Key clinical point: ABP 501, an adalimumab biosimilar, was safe and effective for the treatment of plaque-type psoriasis and psoriatic arthritis (PsA) irrespective of whether patients were originator-naive or switched from the reference adalimumab.

Major finding: In originator-naive patients, mean Psoriasis Area and Severity Index (PASI) significantly improved from baseline to week 24 (P less than .0001). Among patients who underwent nonmedical switch from adalimumab to ABP 501, PASI (0.45 vs. 0.45) and 28-joints Disease Activity Score erythrocyte sedimentation rate (2.35 vs. 2.31) were not significantly different at 16 weeks before to 24 weeks after the switch. The incidence of adverse events was similar in ABP 501 vs. adalimumab groups (67.2% vs. 63.6%).

Study details: Data come from a retrospective, real-life study of 94 patients with psoriasis and PsA who received ABP 501, of which 46 patients underwent a nonmedical switch from the adalimumab reference product to ABP 501.

Disclosures: The study did not receive any funding. A Giunta reported serving as a consultant, board member, and/or speaker for various sources. No other disclosures were reported.

Source: Giunta A et al. Curr Med Res Opin. 2021 May 20. doi: 10.1080/03007995.2021.1923467.

Key clinical point: ABP 501, an adalimumab biosimilar, was safe and effective for the treatment of plaque-type psoriasis and psoriatic arthritis (PsA) irrespective of whether patients were originator-naive or switched from the reference adalimumab.

Major finding: In originator-naive patients, mean Psoriasis Area and Severity Index (PASI) significantly improved from baseline to week 24 (P less than .0001). Among patients who underwent nonmedical switch from adalimumab to ABP 501, PASI (0.45 vs. 0.45) and 28-joints Disease Activity Score erythrocyte sedimentation rate (2.35 vs. 2.31) were not significantly different at 16 weeks before to 24 weeks after the switch. The incidence of adverse events was similar in ABP 501 vs. adalimumab groups (67.2% vs. 63.6%).

Study details: Data come from a retrospective, real-life study of 94 patients with psoriasis and PsA who received ABP 501, of which 46 patients underwent a nonmedical switch from the adalimumab reference product to ABP 501.

Disclosures: The study did not receive any funding. A Giunta reported serving as a consultant, board member, and/or speaker for various sources. No other disclosures were reported.

Source: Giunta A et al. Curr Med Res Opin. 2021 May 20. doi: 10.1080/03007995.2021.1923467.

Key clinical point: ABP 501, an adalimumab biosimilar, was safe and effective for the treatment of plaque-type psoriasis and psoriatic arthritis (PsA) irrespective of whether patients were originator-naive or switched from the reference adalimumab.

Major finding: In originator-naive patients, mean Psoriasis Area and Severity Index (PASI) significantly improved from baseline to week 24 (P less than .0001). Among patients who underwent nonmedical switch from adalimumab to ABP 501, PASI (0.45 vs. 0.45) and 28-joints Disease Activity Score erythrocyte sedimentation rate (2.35 vs. 2.31) were not significantly different at 16 weeks before to 24 weeks after the switch. The incidence of adverse events was similar in ABP 501 vs. adalimumab groups (67.2% vs. 63.6%).

Study details: Data come from a retrospective, real-life study of 94 patients with psoriasis and PsA who received ABP 501, of which 46 patients underwent a nonmedical switch from the adalimumab reference product to ABP 501.

Disclosures: The study did not receive any funding. A Giunta reported serving as a consultant, board member, and/or speaker for various sources. No other disclosures were reported.

Source: Giunta A et al. Curr Med Res Opin. 2021 May 20. doi: 10.1080/03007995.2021.1923467.

Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).

Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.

Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.

Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.

Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.

Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).

Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.

Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.

Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.

Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.

Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).

Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.

Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.

Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.

Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.

Key clinical point: Apremilast therapy was associated with weight loss, principally abdominal subcutaneous fat, and improvement in psoriatic disease activity in patients with psoriatic arthritis (PsA) or psoriasis.

Major finding: At 6 months after therapy, apremilast was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P less than .001). On assessing the nature of this weight loss, there was reduction in the total abdominal fat volume (mean decrease, 0.52 L; P = .022), mainly the abdominal subcutaneous adipose tissue (mean decrease, 0.37 L; P = .022). After 6 months of apremilast treatment, there were improvements in tender and swollen joint counts and disease activity.

Study details: This was a prospective, open-label study (IMAPA) involving 60 patients with PsA (n=56) and/or psoriasis (n=4) who received 30 mg of apremilast as part of routine care.

Disclosures: This study was supported by Amgen and the British Heart Foundation (BHF). The lead author reported receiving grants from the BHF Centre of Excellence. Three of the authors reported receiving grants and personal fees from various sources. All the other authors reported no conflicts of interest.

Source: Ferguson LD et al. Rheumatology (Oxford). 2021 Jun 7. doi: 10.1093/rheumatology/keab474.

Key clinical point: Apremilast therapy was associated with weight loss, principally abdominal subcutaneous fat, and improvement in psoriatic disease activity in patients with psoriatic arthritis (PsA) or psoriasis.

Major finding: At 6 months after therapy, apremilast was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P less than .001). On assessing the nature of this weight loss, there was reduction in the total abdominal fat volume (mean decrease, 0.52 L; P = .022), mainly the abdominal subcutaneous adipose tissue (mean decrease, 0.37 L; P = .022). After 6 months of apremilast treatment, there were improvements in tender and swollen joint counts and disease activity.

Study details: This was a prospective, open-label study (IMAPA) involving 60 patients with PsA (n=56) and/or psoriasis (n=4) who received 30 mg of apremilast as part of routine care.

Disclosures: This study was supported by Amgen and the British Heart Foundation (BHF). The lead author reported receiving grants from the BHF Centre of Excellence. Three of the authors reported receiving grants and personal fees from various sources. All the other authors reported no conflicts of interest.

Source: Ferguson LD et al. Rheumatology (Oxford). 2021 Jun 7. doi: 10.1093/rheumatology/keab474.

Key clinical point: Apremilast therapy was associated with weight loss, principally abdominal subcutaneous fat, and improvement in psoriatic disease activity in patients with psoriatic arthritis (PsA) or psoriasis.

Major finding: At 6 months after therapy, apremilast was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P less than .001). On assessing the nature of this weight loss, there was reduction in the total abdominal fat volume (mean decrease, 0.52 L; P = .022), mainly the abdominal subcutaneous adipose tissue (mean decrease, 0.37 L; P = .022). After 6 months of apremilast treatment, there were improvements in tender and swollen joint counts and disease activity.

Study details: This was a prospective, open-label study (IMAPA) involving 60 patients with PsA (n=56) and/or psoriasis (n=4) who received 30 mg of apremilast as part of routine care.

Disclosures: This study was supported by Amgen and the British Heart Foundation (BHF). The lead author reported receiving grants from the BHF Centre of Excellence. Three of the authors reported receiving grants and personal fees from various sources. All the other authors reported no conflicts of interest.

Source: Ferguson LD et al. Rheumatology (Oxford). 2021 Jun 7. doi: 10.1093/rheumatology/keab474.

Key clinical point: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was associated with 25% improved clinical remission rates compared with tumor necrosis factor inhibitors (TNFi) monotherapy in patients with psoriatic arthritis (PsA) who initiated first-ever TNFi.

Major finding: At 12 months, the rate of achieving clinical remission was significantly higher with comedication vs. monotherapy (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.12-1.41). Methotrexate comedication showed better remission for adalimumab (OR, 1.45; 95% CI, 1.23-1.72) and infliximab (OR, 1.55; 95% CI, 1.21-1.98) vs. monotherapy. No effect of comedication was observed for etanercept.

Study details: The data come from an observational study of 15,332 patients with PsA who initiated treatment with TNFi, of whom 9,440 were included in the TNFi and csDMARD comedication group and 5,892 in the TNFi monotherapy group.

Disclosures: This work was supported by Novartis. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources.

Source: Lindström U et al. Ann Rheum Dis. 2021 Jun 3. doi: 10.1136/annrheumdis-2021-220097.

Key clinical point: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was associated with 25% improved clinical remission rates compared with tumor necrosis factor inhibitors (TNFi) monotherapy in patients with psoriatic arthritis (PsA) who initiated first-ever TNFi.

Major finding: At 12 months, the rate of achieving clinical remission was significantly higher with comedication vs. monotherapy (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.12-1.41). Methotrexate comedication showed better remission for adalimumab (OR, 1.45; 95% CI, 1.23-1.72) and infliximab (OR, 1.55; 95% CI, 1.21-1.98) vs. monotherapy. No effect of comedication was observed for etanercept.

Study details: The data come from an observational study of 15,332 patients with PsA who initiated treatment with TNFi, of whom 9,440 were included in the TNFi and csDMARD comedication group and 5,892 in the TNFi monotherapy group.

Disclosures: This work was supported by Novartis. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources.

Source: Lindström U et al. Ann Rheum Dis. 2021 Jun 3. doi: 10.1136/annrheumdis-2021-220097.

Key clinical point: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was associated with 25% improved clinical remission rates compared with tumor necrosis factor inhibitors (TNFi) monotherapy in patients with psoriatic arthritis (PsA) who initiated first-ever TNFi.

Major finding: At 12 months, the rate of achieving clinical remission was significantly higher with comedication vs. monotherapy (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.12-1.41). Methotrexate comedication showed better remission for adalimumab (OR, 1.45; 95% CI, 1.23-1.72) and infliximab (OR, 1.55; 95% CI, 1.21-1.98) vs. monotherapy. No effect of comedication was observed for etanercept.

Study details: The data come from an observational study of 15,332 patients with PsA who initiated treatment with TNFi, of whom 9,440 were included in the TNFi and csDMARD comedication group and 5,892 in the TNFi monotherapy group.

Disclosures: This work was supported by Novartis. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources.

Source: Lindström U et al. Ann Rheum Dis. 2021 Jun 3. doi: 10.1136/annrheumdis-2021-220097.

Key clinical point: Apremilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.

Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.

Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).

Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.

Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449.

Key clinical point: Apremilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.

Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.

Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).

Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.

Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449.

Key clinical point: Apremilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.

Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.

Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).

Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.

Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449.

Most research published on psoriatic arthritis (PsA) in the month of June 2021 were related to treatment. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and anti-tumour necrosis factor (TNF) remain the most used drugs to treat PsA worldwide. However, the benefits of combining csDMARDs and anti-TNF therapies have been less well studied. Lindström et al studied this question using data from 15,332 patients with PsA from 13 European countries participating in the EuroSpA collaboration who initiated a first anti-TNF treatment in 2006–2017.  Sixty-two percent of the patients were on combined therapy, while 38% were no anti-TNF monotherapy. Overall, combined treatment was associated with better remission rates, pooled odds ratio (OR) 1.25 (1.12–1.41). Methotrexate (MTX) comedication was associated with improved rates of remission with adalimumab (OR 1.45 [1.23–1.72]) and infliximab (OR 1.55 [1.21–1.98]) and improved drug retention with infliximab. No effect of comedication could be demonstrated for etanercept. Thus, in clinical practice there may be an advantage to combine MTX with infliximab or adalimumab.

Biosimilars provide similar efficacy and safety to originator biologics at lower cost. Many jurisdictions are mandating nonmedical switch from a biologic to a biosimilar but concerns about such administrative switches remain among patients and physicians. Giunta et al report their observations in patients undergoing nonmedical switch from originator adalimumab to biosimilar adalimumab (ABP 501/ adalimumab-atto). In this retrospective study of 94 patients, 46 of whom underwent nonmedical switch from originator adalimumab to ABP 501, they found no significant differences in PASI or DAS-28 ESR at before and after switch in patients undergoing nonmedical switch from adalimumab originator to ABP 501. This study, although small and observational, adds to the growing body of literature on the effectiveness and safety of biosimilars including nonmedical switching.

About newer therapies, Mease et al reported the 52-week results of the phase 2b trial with tildrakizumab (an anti-IL23 biologic) in PsA. In this study, 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W. At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs placebo (71.4%-79.5% vs 50.6%; all P ≤.0125). However, improvement in dactylitis and enthesitis was not observed. No new safety signals were observed through W52. Tildrakizumab may be another option for the management of PsA but requires further evaluation in phase 3 trials.

About gender differences, Prior-Español et al using the Spanish BIOBADASER III registry demonstrated that women with PsA were at greater risk of discontinuing DMARDs because of both lack of efficacy and adverse events. Finally, Ferguson et al reported results from a prospective, open label study of adults receiving apremilast 30 mg as part of routine care for psoriatic disease. They show that in addition to reduction in disease activity, apremilast treatment was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P < .001). Improvement in disease activity did not correlate with weight change.

Most research published on psoriatic arthritis (PsA) in the month of June 2021 were related to treatment. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and anti-tumour necrosis factor (TNF) remain the most used drugs to treat PsA worldwide. However, the benefits of combining csDMARDs and anti-TNF therapies have been less well studied. Lindström et al studied this question using data from 15,332 patients with PsA from 13 European countries participating in the EuroSpA collaboration who initiated a first anti-TNF treatment in 2006–2017.  Sixty-two percent of the patients were on combined therapy, while 38% were no anti-TNF monotherapy. Overall, combined treatment was associated with better remission rates, pooled odds ratio (OR) 1.25 (1.12–1.41). Methotrexate (MTX) comedication was associated with improved rates of remission with adalimumab (OR 1.45 [1.23–1.72]) and infliximab (OR 1.55 [1.21–1.98]) and improved drug retention with infliximab. No effect of comedication could be demonstrated for etanercept. Thus, in clinical practice there may be an advantage to combine MTX with infliximab or adalimumab.

Biosimilars provide similar efficacy and safety to originator biologics at lower cost. Many jurisdictions are mandating nonmedical switch from a biologic to a biosimilar but concerns about such administrative switches remain among patients and physicians. Giunta et al report their observations in patients undergoing nonmedical switch from originator adalimumab to biosimilar adalimumab (ABP 501/ adalimumab-atto). In this retrospective study of 94 patients, 46 of whom underwent nonmedical switch from originator adalimumab to ABP 501, they found no significant differences in PASI or DAS-28 ESR at before and after switch in patients undergoing nonmedical switch from adalimumab originator to ABP 501. This study, although small and observational, adds to the growing body of literature on the effectiveness and safety of biosimilars including nonmedical switching.

About newer therapies, Mease et al reported the 52-week results of the phase 2b trial with tildrakizumab (an anti-IL23 biologic) in PsA. In this study, 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W. At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs placebo (71.4%-79.5% vs 50.6%; all P ≤.0125). However, improvement in dactylitis and enthesitis was not observed. No new safety signals were observed through W52. Tildrakizumab may be another option for the management of PsA but requires further evaluation in phase 3 trials.

About gender differences, Prior-Español et al using the Spanish BIOBADASER III registry demonstrated that women with PsA were at greater risk of discontinuing DMARDs because of both lack of efficacy and adverse events. Finally, Ferguson et al reported results from a prospective, open label study of adults receiving apremilast 30 mg as part of routine care for psoriatic disease. They show that in addition to reduction in disease activity, apremilast treatment was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P < .001). Improvement in disease activity did not correlate with weight change.

Most research published on psoriatic arthritis (PsA) in the month of June 2021 were related to treatment. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and anti-tumour necrosis factor (TNF) remain the most used drugs to treat PsA worldwide. However, the benefits of combining csDMARDs and anti-TNF therapies have been less well studied. Lindström et al studied this question using data from 15,332 patients with PsA from 13 European countries participating in the EuroSpA collaboration who initiated a first anti-TNF treatment in 2006–2017.  Sixty-two percent of the patients were on combined therapy, while 38% were no anti-TNF monotherapy. Overall, combined treatment was associated with better remission rates, pooled odds ratio (OR) 1.25 (1.12–1.41). Methotrexate (MTX) comedication was associated with improved rates of remission with adalimumab (OR 1.45 [1.23–1.72]) and infliximab (OR 1.55 [1.21–1.98]) and improved drug retention with infliximab. No effect of comedication could be demonstrated for etanercept. Thus, in clinical practice there may be an advantage to combine MTX with infliximab or adalimumab.

Biosimilars provide similar efficacy and safety to originator biologics at lower cost. Many jurisdictions are mandating nonmedical switch from a biologic to a biosimilar but concerns about such administrative switches remain among patients and physicians. Giunta et al report their observations in patients undergoing nonmedical switch from originator adalimumab to biosimilar adalimumab (ABP 501/ adalimumab-atto). In this retrospective study of 94 patients, 46 of whom underwent nonmedical switch from originator adalimumab to ABP 501, they found no significant differences in PASI or DAS-28 ESR at before and after switch in patients undergoing nonmedical switch from adalimumab originator to ABP 501. This study, although small and observational, adds to the growing body of literature on the effectiveness and safety of biosimilars including nonmedical switching.

About newer therapies, Mease et al reported the 52-week results of the phase 2b trial with tildrakizumab (an anti-IL23 biologic) in PsA. In this study, 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W. At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs placebo (71.4%-79.5% vs 50.6%; all P ≤.0125). However, improvement in dactylitis and enthesitis was not observed. No new safety signals were observed through W52. Tildrakizumab may be another option for the management of PsA but requires further evaluation in phase 3 trials.

About gender differences, Prior-Español et al using the Spanish BIOBADASER III registry demonstrated that women with PsA were at greater risk of discontinuing DMARDs because of both lack of efficacy and adverse events. Finally, Ferguson et al reported results from a prospective, open label study of adults receiving apremilast 30 mg as part of routine care for psoriatic disease. They show that in addition to reduction in disease activity, apremilast treatment was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P < .001). Improvement in disease activity did not correlate with weight change.

As doctors struggled through several surges of COVID-19 infections, most of what we learned was acquired through real-life experience. While many treatment options were promoted, most flat-out failed to be real therapeutics at all. Now that we have a safe and effective vaccine, we can prevent many infections from this virus. However, we are still left to manage the many post-COVID symptoms our patients continue to suffer with.

Symptoms following infection can last for months and range widely from “brain fog,” fatigue, dyspnea, chest pain, generalized weakness, depression, and a host of others. Patients may experience one or all of these symptoms, and there is currently no good way to predict who will go on to become a COVID “long hauler”.

Following the example of being educated by COVID as it happened, the same is true for managing post-COVID symptoms. The medical community still has a poor understanding of why some people develop it and there are few evidence-based studies to support any treatment modalities.

Earlier this month, the Centers for Disease Control and Prevention issued a set of clinical guidelines addressing treatment of post-COVID symptoms, which they define as “new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery.” It is important to note that these symptoms can occur in any degree of sickness during the acute infection, including in those who were asymptomatic. Even the actual name of this post-COVID syndrome is still being developed, with several other names being used for it as well.

While the guidelines are quite extensive, the actual clinical recommendations are still vague. For example, it is advised to let the patient know that post-COVID symptoms are still not well understood. While it is important to be transparent with patients, this does little to reassure them. Patients look to doctors, especially their primary care physicians, to guide them on the best treatment paths. Yet, we currently have none for post-COVID syndrome.

It is also advised to treat the patients’ symptoms and help improve functioning. For many diseases, doctors like to get to the root cause of the problem. Treating a symptom often masks an underlying condition. It may make the patient feel better and improve what they are capable of doing, which is important, but it also fails to unmask the real problem. It is also important to note that symptoms can be out of proportion to clinical findings and should not be dismissed: we just don’t have the answers yet.

One helpful recommendation is having a patient keep a diary of their symptoms. This will help both the patient and doctor learn what may be triggering factors. If it is, for example, exertion that induces breathlessness, perhaps the patient can gradually increase their level of activity to minimize symptoms. Additionally, a “comprehensive rehabilitation program” is also advised and this can greatly assist addressing all the issues a patient is experiencing, physically and medically.

It is also advised that management of underlying medical conditions be optimized. While this is very important, it is not something specific to post-COVID syndrome: All patients should have their underlying medical conditions well controlled. It might be that the patient is paying more attention to their overall health, which is a good thing. However, this does not necessarily reduce the current symptoms a patient is experiencing.

The CDC makes a good attempt to offer guidance in the frustrating management of post-COVID syndrome. However, their clinical guidelines fail to offer specific management tools specific to treating post-COVID patients. The recommendations offered are more helpful to health in general. The fact that more specific recommendations are lacking is simply caused by the lack of knowledge of this condition at present. As more research is conducted and more knowledge obtained, new guidelines should become more detailed.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

As doctors struggled through several surges of COVID-19 infections, most of what we learned was acquired through real-life experience. While many treatment options were promoted, most flat-out failed to be real therapeutics at all. Now that we have a safe and effective vaccine, we can prevent many infections from this virus. However, we are still left to manage the many post-COVID symptoms our patients continue to suffer with.

Symptoms following infection can last for months and range widely from “brain fog,” fatigue, dyspnea, chest pain, generalized weakness, depression, and a host of others. Patients may experience one or all of these symptoms, and there is currently no good way to predict who will go on to become a COVID “long hauler”.

Following the example of being educated by COVID as it happened, the same is true for managing post-COVID symptoms. The medical community still has a poor understanding of why some people develop it and there are few evidence-based studies to support any treatment modalities.

Earlier this month, the Centers for Disease Control and Prevention issued a set of clinical guidelines addressing treatment of post-COVID symptoms, which they define as “new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery.” It is important to note that these symptoms can occur in any degree of sickness during the acute infection, including in those who were asymptomatic. Even the actual name of this post-COVID syndrome is still being developed, with several other names being used for it as well.

While the guidelines are quite extensive, the actual clinical recommendations are still vague. For example, it is advised to let the patient know that post-COVID symptoms are still not well understood. While it is important to be transparent with patients, this does little to reassure them. Patients look to doctors, especially their primary care physicians, to guide them on the best treatment paths. Yet, we currently have none for post-COVID syndrome.

It is also advised to treat the patients’ symptoms and help improve functioning. For many diseases, doctors like to get to the root cause of the problem. Treating a symptom often masks an underlying condition. It may make the patient feel better and improve what they are capable of doing, which is important, but it also fails to unmask the real problem. It is also important to note that symptoms can be out of proportion to clinical findings and should not be dismissed: we just don’t have the answers yet.

One helpful recommendation is having a patient keep a diary of their symptoms. This will help both the patient and doctor learn what may be triggering factors. If it is, for example, exertion that induces breathlessness, perhaps the patient can gradually increase their level of activity to minimize symptoms. Additionally, a “comprehensive rehabilitation program” is also advised and this can greatly assist addressing all the issues a patient is experiencing, physically and medically.

It is also advised that management of underlying medical conditions be optimized. While this is very important, it is not something specific to post-COVID syndrome: All patients should have their underlying medical conditions well controlled. It might be that the patient is paying more attention to their overall health, which is a good thing. However, this does not necessarily reduce the current symptoms a patient is experiencing.

The CDC makes a good attempt to offer guidance in the frustrating management of post-COVID syndrome. However, their clinical guidelines fail to offer specific management tools specific to treating post-COVID patients. The recommendations offered are more helpful to health in general. The fact that more specific recommendations are lacking is simply caused by the lack of knowledge of this condition at present. As more research is conducted and more knowledge obtained, new guidelines should become more detailed.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

As doctors struggled through several surges of COVID-19 infections, most of what we learned was acquired through real-life experience. While many treatment options were promoted, most flat-out failed to be real therapeutics at all. Now that we have a safe and effective vaccine, we can prevent many infections from this virus. However, we are still left to manage the many post-COVID symptoms our patients continue to suffer with.

Symptoms following infection can last for months and range widely from “brain fog,” fatigue, dyspnea, chest pain, generalized weakness, depression, and a host of others. Patients may experience one or all of these symptoms, and there is currently no good way to predict who will go on to become a COVID “long hauler”.

Following the example of being educated by COVID as it happened, the same is true for managing post-COVID symptoms. The medical community still has a poor understanding of why some people develop it and there are few evidence-based studies to support any treatment modalities.

Earlier this month, the Centers for Disease Control and Prevention issued a set of clinical guidelines addressing treatment of post-COVID symptoms, which they define as “new, recurring, or ongoing symptoms more than 4 weeks after infection, sometimes after initial symptom recovery.” It is important to note that these symptoms can occur in any degree of sickness during the acute infection, including in those who were asymptomatic. Even the actual name of this post-COVID syndrome is still being developed, with several other names being used for it as well.

While the guidelines are quite extensive, the actual clinical recommendations are still vague. For example, it is advised to let the patient know that post-COVID symptoms are still not well understood. While it is important to be transparent with patients, this does little to reassure them. Patients look to doctors, especially their primary care physicians, to guide them on the best treatment paths. Yet, we currently have none for post-COVID syndrome.

It is also advised to treat the patients’ symptoms and help improve functioning. For many diseases, doctors like to get to the root cause of the problem. Treating a symptom often masks an underlying condition. It may make the patient feel better and improve what they are capable of doing, which is important, but it also fails to unmask the real problem. It is also important to note that symptoms can be out of proportion to clinical findings and should not be dismissed: we just don’t have the answers yet.

One helpful recommendation is having a patient keep a diary of their symptoms. This will help both the patient and doctor learn what may be triggering factors. If it is, for example, exertion that induces breathlessness, perhaps the patient can gradually increase their level of activity to minimize symptoms. Additionally, a “comprehensive rehabilitation program” is also advised and this can greatly assist addressing all the issues a patient is experiencing, physically and medically.

It is also advised that management of underlying medical conditions be optimized. While this is very important, it is not something specific to post-COVID syndrome: All patients should have their underlying medical conditions well controlled. It might be that the patient is paying more attention to their overall health, which is a good thing. However, this does not necessarily reduce the current symptoms a patient is experiencing.

The CDC makes a good attempt to offer guidance in the frustrating management of post-COVID syndrome. However, their clinical guidelines fail to offer specific management tools specific to treating post-COVID patients. The recommendations offered are more helpful to health in general. The fact that more specific recommendations are lacking is simply caused by the lack of knowledge of this condition at present. As more research is conducted and more knowledge obtained, new guidelines should become more detailed.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Key clinical point: Cluster of differentiation 33 (CD33) single-nucleotide polymorphism (SNP) rs12459419 predicts the rate of relapse in patients with nucleophosmin1 (NPM1)-mutated acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO).

Major finding: Complete remission, event-free survival, and cumulative incidence of death were not significantly different between genotypes in the treatment arms. However, patients with c.41 C/C genotype for rs12459419 in the GO vs. standard arm showed significant improvement in relapse-free survival (P = .03) and cumulative incidence of relapse (P = .023).

Study details: Findings are from the phase 3 AMLSG 09-09 trial including 588 adult patients with NPM1-mutated AML who were eligible for intensive therapy. Patients were randomly allocated to receive 2 cycles of induction chemotherapy with (n=273) or without (n=272) GO.

Disclosures: This work was supported by grants from the Deutsche José Carreras Leukämie-Stiftung e.V., German Federal Ministry of Education and Research, and Deutsche Forschungsgemeinschaft. The authors declared no conflicts of interest.

Source: Teich K et al. Haematologica. 2021 May 27. doi: 10.3324/haematol.2021.278894.

Key clinical point: Cluster of differentiation 33 (CD33) single-nucleotide polymorphism (SNP) rs12459419 predicts the rate of relapse in patients with nucleophosmin1 (NPM1)-mutated acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO).

Major finding: Complete remission, event-free survival, and cumulative incidence of death were not significantly different between genotypes in the treatment arms. However, patients with c.41 C/C genotype for rs12459419 in the GO vs. standard arm showed significant improvement in relapse-free survival (P = .03) and cumulative incidence of relapse (P = .023).

Study details: Findings are from the phase 3 AMLSG 09-09 trial including 588 adult patients with NPM1-mutated AML who were eligible for intensive therapy. Patients were randomly allocated to receive 2 cycles of induction chemotherapy with (n=273) or without (n=272) GO.

Disclosures: This work was supported by grants from the Deutsche José Carreras Leukämie-Stiftung e.V., German Federal Ministry of Education and Research, and Deutsche Forschungsgemeinschaft. The authors declared no conflicts of interest.

Source: Teich K et al. Haematologica. 2021 May 27. doi: 10.3324/haematol.2021.278894.

Key clinical point: Cluster of differentiation 33 (CD33) single-nucleotide polymorphism (SNP) rs12459419 predicts the rate of relapse in patients with nucleophosmin1 (NPM1)-mutated acute myeloid leukemia (AML) treated with gemtuzumab ozogamicin (GO).

Major finding: Complete remission, event-free survival, and cumulative incidence of death were not significantly different between genotypes in the treatment arms. However, patients with c.41 C/C genotype for rs12459419 in the GO vs. standard arm showed significant improvement in relapse-free survival (P = .03) and cumulative incidence of relapse (P = .023).

Study details: Findings are from the phase 3 AMLSG 09-09 trial including 588 adult patients with NPM1-mutated AML who were eligible for intensive therapy. Patients were randomly allocated to receive 2 cycles of induction chemotherapy with (n=273) or without (n=272) GO.

Disclosures: This work was supported by grants from the Deutsche José Carreras Leukämie-Stiftung e.V., German Federal Ministry of Education and Research, and Deutsche Forschungsgemeinschaft. The authors declared no conflicts of interest.

Source: Teich K et al. Haematologica. 2021 May 27. doi: 10.3324/haematol.2021.278894.

Key clinical point: The detection of measurable residual disease (MRD) using next-generation sequencing (NGS) has a prognostic value before and 1 month after allogeneic hematopoietic stem cell transplantation (allo-HSCT), depending on the conditioning intensity.

Major finding: In patients receiving myeloablative conditioning, pre-allo-HSCT NGS-MRD detection was associated with posttransplant relapse. Conversely, in patients receiving reduced intensity conditioning 1 month post-allo-HSCT, NGS-MRD was associated with posttransplant relapse (both P less than .001).

Study details: This study included 146 patients with AML who underwent allo-HSCT in complete remission between 2013 and 2018.

Disclosures: This work was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors declared no conflicts of interest.

Source: Kim HJ et al. Blood Cancer J. 2021 Jun 4. doi: 10.1038/s41408-021-00500-9.

Key clinical point: The detection of measurable residual disease (MRD) using next-generation sequencing (NGS) has a prognostic value before and 1 month after allogeneic hematopoietic stem cell transplantation (allo-HSCT), depending on the conditioning intensity.

Major finding: In patients receiving myeloablative conditioning, pre-allo-HSCT NGS-MRD detection was associated with posttransplant relapse. Conversely, in patients receiving reduced intensity conditioning 1 month post-allo-HSCT, NGS-MRD was associated with posttransplant relapse (both P less than .001).

Study details: This study included 146 patients with AML who underwent allo-HSCT in complete remission between 2013 and 2018.

Disclosures: This work was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors declared no conflicts of interest.

Source: Kim HJ et al. Blood Cancer J. 2021 Jun 4. doi: 10.1038/s41408-021-00500-9.

Key clinical point: The detection of measurable residual disease (MRD) using next-generation sequencing (NGS) has a prognostic value before and 1 month after allogeneic hematopoietic stem cell transplantation (allo-HSCT), depending on the conditioning intensity.

Major finding: In patients receiving myeloablative conditioning, pre-allo-HSCT NGS-MRD detection was associated with posttransplant relapse. Conversely, in patients receiving reduced intensity conditioning 1 month post-allo-HSCT, NGS-MRD was associated with posttransplant relapse (both P less than .001).

Study details: This study included 146 patients with AML who underwent allo-HSCT in complete remission between 2013 and 2018.

Disclosures: This work was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors declared no conflicts of interest.

Source: Kim HJ et al. Blood Cancer J. 2021 Jun 4. doi: 10.1038/s41408-021-00500-9.

Key clinical point: Clonal hematopoiesis (CH) persisted after complete remission (CR) in patients with acute myeloid leukemia (AML) and was resistant to consolidation and maintenance therapies, except for allogeneic stem cell transplantation (allo-SCT). However, the presence of postremission CH did not affect clinical outcomes.

Major finding: Following induction chemotherapies, 48% of patients had post-CR CH, and it persisted in 91% of patients during and postremission chemotherapies, but disappeared in 95% of patients after allo-SCT. However, the risk for relapse (P = .174) and nonrelapse mortality (P = .827) was similar in patients with vs. without post-CR CH.

Study details: Findings are from assessment of 164 patients with AML who achieved morphological CR following induction chemotherapies.

Disclosures: This work was supported by grants from the Cancer Prevention and Research Institute of Texas, Welch Foundation, University of Texas System STARS Award, Lyda Hill Foundation, Charif Souki Cancer Research Fund, Japan Society for the Promotion of Science, Sabin Family Foundation Fellowship, and various funding programs at the MD Anderson Cancer Center. The authors declared no conflicts of interest.

Source: Tanaka T et al. Blood. 2021 Jun 3. doi: 10.1182/blood.2020010483.

Key clinical point: Clonal hematopoiesis (CH) persisted after complete remission (CR) in patients with acute myeloid leukemia (AML) and was resistant to consolidation and maintenance therapies, except for allogeneic stem cell transplantation (allo-SCT). However, the presence of postremission CH did not affect clinical outcomes.

Major finding: Following induction chemotherapies, 48% of patients had post-CR CH, and it persisted in 91% of patients during and postremission chemotherapies, but disappeared in 95% of patients after allo-SCT. However, the risk for relapse (P = .174) and nonrelapse mortality (P = .827) was similar in patients with vs. without post-CR CH.

Study details: Findings are from assessment of 164 patients with AML who achieved morphological CR following induction chemotherapies.

Disclosures: This work was supported by grants from the Cancer Prevention and Research Institute of Texas, Welch Foundation, University of Texas System STARS Award, Lyda Hill Foundation, Charif Souki Cancer Research Fund, Japan Society for the Promotion of Science, Sabin Family Foundation Fellowship, and various funding programs at the MD Anderson Cancer Center. The authors declared no conflicts of interest.

Source: Tanaka T et al. Blood. 2021 Jun 3. doi: 10.1182/blood.2020010483.

Key clinical point: Clonal hematopoiesis (CH) persisted after complete remission (CR) in patients with acute myeloid leukemia (AML) and was resistant to consolidation and maintenance therapies, except for allogeneic stem cell transplantation (allo-SCT). However, the presence of postremission CH did not affect clinical outcomes.

Major finding: Following induction chemotherapies, 48% of patients had post-CR CH, and it persisted in 91% of patients during and postremission chemotherapies, but disappeared in 95% of patients after allo-SCT. However, the risk for relapse (P = .174) and nonrelapse mortality (P = .827) was similar in patients with vs. without post-CR CH.

Study details: Findings are from assessment of 164 patients with AML who achieved morphological CR following induction chemotherapies.

Disclosures: This work was supported by grants from the Cancer Prevention and Research Institute of Texas, Welch Foundation, University of Texas System STARS Award, Lyda Hill Foundation, Charif Souki Cancer Research Fund, Japan Society for the Promotion of Science, Sabin Family Foundation Fellowship, and various funding programs at the MD Anderson Cancer Center. The authors declared no conflicts of interest.

Source: Tanaka T et al. Blood. 2021 Jun 3. doi: 10.1182/blood.2020010483.