The European Commission has granted approval of Remicade ( Infliximab ), an anti-tumor necrosis factor alpha ( TNF-alpha ) blocker, for the treatment of moderate to severe plaque psoriasis.
The new indication includes the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including Cyclosporine, Methotrexate or Psoralen plus ultraviolet A light ( PUVA ).
The approval of Remicade for the treatment of psoriasis is primarily based on data from the SPIRIT ( Study of Psoriasis with Infliximab Induction Therapy ) and EXPRESS ( European Infliximab for Psoriasis Efficacy and Safety Study ) trials.
SPIRIT and EXPRESS were large multicenter, randomized, double-blind, placebo-controlled studies that assessed the efficacy of Remicade in patients with plaque psoriasis with a Body Surface Area ( BSA ) of greater than or equal to 10 percent and Psoriasis Area and Severity Index ( PASI ) score greater than or equal to 12. The primary efficacy endpoint in both studies was at least 75 percent improvement in PASI from baseline at week 10.
SPIRIT evaluated the efficacy of Infliximab induction therapy in 249 patients who had previously received PUVA or systemic therapy for psoriasis.
Patients were randomized to receive either placebo ( n=51 ) or 3mg/kg ( n=99 ) or 5 mg/kg ( n=99 ) of Infliximab monotherapy at weeks zero, two and six.
At week 10, 88 percent and 72 percent of patients treated with 5 mg/kg and 3 mg/kg of Infliximab, respectively, achieved PASI 75 versus only 6 percent of patients receiving placebo ( P < 0.001 for both Infliximab groups).
Among those treated with 5 mg/kg of Infliximab, nearly half achieved PASI 75 as early as week 4, and 58 percent experienced PASI 90, a 90 percent improvement from baseline, almost complete skin clearance, by week 10.
EXPRESS evaluated the efficacy of Infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Patients were randomized to receive 5 mg/kg Inflixiamb ( n=301 ) or placebo ( n=77 ) infusions at weeks zero, two and six, followed by maintenance treatment every eight weeks.
At week 10, 80 percent of patients receiving Infliximab therapy achieved a PASI 75 response and 57 percent experienced a PASI 90 response versus 3 percent and 1 percent of patients receiving placebo, respectively ( P < 0.001 ).
Results were maintained at week 24 with 82 percent of Infliximab-treated patients achieving PASI 75, and 58 percent of patients experiencing PASI 90 responses, versus 4 percent and 1 percent of patients receiving placebo, respectively ( P < 0.001 ).
The majority of patients maintained significant improvement in psoriasis through week 50 with continued Infliximab treatment.
In SPIRIT, the percentage of subjects with one or more adverse events ( Aes ) was slightly higher in the Infliximab groups compared with placebo ( 78 percent in the Infliximab groups versus 63 percent in the placebo group ).
Serious adverse reactions occurred in 6 percent of Infliximab-treated patients compared with 0 percent in placebo.
In EXPRESS, through week 24, adverse events occurred at a slightly higher incidence in the Infliximab group ( 82 percent ) compared with the placebo group ( 71 percent ).
The only clinically significant laboratory abnormalities that occurred more frequently in the Infliximab group compared with placebo were elevated liver function tests.
There were more serious adverse reactions, including one fatal infection, in the Infliximab group ( 6 percent ) than in the placebo group ( 3 percent ).
Important safety information
Remicade can develop new or worsening symptoms of heart failure ( such as shortness of breath or swelling of your ankles or feet ).
There are reports of serious infections, including tuberculosis ( TB ), sepsis and pneumonia. Some of these infections have been fatal.
There have been rare cases of serious liver injury in people taking Remicade, some fatal.
Blood disorders have been reported, some fatal. Nervous system disorders have also been reported.
Reports of lymphoma in patients on Remicade or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported.
Source: Centocor, 2005