Certolizumab pegol (CDP870) for rheumatoid arthritis in adults

Abstract

With an overall high grade of evidence this review revealed an improvement of clinical results (ACR50, 28 joint disease activity score (DAS-28) remission and HAQ scores) with certolizumab pegol. Adverse events were more frequent with certolizumab; there was a statistically significant increase in the number of serious adverse events, infections and hypertension.

2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty

“…Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk . The literature review also revealed that the risk of postoperative infection complications after total joint arthroplasty (TJA) was increased in patients with RA nearly 2‐fold, and deep infection complications increased by 1.5‐fold ; in SLE, overall postoperative complications were increased 1.3‐fold, and septicemia by 2‐fold , although medication use at the time of surgery was not always reported.…”

“…This recommendation was based on evidence that was rated down in quality for indirectness, as no RCTs were performed in patients undergoing THA or TKA. We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents .…”

“…We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk .…”

2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty

“…Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk . The literature review also revealed that the risk of postoperative infection complications after total joint arthroplasty (TJA) was increased in patients with RA nearly 2‐fold, and deep infection complications increased by 1.5‐fold ; in SLE, overall postoperative complications were increased 1.3‐fold, and septicemia by 2‐fold , although medication use at the time of surgery was not always reported.…”

“…This recommendation was based on evidence that was rated down in quality for indirectness, as no RCTs were performed in patients undergoing THA or TKA. We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents .…”

“…We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk .…”

Biologics-Based Therapy for the Treatment of Rheumatoid Arthritis

“…This review showed that, after 6 months of treatment, the weighted mean difference in HAQ scores was −0.37 (95% CI: −0.77, 0.03). Subsequent systematic reviews showed similar data with respect to adalimumab (mean difference −0.32; 95% CI: −0.51, −0.13), 32 certolizumab (mean difference −0.39; 95% CI: −0.45, −0.32), 33 and tocilizumab (mean difference −0.30; 95% CI: −0.44, −0.16) 35 . In the case of some of the biologics, there has been a greater focus on the numbers of patients who show important clinical improvements, which are generally considered to be reductions in HAQ score of 0.22 or more.…”

Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifying antirheumatic drugs only: systematic review and economic evaluation

“…This review differed from other reviews of biologics in RA, 123, [161][162][163][164][165][166][167][168][169][170][171][172] in that it included only licensed doses of biologics, was limited to first-line biologics, and considered separately MTX-naive and cDMARD-experienced trials.…”

2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty

“…Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk . The literature review also revealed that the risk of postoperative infection complications after total joint arthroplasty (TJA) was increased in patients with RA nearly 2‐fold, and deep infection complications increased by 1.5‐fold ; in SLE, overall postoperative complications were increased 1.3‐fold, and septicemia by 2‐fold , although medication use at the time of surgery was not always reported.…”

“…This recommendation was based on evidence that was rated down in quality for indirectness, as no RCTs were performed in patients undergoing THA or TKA. We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents .…”

“…We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk .…”

Biologics-Based Therapy for the Treatment of Rheumatoid Arthritis

“…This review showed that, after 6 months of treatment, the weighted mean difference in HAQ scores was −0.37 (95% CI: −0.77, 0.03). Subsequent systematic reviews showed similar data with respect to adalimumab (mean difference −0.32; 95% CI: −0.51, −0.13), 32 certolizumab (mean difference −0.39; 95% CI: −0.45, −0.32), 33 and tocilizumab (mean difference −0.30; 95% CI: −0.44, −0.16) 35 . In the case of some of the biologics, there has been a greater focus on the numbers of patients who show important clinical improvements, which are generally considered to be reductions in HAQ score of 0.22 or more.…”

Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifying antirheumatic drugs only: systematic review and economic evaluation

“…This review differed from other reviews of biologics in RA, 123, [161][162][163][164][165][166][167][168][169][170][171][172] in that it included only licensed doses of biologics, was limited to first-line biologics, and considered separately MTX-naive and cDMARD-experienced trials.…”

2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty

“…Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk . The literature review also revealed that the risk of postoperative infection complications after total joint arthroplasty (TJA) was increased in patients with RA nearly 2‐fold, and deep infection complications increased by 1.5‐fold ; in SLE, overall postoperative complications were increased 1.3‐fold, and septicemia by 2‐fold , although medication use at the time of surgery was not always reported.…”

“…This recommendation was based on evidence that was rated down in quality for indirectness, as no RCTs were performed in patients undergoing THA or TKA. We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents .…”

“…We abstracted data from a systematic review of literature that included systematic reviews and meta‐analyses of biologic agents versus placebo (and occasionally versus control treatment including nonbiologic DMARDs) in nonsurgical patients, which revealed that the risk of serious infections was increased with biologic agents, with most odds/hazards/risk ratios ∼1.5 (range 0.61–8.87) and a higher risk of serious adverse events with most odds/hazards/risk ratios ∼1.5 (range 0.33–2.54) . Our systematic review did not provide ample evidence that would support a differential risk of serious infection among available biologic agents . Because avoiding infection was significantly more important to patients than flares in the postoperative period, the Panel did not support separating biologic agents regarding infection risk in the perioperative period until further studies clarify and establish differences in risk .…”

Biologics-Based Therapy for the Treatment of Rheumatoid Arthritis

“…This review showed that, after 6 months of treatment, the weighted mean difference in HAQ scores was −0.37 (95% CI: −0.77, 0.03). Subsequent systematic reviews showed similar data with respect to adalimumab (mean difference −0.32; 95% CI: −0.51, −0.13), 32 certolizumab (mean difference −0.39; 95% CI: −0.45, −0.32), 33 and tocilizumab (mean difference −0.30; 95% CI: −0.44, −0.16) 35 . In the case of some of the biologics, there has been a greater focus on the numbers of patients who show important clinical improvements, which are generally considered to be reductions in HAQ score of 0.22 or more.…”

Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifying antirheumatic drugs only: systematic review and economic evaluation

“…This review differed from other reviews of biologics in RA, 123, [161][162][163][164][165][166][167][168][169][170][171][172] in that it included only licensed doses of biologics, was limited to first-line biologics, and considered separately MTX-naive and cDMARD-experienced trials.…”