Psoriatic Arthritis

Key clinical point: In patients with psoriatic arthritis (PsA), risankizumab demonstrated long-term (76 weeks) effectiveness in reducing joint symptoms with a favorable safety profile.

Major finding: At week 16, the American College of Rheumatology 20 criteria response rate was significantly higher with 150 mg risankizumab at weeks 0, 4, 8, 12, and 16 (arm 1) or 150 mg risankizumab at weeks 0, 4, and 16 (arm 2) vs placebo (59.5% [pooled arms 1 and 2] vs 35.7%; P  =  .007), which further improved (75.2%) at week 52. Both risankizumab and placebo had a similar safety profile.

Study details: Findings are from a phase 2 study including 185 patients with active PsA and inadequate response or intolerance to standard therapies who were randomly assigned to receive risankizumab or placebo, of which 145 patients entered the 52-week open-label extension study and received 150 mg risankizumab for 36 weeks.

Disclosures: This study was funded by AbbVie and Boehringer Ingelheim. Some authors declared being current or former employees of Boehringer Ingelheim or AbbVie or owning stocks in AbbVie. The other authors reported ties with several sources, including AbbVie and Boehringer Ingelheim.

Source: Mease PJ et al. Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: Results from a 76-week phase 2 randomized trial. Rheumatol Ther. 2022 (Aug 5). Doi: 10.1007/s40744-022-00474-5

Key clinical point: In patients with psoriatic arthritis (PsA), risankizumab demonstrated long-term (76 weeks) effectiveness in reducing joint symptoms with a favorable safety profile.

Major finding: At week 16, the American College of Rheumatology 20 criteria response rate was significantly higher with 150 mg risankizumab at weeks 0, 4, 8, 12, and 16 (arm 1) or 150 mg risankizumab at weeks 0, 4, and 16 (arm 2) vs placebo (59.5% [pooled arms 1 and 2] vs 35.7%; P  =  .007), which further improved (75.2%) at week 52. Both risankizumab and placebo had a similar safety profile.

Study details: Findings are from a phase 2 study including 185 patients with active PsA and inadequate response or intolerance to standard therapies who were randomly assigned to receive risankizumab or placebo, of which 145 patients entered the 52-week open-label extension study and received 150 mg risankizumab for 36 weeks.

Disclosures: This study was funded by AbbVie and Boehringer Ingelheim. Some authors declared being current or former employees of Boehringer Ingelheim or AbbVie or owning stocks in AbbVie. The other authors reported ties with several sources, including AbbVie and Boehringer Ingelheim.

Source: Mease PJ et al. Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: Results from a 76-week phase 2 randomized trial. Rheumatol Ther. 2022 (Aug 5). Doi: 10.1007/s40744-022-00474-5

Key clinical point: In patients with psoriatic arthritis (PsA), risankizumab demonstrated long-term (76 weeks) effectiveness in reducing joint symptoms with a favorable safety profile.

Major finding: At week 16, the American College of Rheumatology 20 criteria response rate was significantly higher with 150 mg risankizumab at weeks 0, 4, 8, 12, and 16 (arm 1) or 150 mg risankizumab at weeks 0, 4, and 16 (arm 2) vs placebo (59.5% [pooled arms 1 and 2] vs 35.7%; P  =  .007), which further improved (75.2%) at week 52. Both risankizumab and placebo had a similar safety profile.

Study details: Findings are from a phase 2 study including 185 patients with active PsA and inadequate response or intolerance to standard therapies who were randomly assigned to receive risankizumab or placebo, of which 145 patients entered the 52-week open-label extension study and received 150 mg risankizumab for 36 weeks.

Disclosures: This study was funded by AbbVie and Boehringer Ingelheim. Some authors declared being current or former employees of Boehringer Ingelheim or AbbVie or owning stocks in AbbVie. The other authors reported ties with several sources, including AbbVie and Boehringer Ingelheim.

Source: Mease PJ et al. Long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis: Results from a 76-week phase 2 randomized trial. Rheumatol Ther. 2022 (Aug 5). Doi: 10.1007/s40744-022-00474-5

Key clinical point: A dose of 100 mg guselkumab every 4/8 weeks (Q4W/Q8W) improved health-related quality of life (HRQoL) through 52 weeks in patients with psoriatic arthritis (PsA).

Major finding: A significantly higher proportion of patients receiving guselkumab Q4W/Q8W vs placebo reported minimally important differences in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index (56.0%/56.0% vs 43.4%; P < .006) and Visual Analog Scale (EQ-VAS) score (62.8%/63.5% vs 44.4%; P < .0001) at week 24, with >60% of patients reporting improvements at week 52.

Study details: Findings are from an analysis of the phase 3 DISCOVER 2 trial including 738 biologic-naive patients with active PsA and an inadequate response to standard treatments who were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was supported by Janssen, a subsidiary of Johnson and Johnson. Eight authors declared being employees of one of the subsidiaries of or owning stocks in Johnson and Johnson. The other authors reported ties with several sources.

Source: Curtis JR et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022 (Aug 10). Doi: 10.1007/s12325-022-02269-0

Key clinical point: A dose of 100 mg guselkumab every 4/8 weeks (Q4W/Q8W) improved health-related quality of life (HRQoL) through 52 weeks in patients with psoriatic arthritis (PsA).

Major finding: A significantly higher proportion of patients receiving guselkumab Q4W/Q8W vs placebo reported minimally important differences in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index (56.0%/56.0% vs 43.4%; P < .006) and Visual Analog Scale (EQ-VAS) score (62.8%/63.5% vs 44.4%; P < .0001) at week 24, with >60% of patients reporting improvements at week 52.

Study details: Findings are from an analysis of the phase 3 DISCOVER 2 trial including 738 biologic-naive patients with active PsA and an inadequate response to standard treatments who were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was supported by Janssen, a subsidiary of Johnson and Johnson. Eight authors declared being employees of one of the subsidiaries of or owning stocks in Johnson and Johnson. The other authors reported ties with several sources.

Source: Curtis JR et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022 (Aug 10). Doi: 10.1007/s12325-022-02269-0

Key clinical point: A dose of 100 mg guselkumab every 4/8 weeks (Q4W/Q8W) improved health-related quality of life (HRQoL) through 52 weeks in patients with psoriatic arthritis (PsA).

Major finding: A significantly higher proportion of patients receiving guselkumab Q4W/Q8W vs placebo reported minimally important differences in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index (56.0%/56.0% vs 43.4%; P < .006) and Visual Analog Scale (EQ-VAS) score (62.8%/63.5% vs 44.4%; P < .0001) at week 24, with >60% of patients reporting improvements at week 52.

Study details: Findings are from an analysis of the phase 3 DISCOVER 2 trial including 738 biologic-naive patients with active PsA and an inadequate response to standard treatments who were randomly assigned to receive 100 mg guselkumab (Q4W/Q8W) or placebo.

Disclosures: This study was supported by Janssen, a subsidiary of Johnson and Johnson. Eight authors declared being employees of one of the subsidiaries of or owning stocks in Johnson and Johnson. The other authors reported ties with several sources.

Source: Curtis JR et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022 (Aug 10). Doi: 10.1007/s12325-022-02269-0

Key clinical point: Patients with psoriatic arthritis (PsA) who received risankizumab vs placebo were more likely to achieve clinically meaningful improvements in patient-reported outcomes (PRO).

Major finding: At week 24, patients receiving risankizumab vs placebo were significantly more likely to report minimal clinically important differences (MCID) in Patient’s Global Assessment of Disease Activity (PtGA) in both KEEPsAKE-1 (odds ratio [OR] 2.0; P < .001) and KEEPsAKE-2 (OR 1.9; P < .01) studies, with further improvement until week 52. Risankizumab significantly improved other PRO like pain, fatigue, quality of life, and physical functioning (P < .05).

Study details: The data come from an analysis of 2 phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, including adults with PsA and inadequate response or intolerance to disease-modifying antirheumatic drugs or biologics who were randomly assigned to receive risankizumab or placebo for 24 weeks and only risankizumab during weeks 24-52.

Disclosures: This study was funded by AbbVie. Three authors declared being employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18475

Key clinical point: Patients with psoriatic arthritis (PsA) who received risankizumab vs placebo were more likely to achieve clinically meaningful improvements in patient-reported outcomes (PRO).

Major finding: At week 24, patients receiving risankizumab vs placebo were significantly more likely to report minimal clinically important differences (MCID) in Patient’s Global Assessment of Disease Activity (PtGA) in both KEEPsAKE-1 (odds ratio [OR] 2.0; P < .001) and KEEPsAKE-2 (OR 1.9; P < .01) studies, with further improvement until week 52. Risankizumab significantly improved other PRO like pain, fatigue, quality of life, and physical functioning (P < .05).

Study details: The data come from an analysis of 2 phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, including adults with PsA and inadequate response or intolerance to disease-modifying antirheumatic drugs or biologics who were randomly assigned to receive risankizumab or placebo for 24 weeks and only risankizumab during weeks 24-52.

Disclosures: This study was funded by AbbVie. Three authors declared being employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18475

Key clinical point: Patients with psoriatic arthritis (PsA) who received risankizumab vs placebo were more likely to achieve clinically meaningful improvements in patient-reported outcomes (PRO).

Major finding: At week 24, patients receiving risankizumab vs placebo were significantly more likely to report minimal clinically important differences (MCID) in Patient’s Global Assessment of Disease Activity (PtGA) in both KEEPsAKE-1 (odds ratio [OR] 2.0; P < .001) and KEEPsAKE-2 (OR 1.9; P < .01) studies, with further improvement until week 52. Risankizumab significantly improved other PRO like pain, fatigue, quality of life, and physical functioning (P < .05).

Study details: The data come from an analysis of 2 phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, including adults with PsA and inadequate response or intolerance to disease-modifying antirheumatic drugs or biologics who were randomly assigned to receive risankizumab or placebo for 24 weeks and only risankizumab during weeks 24-52.

Disclosures: This study was funded by AbbVie. Three authors declared being employees or stockholders of AbbVie. The other authors reported ties with several sources, including AbbVie.

Source: Kristensen LE et al. The effect of risankizumab on achieving minimal clinically important differences in patient-reported outcomes in patients with psoriatic arthritis: Results from KEEPsAKE 1 and 2. J Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18475

Key clinical point: The presence of nail dystrophy predicted a better treatment response to secukinumab in patients with psoriatic arthritis (PsA) and axial symptoms.

Major finding: Presence vs absence of nail dystrophy was associated with the achievement of significantly better Assessment of SpondyloArthritis International Society 20 response in the 300 mg secukinumab (odds ratio 5.0; 95% CI 1.47-17.19) vs placebo group (interaction alone P  =  .029).

Study details: Findings are from a post hoc analysis of the phase 3b MAXIMISE trial including 473 adult patients with PsA and axial manifestations who were randomly assigned to receive secukinumab (150 or 300 mg) or placebo.

Disclosures: H Marzo-Ortega and LC Coates reported receiving grants from the UK National Institute for Health Research. The other authors reported ties with several sources outside this work.

Source: Baraliakos X et al. Predictors of response to secukinumab in patients with psoriatic arthritis and axial manifestations: A post-hoc analysis of the MAXIMISE trial. RMD Open. 2022;8(2):e002303 (Jul 18). Doi: 10.1136/rmdopen-2022-002303

Key clinical point: The presence of nail dystrophy predicted a better treatment response to secukinumab in patients with psoriatic arthritis (PsA) and axial symptoms.

Major finding: Presence vs absence of nail dystrophy was associated with the achievement of significantly better Assessment of SpondyloArthritis International Society 20 response in the 300 mg secukinumab (odds ratio 5.0; 95% CI 1.47-17.19) vs placebo group (interaction alone P  =  .029).

Study details: Findings are from a post hoc analysis of the phase 3b MAXIMISE trial including 473 adult patients with PsA and axial manifestations who were randomly assigned to receive secukinumab (150 or 300 mg) or placebo.

Disclosures: H Marzo-Ortega and LC Coates reported receiving grants from the UK National Institute for Health Research. The other authors reported ties with several sources outside this work.

Source: Baraliakos X et al. Predictors of response to secukinumab in patients with psoriatic arthritis and axial manifestations: A post-hoc analysis of the MAXIMISE trial. RMD Open. 2022;8(2):e002303 (Jul 18). Doi: 10.1136/rmdopen-2022-002303

Key clinical point: The presence of nail dystrophy predicted a better treatment response to secukinumab in patients with psoriatic arthritis (PsA) and axial symptoms.

Major finding: Presence vs absence of nail dystrophy was associated with the achievement of significantly better Assessment of SpondyloArthritis International Society 20 response in the 300 mg secukinumab (odds ratio 5.0; 95% CI 1.47-17.19) vs placebo group (interaction alone P  =  .029).

Study details: Findings are from a post hoc analysis of the phase 3b MAXIMISE trial including 473 adult patients with PsA and axial manifestations who were randomly assigned to receive secukinumab (150 or 300 mg) or placebo.

Disclosures: H Marzo-Ortega and LC Coates reported receiving grants from the UK National Institute for Health Research. The other authors reported ties with several sources outside this work.

Source: Baraliakos X et al. Predictors of response to secukinumab in patients with psoriatic arthritis and axial manifestations: A post-hoc analysis of the MAXIMISE trial. RMD Open. 2022;8(2):e002303 (Jul 18). Doi: 10.1136/rmdopen-2022-002303

Key clinical point: The presence of dactylitis and nail disease were associated with improved outcomes in patients with early psoriatic arthritis (PsA) who received etanercept or methotrexate.

Major finding: The presence of both dactylitis and nail disease at baseline were significantly associated with the achievement of minimal disease activity (DA; odds ratio [OR] 1.4; P  =  .0457, and OR 1.8; P  =  .0233, respectively), PsA DA Score (PASDAS) of  low DA (OR 1.8; P  =  .0014, and OR 1.8; P  =  .0168, respectively) responses, and greater reductions in PASDAS scores at week 24 (estimate –3.8; P  =  .0155, and estimate –0.7; P  =  .0005, respectively).

Study details: Findings are from a post hoc analysis of the phase 3 SEAM-PsA trial including 851 biologic/methotrexate-naive patients with active PsA who were randomly assigned to receive methotrexate monotherapy, etanercept monotherapy, or methotrexate+etanercept combination therapy.

Disclosures: This study was funded by Immunex, a wholly owned subsidiary of Amgen. Three authors declared being employees or owning stocks in Amgen, and the other authors reported ties with several sources, including Amgen.

Source: Helliwell PS et al. Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: Comparison of treatment effects in the SEAM-PsA trial. RMD Open. 2022;8(2):e002366 (Jul 21). Doi: 10.1136/rmdopen-2022-002366

Key clinical point: The presence of dactylitis and nail disease were associated with improved outcomes in patients with early psoriatic arthritis (PsA) who received etanercept or methotrexate.

Major finding: The presence of both dactylitis and nail disease at baseline were significantly associated with the achievement of minimal disease activity (DA; odds ratio [OR] 1.4; P  =  .0457, and OR 1.8; P  =  .0233, respectively), PsA DA Score (PASDAS) of  low DA (OR 1.8; P  =  .0014, and OR 1.8; P  =  .0168, respectively) responses, and greater reductions in PASDAS scores at week 24 (estimate –3.8; P  =  .0155, and estimate –0.7; P  =  .0005, respectively).

Study details: Findings are from a post hoc analysis of the phase 3 SEAM-PsA trial including 851 biologic/methotrexate-naive patients with active PsA who were randomly assigned to receive methotrexate monotherapy, etanercept monotherapy, or methotrexate+etanercept combination therapy.

Disclosures: This study was funded by Immunex, a wholly owned subsidiary of Amgen. Three authors declared being employees or owning stocks in Amgen, and the other authors reported ties with several sources, including Amgen.

Source: Helliwell PS et al. Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: Comparison of treatment effects in the SEAM-PsA trial. RMD Open. 2022;8(2):e002366 (Jul 21). Doi: 10.1136/rmdopen-2022-002366

Key clinical point: The presence of dactylitis and nail disease were associated with improved outcomes in patients with early psoriatic arthritis (PsA) who received etanercept or methotrexate.

Major finding: The presence of both dactylitis and nail disease at baseline were significantly associated with the achievement of minimal disease activity (DA; odds ratio [OR] 1.4; P  =  .0457, and OR 1.8; P  =  .0233, respectively), PsA DA Score (PASDAS) of  low DA (OR 1.8; P  =  .0014, and OR 1.8; P  =  .0168, respectively) responses, and greater reductions in PASDAS scores at week 24 (estimate –3.8; P  =  .0155, and estimate –0.7; P  =  .0005, respectively).

Study details: Findings are from a post hoc analysis of the phase 3 SEAM-PsA trial including 851 biologic/methotrexate-naive patients with active PsA who were randomly assigned to receive methotrexate monotherapy, etanercept monotherapy, or methotrexate+etanercept combination therapy.

Disclosures: This study was funded by Immunex, a wholly owned subsidiary of Amgen. Three authors declared being employees or owning stocks in Amgen, and the other authors reported ties with several sources, including Amgen.

Source: Helliwell PS et al. Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: Comparison of treatment effects in the SEAM-PsA trial. RMD Open. 2022;8(2):e002366 (Jul 21). Doi: 10.1136/rmdopen-2022-002366

Key clinical point: Golimumab was effective as a second-line anti-tumor necrosis factor-alpha (TNFα) treatment in a real-world setting of patients with psoriatic arthritis (PsA) who failed the first-line anti-TNFα therapy.

Major finding: After 6 months, 31.9% (95% CI 21.4%–44.0%) and 73.8% (95% CI 58.0%–86.1%) of patients with PsA achieved minimal disease activity and a good/moderate response as per the European Alliance of Associations for Rheumatology, respectively, along with significant improvements in disease activity score in 28 joints based on C-reactive protein score (P < .001).

Study details: Findings are from the prospective, observational, real-world study including 194 patients with moderate-to-active rheumatoid arthritis (n = 39), PsA (n = 91), or axial spondyloarthritis (n = 64) who started golimumab after first-line anti-TNFα inhibitor failure.

Disclosures: This study was funded by MSD Italia S.r.l. Two authors declared being employees of MSD Italia, and the other authors reported ties with several sources, including Merck.

Source: D’Angelo S et al. Effectiveness of golimumab as second anti-TNFα drug in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis in Italy: GO-BEYOND, a prospective real-world observational study. J Clin Med. 2022;11(14):4178 (Jul 19). Doi: 10.3390/jcm11144178

Key clinical point: Golimumab was effective as a second-line anti-tumor necrosis factor-alpha (TNFα) treatment in a real-world setting of patients with psoriatic arthritis (PsA) who failed the first-line anti-TNFα therapy.

Major finding: After 6 months, 31.9% (95% CI 21.4%–44.0%) and 73.8% (95% CI 58.0%–86.1%) of patients with PsA achieved minimal disease activity and a good/moderate response as per the European Alliance of Associations for Rheumatology, respectively, along with significant improvements in disease activity score in 28 joints based on C-reactive protein score (P < .001).

Study details: Findings are from the prospective, observational, real-world study including 194 patients with moderate-to-active rheumatoid arthritis (n = 39), PsA (n = 91), or axial spondyloarthritis (n = 64) who started golimumab after first-line anti-TNFα inhibitor failure.

Disclosures: This study was funded by MSD Italia S.r.l. Two authors declared being employees of MSD Italia, and the other authors reported ties with several sources, including Merck.

Source: D’Angelo S et al. Effectiveness of golimumab as second anti-TNFα drug in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis in Italy: GO-BEYOND, a prospective real-world observational study. J Clin Med. 2022;11(14):4178 (Jul 19). Doi: 10.3390/jcm11144178

Key clinical point: Golimumab was effective as a second-line anti-tumor necrosis factor-alpha (TNFα) treatment in a real-world setting of patients with psoriatic arthritis (PsA) who failed the first-line anti-TNFα therapy.

Major finding: After 6 months, 31.9% (95% CI 21.4%–44.0%) and 73.8% (95% CI 58.0%–86.1%) of patients with PsA achieved minimal disease activity and a good/moderate response as per the European Alliance of Associations for Rheumatology, respectively, along with significant improvements in disease activity score in 28 joints based on C-reactive protein score (P < .001).

Study details: Findings are from the prospective, observational, real-world study including 194 patients with moderate-to-active rheumatoid arthritis (n = 39), PsA (n = 91), or axial spondyloarthritis (n = 64) who started golimumab after first-line anti-TNFα inhibitor failure.

Disclosures: This study was funded by MSD Italia S.r.l. Two authors declared being employees of MSD Italia, and the other authors reported ties with several sources, including Merck.

Source: D’Angelo S et al. Effectiveness of golimumab as second anti-TNFα drug in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis in Italy: GO-BEYOND, a prospective real-world observational study. J Clin Med. 2022;11(14):4178 (Jul 19). Doi: 10.3390/jcm11144178

Key clinical point: The 3-year bimekizumab treatment was well tolerated and effective in reducing the signs and symptoms of psoriatic arthritis (PsA).

Major finding: By week 152, 89.3% of patients had reported ≥1 treatment-emergent adverse event (TEAE), with serious TEAE being reported by 10.7% of patients. At least 20% improvement in American College of Rheumatology score was maintained by 64.1% of patients at week 152 compared with 72.3% of patients at week 48.

Study details: Findings are 3-year results from the phase 2b BE ACTIVE trial including 206 adults with active PsA who were randomly assigned to receive bimekizumab or placebo for 48 weeks, of which 184 patients were enrolled in the open-label extension phase for a further 104 weeks of treatment.

Disclosures: This study was supported by UCB Pharma. Four authors declared being employees of UCB Pharma and shareholders of UCB Pharma or GlaxoSmithKline. The other authors reported ties with various sources.

Source: Coates LC et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: 3-year results from a phase 2b randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022 (Jul 13). Doi: 10.1002/art.42280

Key clinical point: The 3-year bimekizumab treatment was well tolerated and effective in reducing the signs and symptoms of psoriatic arthritis (PsA).

Major finding: By week 152, 89.3% of patients had reported ≥1 treatment-emergent adverse event (TEAE), with serious TEAE being reported by 10.7% of patients. At least 20% improvement in American College of Rheumatology score was maintained by 64.1% of patients at week 152 compared with 72.3% of patients at week 48.

Study details: Findings are 3-year results from the phase 2b BE ACTIVE trial including 206 adults with active PsA who were randomly assigned to receive bimekizumab or placebo for 48 weeks, of which 184 patients were enrolled in the open-label extension phase for a further 104 weeks of treatment.

Disclosures: This study was supported by UCB Pharma. Four authors declared being employees of UCB Pharma and shareholders of UCB Pharma or GlaxoSmithKline. The other authors reported ties with various sources.

Source: Coates LC et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: 3-year results from a phase 2b randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022 (Jul 13). Doi: 10.1002/art.42280

Key clinical point: The 3-year bimekizumab treatment was well tolerated and effective in reducing the signs and symptoms of psoriatic arthritis (PsA).

Major finding: By week 152, 89.3% of patients had reported ≥1 treatment-emergent adverse event (TEAE), with serious TEAE being reported by 10.7% of patients. At least 20% improvement in American College of Rheumatology score was maintained by 64.1% of patients at week 152 compared with 72.3% of patients at week 48.

Study details: Findings are 3-year results from the phase 2b BE ACTIVE trial including 206 adults with active PsA who were randomly assigned to receive bimekizumab or placebo for 48 weeks, of which 184 patients were enrolled in the open-label extension phase for a further 104 weeks of treatment.

Disclosures: This study was supported by UCB Pharma. Four authors declared being employees of UCB Pharma and shareholders of UCB Pharma or GlaxoSmithKline. The other authors reported ties with various sources.

Source: Coates LC et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: 3-year results from a phase 2b randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022 (Jul 13). Doi: 10.1002/art.42280

The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.

Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).

Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.

The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.

Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.

The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.

A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.

Patients taking Hadlima should not take a live vaccine.

The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.

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

The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.

Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).

Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.

The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.

Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.

The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.

A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.

Patients taking Hadlima should not take a live vaccine.

The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.

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

The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.

Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).

Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.

The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.

Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.

The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.

A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.

Patients taking Hadlima should not take a live vaccine.

The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.

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

Switching from one biosimilar medication to another is safe and effective, a new systematic review indicates, even though this clinical practice is not governed by current health authority regulations or guidance.

“No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date,” the review’s authors noted in their study, published online in BioDrugs.

“The possibility of multiple switches between biosimilars of the same reference biologic is already a reality, and these types of switches are expected to become more common in the future. ... Although it is not covered by current health authority regulations or guidance,” added the authors, led by Hillel P. Cohen, PhD, executive director of scientific affairs at Sandoz, a division of Novartis.

The researchers searched electronic databases through December 2021 and found 23 observational studies that met their search criteria, of which 13 were published in peer-reviewed journals; the remainder appeared in abstract form. The studies totaled 3,657 patients. The researchers did not identify any randomized clinical trials.

“The studies were heterogeneous in size, design, and endpoints, providing data on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns,” the authors wrote.

The authors found that the majority of studies evaluated switches between biosimilars of infliximab, but they also identified switches between biosimilars of adalimumab, etanercept, and rituximab.

“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” Dr. Cohen said in an interview.

The review’s findings – that there were no clinically relevant differences when switching patients from one biosimilar to another – are consistent with the science, Dr. Cohen said. “Physicians should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” he said.

Currently, the published data include biosimilars to only four reference biologics. “However, I anticipate additional biosimilar-to-biosimilar switching data will become available in the future,” Dr. Cohen said. “In fact, several new studies have been published in recent months, after the cut-off date for inclusion in our systematic review.”

Switching common in rheumatology, dermatology, and gastroenterology

Biosimilar-to-biosimilar switching was observed most commonly in rheumatology practice, but also was seen in the specialties of dermatology and gastroenterology.

Jeffrey Weinberg, MD, clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, New York City, said in an interview that the study is among the best to date showing that switching biosimilars does not compromise efficacy or safety. 

“I would hypothesize that the interchangeability would apply to psoriasis patients,” Dr. Weinberg said. However, “over the next few years, we will have an increasing number of biosimilars for an increasing number of different molecules. We will need to be vigilant to observe if similar behavior is observed with the biosimilars yet to come.”

Keith Choate, MD, PhD, professor of dermatology, pathology, and genetics, and associate dean for physician-scientist development at Yale University, New Haven, Conn., said that biosimilars have comparable efficacy to the branded medication they replace. “If response is lost to an individual agent, we would not typically then switch to a biosimilar, but would favor another class of therapy or a distinct therapeutic which targets the same pathway.”

When physicians prescribe a biosimilar for rheumatoid arthritis or psoriatic arthritis, in 9 out 10 people, “it’s going to work as well, and it’s not going to cause any more side effects,” said Stanford Shoor, MD, clinical professor of medicine and rheumatology, Stanford (Calif.) University.

The systematic review, even within its limitations, reinforces confidence in the antitumor necrosis factor biosimilars, said Jean-Frederic Colombel, MD, codirector of the Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, New York, and professor of medicine, division of gastroenterology, Icahn School of Medicine at Mount Sinai.

“Still, studies with longer follow-up are needed,” Dr. Colombel said, adding that the remaining questions relate to the efficacy and safety of switching multiple times, which will likely occur in the near future. There will be a “need to provide information to the patient regarding what originator or biosimilar(s) he has been exposed to during the course of his disease.”

Switching will increasingly become the norm, said Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute, Cleveland Clinic. In his clinical practice, he has the most experience with Crohn’s disease and ulcerative colitis, and biosimilar-to-biosimilar infliximab switches. “Unless there are data that emerge, I have no concerns with this.” 

He added that it’s an “interesting study that affirms my findings in clinical practice – that one can switch from a biosimilar to biosimilar (of the same reference product).”

The review’s results also make sense from an economic standpoint, said Rajat Bhatt, MD, owner of Prime Rheumatology in Richmond, Tex., and an adjunct faculty member at Caribbean Medical University, Willemstad, Curaçao. “Switching to biosimilars will result in cost savings for the health care system.” Patients on certain insurances also will save by switching to a biosimilar with a lower copay.

However, the review is limited by a relatively small number of studies that have provided primary data on this topic, and most of these were switching from infliximab to a biosimilar for inflammatory bowel disease, said Alfred Kim, MD, PhD, an adult rheumatologist at Barnes-Jewish Hospital, St. Louis, and assistant professor of medicine at Washington University in St. Louis.

As with any meta-analysis evaluating a small number of studies, “broad applicability to all conditions and reference/biosimilar pair can only be assumed. Also, many of the studies used for this meta-analysis are observational, which can introduce a variety of biases that can be difficult to adjust for,” Dr. Kim said. “Nevertheless, these analyses are an important first step in validating the [Food and Drug Administration’s] approach to evaluating biosimilars, as the clinical outcomes are consistent between different biosimilars.”

This systematic review is not enough to prove that all patients will do fine when switching from one biosimilar to another, said Florence Aslinia, MD, a gastroenterologist at the University of Kansas Health System in Kansas City. It’s possible that some patients may not do as well, she said, noting that, in one study of patients with inflammatory bowel disease, 10% of patients on a biosimilar infliximab needed to switch back to the originator infliximab (Remicade, Janssen) because of side effects attributed to the biosimilar. The same thing may or may not happen with biosimilar-to-biosimilar switching, and it requires further study.

The authors did not receive any funding for writing this review. Dr. Cohen is an employee of Sandoz, a division of Novartis. He may own stock in Novartis. Two coauthors are also employees of Sandoz. The other three coauthors reported having financial relationships with numerous pharmaceutical companies, including Sandoz and/or Novartis. Dr. Colombel reported financial relationships with many pharmaceutical companies, including Novartis and other manufacturers of biosimilars. Dr. Regueiro reports financial relationships with numerous pharmaceutical companies, including some manufacturers of biosimilars. Dr. Weinberg reported financial relationships with Celgene, AbbVie, Eli Lilly, and Novartis. Kim reports financial relationships with GlaxoSmithKline, Pfizer, and AstraZeneca. Dr. Aslinia, Dr. Shoor, Dr. Choate, and Dr. Bhatt reported no relevant financial relationships.

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

Switching from one biosimilar medication to another is safe and effective, a new systematic review indicates, even though this clinical practice is not governed by current health authority regulations or guidance.

“No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date,” the review’s authors noted in their study, published online in BioDrugs.

“The possibility of multiple switches between biosimilars of the same reference biologic is already a reality, and these types of switches are expected to become more common in the future. ... Although it is not covered by current health authority regulations or guidance,” added the authors, led by Hillel P. Cohen, PhD, executive director of scientific affairs at Sandoz, a division of Novartis.

The researchers searched electronic databases through December 2021 and found 23 observational studies that met their search criteria, of which 13 were published in peer-reviewed journals; the remainder appeared in abstract form. The studies totaled 3,657 patients. The researchers did not identify any randomized clinical trials.

“The studies were heterogeneous in size, design, and endpoints, providing data on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns,” the authors wrote.

The authors found that the majority of studies evaluated switches between biosimilars of infliximab, but they also identified switches between biosimilars of adalimumab, etanercept, and rituximab.

“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” Dr. Cohen said in an interview.

The review’s findings – that there were no clinically relevant differences when switching patients from one biosimilar to another – are consistent with the science, Dr. Cohen said. “Physicians should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” he said.

Currently, the published data include biosimilars to only four reference biologics. “However, I anticipate additional biosimilar-to-biosimilar switching data will become available in the future,” Dr. Cohen said. “In fact, several new studies have been published in recent months, after the cut-off date for inclusion in our systematic review.”

Switching common in rheumatology, dermatology, and gastroenterology

Biosimilar-to-biosimilar switching was observed most commonly in rheumatology practice, but also was seen in the specialties of dermatology and gastroenterology.

Jeffrey Weinberg, MD, clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, New York City, said in an interview that the study is among the best to date showing that switching biosimilars does not compromise efficacy or safety. 

“I would hypothesize that the interchangeability would apply to psoriasis patients,” Dr. Weinberg said. However, “over the next few years, we will have an increasing number of biosimilars for an increasing number of different molecules. We will need to be vigilant to observe if similar behavior is observed with the biosimilars yet to come.”

Keith Choate, MD, PhD, professor of dermatology, pathology, and genetics, and associate dean for physician-scientist development at Yale University, New Haven, Conn., said that biosimilars have comparable efficacy to the branded medication they replace. “If response is lost to an individual agent, we would not typically then switch to a biosimilar, but would favor another class of therapy or a distinct therapeutic which targets the same pathway.”

When physicians prescribe a biosimilar for rheumatoid arthritis or psoriatic arthritis, in 9 out 10 people, “it’s going to work as well, and it’s not going to cause any more side effects,” said Stanford Shoor, MD, clinical professor of medicine and rheumatology, Stanford (Calif.) University.

The systematic review, even within its limitations, reinforces confidence in the antitumor necrosis factor biosimilars, said Jean-Frederic Colombel, MD, codirector of the Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, New York, and professor of medicine, division of gastroenterology, Icahn School of Medicine at Mount Sinai.

“Still, studies with longer follow-up are needed,” Dr. Colombel said, adding that the remaining questions relate to the efficacy and safety of switching multiple times, which will likely occur in the near future. There will be a “need to provide information to the patient regarding what originator or biosimilar(s) he has been exposed to during the course of his disease.”

Switching will increasingly become the norm, said Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute, Cleveland Clinic. In his clinical practice, he has the most experience with Crohn’s disease and ulcerative colitis, and biosimilar-to-biosimilar infliximab switches. “Unless there are data that emerge, I have no concerns with this.” 

He added that it’s an “interesting study that affirms my findings in clinical practice – that one can switch from a biosimilar to biosimilar (of the same reference product).”

The review’s results also make sense from an economic standpoint, said Rajat Bhatt, MD, owner of Prime Rheumatology in Richmond, Tex., and an adjunct faculty member at Caribbean Medical University, Willemstad, Curaçao. “Switching to biosimilars will result in cost savings for the health care system.” Patients on certain insurances also will save by switching to a biosimilar with a lower copay.

However, the review is limited by a relatively small number of studies that have provided primary data on this topic, and most of these were switching from infliximab to a biosimilar for inflammatory bowel disease, said Alfred Kim, MD, PhD, an adult rheumatologist at Barnes-Jewish Hospital, St. Louis, and assistant professor of medicine at Washington University in St. Louis.

As with any meta-analysis evaluating a small number of studies, “broad applicability to all conditions and reference/biosimilar pair can only be assumed. Also, many of the studies used for this meta-analysis are observational, which can introduce a variety of biases that can be difficult to adjust for,” Dr. Kim said. “Nevertheless, these analyses are an important first step in validating the [Food and Drug Administration’s] approach to evaluating biosimilars, as the clinical outcomes are consistent between different biosimilars.”

This systematic review is not enough to prove that all patients will do fine when switching from one biosimilar to another, said Florence Aslinia, MD, a gastroenterologist at the University of Kansas Health System in Kansas City. It’s possible that some patients may not do as well, she said, noting that, in one study of patients with inflammatory bowel disease, 10% of patients on a biosimilar infliximab needed to switch back to the originator infliximab (Remicade, Janssen) because of side effects attributed to the biosimilar. The same thing may or may not happen with biosimilar-to-biosimilar switching, and it requires further study.

The authors did not receive any funding for writing this review. Dr. Cohen is an employee of Sandoz, a division of Novartis. He may own stock in Novartis. Two coauthors are also employees of Sandoz. The other three coauthors reported having financial relationships with numerous pharmaceutical companies, including Sandoz and/or Novartis. Dr. Colombel reported financial relationships with many pharmaceutical companies, including Novartis and other manufacturers of biosimilars. Dr. Regueiro reports financial relationships with numerous pharmaceutical companies, including some manufacturers of biosimilars. Dr. Weinberg reported financial relationships with Celgene, AbbVie, Eli Lilly, and Novartis. Kim reports financial relationships with GlaxoSmithKline, Pfizer, and AstraZeneca. Dr. Aslinia, Dr. Shoor, Dr. Choate, and Dr. Bhatt reported no relevant financial relationships.

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

Switching from one biosimilar medication to another is safe and effective, a new systematic review indicates, even though this clinical practice is not governed by current health authority regulations or guidance.

“No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date,” the review’s authors noted in their study, published online in BioDrugs.

“The possibility of multiple switches between biosimilars of the same reference biologic is already a reality, and these types of switches are expected to become more common in the future. ... Although it is not covered by current health authority regulations or guidance,” added the authors, led by Hillel P. Cohen, PhD, executive director of scientific affairs at Sandoz, a division of Novartis.

The researchers searched electronic databases through December 2021 and found 23 observational studies that met their search criteria, of which 13 were published in peer-reviewed journals; the remainder appeared in abstract form. The studies totaled 3,657 patients. The researchers did not identify any randomized clinical trials.

“The studies were heterogeneous in size, design, and endpoints, providing data on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns,” the authors wrote.

The authors found that the majority of studies evaluated switches between biosimilars of infliximab, but they also identified switches between biosimilars of adalimumab, etanercept, and rituximab.

“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” Dr. Cohen said in an interview.

The review’s findings – that there were no clinically relevant differences when switching patients from one biosimilar to another – are consistent with the science, Dr. Cohen said. “Physicians should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” he said.

Currently, the published data include biosimilars to only four reference biologics. “However, I anticipate additional biosimilar-to-biosimilar switching data will become available in the future,” Dr. Cohen said. “In fact, several new studies have been published in recent months, after the cut-off date for inclusion in our systematic review.”

Switching common in rheumatology, dermatology, and gastroenterology

Biosimilar-to-biosimilar switching was observed most commonly in rheumatology practice, but also was seen in the specialties of dermatology and gastroenterology.

Jeffrey Weinberg, MD, clinical professor of dermatology, Icahn School of Medicine at Mount Sinai, New York City, said in an interview that the study is among the best to date showing that switching biosimilars does not compromise efficacy or safety. 

“I would hypothesize that the interchangeability would apply to psoriasis patients,” Dr. Weinberg said. However, “over the next few years, we will have an increasing number of biosimilars for an increasing number of different molecules. We will need to be vigilant to observe if similar behavior is observed with the biosimilars yet to come.”

Keith Choate, MD, PhD, professor of dermatology, pathology, and genetics, and associate dean for physician-scientist development at Yale University, New Haven, Conn., said that biosimilars have comparable efficacy to the branded medication they replace. “If response is lost to an individual agent, we would not typically then switch to a biosimilar, but would favor another class of therapy or a distinct therapeutic which targets the same pathway.”

When physicians prescribe a biosimilar for rheumatoid arthritis or psoriatic arthritis, in 9 out 10 people, “it’s going to work as well, and it’s not going to cause any more side effects,” said Stanford Shoor, MD, clinical professor of medicine and rheumatology, Stanford (Calif.) University.

The systematic review, even within its limitations, reinforces confidence in the antitumor necrosis factor biosimilars, said Jean-Frederic Colombel, MD, codirector of the Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai, New York, and professor of medicine, division of gastroenterology, Icahn School of Medicine at Mount Sinai.

“Still, studies with longer follow-up are needed,” Dr. Colombel said, adding that the remaining questions relate to the efficacy and safety of switching multiple times, which will likely occur in the near future. There will be a “need to provide information to the patient regarding what originator or biosimilar(s) he has been exposed to during the course of his disease.”

Switching will increasingly become the norm, said Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute, Cleveland Clinic. In his clinical practice, he has the most experience with Crohn’s disease and ulcerative colitis, and biosimilar-to-biosimilar infliximab switches. “Unless there are data that emerge, I have no concerns with this.” 

He added that it’s an “interesting study that affirms my findings in clinical practice – that one can switch from a biosimilar to biosimilar (of the same reference product).”

The review’s results also make sense from an economic standpoint, said Rajat Bhatt, MD, owner of Prime Rheumatology in Richmond, Tex., and an adjunct faculty member at Caribbean Medical University, Willemstad, Curaçao. “Switching to biosimilars will result in cost savings for the health care system.” Patients on certain insurances also will save by switching to a biosimilar with a lower copay.

However, the review is limited by a relatively small number of studies that have provided primary data on this topic, and most of these were switching from infliximab to a biosimilar for inflammatory bowel disease, said Alfred Kim, MD, PhD, an adult rheumatologist at Barnes-Jewish Hospital, St. Louis, and assistant professor of medicine at Washington University in St. Louis.

As with any meta-analysis evaluating a small number of studies, “broad applicability to all conditions and reference/biosimilar pair can only be assumed. Also, many of the studies used for this meta-analysis are observational, which can introduce a variety of biases that can be difficult to adjust for,” Dr. Kim said. “Nevertheless, these analyses are an important first step in validating the [Food and Drug Administration’s] approach to evaluating biosimilars, as the clinical outcomes are consistent between different biosimilars.”

This systematic review is not enough to prove that all patients will do fine when switching from one biosimilar to another, said Florence Aslinia, MD, a gastroenterologist at the University of Kansas Health System in Kansas City. It’s possible that some patients may not do as well, she said, noting that, in one study of patients with inflammatory bowel disease, 10% of patients on a biosimilar infliximab needed to switch back to the originator infliximab (Remicade, Janssen) because of side effects attributed to the biosimilar. The same thing may or may not happen with biosimilar-to-biosimilar switching, and it requires further study.

The authors did not receive any funding for writing this review. Dr. Cohen is an employee of Sandoz, a division of Novartis. He may own stock in Novartis. Two coauthors are also employees of Sandoz. The other three coauthors reported having financial relationships with numerous pharmaceutical companies, including Sandoz and/or Novartis. Dr. Colombel reported financial relationships with many pharmaceutical companies, including Novartis and other manufacturers of biosimilars. Dr. Regueiro reports financial relationships with numerous pharmaceutical companies, including some manufacturers of biosimilars. Dr. Weinberg reported financial relationships with Celgene, AbbVie, Eli Lilly, and Novartis. Kim reports financial relationships with GlaxoSmithKline, Pfizer, and AstraZeneca. Dr. Aslinia, Dr. Shoor, Dr. Choate, and Dr. Bhatt reported no relevant financial relationships.

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

Patients with psoriasis and psoriatic arthritis who belong to underserved groups may not be getting the health care they need because of lack of access, a study based on national registry data suggests.

“Using the All of Us dataset, we identified lower rates of psoriasis and psoriatic arthritis in participants with skin of color, lower education levels, and no health insurance,” lead author Megan M. Tran said in her oral presentation at the annual meeting of the Society for Investigative Dermatology.

“This suggests psoriasis and psoriatic arthritis underdiagnosis in these underserved populations, possibly due to limited dermatologic care access,” added Ms. Tran, a second-year medical student at Brown University in Providence, R.I.

Ms. Tran and colleagues used the ongoing National Institutes of Health All of Us Research Program registry that contains a large proportion of participants from groups in the United States who have historically been underrepresented in biomedical research, she said in her talk. 

Of the 329,038 participants with data in version 5 (released this past March) of the All of Us database, 150,158 (45.6%) had skin of color, and 251,597 (76.5%) had available electronic health records (EHRs).
 

Underserved groups need better access to health care

Linking data from EHRs, surveys, and physical measurements at enrollment, the researchers used several variables to estimate psoriasis and psoriatic arthritis (PsA) prevalence, and they used multivariate logistic regression to adjust for the variables. They found:

• Twenty-two percent of patients with psoriasis had PsA. Odds of psoriasis and PsA were lower among Black (psoriasis odds ratio [OR], 0.32, 95% confidence interval [CI], 0.28-0.36; PsA OR, 0.20, 95% CI, 0.15-0.26) and Hispanic participants (psoriasis OR, 0.77, 95% CI, 0.71-0.84; PsA OR, 0.74, 95% CI, 0.61-0.89) compared with White participants.
• Psoriasis prevalence increased linearly with age (topping off at age 70 and older [OR, 3.35, 95% CI, 2.91-3.88], with 18-29 years as the reference). The same trend was found with PsA (70 years and above [OR, 4.41, 95% CI, 3.07-6.55] compared with those aged 18-29 years).  
• Psoriasis prevalence increased linearly with body mass index (BMI 40 and above [OR, 1.71, 95% CI, 1.54-1.90], with 20-24.9 as the reference). The same trend was found with PsA (BMI 40 and above [OR, 2.09, 95% CI, 1.68-2.59], with 20-24.9 as the reference).  
• Former smokers were at increased risk for disease, compared with people who had never smoked (psoriasis OR, 1.30, 95% CI, 1.22-1.39; PsA OR, 2.15, 95% CI, 1.33-3.78).
• Lower odds were found in uninsured adults (psoriasis OR, 0.43, 95% CI, 0.35-0.52; PsA OR, 0.37, 95% CI, 0.22-0.58) compared with those who were insured, and in those with less than a high school degree (psoriasis OR, 0.72, 95% CI, 0.63-0.82; PsA OR, 0.65, 95% CI, 0.47-0.87) compared with those with a college degree.

“The All of Us research program has demonstrated to be a valuable resource to gain unique dermatologic insights on diverse participant populations,” Ms. Tran said.

“There needs to be improvement in access to quality dermatologic care, as this may help to reduce underdiagnosis of psoriasis and psoriatic arthritis,” she added. Access can be increased  in various ways, including “outreach to underserved communities, equitable distribution of resources, and increased awareness of clinical variations in skin of color.”

Laura Korb Ferris, MD, PhD, professor of dermatology and director of clinical trials for the department of dermatology at University of Pittsburgh Medical Center, said the study is interesting.

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

Patients with psoriasis and psoriatic arthritis who belong to underserved groups may not be getting the health care they need because of lack of access, a study based on national registry data suggests.

“Using the All of Us dataset, we identified lower rates of psoriasis and psoriatic arthritis in participants with skin of color, lower education levels, and no health insurance,” lead author Megan M. Tran said in her oral presentation at the annual meeting of the Society for Investigative Dermatology.

“This suggests psoriasis and psoriatic arthritis underdiagnosis in these underserved populations, possibly due to limited dermatologic care access,” added Ms. Tran, a second-year medical student at Brown University in Providence, R.I.

Ms. Tran and colleagues used the ongoing National Institutes of Health All of Us Research Program registry that contains a large proportion of participants from groups in the United States who have historically been underrepresented in biomedical research, she said in her talk. 

Of the 329,038 participants with data in version 5 (released this past March) of the All of Us database, 150,158 (45.6%) had skin of color, and 251,597 (76.5%) had available electronic health records (EHRs).
 

Underserved groups need better access to health care

Linking data from EHRs, surveys, and physical measurements at enrollment, the researchers used several variables to estimate psoriasis and psoriatic arthritis (PsA) prevalence, and they used multivariate logistic regression to adjust for the variables. They found:

• Twenty-two percent of patients with psoriasis had PsA. Odds of psoriasis and PsA were lower among Black (psoriasis odds ratio [OR], 0.32, 95% confidence interval [CI], 0.28-0.36; PsA OR, 0.20, 95% CI, 0.15-0.26) and Hispanic participants (psoriasis OR, 0.77, 95% CI, 0.71-0.84; PsA OR, 0.74, 95% CI, 0.61-0.89) compared with White participants.
• Psoriasis prevalence increased linearly with age (topping off at age 70 and older [OR, 3.35, 95% CI, 2.91-3.88], with 18-29 years as the reference). The same trend was found with PsA (70 years and above [OR, 4.41, 95% CI, 3.07-6.55] compared with those aged 18-29 years).  
• Psoriasis prevalence increased linearly with body mass index (BMI 40 and above [OR, 1.71, 95% CI, 1.54-1.90], with 20-24.9 as the reference). The same trend was found with PsA (BMI 40 and above [OR, 2.09, 95% CI, 1.68-2.59], with 20-24.9 as the reference).  
• Former smokers were at increased risk for disease, compared with people who had never smoked (psoriasis OR, 1.30, 95% CI, 1.22-1.39; PsA OR, 2.15, 95% CI, 1.33-3.78).
• Lower odds were found in uninsured adults (psoriasis OR, 0.43, 95% CI, 0.35-0.52; PsA OR, 0.37, 95% CI, 0.22-0.58) compared with those who were insured, and in those with less than a high school degree (psoriasis OR, 0.72, 95% CI, 0.63-0.82; PsA OR, 0.65, 95% CI, 0.47-0.87) compared with those with a college degree.

“The All of Us research program has demonstrated to be a valuable resource to gain unique dermatologic insights on diverse participant populations,” Ms. Tran said.

“There needs to be improvement in access to quality dermatologic care, as this may help to reduce underdiagnosis of psoriasis and psoriatic arthritis,” she added. Access can be increased  in various ways, including “outreach to underserved communities, equitable distribution of resources, and increased awareness of clinical variations in skin of color.”

Laura Korb Ferris, MD, PhD, professor of dermatology and director of clinical trials for the department of dermatology at University of Pittsburgh Medical Center, said the study is interesting.

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

Patients with psoriasis and psoriatic arthritis who belong to underserved groups may not be getting the health care they need because of lack of access, a study based on national registry data suggests.

“Using the All of Us dataset, we identified lower rates of psoriasis and psoriatic arthritis in participants with skin of color, lower education levels, and no health insurance,” lead author Megan M. Tran said in her oral presentation at the annual meeting of the Society for Investigative Dermatology.

“This suggests psoriasis and psoriatic arthritis underdiagnosis in these underserved populations, possibly due to limited dermatologic care access,” added Ms. Tran, a second-year medical student at Brown University in Providence, R.I.

Ms. Tran and colleagues used the ongoing National Institutes of Health All of Us Research Program registry that contains a large proportion of participants from groups in the United States who have historically been underrepresented in biomedical research, she said in her talk. 

Of the 329,038 participants with data in version 5 (released this past March) of the All of Us database, 150,158 (45.6%) had skin of color, and 251,597 (76.5%) had available electronic health records (EHRs).
 

Underserved groups need better access to health care

Linking data from EHRs, surveys, and physical measurements at enrollment, the researchers used several variables to estimate psoriasis and psoriatic arthritis (PsA) prevalence, and they used multivariate logistic regression to adjust for the variables. They found:

• Twenty-two percent of patients with psoriasis had PsA. Odds of psoriasis and PsA were lower among Black (psoriasis odds ratio [OR], 0.32, 95% confidence interval [CI], 0.28-0.36; PsA OR, 0.20, 95% CI, 0.15-0.26) and Hispanic participants (psoriasis OR, 0.77, 95% CI, 0.71-0.84; PsA OR, 0.74, 95% CI, 0.61-0.89) compared with White participants.
• Psoriasis prevalence increased linearly with age (topping off at age 70 and older [OR, 3.35, 95% CI, 2.91-3.88], with 18-29 years as the reference). The same trend was found with PsA (70 years and above [OR, 4.41, 95% CI, 3.07-6.55] compared with those aged 18-29 years).  
• Psoriasis prevalence increased linearly with body mass index (BMI 40 and above [OR, 1.71, 95% CI, 1.54-1.90], with 20-24.9 as the reference). The same trend was found with PsA (BMI 40 and above [OR, 2.09, 95% CI, 1.68-2.59], with 20-24.9 as the reference).  
• Former smokers were at increased risk for disease, compared with people who had never smoked (psoriasis OR, 1.30, 95% CI, 1.22-1.39; PsA OR, 2.15, 95% CI, 1.33-3.78).
• Lower odds were found in uninsured adults (psoriasis OR, 0.43, 95% CI, 0.35-0.52; PsA OR, 0.37, 95% CI, 0.22-0.58) compared with those who were insured, and in those with less than a high school degree (psoriasis OR, 0.72, 95% CI, 0.63-0.82; PsA OR, 0.65, 95% CI, 0.47-0.87) compared with those with a college degree.

“The All of Us research program has demonstrated to be a valuable resource to gain unique dermatologic insights on diverse participant populations,” Ms. Tran said.

“There needs to be improvement in access to quality dermatologic care, as this may help to reduce underdiagnosis of psoriasis and psoriatic arthritis,” she added. Access can be increased  in various ways, including “outreach to underserved communities, equitable distribution of resources, and increased awareness of clinical variations in skin of color.”

Laura Korb Ferris, MD, PhD, professor of dermatology and director of clinical trials for the department of dermatology at University of Pittsburgh Medical Center, said the study is interesting.

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