 guidance, the ACR, like the Food and Drug Administration, recommends health care providers not to routinely order antibody tests for IgM or IgG to assess immunity after a person has been vaccinated or to assess the need for vaccination in an unvaccinated person. More research is needed to determine if antibodies provide protection, and if so, for how long and how much. Plus, the antibody testing process is not clear cut, so ordering the wrong test is possible, Dr. Curtis said. The tests should clearly differentiate between spike proteins or nucleocapsid proteins.

“The bottom line is that you might be ordering the wrong lab test. Even if you’re ordering the right lab test, I would assert that you probably don’t know what to do with the result. I would then ask you, ‘Does it mean they are protected? Does it mean they are not protected? What are you going to do with the results?’ ” he asked.

Kevin Winthrop, MD, MPH, a specialist in infectious diseases at Oregon Health & Science University, Portland, said that, at this point, it’s too early to know what antibody tests mean. “I think it is tempting to test some people, especially patients on B-cell depletion therapy and those on mycophenolate mofetil (MMF). Outside of those two types of [disease-modifying antirheumatic drug] users, I wouldn’t be tempted to test. We don’t know how well protected they are, but we assume they are protected to some extent,” he said. “They’re probably partially protected and as such, they should take the same precautions they were taking a year ago: masking and avoidance. I think that’s just how it’s going to be for those folks for another year until we get this thing sorted out.”
 

Modifications to existing rheumatic disease therapies

In its COVID-19 vaccine guidance, the ACR issued recommendations for some common rheumatic disease therapeutics before and/or after the COVID-19 vaccine is administered. The modifications are limited to MMF, methotrexate, JAK inhibitors, subcutaneous abatacept, acetaminophen, and NSAIDs. The recommendations include: hold mycophenolate for 1 week after vaccination if disease is stable; for patients with well-controlled disease, hold methotrexate for 1 week after each of the two mRNA vaccine doses; for patients with well-controlled disease receiving the Johnson & Johnson vaccine, hold methotrexate for 2 weeks after receiving the vaccine; hold JAK inhibitors for 1 week after each dose; for abatacept subcutaneous, hold treatment for 1 week before and after the first dose; and in patients with stable disease, hold acetaminophen and NSAIDs for 24 hours before vaccination, because taking either before vaccination could blunt the vaccine response, Dr. Curtis said.

Holding medication, such as methotrexate, could risk having a flare-up of disease. One study showed the rate of disease flare-up because of withholding standard treatment may be up to 11%, compared with 5.1% in patients who did not hold treatment, he said.

“The point is, if you hold some of these therapies, whether methotrexate or tofacitinib, arthritis will get a little bit worse,” Dr. Curtis said.

A study published on the preprint server medRxiv found that immunosuppressive therapies blunted the response of SARS-CoV-2 vaccines in patients with chronic inflammatory diseases, most significantly with glucocorticoids and B-cell therapies.

“That’s what’s led to a lot of the guidance statements about holding treatments for a week or 2 for rituximab. If you’re giving it at 6-month intervals, you want to schedule the vaccine dose or series at about month 5, or a month before the next cycle,” he said.

Talking with patients about COVID-19 vaccination

In talking with patients about vaccine safety, Dr. Curtis recommends addressing a few common misperceptions. First, COVID-19 viruses were not created with a live-attenuated virus (which would be contraindicated for immunosuppressed patients). “You can put patients’ mind at ease that none of the vaccine candidates or platforms – even those that say viral vector – put patients at risk for contracting the infection. These are nonreplicating. So, it’s like you extracted the engine that would allow this virus to replicate,” he said.

Of three COVID-19 vaccinations available in the United States, is one better than the other? The ACR COVID-19 vaccine task force did not reach a consensus on safety profiles of the vaccines because, without head-to-head comparisons, it’s impossible to know, he said.

In talking with patients, review the protocol for continuing with prescribed treatment modalities before the patient receives a COVID-19 vaccine. Safety concerns and concerns about the possibility of having a disease flare-up should be addressed, he said.

With 49% of the U.S. population fully vaccinated against SARS-CoV-2, a new study highlights the degree of vaccine hesitancy among patients with rheumatic disease to get the vaccine.

Halfpoint Images/Moment/Getty Images

The international study, published in May 2021 in Rheumatology, suggests that, of 1,258 patients surveyed worldwide, approximately 40% of patients said they would decline the vaccine.

“Sometimes it’s helpful to talk through their concerns,” said Jeffrey Curtis, MD, MPH, a University of Alabama at Birmingham rheumatologist who leads the American College of Rheumatology COVID-19 vaccine task force. Dr. Curtis recently reviewed the current literature on COVID-19 vaccination in patients with rheumatic and musculoskeletal diseases (RMDs) at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

COVID-19 vaccinations for patients with autoimmune inflammatory rheumatic disease (AIIRD) is not straightforward. The immune response can be blunted by existing treatments and disease flares can occur.

Courtesy UAB Photo

The latest version of COVID-19 vaccination guidance for patients with RMDs from the ACR addresses vaccine use and implementation strategies. The guidance was issued as conditional or provisional because of the lack of evidence. Its principals are largely based on accepted practice for other vaccines. The guidance is routinely updated as new evidence becomes available. In his presentation at GRAPPA, Dr. Curtis reviewed the latest version of the guidance, which he emphasized is a guidance only and not meant to replace clinical judgment or shared decision-making with patients.

“This is a platform for you to start from as you are thinking about and discussing with your patient what might be best for him or her,” he said.
 

Concerns about impact of disease activity, treatments on effectiveness

Dr. Curtis highlighted some controversial aspects of COVID-19 vaccines, including heterogeneity of rheumatic diseases and treatment. Patients with AIIRD, including psoriatic arthritis, spondyloarthritis, RA, and lupus, are at higher risk for hospitalized COVID-19 and worse outcomes, and as such, they are prioritized for vaccination by the Centers for Disease Control and Prevention.

However, for AIIRD patients, the immune response to COVID-19 vaccination can be “blunted,” according to one study. This may be because of glucocorticoid use or high disease activity. Immunomodulatory therapies, such as methotrexate, rituximab, and abatacept, are known to diminish vaccine response in general. The evidence is less clear for tumor necrosis factor and Janus kinase inhibitors, but they are thought to have the same impact on vaccine effectiveness, Dr. Curtis said. But in these cases, if the effect of a COVID-19 vaccine drops from 90% to 70%, the benefits of vaccination still far outweighs the risk of contracting COVID-19.

“Although we don’t have strong data with clinical outcomes for autoimmune disease or inflammatory disease patients, I’ll run a hypothetical and say: ‘Look, if this vaccine starts 90%-95% effective, even if it’s only 70% effective in somebody with lupus or vasculitis or someone who is taking a higher dose of steroids, I’ll take 70% over nothing if you chose to be vaccinated,’ ” he said.

The benefit of vaccination also outweighs the potential risk of disease flare, he said. The risk is real, but to date, no studies have pointed to a significant risk of disease flare or worsening. However, there have been reported cases of myocardial infarction.

Autoimmune manifestations after vaccination vs. after infection

Researchers writing in the June 29, 2021, issue of JAMA Cardiology described case reports of acute myocarditis in 23 people who received the BNT162b2-mRNA (Pfizer-BioNTech) or mRNA-1273 (Moderna) messenger RNA (mRNA) COVID-19 vaccines. Plus, there been subsequent reports of myocarditis in other patients, wrote David K. Shay, MD, MPH, in an accompanying editorial. Dr. Shay is a member of the CDC COVID-19 Response Team.

“What do we know about this possible association between myocarditis and immunization with mRNA-based COVID-19 vaccines, and what remains unclear? Acute onset of chest pain 3-5 days after vaccine administration, usually after a second dose, is a typical feature of reported cases and suggests an immune-mediated mechanism,” he said.

The cases of myocarditis are concerning, Dr. Curtis said, but the risk is very low with relatively few cases reported among 161 million fully vaccinated people in the United States.

“Certainly, we’re not seeking to minimize that, but the risk of getting COVID and some of the downstream sequelae (autoimmune manifestations) almost certainly outweigh the risks for some of the autoimmune manifestations or worsening [condition],” he said.

A nationwide cohort study from Denmark of 58,052 patients with inflammatory rheumatic disease published in December 2020 in Rheumatology, found that patients with COVID-19 who had an inflammatory rheumatic disease were more likely to be admitted to the hospital, compared with COVID-19 patients without rheumatic disease. Patients with rheumatic disease had a higher risk of a severe COVID-19 outcome, but it was not a statistically significant difference, said Dr. Curtis, adding that the individual factors such as age and treatment currently received largely determines the risk. The strongest associations between hospitalization for COVID-19 and rheumatic disease were found among patients with RA, vasculitis, and connective tissue disease. Dr. Curtis noted that his own new study results show that risk of death from a COVID-19 infection is higher for patients who have RA or psoriatic arthritis.

There have been published case reports of patients who have developed new-onset lupus, vasculitis, Kawasaki disease, multiple sclerosis, autoimmune cytopenias, and other manifestations after a COVID-19 infection. “These authors suggest that perhaps there is a transient influence on the immune system that leads to a loss of self-tolerance to antigens,” Dr. Curtis said. “Some patients may have an underlying predisposition to autoimmunity in which infections just unmask as we sometimes see with other infections – chronic hepatitis for example.”
 

Antibody tests not recommended

In its COVID-19 guidance, the ACR, like the Food and Drug Administration, recommends health care providers not to routinely order antibody tests for IgM or IgG to assess immunity after a person has been vaccinated or to assess the need for vaccination in an unvaccinated person. More research is needed to determine if antibodies provide protection, and if so, for how long and how much. Plus, the antibody testing process is not clear cut, so ordering the wrong test is possible, Dr. Curtis said. The tests should clearly differentiate between spike proteins or nucleocapsid proteins.

“The bottom line is that you might be ordering the wrong lab test. Even if you’re ordering the right lab test, I would assert that you probably don’t know what to do with the result. I would then ask you, ‘Does it mean they are protected? Does it mean they are not protected? What are you going to do with the results?’ ” he asked.

Kevin Winthrop, MD, MPH, a specialist in infectious diseases at Oregon Health & Science University, Portland, said that, at this point, it’s too early to know what antibody tests mean. “I think it is tempting to test some people, especially patients on B-cell depletion therapy and those on mycophenolate mofetil (MMF). Outside of those two types of [disease-modifying antirheumatic drug] users, I wouldn’t be tempted to test. We don’t know how well protected they are, but we assume they are protected to some extent,” he said. “They’re probably partially protected and as such, they should take the same precautions they were taking a year ago: masking and avoidance. I think that’s just how it’s going to be for those folks for another year until we get this thing sorted out.”
 

Modifications to existing rheumatic disease therapies

In its COVID-19 vaccine guidance, the ACR issued recommendations for some common rheumatic disease therapeutics before and/or after the COVID-19 vaccine is administered. The modifications are limited to MMF, methotrexate, JAK inhibitors, subcutaneous abatacept, acetaminophen, and NSAIDs. The recommendations include: hold mycophenolate for 1 week after vaccination if disease is stable; for patients with well-controlled disease, hold methotrexate for 1 week after each of the two mRNA vaccine doses; for patients with well-controlled disease receiving the Johnson & Johnson vaccine, hold methotrexate for 2 weeks after receiving the vaccine; hold JAK inhibitors for 1 week after each dose; for abatacept subcutaneous, hold treatment for 1 week before and after the first dose; and in patients with stable disease, hold acetaminophen and NSAIDs for 24 hours before vaccination, because taking either before vaccination could blunt the vaccine response, Dr. Curtis said.

Holding medication, such as methotrexate, could risk having a flare-up of disease. One study showed the rate of disease flare-up because of withholding standard treatment may be up to 11%, compared with 5.1% in patients who did not hold treatment, he said.

“The point is, if you hold some of these therapies, whether methotrexate or tofacitinib, arthritis will get a little bit worse,” Dr. Curtis said.

A study published on the preprint server medRxiv found that immunosuppressive therapies blunted the response of SARS-CoV-2 vaccines in patients with chronic inflammatory diseases, most significantly with glucocorticoids and B-cell therapies.

“That’s what’s led to a lot of the guidance statements about holding treatments for a week or 2 for rituximab. If you’re giving it at 6-month intervals, you want to schedule the vaccine dose or series at about month 5, or a month before the next cycle,” he said.

Talking with patients about COVID-19 vaccination

In talking with patients about vaccine safety, Dr. Curtis recommends addressing a few common misperceptions. First, COVID-19 viruses were not created with a live-attenuated virus (which would be contraindicated for immunosuppressed patients). “You can put patients’ mind at ease that none of the vaccine candidates or platforms – even those that say viral vector – put patients at risk for contracting the infection. These are nonreplicating. So, it’s like you extracted the engine that would allow this virus to replicate,” he said.

Of three COVID-19 vaccinations available in the United States, is one better than the other? The ACR COVID-19 vaccine task force did not reach a consensus on safety profiles of the vaccines because, without head-to-head comparisons, it’s impossible to know, he said.

In talking with patients, review the protocol for continuing with prescribed treatment modalities before the patient receives a COVID-19 vaccine. Safety concerns and concerns about the possibility of having a disease flare-up should be addressed, he said.

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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