Select therapeutic use:

Arthritis/rheumatic disorders:

Indications for: AVSOLA

To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in psoriatic arthritis and with methotrexate in moderately to severely active rheumatoid arthritis (RA). To reduce signs/symptoms of active ankylosing spondylitis.

Clinical Trials:

Rheumatoid Arthritis  

  • The safety and efficacy of infliximab in adult patients with RA were assessed in 2 multicenter, randomized, double-blind, pivotal trials: ATTRACT (Study RA I) and ASPIRE (Study RA II). Concurrent use of stable doses of folic acid, oral corticosteroids (≤10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted. 

  • Study RA I was a placebo-controlled study of 428 patients with active RA despite treatment with MTX. Patients received either placebo+MTX or one of 4 doses/schedules of the infliximab+MTX: 3 mg/kg or 10 mg/kg infliximab by IV infusion at Weeks 0, 2 and 6 followed by additional infusions every 4 or 8 weeks in combination with MTX.

  • Study RA II was a placebo-controlled study of 3 active treatment arms in 1004 MTX naïve patients of 3 or fewer years’ duration active RA. At randomization, all patients received MTX (optimized to 20 mg/wk by Week 8) and either placebo, 3 mg/kg or 6 mg/kg of infliximab at Weeks 0, 2, and 6 and every 8 weeks thereafter. 

  • Results from Study RA I showed that a higher percentage of patients treated with all doses/schedules of infliximab + MTX achieved ACR 20, 50, and 70 compared with placebo + MTX. Improvement was observed as early as Week 2 and maintained through Week 102. In Study RA II, both doses of infliximab + MTX achieved statistically significantly greater ACR 20, 50, and 70 responses compared with MTX alone.

  • In both Study RA I and RA II, all doses/schedules of infliximab + MTX had significantly greater improvement from baseline in HAQ-DI and SF-36 physical component summary score averaged over time through Week 54 compared with placebo + MTX and MTX alone.

Ankylosing Spondylitis 

  • The safety and efficacy of infliximab were assessed in a randomized, multicenter, double-blind, placebo-controlled study in 279 adult patients with active AS. Patients were randomly assigned to receive either infliximab 5mg/kg or placebo at Weeks 0, 2, 6, 12, and 18.

  • Results showed that 60% of patients treated with infliximab achieved a 20% improvement in ASAS response criteria at Week 24 vs 18% of patients treated with placebo (P <.001). At Week 24, 44% and 28% of patients treated with infliximab achieved 50% and 70% improvement in ASAS response criteria vs 9% and 4% of patients treated with placebo (P <.001). 

  • There was a low level of disease activity (defined as a value <20 [on a scale of 0-100mm] in each of the 4 ASAS response parameters) achieved in 22% of infliximab-treated patients vs 1% of placebo-treated patients.

  • The median improvement from baseline in the general health-related quality-of-life questionnaire SF-36 physical component summary score at Week 24 was 10.2 for the infliximab group vs. 0.8 for the placebo group (P <.001). 

Psoriatic Arthritis  

  • A multicenter, double-blind, placebo-controlled study evaluated the safety and efficacy of infliximab  in 200 adults with active PsA despite DMARD or NSAID therapy (≥5 swollen joints and ≥5 tender joints) with 1 or more of the following subtypes: arthritis involving DIP joints (n=49), arthritis mutilans (n=3), asymmetric peripheral arthritis (n=40), polyarticular arthritis (n=100), and spondylitis with peripheral arthritis (n=8). 

  • During the 24-week double-blind phase, patients received either infliximab 5 mg/kg or placebo at Weeks 0, 2, 6, 14, and 22 (100 patients in each group). At Week 16, placebo patients with <10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape). At Week 24, all placebo-treated patients crossed over to infliximab induction. Dosing continued for all patients through Week 46. 

  • Clinical Response:

    • 58% of patients treated with infliximab achieved ACR 20 response at Week 14 vs 11% of patients treated with placebo (P <.001). Improvement was observed as early as Week 2.

    • At 6 months, 54%, 41%, and 27% of patients treated with infliximab achieved ACR 20, 50, and 70 responses, respectively, vs 16%, 4%, and 2% of patients treated with placebo, respectively.

    • At Week 14, 64% of infliximab-treated patients achieved at least 75% improvement from baseline in PASI vs 2% of placebo-treated patients. At 6 months, 60% and 39% of infliximab-treated patients achieved PASI 75 and PASI 90 responses, respectively, vs 1% and 0% of placebo-treated patients.

  • Radiographic Response:

    • At Week 24, patients treated with infliximab had less radiographic progression than placebo-treated patients (mean change of -0.70 vs. 0.82; P <.001).

    • The patients in the infliximab group demonstrated continued inhibition of structural damage at Week 54. Most patients showed little or no change in the vdH-S score during this 12-month study (median change of 0 in both patients who initially received infliximab or placebo).

  • Physical Function:

    • Patients treated with infliximab demonstrated significant improvement in physical function as assessed by HAQ-DI (median percent improvement in HAQ-DI score from baseline to Week 14 and 24 of 43% for infliximab-treated patients vs 0% for placebo-treated patients).

    • During the placebo-controlled portion of the trial (24 weeks), 54% of patients treated with infliximab achieved a clinically meaningful improvement in HAQ-DI (≥0.3 unit decrease) compared to 22% of placebo-treated patients.

Adult Dosage:

Give by IV infusion over at least 2hrs. RA: 3mg/kg at weeks 0, 2, 6, then once every 8 weeks. May increase to 10mg/kg or give every 4 weeks. Ankylosing spondylitis: 5mg/kg at weeks 0, 2, 6, then once every 6 weeks. Psoriatic arthritis: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks; may be used alone or with methotrexate. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.

Children Dosage:

Not established.

AVSOLA Contraindications:

Moderate to severe heart failure (doses >5mg/kg). Allergy to murine proteins.

Boxed Warning:

Serious infections. Malignancy.

AVSOLA Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections or hematologic abnormalities. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. History of malignancies; perform periodic screening. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, or jaundice with marked liver enzyme elevations ≥5×ULN occurs. Preexisting heart failure; closely monitor and discontinue if new or worsening symptoms occur. Monitor for cardiovascular and cerebrovascular reactions during and after infusion; discontinue if serious. Neurologic disorders (eg, CNS demyelinating, seizures, multiple sclerosis, optic neuritis, others); discontinue if occurs. Update vaccinations accordingly with current guidelines prior to initiation. Elderly: monitor closely for serious infections. Neonatal/infants. Pregnancy. Nursing mothers.

AVSOLA Classification:

Tumor necrosis factor (TNF) blocker.

AVSOLA Interactions:

Concurrent anakinra, abatacept, tocilizumab, live vaccines, therapeutic infectious agents (eg, live attenuated bacteria), other TNF blockers or biological therapeutics: not recommended. Concomitant azathioprine or 6-mercaptopurine; possible higher risk of HSTCL. Concomitant immunosuppressants (eg, corticosteroids, methotrexate) may increase risk of infection. May be potentiated by methotrexate. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline): monitor and may need to adjust dose of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.

Adverse Reactions:

Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, GI upset, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, lupus-like syndrome, blood dyscrasias, hepatotoxicity.

Drug Elimination:

Half-life: ~7.7–9.5 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (20mL)—1

Colorectal disorders:

Indications for: AVSOLA

In moderately to severely active Crohn’s disease: to reduce signs/symptoms and to induce and maintain clinical remission in adult and pediatric patients with inadequate response to conventional therapy. In fistulizing Crohn’s disease: to reduce number of draining enterocutaneous and rectovaginal fistula(s); and maintain fistula closure in adults. In moderately to severely active ulcerative colitis (UC): to reduce signs/symptoms, to induce and maintain clinical remission and mucosal healing, and to eliminate corticosteroid use in adults with inadequate response to conventional therapy. In moderately to severely active UC: to reduce signs/symptoms and to induce and maintain clinical remission in pediatric patients with inadequate response to conventional therapy.

Clinical Trials:

Active Crohn’s Disease in Adults  

  • The efficacy and safety of single and multiple doses of infliximab were evaluated in 2 randomized, double-blind, placebo-controlled clinical studies in 653 adults with moderate to severe active CD who had an inadequate response to prior conventional therapies.

  • In the single-dose trial (N=108):

    • 81% (n=22/27) of patients treated with infliximab 5mg/kg achieved clinical response (decrease in CDAI ≥70 points) at Week 4 vs 16% (n=4/25) of patients treated with placebo (P <.001, 2-sided, Fisher’s Exact test).

    • 48% (n=13/27) of patients treated with infliximab 5mg/kg achieved clinical remission (CDAI <150) at Week 4 vs 4% (n=1/25) of patients treated with placebo.

  • In the multidose trial, 545 patients received infliximab 5mg/kg at Week 0 then randomly assigned to 1 of 3 treatment groups: infliximab 5mg/kg or 10mg/kg at Weeks 2 and 6, then continued every 8 weeks, or placebo. Patients were permitted to use corticosteroid taper after Week 6.

    • At Week 2, 57% (n=311/545) of patients were in clinical response.

    • At Week 30, 39% (P =.022) and 46% (P =.001) of patients in the 5mg/kg and 10mg/kg maintenance groups, respectively, achieved clinical remission vs 25% of patients in the placebo maintenance group.

    • At Week 54, 25% (P =.059) and 34% (P =.005) of patients in the 5mg/kg and 10mg/kg maintenance groups, respectively, in remission were able to discontinue corticosteroid use vs 11% of patients in the placebo maintenance group.

    • At Weeks 30 and 54, there was significant improvement observed in the 5mg/kg and 10mg/kg groups in the disease-specific inflammatory bowel disease (IBDQ) and in the physical component summary score of the general health-related quality of life questionnaire SF-36 compared with placebo.

Fistulizing Crohn’s Disease in Adults  

  • The safety and efficacy of infliximab were assessed in 2 randomized, double-blind, placebo-controlled studies in adult patients with fistulizing CD with fistula(s) that were of at least 3 months duration. Patients were allowed to use concurrently with stable doses of corticosteroids, 5-aminosalicylates, antibiotics, MTX, 6-MP and/or AZA.

  • Study 1 included 94 adults who received 3 doses of either placebo or infliximab at Weeks 0, 2, and 6. Fistula response was defined as at least a 50% reduction in number of enterocutaneous fistulas draining upon gentle compression on at least 2 consecutive visits without an increase in medication or surgery for CD.

    • 68% (n=21/31) of patients in the 5mg/kg infliximab arm (P =.002) and 56% (n=18/32) of patients in the 10mg/kg infliximab arm (P =.021) achieved fistula response vs 26% (n=8/31) of patients in the placebo arm.

    • Patients treated with infliximab had a median time to onset of response of 2 weeks and a median duration of response of 12 weeks.

    • 52% of patients treated with infliximab achieved closure of all fistulas vs 13% of patients treated with placebo (P <.001).

  • Study 2 included adults who had to have at least 1 draining enterocutaneous (perianal, abdominal) fistula. All patients received infliximab 5mg/kg at Weeks 0, 2, and 6, then were randomly assigned to receive placebo or infliximab 5mg/kg maintenance at Week 14 and every 8 weeks through Week 46. The primary endpoint was time from randomization to loss of response among those patients who were in fistula response.

    • At Week 14, 65% (n=177/273) of patients were in fistula response.

    • At Week 54, 38% (n=33/87) of patients treated with infliximab had no draining fistulas vs 22% (n=20/90) of patients treated with placebo (P =.02).

    • Of the placebo maintenance patients, 66% (n=25/38) responded to infliximab 5mg/kg, and 57% (n=12/21) of maintenance patients on infliximab responded to 10mg/kg.

Pediatric Crohn’s Disease

  • The efficacy and safety of infliximab was assessed in a randomized, open-label study (Study Peds Crohns) in 112 patients 6 to 17 years of age with moderately to severely active CD who had an inadequate response to conventional therapies. All patients were required to be on a stable dose of 6-MP, AZA, or MTX.

  • Patients received induction dosing of infliximab 5mg/kg at Weeks 0, 2, and 6. At Week 10, 103 patients were randomly assigned to receive a maintenance regimen of infliximab 5mg/kg given either every 8 weeks or every 12 weeks.

    • At Week 10, 88% of patients achieved clinical response, defined as a decrease from baseline in the PCDAI score of ≥15 points and total PCDAI score of ≤30 points, and 59% achieved clinical remission, defined as PCDAI score of  ≤10 points.

    • At Week 30 and Week 54, a greater proportion of patients in the every 8-week treatment group achieved clinical response vs the every 12-week treatment group (73% [P <.01] vs 47% at Week 30, and 64% [P <.01] vs 33% at Week 54).

    • At Week 30 and Week 54, a greater proportion of patients in the every 8-week treatment group achieved clinical remission vs the every 12-week treatment group (60% [P <.05] vs 35% at Week 30, and 56% [P <.01] vs 24% at Week 54).

    • At Week 30, 46% and 33% of patients in the every 8-week and every 12-week maintenance groups, respectively, were able to discontinue corticosteroids while in remission. 

    • At Week 54, 46% and 17% of patients in the every 8-week and every 12-week maintenance groups, respectively, were able to discontinue corticosteroids while in remission. 

Adult Ulcerative Colitis

  • The safety and efficacy of infliximab were assessed in 2 randomized, double-blind, placebo-controlled clinical studies in 728 adult patients with moderately to severely active UC (Mayo score 6 to 12 [of possible range 0 to 12], Endoscopy subscore ≥2) with an inadequate response to conventional oral therapies (Studies UC I and UC II). Patients were allowed to use concomitant treatment with stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents.

  • Patients were randomly assigned to receive either placebo or infliximab 5mg/kg or 10mg/kg at Weeks 0, 2, 6, and every 8 weeks thereafter through Week 46 in Study UC I, and at Weeks 0, 2, 6, and every 8 weeks thereafter through Week 22 in Study UC II.

  • Study UC I included adults who failed to respond or were intolerant to oral corticosteroids, 6-MP, or AZA. Study UC II included adults who failed to respond or were intolerant to the above treatments and/or aminosalicylates.

  • Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, accompanied by a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. 

  • Results from Study UC I showed that a greater proportion of patients treated with infliximab 5mg/kg and 10mg/kg achieved clinical response, clinical remission and mucosal healing vs placebo:

    • Clinical Response

      • Week 8: 69% (P <.001) vs 62% (P <.001) vs 37%

      • Week 30: 52% (P <.001) vs 51% (P <.01) vs 30%

      • Week 54: 45% (P <.001) vs 44% (P <.001) vs 20%

    • Sustained Response

      • Clinical response at both Week 8 and Week 30: 49% (P <.001) vs 46% (P <.001) vs 23%

      • Clinical response at Weeks 8, 30, and 54: 39% (P <.001) vs 37% (P <.001) vs 14%

    • Clinical Remission

      • Week 8: 39% (P <.001) vs 32% (P <.01) vs 15%

      • Week 30: 34% (P <.01) vs 37% (P <.001) vs 16%

      • Week 54: 35% (P <.01) vs 34% (P <.001) vs 17%

    • Sustained Remission

      • Clinical remission at both Week 8 and Week 30: 23% (P <.01) vs 26% (P <.001) vs 8%

      • Clinical remission at Weeks 8, 30, and 54: 20% (P <.01) vs 20% (P <.01) vs 7%

    • Mucosal Healing

      • Week 8: 62% (P <.001) vs 59% (P <.001) vs 34%

      • Week 30: 50% (P <.001) vs 49% (P <.001) vs 25%

      • Week 54: 45% (P <.001) vs 47% (P <.001) vs 18%

  • Results from Study UC II showed that a greater proportion of patients treated with infliximab 5mg/kg and 10mg/kg achieved clinical response, clinical remission and mucosal healing vs placebo:

    • Clinical Response

      • Week 8: 65% (P <.001) vs 69% (P <.001) vs 29%

      • Week 30: 47% (P <.001) vs 60% (P <.01) vs 26%

    • Sustained Response

      • Clinical response at both Week 8 and Week 30: 41% (P <.001) vs 53% (P <.001) vs 15%

    • Clinical Remission

      • Week 8: 34% (P <.001) vs 28% (P <.001) vs 6%

      • Week 30: 26% (P <.01) vs 36% (P <.001) vs 11%

    • Sustained Remission

      • Clinical remission at both Week 8 and Week 30: 15% (P <.001) vs 23% (P <.001) vs 2%

    • Mucosal Healing

      • Week 8: 60% (P <.001) vs 62% (P <.001) vs 31%

      • Week 30: 46% (P <.01) vs 57% (P <.001) vs 30%

Pediatric Ulcerative Colitis

  • The safety and efficacy of infliximab for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients aged 6 years and older with moderately to severely active UC who have had an inadequate response to conventional therapy are supported by evidence from adequate and well-controlled studies of infliximab in adults. 

  • The open-label pediatric UC trial included 60 pediatric patients 6 through 17 years of age with moderately to severely active UC (Mayo score of 6 to 12; Endoscopic subscore ≥2) and an inadequate response to conventional therapies. Patients received induction dosing of infliximab 5mg/kg at Weeks 0, 2, and 6, then patient responders were randomly assigned to a maintenance regimen of infliximab 5mg/kg at Week 8 every 8 weeks through Week 46 or every 12 weeks through Week 42.

  • Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, accompanied by a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1. Clinical remission at Week 8 was measured by the Mayo score, defined as a Mayo score of ≤2 points with no individual subscore >1.

  • At Week 8, 44 patients were in clinical response. Of 32 patients taking concomitant immunomodulators at baseline, 23 achieved clinical response at Week 8 compared with 21 out of 28 of patients not taking concomitant immunomodulators at baseline.

  • At Week 8, 24 of 60 patients were in clinical remission as measured by the Mayo score and 17 of 51 patients were in remission as measured by the PUCAI score.

  • At Week 54, 8 of 21 patients in the every 8-week maintenance group and 4 of 22 patients in the every 12-week maintenance group achieved clinical remission as measured by the PUCAI score.

Adult Dosage:

Give by IV infusion over at least 2hrs. Crohn's disease: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks; if relapse, may increase to 10mg/kg; discontinue if no response by week 14. UC: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.

Children Dosage:

<6yrs: not established. ≥6yrs: Give by IV infusion over at least 2hrs. Active Crohn's disease or UC: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.

AVSOLA Contraindications:

Moderate to severe heart failure (doses >5mg/kg). Allergy to murine proteins.

Boxed Warning:

Serious infections. Malignancy.

AVSOLA Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections or hematologic abnormalities. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. History of malignancies; perform periodic screening. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, or jaundice with marked liver enzyme elevations ≥5×ULN occurs. Preexisting heart failure; closely monitor and discontinue if new or worsening symptoms occur. Monitor for cardiovascular and cerebrovascular reactions during and after infusion; discontinue if serious. Neurologic disorders (eg, CNS demyelinating, seizures, multiple sclerosis, optic neuritis, others); discontinue if occurs. Update vaccinations accordingly with current guidelines prior to initiation. Elderly: monitor closely for serious infections. Neonatal/infants. Pregnancy. Nursing mothers.

AVSOLA Classification:

Tumor necrosis factor (TNF) blocker.

AVSOLA Interactions:

Concurrent anakinra, abatacept, tocilizumab, live vaccines, therapeutic infectious agents (eg, live attenuated bacteria), other TNF blockers or biological therapeutics: not recommended. Concomitant azathioprine or 6-mercaptopurine; possible higher risk of HSTCL. Concomitant immunosuppressants (eg, corticosteroids, methotrexate) may increase risk of infection. May be potentiated by methotrexate. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline): monitor and may need to adjust dose of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.

Adverse Reactions:

Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, GI upset, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, lupus-like syndrome, blood dyscrasias, hepatotoxicity.

Drug Elimination:

Half-life: ~7.7–9.5 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (20mL)—1

Psoriasis:

Indications for: AVSOLA

Severe chronic plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Clinical Trials:

Plaque Psoriasis

The 3 randomized, double-blind, placebo-controlled studies (EXPRESS, EXPRESS II, SPIRIT) evaluated the efficacy and safety of infliximab in patients 18 years of age and older with chronic, stable Ps involving ≥10% BSA, a minimum PASI score of 12, and who were candidates for systemic therapy or phototherapy. Patients were not allowed to use concomitant anti-psoriatic therapies during the study, with the exception of low-potency topical corticosteroids on the face and groin after Week 10 of study initiation. The primary endpoint was the proportion of patients who achieved a reduction in score of at least 75% from baseline at Week 10 by the PASI (PASI 75).

Study I - EXPRESS 

  • The study included 378 patients who were randomly assigned to receive either placebo or infliximab 5mg/g at Weeks 0, 2, and 6 (induction therapy), followed by maintenance therapy every 8 weeks. At Week 24, the placebo group crossed over to infliximab induction therapy, followed by maintenance therapy every 8 weeks.

  • At Week 10, 80% (n=242) of patients treated with infliximab 5mg/kg achieved PASI 75 vs 3% (n=2) of patients treated with placebo (P <.001).

  • At Week 10, 80% (n=242) of patients treated with infliximab 5mg/kg achieved sPGA vs 4% (n=3) of patients treated with placebo (P <.001).

Study II - EXPRESS II

  • The study included 835 patients who were randomly assigned to receive either placebo or infliximab 3mg/kg or 5mg/kg at Weeks 0, 2, and 6 (induction therapy). At Week 14, patients in each infliximab dose group were randomly assigned to receive either infliximab every 8 weeks or as needed maintenance treatment through Week 46.

  • At Week 10, 70% (n=220) and 75% (n=237) of patients treated with infliximab 3mg/kg and 5mg/kg, respectively, achieved PASI 75 vs 2% (n=4) of patients treated with placebo (P <.001 for both).

  • At Week 10, 69% (n=217) and 75% (n=234) of patients treated with infliximab 3mg/kg and 5mg/kg, respectively, achieved rPGA vs 1% (n=2) of patients treated with placebo (P <.001 for both).

  • The every 8-week maintenance group had a greater percentage of patients maintaining PASI 75 through week 50 vs the as-needed or PRN group. The best response was maintained with the 5mg/kg every 8-week dose.

Study III - SPIRIT

  • The study included 249 patients who had previously received either psoralen plus ultraviolet A treatment (PUVA) or other systemic therapy for their psoriasis. Patients were randomly assigned to receive either placebo or infliximab 3mg/kg or 5mg/kg at Weeks 0, 2, and 6. At Week 26, patients with a sPGA score of moderate or worse (score ≥3) received an additional dose of the randomized treatment.

  • At Week 10, 72% (n=71) and 88% (n=87) of patients treated with infliximab 3mg/kg and 5mg/kg, respectively, achieved PASI 75 vs 6% (n=3) of patients treated with placebo (P <.001 for both).

  • At Week 10, 72% (n=71) and 90% (n=89) of patients treated with infliximab 3mg/kg and 5mg/kg, respectively, achieved sPGA vs 10% (n=5) of patients treated with placebo (P <.001 for both).

Adult Dosage:

Give by IV infusion over at least 2hrs. 5mg/kg at weeks 0, 2, 6, then once every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.

Children Dosage:

Not established.

AVSOLA Contraindications:

Moderate to severe heart failure (doses >5mg/kg). Allergy to murine proteins.

Boxed Warning:

Serious infections. Malignancy.

AVSOLA Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections or hematologic abnormalities. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. History of malignancies; perform periodic screening. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, or jaundice with marked liver enzyme elevations ≥5×ULN occurs. Preexisting heart failure; closely monitor and discontinue if new or worsening symptoms occur. Monitor for cardiovascular and cerebrovascular reactions during and after infusion; discontinue if serious. Neurologic disorders (eg, CNS demyelinating, seizures, multiple sclerosis, optic neuritis, others); discontinue if occurs. Update vaccinations accordingly with current guidelines prior to initiation. Elderly: monitor closely for serious infections. Neonatal/infants. Pregnancy. Nursing mothers.

AVSOLA Classification:

Tumor necrosis factor (TNF) blocker.

AVSOLA Interactions:

Concurrent anakinra, abatacept, tocilizumab, live vaccines, therapeutic infectious agents (eg, live attenuated bacteria), other TNF blockers or biological therapeutics: not recommended. Concomitant azathioprine or 6-mercaptopurine; possible higher risk of HSTCL. Concomitant immunosuppressants (eg, corticosteroids, methotrexate) may increase risk of infection. May be potentiated by methotrexate. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline): monitor and may need to adjust dose of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.

Adverse Reactions:

Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, GI upset, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, lupus-like syndrome, blood dyscrasias, hepatotoxicity.

Drug Elimination:

Half-life: ~7.7–9.5 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (20mL)—1